Cleared Traditional

K904893 - FIAX LYME M TEST KIT

K904893 is an FDA 510(k) clearance for FIAX LYME M TEST KIT, manufactured by Whittaker Bioproducts, Inc.. The device is a Class 2 Microbiology device with product code LSR cleared through the Traditional 510(k) pathway after a 351-day FDA review.

K904893 · Whittaker Bioproducts, Inc. · Microbiology device
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Oct 1991
Decision
351d
Days
Class 2
Risk

K904893 is an FDA 510(k) clearance for the FIAX LYME 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 16, 1991 after a review of 351 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

FDA 510(k) Submission Details - K904893

510(k) Number K904893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1990
Decision Date October 16, 1991
Days to Decision 351 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
249d slower than avg
Panel avg: 102d · This submission: 351d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LSR Device Classification - Class 2, Special Controls

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 97
Devices cleared under the same product code (LSR) and FDA review panel - the closest regulatory comparables to K904893.
IMMUNOWELL BORRELIA (LYME)TEST
K911590 · General Biometrics, Inc. · Dec 1991
LYME-CHECK(TM) TEST KIT
K896378 · Diagnostic Technology, Inc. · Nov 1991
LYME STAT M TEST KIT
K904652 · Whittaker Bioproducts, Inc. · Oct 1991
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