Cleared Traditional

K841943 - GIBCO HERPES ID KIT

K841943 is the FDA 510(k) clearance for GIBCO HERPES ID KIT by Gibco Laboratories Life Technologies, Inc.. It is a Class 2 Microbiology device (product code GQL) cleared through the Traditional 510(k) pathway after a 306-day FDA review.

K841943 · Gibco Laboratories Life Technologies, Inc. · Microbiology device
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Mar 1985
Decision
306d
Days
Class 2
Risk

K841943 is an FDA 510(k) clearance for the GIBCO HERPES ID KIT. Classified as Antisera, Fluorescent, Herpesvirus Hominis 1,2 (product code GQL), Class II - Special Controls.

Submitted by Gibco Laboratories Life Technologies, Inc. (Grandisland, US). The FDA issued a Cleared decision on March 13, 1985 after a review of 306 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Gibco Laboratories Life Technologies, Inc. devices

Submission Details

510(k) Number K841943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1984
Decision Date March 13, 1985
Days to Decision 306 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
204d slower than avg
Panel avg: 102d · This submission: 306d
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 K841943.
ORTHO DNA PROBE HSV CONFIRMATION TEST
K852360 · Ortho Diagnostic Systems, Inc. · Sep 1985
PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP
K852125 · Kallestad Laboratories, Inc. · Jul 1985
CELLMATICS HERPES SIMPLEX VIRUS DETECT-SYS
K851372 · Difco Laboratories, Inc. · Jul 1985
AMENDMENT TO LABELING MICROTRAK HSV 1/HSV 2 DIRECT
K850739 · Syva Co. · Mar 1985
CULTURESET HSV ISOLATION & ID SYS
K842216 · Ortho Diagnostic Systems, Inc. · Jan 1985
MICROTRAK HSV 1 & 2 DIRECT SPECIMAN
K841190 · Syva Co. · Jan 1985