Cleared Traditional

K851372 - CELLMATICS HERPES SIMPLEX VIRUS DETECT-SYS

K851372 is the FDA 510(k) clearance for CELLMATICS HERPES SIMPLEX VIRUS DETECT-SYS by Difco Laboratories, Inc.. It is a Class 2 Microbiology device (product code GQL) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K851372 · Difco Laboratories, Inc. · Microbiology device
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Jul 1985
Decision
95d
Days
Class 2
Risk

K851372 is an FDA 510(k) clearance for the CELLMATICS HERPES SIMPLEX VIRUS DETECT-SYS. Classified as Antisera, Fluorescent, Herpesvirus Hominis 1,2 (product code GQL), Class II - Special Controls.

Submitted by Difco Laboratories, Inc. (Detroit, US). The FDA issued a Cleared decision on July 12, 1985 after a review of 95 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 Difco Laboratories, Inc. devices

Submission Details

510(k) Number K851372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1985
Decision Date July 12, 1985
Days to Decision 95 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
7d faster than avg
Panel avg: 102d · This submission: 95d
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 K851372.
ORTHO HSV 1&2 DICHROMATIC TYPING REAGENT & SLIDES
K891382 · Ortho Diagnostic Systems, Inc. · Jun 1989
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
GIBCO HERPES ID KIT
K841943 · Gibco Laboratories Life Technologies, Inc. · Mar 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