Cleared Traditional

K851635 - DIAGNON HERPES IMMUNOPEROXIDASE TYPING ...

K851635 is the FDA 510(k) clearance for DIAGNON HERPES IMMUNOPEROXIDASE TYPING ... by Diagnon Corp.. It is a Class 2 Microbiology device (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

Submission Details

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.

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 23
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