510(k) Report

510(k) · Cleared

Cleared

Pathodx Herpes Typing

K904167510(k) TraditionalCleared Dec 13, 199093-day reviewClass II21 CFR 866.3305

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

Diagnostic Products Corp. · GQL Antisera, Fluorescent, Herpesvirus Hominis 1,2

Cleared on Dec 13, 1990 after a 93-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
Dec 13, 1990
Review
93 days
Class
Class II
Product code
GQL
Recalls
None
Predicates
0

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

Descendants, by year cleared 2007: 2 descendants cleared1990200020102020
  1. This deviceK904167 Pathodx Herpes TypingDiagnostic Products Corp. · 1990
  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)K904167Pathodx Herpes TypingDiagnostic Products Corp.1990—
+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 K904167, 1990–2007Source: 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 GQL? 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 GQL devices

GQL Antisera, Fluorescent, Herpesvirus Hominis 1,2: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GQL

2in 2009

2009: 2
2007high 2 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GQL

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

Recalls per year · GQL

No recall names GQL since 2007.

Adverse event reports per year · GQL

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2025

MAUDE reports naming product code GQL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20092—01
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 Diagnostic Products Corp.

321 FDA decisions under this applicant name. See the company

  • K063045Immulite 2000, Immulite 2500 VancomycinDiagnostic Products Corp. · 2006
  • K034055Immulite 2500 CK-MB, 2500 Myoglobin, 2500 Stat Troponin IDiagnostic Products Corp. · 20041 recall
  • K033234Immulite 2500 Automated Immunoassay AnalyzerDiagnostic Products Corp. · 20033 recalls
  • K032881Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total TestosteroneDiagnostic Products Corp. · 20032 recalls
  • K023152Immulite 2000 Allergen-Specific IgeDiagnostic Products Corp. · 2002

Recent decisions in GQL

The GQL category page

  • K091753Elvis HSV ID and D3 Typing Test SystemDiagnostic Hybrids, Inc. · 2009
  • K081527Light Diagnostics HSV 1/2 Typing Dfa KitMillipore Corporation · 2009
  • K984120The Aptus (Automated) Application of the HSV-2 Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay…Zeus Scientific, Inc. · 1999
  • K984135The Aptus (Automated) Application of the HSV-1 Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay…Zeus Scientific, Inc. · 1999
  • K905608Indirect Fluorescent Assay for Herpes Simplex 1Stellar Bio Systems, Inc. · 1991

https://510kreport.com/device/K904167 · printed Nov 6, 2026

Cite this page

510(k) Report. “K904167: Pathodx Herpes Typing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K904167

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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