Cleared Traditional

K904095 - HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING

K904095 is an FDA 510(k) clearance for HERPES SIMPLEX VIRUS TISSUE CULTURE CON..., manufactured by California Integrated Diagnostics, Inc.. The device is a Class 2 Microbiology device with product code GQL cleared through the Traditional 510(k) pathway after a 148-day FDA review.

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

FDA 510(k) Submission Details - K904095

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.

GQL Device Classification - Class 2, Special Controls

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 26
Devices cleared under the same product code (GQL) and FDA review panel - the closest regulatory comparables to K904095.
LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT
K081527 · Millipore Corporation · Apr 2009
THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH
K984120 · Zeus Scientific, Inc. · May 1999
THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
K984135 · Zeus Scientific, Inc. · May 1999
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