Cleared Traditional

K880436 - MICROTRAK HSV CULTURE IDENTIFICATION TEST

K880436 is an FDA 510(k) clearance for MICROTRAK HSV CULTURE IDENTIFICATION TEST, manufactured by Syva Co.. The device is a Class 2 Microbiology device with product code GQN cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K880436 · Syva Co. · Microbiology device
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Feb 1988
Decision
16d
Days
Class 2
Risk

K880436 is an FDA 510(k) clearance for the MICROTRAK HSV CULTURE IDENTIFICATION TEST. Classified as Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 (product code GQN), Class II - Special Controls.

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on February 18, 1988 after a review of 16 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 Syva Co. devices

FDA 510(k) Submission Details - K880436

510(k) Number K880436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1988
Decision Date February 18, 1988
Days to Decision 16 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
86d faster than avg
Panel avg: 102d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GQN Device Classification - Class 2, Special Controls

Product Code GQN Antigen, Cf (including Cf Control), 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 - GQN Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2

All 22
Devices cleared under the same product code (GQN) and FDA review panel - the closest regulatory comparables to K880436.
FITC MURINE MONOCLONAL ANTI-HSV BIVALENT IGG
K880996 · Whittaker Bioproducts, Inc. · May 1988
FITC MURINE MONOCLONAL ANTI-HERPES TYPE 1 IGG
K881180 · Whittaker Bioproducts, Inc. · May 1988
DU PONT HERPCHEK HSV ANTIGEN ELISA TEST KIT
K872632 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1988
IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST
K870602 · Boots-Celltech Diagnostics, Inc. · May 1987
ORTHO HSV ANTIGEN ELISA TEST
K854488 · Ortho Diagnostic Systems, Inc. · Feb 1986
IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF
K842830 · Bartels Immunodiagnostic Supplies, Inc. · Nov 1985