Cleared Traditional

K830953 - MICRO TRAK HSV1 & 2 CULTURE CONFIRMATION

K830953 is the FDA 510(k) clearance for MICRO TRAK HSV1 & 2 CULTURE CONFIRMATION by Syva Co.. It is a Class 2 Microbiology device (product code GQL) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K830953 · Syva Co. · Microbiology device
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Jun 1983
Decision
89d
Days
Class 2
Risk

K830953 is an FDA 510(k) clearance for the MICRO TRAK HSV1 & 2 CULTURE CONFIRMATION. Classified as Antisera, Fluorescent, Herpesvirus Hominis 1,2 (product code GQL), Class II - Special Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on June 22, 1983 after a review of 89 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

Submission Details

510(k) Number K830953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1983
Decision Date June 22, 1983
Days to Decision 89 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
13d faster than avg
Panel avg: 102d · This submission: 89d
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 22
Devices cleared under the same product code (GQL) and FDA review panel - the closest regulatory comparables to K830953.
MICROTRAK HSV 1 & 2 CULTURE
K840494 · Syva Co. · May 1984
HERPES IDENT. & TYPING TEST HITT
K831504 · Electro-Nucleonics Laboratories, Inc. · Sep 1983
HSV IGM TEST
K830865 · Gull Laboratories, Inc. · Jul 1983
HERPES VIRUS HOMINIS ANTIBODY TEST SYS.
K812085 · Zeus Scientific, Inc. · Sep 1981
HERPES I.D. TM TEST
K771445 · Hyland Therapeutic Div., Travenol Laboratories · Dec 1977
HSV TEST
K771063 · Gull Laboratories, Inc. · Jul 1977