Cleared Traditional

HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING (K904095) - FDA 510(k) Clearance

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

K904095 · California Integrated Diagnostics, Inc. · Microbiology device
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Feb 1991
Decision
148d
Days
Class 2
Risk

K904095 is an FDA 510(k) clearance for the HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING. Classified as Antisera, Fluorescent, Herpesvirus Hominis 1,2 (product code GQL), Class II - Special Controls.

Submitted by California Integrated Diagnostics, Inc. (Benica, US). The FDA issued a Cleared decision on February 1, 1991 after a review of 148 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 California Integrated Diagnostics, Inc. devices

Submission Details

510(k) Number K904095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1990
Decision Date February 01, 1991
Days to Decision 148 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 102d · This submission: 148d
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 K904095.
PATHODX HERPES TYPING
K904167 · Diagnostic Products Corp. · Dec 1990
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