Cleared Traditional

K880476 - LYME DISEASE ELISA

K880476 is the FDA 510(k) clearance for LYME DISEASE ELISA by Hillcrest Biologicals. It is a Class 2 Microbiology device (product code LSR) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K880476 · Hillcrest Biologicals · Microbiology device
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Apr 1988
Decision
82d
Days
Class 2
Risk

K880476 is an FDA 510(k) clearance for the LYME DISEASE 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 April 26, 1988 after a review of 82 days - a notably fast clearance cycle.

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: 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 Hillcrest Biologicals devices

Submission Details

510(k) Number K880476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1988
Decision Date April 26, 1988
Days to Decision 82 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 102d · This submission: 82d
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 K880476.
BORRELIA BURGDORFERI IGM ANTIBODY TEST SYSTEM
K885294 · Medical Diagnostic Technologies, Inc. · Apr 1989
LYME ELISA TEST SYSTEM
K885317 · Zeus Scientific, Inc. · Mar 1989
LYME FAST TEST
K883544 · 3M Company · Jan 1989
IFA TEST FOR ANTIBODIES TO BORRELIA BURGDORFERI
K871246 · Zeus Scientific, Inc. · Aug 1987