Cleared Traditional

K854488 - ORTHO HSV ANTIGEN ELISA TEST

K854488 is an FDA 510(k) clearance for ORTHO HSV ANTIGEN ELISA TEST, manufactured by Ortho Diagnostic Systems, Inc.. The device is a Class 2 Microbiology device with product code GQN cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K854488 · Ortho Diagnostic Systems, Inc. · Microbiology device
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Feb 1986
Decision
88d
Days
Class 2
Risk

K854488 is an FDA 510(k) clearance for the ORTHO HSV ANTIGEN ELISA TEST. Classified as Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 (product code GQN), Class II - Special Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Carpinteria, US). The FDA issued a Cleared decision on February 4, 1986 after a review of 88 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 - K854488

510(k) Number K854488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1985
Decision Date February 04, 1986
Days to Decision 88 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
14d faster than avg
Panel avg: 102d · This submission: 88d
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 K854488.
COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA.
K870733 · Enzo Biochem, Inc. · May 1987
IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST
K870602 · Boots-Celltech Diagnostics, Inc. · May 1987
HSV IDR
K854974 · Genus Diagnostics · Mar 1986
DIRECT ELISA FOR HERPES SIMPLEX VIRUS
K853307 · Fairleigh Dickinson Laboratories, Inc. · Dec 1985
IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF
K842830 · Bartels Immunodiagnostic Supplies, Inc. · Nov 1985
H. SIMPLEX VIRUS
K843658 · Institute Virion , Ltd. · Sep 1985
K854488 · ORTHO HSV ANTIGEN ELISA TEST
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