Cleared Traditional

K841943 - GIBCO HERPES ID KIT

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

K841943 · Gibco Laboratories Life Technologies, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K841943

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.

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 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