FDA record research

Herpes Simplex Virus Nucleic Acid Amplification Assay (OQO) — FDA decisions, comparisons and evidence

The acquired FDA endpoint has no selected substantially-equivalent K-number decisions under primary product code OQO during 2021–2025. Its latest selected record across the endpoint is dated 2018-02-01. Use that dated record only as historical context. Check the recorded scope and current route separately; these data do not provide a recent timing benchmark. The complete-year window has 0 decisions; the separate all-observed-date count is 12. 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 polymerase chain reaction (pcr)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (hsv) dna using vaginal swab specimens.

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?

§ 866.3305 Herpes simplex virus serological assays. (a) Identification. Herpes simplex virus serological assays are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum. Additionally, some of the assays consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by herpes simplex viruses and provides epidemiological information on these diseases. Herpes simplex viral infections range from common and mild lesions of the skin and mucous membranes to a severe form of encephalitis (inflammation of the brain). Neonatal herpes virus infections range from a mild infection to a severe generalized disease with a fatal outcome. (b) Classification. Class II (special controls). The device is classified as class II (special controls). The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e). [72 FR 15830, Apr. 3, 2007, as amended at 74 FR 42775, Aug. 25, 2009; 76 FR 48717, Aug. 9, 2011]

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 OQO

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.

0Selected decisions in these five years

WithheldMedian receipt-to-decision calendar days

0Valid date pairs in the distribution

There are 0 valid recent date pairs. Distribution summaries require at least 20; older records are not substituted for a current benchmark.

20210

20220

20230

20240

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.

12 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
K172509 ↗Sentosa SA201 HSV 1/2 Qualitative PCR Test	Vela Diagnostics USA, Inc.	2018-02-01	Traditional	164
K162673 ↗Aptima Herpes Simplex Viruses 1 & 2 Assay	Hologic, Inc.	2017-06-15	Traditional	262
K150962 ↗Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack	Focus Diagnostics	2015-08-28	Traditional	140
K150617 ↗cobas HSV 1 and 2 Test	Roche Molecular Systems, Inc.	2015-06-01	Traditional	83
K142156 ↗SEEGENE ANYPLEX II HSV-1/2 ASSAY	Seegene	2015-02-13	Traditional	191
K142738 ↗artus HSV-1/2 QS-RGQ MDx Kit	Qiagen	2014-12-19	Traditional	87
K140198 ↗IMDX HSV-1/2 FOR ABBOTT M2000	Intelligent Medical Devices, Inc.	2014-05-13	Traditional	106
K140029 ↗AMIPLIVUE HSV 1&2 ASSAY	Quidel Corporation	2014-03-26	Traditional	79

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.

K172509 · official summary PDF ↗

Term mention: Clinical performance · PDF page 15 Term occurrence only; read the original passage, including limitations and negation.

K162673 · official summary PDF ↗

Term mention: Clinical performance · PDF page 19 Term occurrence only; read the original passage, including limitations and negation.

K150962 · official summary PDF ↗

No reviewed topic index available; open the original document.

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	OQO [1]
Generic device category	Herpes Simplex Virus Nucleic Acid Amplification Assay [1]
Recorded scope	A polymerase chain reaction (pcr)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (hsv) dna using vaginal swab specimens. [1]
Recorded class	2 [1]
Regulation	866.3305 [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.
Separate historical research from a recent comparator
No selected decision falls in the complete-year window. Any named records shown are separately dated historical or current-year research. Obtain their actual indications and assess the current route before using a comparator; the absence of a recent record does not establish an exemption or a route.
Useful evidence: Proposed indication/design, the dated named record if available, and a current route/comparator research rationale.
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 OQO 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.