Cleared Traditional

K854712 - VISIBLE-HERPES TM TEST SYSTEM

K854712 is an FDA 510(k) clearance for VISIBLE-HERPES TM TEST SYSTEM, manufactured by Isolab, Inc.. The device is a Class 2 Microbiology device with product code GQO cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K854712 · Isolab, Inc. · Microbiology device
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May 1986
Decision
179d
Days
Class 2
Risk

K854712 is an FDA 510(k) clearance for the VISIBLE-HERPES TM TEST SYSTEM. Classified as Antisera, Cf, Herpesvirus Hominis 1,2 (product code GQO), Class II - Special Controls.

Submitted by Isolab, Inc. (Akron, US). The FDA issued a Cleared decision on May 20, 1986 after a review of 179 days - an extended review cycle.

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 Isolab, Inc. devices

FDA 510(k) Submission Details - K854712

510(k) Number K854712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1985
Decision Date May 20, 1986
Days to Decision 179 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
77d slower than avg
Panel avg: 102d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GQO Device Classification - Class 2, Special Controls

Product Code GQO Antisera, Cf, 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 - GQO Antisera, Cf, Herpesvirus Hominis 1,2

All 9
Devices cleared under the same product code (GQO) and FDA review panel - the closest regulatory comparables to K854712.
THE DDI SERODOT HERPES IGG TEST KIT
K875366 · Disease Detection International, Inc. · May 1988
VIROGEN HSV ANTIBODY TEST
K871426 · Armkel, LLC · Oct 1987
HSV2 - IGG ELISA-KIT
K852781 · Clinical Sciences, Inc. · Jan 1986
HSVI - IGG ELISA-KIT
K852782 · Clinical Sciences, Inc. · Jan 1986
AMIZYME-HSV TYPES 1 & 2 TEST KITS
K842531 · Amico Lab, Inc. · Dec 1985
ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2
K842663 · Amico Lab, Inc. · Dec 1985