510(k) Report

510(k) · Cleared

Cleared

Microtrak HSV 1/HSV 2 Culture Identi./Typing Test

K880157510(k) TraditionalCleared Feb 4, 198822-day reviewClass II21 CFR 866.3510

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Syva Co. · GON Antigen, Cf (Including Cf Control), Rubella

Cleared on Feb 4, 1988 after a 22-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Feb 4, 1988
Review
22 days
Class
Class II
Product code
GON
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2007: 2 descendants cleared1990200020102020
  1. This deviceK880157 Microtrak HSV 1/HSV 2 Culture Identi./Typing TestSyva Co. · 1988
  2. Descendant · cites it directly · 0 of its ownK070265 Diagnostic Hybrids' D3 Dfa Herpes Simplex Virus Identification and…Diagnostic Hybrids, Inc. · 2007
  3. Descendant · cites it directly · 0 of its ownK063798 Diagnostic Hybrids' D3 Dfa Herpes Simplex Virus Identification Kit…Diagnostic Hybrids, Inc. · 2007

Most influential descendants

Showing 2 of 2 · See all
  • K070265Diagnostic Hybrids' D3 Dfa Herpes Simplex Virus Identification and Typing Kit, Model…Diagnostic Hybrids, Inc. · 2007 · cites it directly0descendants
  • K063798Diagnostic Hybrids' D3 Dfa Herpes Simplex Virus Identification Kit, Model 01-080000Diagnostic Hybrids, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K880157Microtrak HSV 1/HSV 2 Culture Identi./Typing TestSyva Co.1988—
+1K070265Diagnostic Hybrids' D3 Dfa Herpes Simplex Virus Identification and Typing Kit…Diagnostic Hybrids, Inc.2007—
+1K063798Diagnostic Hybrids' D3 Dfa Herpes Simplex Virus Identification Kit, Model…Diagnostic Hybrids, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200720
FIG. 1 — Lineage of K880157, 1988–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GON? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K070265Diagnostic Hybrids' D3 Dfa Herpes Simplex Virus Identification and Typing Kit, Model…Diagnostic Hybrids, Inc.20070
K063798Diagnostic Hybrids' D3 Dfa Herpes Simplex Virus Identification Kit, Model 01-080000Diagnostic Hybrids, Inc.20070

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K070265 (Diagnostic Hybrids, Inc., 2007) has gone furthest, with 0 descendants of its own.

How does its category compare?

All GON devices

GON Antigen, Cf (Including Cf Control), Rubella: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GON

FDA has decided no GON device since 2007.

Median 510(k) review, days · GON

Too few GON 510(k)s in any year since 2007 to give a median.

Recalls per year · GON

No recall names GON since 2007.

Adverse event reports per year · GON

No MAUDE report names GON since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Syva Co.

448 FDA decisions under this applicant name. See the company

  • K011878Emit (R) Tox Salicylic Assay, Model 7SO19UL, Emit (R) Tox Salicylic Acid Calibrators, Model 7S109ULSyva Co. · 2001
  • K012257Emit II Plus Monoclonal Amphetamine/Methamphetamine Assay Model OSR9C229Syva Co. · 2001
  • K011947Emit 2000 Valproic Acid Assay, Model OSR4G229ULSyva Co. · 2001
  • K011528Emit 2000 Phenobarbital Assay, Model OSR4D229Syva Co. · 20013 recalls
  • K011347Emit 2000 Phenytoin Assay, Model 0SR4A229Syva Co. · 2001

Recent decisions in GON

The GON category page

  • K894262Rubella Antigen and Control AntigenMicrobix Biosystems, Inc. · 1989
  • K802937Rubella Virus Antigens & ControlsOrion Diagnostica, Inc. · 1980
  • K802939Herpes Simplex Type IOrion Diagnostica, Inc. · 1980
  • K780996Rubelisa Test KitMicrobiological Assoc. · 1978

https://510kreport.com/device/K880157 · printed Nov 6, 2026

Cite this page

510(k) Report. “K880157: Microtrak HSV 1/HSV 2 Culture Identi./Typing Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K880157

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026