Cleared Traditional

K870814 - HERPES SIMPLEX ANTIBODY TEST FOR DECT. ...

K870814 is an FDA 510(k) clearance for HERPES SIMPLEX ANTIBODY TEST FOR DECT. ..., manufactured by Microscan Div. Baxter Healthcare Corp.. The device is a Class 2 Microbiology device with product code GQL cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K870814 · Microscan Div. Baxter Healthcare Corp. · Microbiology device
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Jun 1987
Decision
93d
Days
Class 2
Risk

K870814 is an FDA 510(k) clearance for the HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2. Classified as Antisera, Fluorescent, Herpesvirus Hominis 1,2 (product code GQL), Class II - Special Controls.

Submitted by Microscan Div. Baxter Healthcare Corp. (West Sacramento, US). The FDA issued a Cleared decision on June 4, 1987 after a review of 93 days - within the typical 510(k) review window.

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 Microscan Div. Baxter Healthcare Corp. devices

FDA 510(k) Submission Details - K870814

510(k) Number K870814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1987
Decision Date June 04, 1987
Days to Decision 93 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 102d · This submission: 93d
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 25
Devices cleared under the same product code (GQL) and FDA review panel - the closest regulatory comparables to K870814.
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