Cleared Traditional

K870602 - IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST

K870602 is an FDA 510(k) clearance for IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPIN..., manufactured by Boots-Celltech Diagnostics, Inc.. The device is a Class 2 Microbiology device with product code GQN cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K870602 · Boots-Celltech Diagnostics, Inc. · Microbiology device
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May 1987
Decision
86d
Days
Class 2
Risk

K870602 is an FDA 510(k) clearance for the IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST. Classified as Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 (product code GQN), Class II - Special Controls.

Submitted by Boots-Celltech Diagnostics, Inc. (Berkshire, England, GB). The FDA issued a Cleared decision on May 8, 1987 after a review of 86 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K870602

510(k) Number K870602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1987
Decision Date May 08, 1987
Days to Decision 86 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
16d faster than avg
Panel avg: 102d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GQN Device Classification - Class 2, Special Controls

Product Code GQN Antigen, Cf (including Cf Control), 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 - GQN Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2

All 33
Devices cleared under the same product code (GQN) and FDA review panel - the closest regulatory comparables to K870602.
MICROTRAK HSV CULTURE IDENTIFICATION TEST
K880436 · Syva Co. · Feb 1988
RAMP HERPES SIMPLEX VIRUS (HSV) (CCT)
K874863 · Monoclonal Antibodies, Inc. · Feb 1988
COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA.
K870733 · Enzo Biochem, Inc. · May 1987
HSV IDR
K854974 · Genus Diagnostics · Mar 1986
ORTHO HSV ANTIGEN ELISA TEST
K854488 · Ortho Diagnostic Systems, Inc. · Feb 1986
DIRECT ELISA FOR HERPES SIMPLEX VIRUS
K853307 · Fairleigh Dickinson Laboratories, Inc. · Dec 1985
K870602 · IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST
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