Cleared Traditional

K991185 - BORRELIA BURGDORFERI IGM WESTERN BLOT T...

K991185 is an FDA 510(k) clearance for BORRELIA BURGDORFERI IGM WESTERN BLOT T..., manufactured by Zeus Scientific, Inc.. The device is a Class 2 Microbiology device with product code LSR cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K991185 · Zeus Scientific, Inc. · Microbiology device
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Sep 1999
Decision
148d
Days
Class 2
Risk

K991185 is an FDA 510(k) clearance for the BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEM. Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on September 3, 1999 after a review of 148 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Zeus Scientific, Inc. devices

FDA 510(k) Submission Details - K991185

510(k) Number K991185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1999
Decision Date September 03, 1999
Days to Decision 148 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 102d · This submission: 148d
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 59
Devices cleared under the same product code (LSR) and FDA review panel - the closest regulatory comparables to K991185.
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