Cleared Traditional

K830971 - HERPES SIMPLEX VIRUS TYPING REAGENTS

K830971 is an FDA 510(k) clearance for HERPES SIMPLEX VIRUS TYPING REAGENTS, manufactured by Immulok, Inc.. The device is a Class 2 Microbiology device with product code GQL cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K830971 · Immulok, Inc. · Microbiology device
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Jun 1983
Decision
94d
Days
Class 2
Risk

K830971 is an FDA 510(k) clearance for the HERPES SIMPLEX VIRUS TYPING REAGENTS. Classified as Antisera, Fluorescent, Herpesvirus Hominis 1,2 (product code GQL), Class II - Special Controls.

Submitted by Immulok, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 30, 1983 after a review of 94 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 Immulok, Inc. devices

FDA 510(k) Submission Details - K830971

510(k) Number K830971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1983
Decision Date June 30, 1983
Days to Decision 94 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 102d · This submission: 94d
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 K830971.
HERPES IDENT. & TYPING TEST HITT
K831504 · Electro-Nucleonics Laboratories, Inc. · Sep 1983
HSV IGM TEST
K830865 · Gull Laboratories, Inc. · Jul 1983
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