Cleared Traditional

K983605 - IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM

K983605 is an FDA 510(k) clearance for IS BORRELIA BURGDORFERI IGG/IGM ELISA T..., manufactured by Columbia Bioscience, Inc.. The device is a Class 2 Microbiology device with product code LSR cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K983605 · Columbia Bioscience, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
63d
Days
Class 2
Risk

K983605 is an FDA 510(k) clearance for the IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM. Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Columbia Bioscience, Inc. (Columbia, US). The FDA issued a Cleared decision on December 16, 1998 after a review of 63 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 Columbia Bioscience, Inc. devices

FDA 510(k) Submission Details - K983605

510(k) Number K983605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1998
Decision Date December 16, 1998
Days to Decision 63 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 102d · This submission: 63d
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 83
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