FDA record research

Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers (PRE) — FDA decisions, comparisons and evidence

The 2021–2025 analysis contains 3 selected substantially-equivalent FDA decisions under primary product code PRE. Use it to compare documented submissions and evidence with your product. A separate 2026 update contains 0 decisions through 2026-09-27. The latest selected decision across the acquired endpoint is dated 2025-01-10. Neither set establishes a suitable predicate or the route for your device. The complete-year window has 3 decisions; the separate all-observed-date count is 4. These denominators describe different date ranges.

Evidence retrieved 2026-10-07. Source versions and topic-specific limits are listed below.

Recorded scope and its declared regulatory reference

An exact FDA-record regulation_number match to one acquired Title 21 section. Records with the same normalized scope definition, class, regulation and recorded submission/GMP flags are grouped. Sparse definitions and generic exemption boilerplate do not qualify. No text-similarity equivalence or legal applicability is inferred.

What scope does the FDA record describe?

A quantitative gene expression assay using reverse transcription polymerase chain reaction to quantify the relative expression levels of host response genes isolated from whole blood.

Compare the proposed indication, user, anatomy, technology and operating principle with this actual scope; record differences and unresolved facts.

Cited source

Which current section does the record cite?

§ 866.3215 Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis. (a) Identification. A device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis is identified as an in vitro device intended for the detection and qualitative and/or quantitative measurement of one or more non-microbial analytes in human clinical specimens to aid in the assessment of patients with suspected sepsis when used in conjunction with clinical signs and symptoms and other clinical and laboratory findings. (b) Classification. Class II (special controls). The special controls for this device are: (1) Premarket notification submissions must include the device's detailed Indications for Use statement describing what the device detects and measures, the results provided to the user, whether the measure is qualitative and/or quantitative, the clinical indications for which the test is to be used, and the specific population(s) for which the device use is intended. (2) Premarket notification submissions must include detailed documentation of the device description, including (as applicable), all device components, software, ancillary reagents required but not provided, explanation of the device principle and methodology, and for molecular devices include detailed documentation of the primer/probe sequence, design, and rationale for sequence selection. (3) Premarket notification submissions must include detailed documentation of applicable analytical studies, such as, analytical sensitivity (Limit of Detection, Limit of Blank, and Limit of Quantitation), precision, reproducibility, analytical measuring range, interference, cross-reactivity, and specimen stability. (4) Premarket notification submissions must include detailed documentation of a prospective clinical study or, if appropriate, results from an equivalent sample set. This detailed documentation must include the following information: (i) Results must demonstrate adequate device performance relative to a well-accepted comparator. (ii) Clinical sample results must demonstrate consistency of device output throughout the device measuring range likely to be encountered in the Intended Use population. (iii) Clinical study documentation must include the original study protocol (including predefined statistical analysis plan), study report documenting support for the Indications for Use(s), and results of all statistical analyses. (5) Premarket notification submissions must include evaluation of the level of the non-microbial analyte in asymptomatic patients with demographic characteristics ( e.g., age, racial, ethnic, and gender distribution) similar to the Intended Use population. (6) As part of the risk management activities performed under 21 CFR 820.10(c) design and development, you must document an appropriate end user device training program that will be offered as part of your efforts to mitigate the risk of failure to correctly operate the instrument. (7) A detailed explanation of the interpretation of results and acceptance criteria must be included in the device's 21 CFR 809.10(b)(9) compliant labeling, and a detailed explanation of the interpretation of the limitations of the samples ( e.g., collected on day of diagnosis) must be included in the device's 21 CFR 809.10(b)(10) compliant labeling. [82 FR 49099, Oct. 24, 2017, as amended at 90 FR 55982, Dec. 4, 2025]

Read the identification, classification, conditions and referenced limitations in the cited section. A numeric reference match is not a buyer classification or exemption determination.

Cited source

Historical FDA comparison

2021–2025: five complete calendar years

Primary code PRE

All statistics in this section use decisions dated 2021-01-01 to 2025-12-31. The partial 2026 update below is excluded from these distributions.

3Selected decisions in these five years

WithheldMedian receipt-to-decision calendar days

3Valid date pairs in the distribution

There are 3 valid recent date pairs. Distribution summaries require at least 20; older records are not substituted for a current benchmark.

20211

20220

20231

20240

20251

Statistical source: FDA openFDA 510(k) decision dataset. Partition 1 Download the identified records and dates (CSV).

Filters, exclusions and reproducible calculation

Deduplicate by official submission ID across the complete current manifest partitions. Select exact primary product code, K-number format and the stated SE decision codes with valid dates. Recent distributions use the five complete calendar years preceding the latest valid endpoint decision year. Partial-year counts compare equal January-to-cutoff periods. Quartiles use linear interpolation at (n-1)*p and are withheld below 20 valid date pairs. The analysis n describes only its declared complete-year window; selected_se_n separately counts all selected recorded dates through the cutoff.

4 selected records across all observed dates; 0 other/invalid identifier or decision-date records excluded. 0 missing or invalid date pairs in the five-year window.

Date fields: date_received → decision_date. Quantiles: Hyndman–Fan type 7: linear interpolation at (n − 1) × p; displayed to one decimal; n ≥ 20 valid pairs.

Receipt-to-decision calendar elapsed time includes time outside active FDA review; it is not FDA review time, a promised project timeline or an estimate of future clearance. This selected recorded cohort does not include all applications or establish a success probability, predicate suitability, market size, current market availability or legal authorization for another product.

