Cleared Traditional

K880996 - FITC MURINE MONOCLONAL ANTI-HSV BIVALEN...

K880996 is the FDA 510(k) clearance for FITC MURINE MONOCLONAL ANTI-HSV BIVALEN... by Whittaker Bioproducts, Inc.. It is a Class 2 Microbiology device (product code GQN) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K880996 · Whittaker Bioproducts, Inc. · Microbiology device
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May 1988
Decision
66d
Days
Class 2
Risk

K880996 is an FDA 510(k) clearance for the FITC MURINE MONOCLONAL ANTI-HSV BIVALENT IGG. Classified as Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 (product code GQN), Class II - Special Controls.

Submitted by Whittaker Bioproducts, Inc. (Walkersville, US). The FDA issued a Cleared decision on May 13, 1988 after a review of 66 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.

View all Whittaker Bioproducts, Inc. devices

Submission Details

510(k) Number K880996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1988
Decision Date May 13, 1988
Days to Decision 66 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 102d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 16
Devices cleared under the same product code (GQN) and FDA review panel - the closest regulatory comparables to K880996.
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MICROTRAK HSV CULTURE IDENTIFICATION TEST
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