Cleared Traditional

K851635 - DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST

K851635 is an FDA 510(k) clearance for DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST, manufactured by Diagnon Corp.. The device is a Class 2 Microbiology device with product code GQL cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K851635 · Diagnon Corp. · Microbiology device
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Oct 1985
Decision
175d
Days
Class 2
Risk

K851635 is an FDA 510(k) clearance for the DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST. Classified as Antisera, Fluorescent, Herpesvirus Hominis 1,2 (product code GQL), Class II - Special Controls.

Submitted by Diagnon Corp. (Laurel, US). The FDA issued a Cleared decision on October 10, 1985 after a review of 175 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 Diagnon Corp. devices

FDA 510(k) Submission Details - K851635

510(k) Number K851635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1985
Decision Date October 10, 1985
Days to Decision 175 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 102d · This submission: 175d
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 26
Devices cleared under the same product code (GQL) and FDA review panel - the closest regulatory comparables to K851635.
HSV-1 ELISA TEST SYSTEM
K891162 · Zeus Scientific, Inc. · Jun 1989
HSV-2 ELISA TEST SYSTEM
K891782 · Zeus Scientific, Inc. · Jun 1989
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
CELLMATICS HERPES SIMPLEX VIRUS DETECT-SYS
K851372 · Difco Laboratories, Inc. · Jul 1985