Cleared Traditional

K890281 - HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES

K890281 is an FDA 510(k) clearance for HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES, manufactured by Cambridge Bioscience Corp.. The device is a Class 2 Microbiology device with product code LSR cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K890281 · Cambridge Bioscience Corp. · Microbiology device
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Mar 1989
Decision
57d
Days
Class 2
Risk

K890281 is an FDA 510(k) clearance for the HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES. Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Cambridge Bioscience Corp. (Worcester, US). The FDA issued a Cleared decision on March 15, 1989 after a review of 57 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 Cambridge Bioscience Corp. devices

FDA 510(k) Submission Details - K890281

510(k) Number K890281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1989
Decision Date March 15, 1989
Days to Decision 57 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 102d · This submission: 57d
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 99
Devices cleared under the same product code (LSR) and FDA review panel - the closest regulatory comparables to K890281.
BORRELIA BURGDORFERI IGG ANTIBODY TEST SYSTEM
K885293 · Medical Diagnostic Technologies, Inc. · Apr 1989
BORRELIA BURGDORFERI IGM ANTIBODY TEST SYSTEM
K885294 · Medical Diagnostic Technologies, Inc. · Apr 1989
LYME DISEASE IFA (IGM)
K883767 · Hillcrest Biologicals · Mar 1989
LYME ELISA TEST SYSTEM
K885317 · Zeus Scientific, Inc. · Mar 1989
LYME FAST TEST
K883544 · 3M Company · Jan 1989
LYME DISEASE IFA (IGG)
K883487 · Hillcrest Biologicals · Dec 1988