Cleared Traditional

K902662 - BARTELS HERPES SIMPLEX VIR FLU MONO ANTIBODY TEST

K902662 is an FDA 510(k) clearance for BARTELS HERPES SIMPLEX VIR FLU MONO ANT..., manufactured by Baxter Healthcare Corp. The device is a Class 2 Microbiology device with product code GQL cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K902662 · Baxter Healthcare Corp · Microbiology device
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Jul 1990
Decision
43d
Days
Class 2
Risk

K902662 is an FDA 510(k) clearance for the BARTELS HERPES SIMPLEX VIR FLU MONO ANTIBODY TEST. Classified as Antisera, Fluorescent, Herpesvirus Hominis 1,2 (product code GQL), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Bellevue, US). The FDA issued a Cleared decision on July 31, 1990 after a review of 43 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K902662

510(k) Number K902662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1990
Decision Date July 31, 1990
Days to Decision 43 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
59d faster than avg
Panel avg: 102d · This submission: 43d
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 24
Devices cleared under the same product code (GQL) and FDA review panel - the closest regulatory comparables to K902662.
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
HSV-1 ELISA TEST SYSTEM
K891162 · Zeus Scientific, Inc. · Jun 1989
HSV-2 ELISA TEST SYSTEM
K891782 · Zeus Scientific, Inc. · Jun 1989
ORTHO HSV 1&2 DICHROMATIC TYPING REAGENT & SLIDES
K891382 · Ortho Diagnostic Systems, Inc. · Jun 1989