FDA record research

System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species (NIJ) — FDA decisions, comparisons and evidence

The 2021–2025 analysis contains 1 selected substantially-equivalent FDA decisions under primary product code NIJ. 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 2024-11-21. Neither set establishes a suitable predicate or the route for your device. The complete-year window has 1 decisions; the separate all-observed-date count is 6. 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?

The in vitro device is intended to detect the presence of the vanA and vanB genes in isolated colonies of Enterococcus spp. as a marker for vancomycin resistance using DNA probe technology

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?

§ 866.1640 Antimicrobial susceptibility test powder. (a) Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases. (b) Classification. Class II (performance standards).

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 NIJ

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.

1Selected decisions in these five years

WithheldMedian receipt-to-decision calendar days

1Valid date pairs in the distribution

There are 1 valid recent date pairs. Distribution summaries require at least 20; older records are not substituted for a current benchmark.

20210

20220

20230

20241

20250

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.

6 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 0 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
K243405 ↗Xpert vanA	Cepheid®	2024-11-21	Special	20
K123753 ↗IMDX VANR FOR ABBOTT M2000	Intelligent Medical Devices, Inc.	2013-07-17	Traditional	223
K102416 ↗BD GENEOHM VANR ASSAY	Bd Diagnostics Science	2011-10-20	Traditional	422
K092953 ↗Xpert VanA Assay	Cepheid	2009-12-17	Traditional	84
K061686 ↗IDI-VANR ASSAY	Geneohm Sciences Canada, Inc.	2006-08-30	Traditional	76
K020576 ↗VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE	Id Biomedical Corp.	2002-05-01	Traditional	69

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.

K243405 · official summary PDF ↗

No reviewed topic index available; open the original document.

K123753 · official summary PDF ↗

Term mention: Clinical performance · PDF page 6 Term occurrence only; read the original passage, including limitations and negation.

K102416 · official summary PDF ↗

Term mention: Clinical performance · PDF page 2 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	NIJ [1]
Generic device category	System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species [1]
Recorded scope	The in vitro device is intended to detect the presence of the vanA and vanB genes in isolated colonies of Enterococcus spp. as a marker for vancomycin resistance using DNA probe technology [1]
Recorded class	2 [1]
Regulation	866.1640 [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 NIJ 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.