Cleared Traditional

K900206 - LYME DISEASE IGM ELISA

K900206 is the FDA 510(k) clearance for LYME DISEASE IGM ELISA by Hillcrest Biologicals. It is a Class 2 Microbiology device (product code LSR) cleared through the Traditional 510(k) pathway after a 528-day FDA review.

K900206 · Hillcrest Biologicals · Microbiology device
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Jun 1991
Decision
528d
Days
Class 2
Risk

K900206 is an FDA 510(k) clearance for the LYME DISEASE IGM ELISA. Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Hillcrest Biologicals (Cypress, US). The FDA issued a Cleared decision on June 28, 1991 after a review of 528 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Hillcrest Biologicals devices

Submission Details

510(k) Number K900206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1990
Decision Date June 28, 1991
Days to Decision 528 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
426d slower than avg
Panel avg: 102d · This submission: 528d
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 51
Devices cleared under the same product code (LSR) and FDA review panel - the closest regulatory comparables to K900206.
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 IGM ELISA TEST
K903013 · Gull Laboratories, Inc. · Jun 1991
LYME DISEASE MICROASSAY
K910899 · Diamedix Corp. · Jun 1991
LYME IGM MICROASSAY
K911330 · Diamedix Corp. · Jun 1991