Cleared Traditional

K903013 - LYME IGM ELISA TEST

K903013 is an FDA 510(k) clearance for LYME IGM ELISA TEST, manufactured by Gull Laboratories, Inc.. The device is a Class 2 Microbiology device with product code LSR cleared through the Traditional 510(k) pathway after a 345-day FDA review.

K903013 · Gull Laboratories, Inc. · Microbiology device
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Jun 1991
Decision
345d
Days
Class 2
Risk

K903013 is an FDA 510(k) clearance for the LYME IGM ELISA TEST. Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on June 21, 1991 after a review of 345 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 Gull Laboratories, Inc. devices

FDA 510(k) Submission Details - K903013

510(k) Number K903013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1990
Decision Date June 21, 1991
Days to Decision 345 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
243d slower than avg
Panel avg: 102d · This submission: 345d
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 K903013.
FIAX LYME M TEST KIT
K904893 · 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 DISEASE MICROASSAY
K910899 · Diamedix Corp. · Jun 1991
LYME IGM MICROASSAY
K911330 · Diamedix Corp. · Jun 1991
BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST
K911145 · Medical Diagnostic Technologies, Inc. · May 1991