Calculation fda-buyer-research-3 · database cutoff 2026-09-27. CSV rows identify each official K-number, cohort, date pair, exclusion reason and source version.

Separate partial-year update

2026 decisions through 2026-09-27

0 selected decisions from 2026-01-01 to 2026-09-27. The equivalent previous-year period contains 1 decisions through 2025-09-27. These counts describe the records; they are not market growth or submission success rates.

Named records to investigate

Latest decisions across the database

These dated records may come from 2026 or earlier years. They are a separate investigation list, not the five-year statistical cohort. Compare the actual indications and technology before considering a record as a comparator.

Official record / device	Recorded applicant	Decision	Recorded type	Calendar days
K241676 ↗TriVerity	Inflammatix, Inc.	2025-01-10	Traditional	213
K232095 ↗SeptiCyte RAPID	Immunexpress, Inc.	2023-12-15	Traditional	155
K203748 ↗SeptiCyte RAPID	Immunexpress, Inc.	2021-11-29	Traditional	341
K163260 ↗SeptiCyte LAB	Immunexpress, Inc.	2017-02-17	Traditional	88

Supporting documents actually acquired

Go beyond the database row

Read the source context, then compare the evidence with your design. Topic locations below are text matches, including possible limitations or negative statements; they are not a mandatory test list.

K241676 · official summary PDF ↗

Term mention: Performance testing · PDF page 10 Term occurrence only; read the original passage, including limitations and negation.
Term mention: Clinical performance · PDF page 31 Term occurrence only; read the original passage, including limitations and negation.

K203748 · official summary PDF ↗

Term mention: Clinical performance · PDF page 14 Term occurrence only; read the original passage, including limitations and negation.

K163260 · official summary PDF ↗

Term mention: Software verification · PDF page 8 Term occurrence only; read the original passage, including limitations and negation.
Term mention: Clinical performance · PDF page 8 Term occurrence only; read the original passage, including limitations and negation.

The documents are a bounded sample of acquired summaries, not complete evidence coverage of the cohort.

Recorded classification context

Known context: US. Match the intended use and design with the recorded category before treating it as applicable.

Source fact	Recorded value
FDA product code	PRE [1]
Generic device category	Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers [1]
Recorded scope	A quantitative gene expression assay using reverse transcription polymerase chain reaction to quantify the relative expression levels of host response genes isolated from whole blood. [1]
Recorded class	2 [1]
Regulation	866.3215 [1]
Medical specialty	Microbiology [1]

Build a comparison that explains the differences

Use this checklist to gather your business or product details before speaking with a specialist. The items below explain what to record and suggest useful supporting documents. You can add your own answers in the editable project brief.

Which specific part of the recorded scope fits or differs?
Put your proposed label and design beside the quoted definition. Record matching facts, differences and missing facts separately; naming the category alone cannot resolve scope.
Useful evidence: Proposed indication/design and a definition-to-product comparison with source locators.
Have the cited section and its limitations been reviewed?
Record the applicable paragraph, conditions and cross-referenced limitations after specialist review. Keep a claimed exemption separate from actual establishment, listing and quality-system responsibilities.
Useful evidence: Dated classification/route rationale and the current provisions relied on, with unresolved conditions.
Compare your intended use with a named decision
Choose a named record above. Put your proposed claim beside its actual indications-for-use statement. Record different patients, users, anatomy, settings and output claims; do not treat a shared code as proof of equivalence.
Useful evidence: Your draft indications for use + the selected official summary and its exact page.
Explain the technology and evidence differences
For each comparison, record the different materials, hardware, software functions and operating conditions. Link each difference to existing evidence or an unresolved evaluation task.
Useful evidence: A three-column matrix: comparator fact / your design fact / evidence or unresolved gap.
Prepare a scope-based schedule without a sparse timing benchmark
This recent cohort has fewer than 20 valid date pairs, so it supplies no median or percentile benchmark. Ask for a schedule based on actual preparation, evidence gaps, interactions and response assumptions; keep any historical decision context separately dated.
Useful evidence: Document/test readiness, unresolved route/evidence tasks and the assumptions behind the specialist’s proposed sequence.

Work packages and dependencies

Conditional: FDA 510(k) Submission Services — Review the supplied facts and evidence gaps before confirming the service scope.
Optional: Find FDA US Agent Services | Compare & Get Quotes — Include only if your product, actor and delivery needs justify this additional scope. Confirm the responsibility and evidence handoff with the coordinating specialist.
Optional: FDA QMSR Transition & Inspection Readiness (ISO 13485 Alignment) — Include only if your product, actor and delivery needs justify this additional scope. Confirm the responsibility and evidence handoff with the coordinating specialist.

What needs to happen first

FDA 510(k) Submission Services → Find FDA US Agent Services | Compare & Get Quotes: Confirm the main product/actor scope and evidence gaps before deciding whether to commission this additional service.
FDA 510(k) Submission Services → FDA QMSR Transition & Inspection Readiness (ISO 13485 Alignment): Confirm the main product/actor scope and evidence gaps before deciding whether to commission this additional service.

Questions for providers

Which of the named PRE decisions are actually comparable to our proposed indications and technology, and which would you exclude?
Which evidence differences prevent us from using the comparison yet, and what deliverable resolves each one?
Does your schedule separate submission preparation, testing, FDA interactions and customer response time? What assumptions change it?

Sources and data dates

Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.