Cleared Traditional

K830865 - HSV IGM TEST

K830865 is an FDA 510(k) clearance for HSV IGM TEST, manufactured by Gull Laboratories, Inc.. The device is a Class 2 Microbiology device with product code GQL cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K830865 · Gull Laboratories, Inc. · Microbiology device
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Jul 1983
Decision
122d
Days
Class 2
Risk

K830865 is an FDA 510(k) clearance for the HSV IGM TEST. Classified as Antisera, Fluorescent, Herpesvirus Hominis 1,2 (product code GQL), Class II - Special Controls.

Submitted by Gull Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 18, 1983 after a review of 122 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 Gull Laboratories, Inc. devices

FDA 510(k) Submission Details - K830865

510(k) Number K830865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1983
Decision Date July 18, 1983
Days to Decision 122 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
20d slower than avg
Panel avg: 102d · This submission: 122d
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 K830865.
MICROTRAK HSV 1 & 2 DIRECT SPECIMAN
K841190 · Syva Co. · Jan 1985
MICROTRAK HSV 1 & 2 CULTURE
K840494 · Syva Co. · May 1984
HERPES IDENT. & TYPING TEST HITT
K831504 · Electro-Nucleonics Laboratories, Inc. · Sep 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