Cleared Traditional

K953683 - MMUNO DOT BORRELIA DOT BLOT M TEST

K953683 is an FDA 510(k) clearance for MMUNO DOT BORRELIA DOT BLOT M TEST, manufactured by Genbio. The device is a Class 2 Microbiology device with product code LSR cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K953683 · Genbio · Microbiology device
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May 1996
Decision
270d
Days
Class 2
Risk

K953683 is an FDA 510(k) clearance for the MMUNO DOT BORRELIA DOT BLOT M TEST. Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Genbio (San Diego, US). The FDA issued a Cleared decision on May 3, 1996 after a review of 270 days - an extended review 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: 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 Genbio devices

FDA 510(k) Submission Details - K953683

510(k) Number K953683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1995
Decision Date May 03, 1996
Days to Decision 270 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
168d slower than avg
Panel avg: 102d · This submission: 270d
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 84
Devices cleared under the same product code (LSR) and FDA review panel - the closest regulatory comparables to K953683.
ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL
K974810 · Boston Biomedica, Inc. · Feb 1998
BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM
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BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
K965131 · Wampole Laboratories · Mar 1997
VIDAS LYME SCREEN II
K943812 · Biomerieux Vitek, Inc. · Jun 1995
BARTELS LYME DISEASE IGM EIA
K922578 · Baxter Diagnostics, Inc. · Sep 1992
IMMUNODOT BORRELIA (LYME) TEST
K911627 · General Biometrics, Inc. · Apr 1992