Cleared Traditional

K802590 - DIRECT FLUORESCENT ANTIBODY KIT/HERPES

K802590 is the FDA 510(k) clearance for DIRECT FLUORESCENT ANTIBODY KIT/HERPES by Bartels & Stout, Inc.. It is a Class 2 Microbiology device (product code GQL) cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K802590 · Bartels & Stout, Inc. · Microbiology device
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Feb 1981
Decision
117d
Days
Class 2
Risk

K802590 is an FDA 510(k) clearance for the DIRECT FLUORESCENT ANTIBODY KIT/HERPES. Classified as Antisera, Fluorescent, Herpesvirus Hominis 1,2 (product code GQL), Class II - Special Controls.

Submitted by Bartels & Stout, Inc. (Walker, US). The FDA issued a Cleared decision on February 9, 1981 after a review of 117 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 Bartels & Stout, Inc. devices

Submission Details

510(k) Number K802590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1980
Decision Date February 09, 1981
Days to Decision 117 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 102d · This submission: 117d
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 25
Devices cleared under the same product code (GQL) and FDA review panel - the closest regulatory comparables to K802590.
INDIRECT FLUORO-KIT HSV
K830623 · Clinical Sciences, Inc. · Jul 1983
MICRO TRAK HSV1 & 2 CULTURE CONFIRMATION
K830953 · Syva Co. · Jun 1983
HERPES VIRUS HOMINIS ANTIBODY TEST SYS.
K812085 · Zeus Scientific, Inc. · Sep 1981
FIAX TEST KIT FOR HERPES SIMPLEX VIRUS
K792559 · Intl. Diagnostic Technology · Mar 1980
HERPES I.D. TM TEST
K771445 · Hyland Therapeutic Div., Travenol Laboratories · Dec 1977
HSV TEST
K771063 · Gull Laboratories, Inc. · Jul 1977