Cleared Traditional

K890281 - HUMAN LYME EIA FOR THE DETECT OF ANTIBO...

K890281 is the FDA 510(k) clearance for HUMAN LYME EIA FOR THE DETECT OF ANTIBO... by Cambridge Bioscience Corp.. It is a Class 2 Microbiology device (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

Submission Details

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.

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 55
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