Cleared Traditional

K904652 - LYME STAT M TEST KIT

K904652 is the FDA 510(k) clearance for LYME STAT M TEST KIT by Whittaker Bioproducts, Inc.. It is a Class 2 Microbiology device (product code LSR) cleared through the Traditional 510(k) pathway after a 371-day FDA review.

K904652 · Whittaker Bioproducts, Inc. · Microbiology device
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Oct 1991
Decision
371d
Days
Class 2
Risk

K904652 is an FDA 510(k) clearance for the LYME STAT M TEST KIT. Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Whittaker Bioproducts, Inc. (Walkersville, US). The FDA issued a Cleared decision on October 21, 1991 after a review of 371 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3830 - 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. Elevated predicate reliance profile. 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 Whittaker Bioproducts, Inc. devices

Submission Details

510(k) Number K904652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1990
Decision Date October 21, 1991
Days to Decision 371 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
269d slower than avg
Panel avg: 102d · This submission: 371d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LSR Reagent, Borrelia Serological Reagent
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3830
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 - LSR Reagent, Borrelia Serological Reagent

All 55
Devices cleared under the same product code (LSR) and FDA review panel - the closest regulatory comparables to K904652.
APTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBODY ELISA TEST SYSTEM
K984138 · Zeus Scientific, Inc. · Mar 1999
VIDAS LYME SCREEN II
K943812 · Biomerieux Vitek, Inc. · Jun 1995
BARTELS LYME DISEASE IGM EIA
K922578 · Baxter Diagnostics, Inc. · Sep 1992
LYME-SPOT IF KIT
K910230 · Vitek Systems, Inc. · Aug 1991
LYME DISEASE IGM ELISA
K900206 · Hillcrest Biologicals · Jun 1991
LYME IGM ELISA TEST
K903013 · Gull Laboratories, Inc. · Jun 1991