Cleared Traditional

PATHODX HERPES TYPING (K904167) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K904167 · Diagnostic Products Corp. · Microbiology device
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Dec 1990
Decision
93d
Days
Class 2
Risk

K904167 is an FDA 510(k) clearance for the PATHODX HERPES TYPING. Classified as Antisera, Fluorescent, Herpesvirus Hominis 1,2 (product code GQL), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on December 13, 1990 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3305 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Products Corp. devices

Submission Details

510(k) Number K904167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1990
Decision Date December 13, 1990
Days to Decision 93 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 102d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GQL Antisera, Fluorescent, Herpesvirus Hominis 1,2
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3305
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - GQL Antisera, Fluorescent, Herpesvirus Hominis 1,2

All 36
Devices cleared under the same product code (GQL) and FDA review panel - the closest regulatory comparables to K904167.
BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2
K902661 · Baxter Healthcare Corp · Jul 1990
BARTELS HERPES SIMPLEX VIR FLU MONO ANTIBODY TEST
K902662 · Baxter Healthcare Corp · Jul 1990
AMENDMENT TO LABELING MICROTRAK HSV 1/HSV 2 DIRECT
K850739 · Syva Co. · Mar 1985
MICROTRAK HSV 1 & 2 DIRECT SPECIMAN
K841190 · Syva Co. · Jan 1985
MICROTRAK HSV 1 & 2 CULTURE
K840494 · Syva Co. · May 1984
MICRO TRAK HSV1 & 2 CULTURE CONFIRMATION
K830953 · Syva Co. · Jun 1983