Cleared Traditional

K922578 - BARTELS LYME DISEASE IGM EIA

K922578 is an FDA 510(k) clearance for BARTELS LYME DISEASE IGM EIA, manufactured by Baxter Diagnostics, Inc.. The device is a Class 2 Microbiology device with product code LSR cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K922578 · Baxter Diagnostics, Inc. · Microbiology device
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Sep 1992
Decision
98d
Days
Class 2
Risk

K922578 is an FDA 510(k) clearance for the BARTELS LYME DISEASE IGM EIA. Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Baxter Diagnostics, Inc. (Bellevue, US). The FDA issued a Cleared decision on September 2, 1992 after a review of 98 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 Baxter Diagnostics, Inc. devices

FDA 510(k) Submission Details - K922578

510(k) Number K922578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1992
Decision Date September 02, 1992
Days to Decision 98 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
4d faster than avg
Panel avg: 102d · This submission: 98d
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 97
Devices cleared under the same product code (LSR) and FDA review panel - the closest regulatory comparables to K922578.
IMMUNO DOT BORRELIA DOT BLOT G TEST
K953682 · Genbio · May 1996
MMUNO DOT BORRELIA DOT BLOT M TEST
K953683 · Genbio · May 1996
VIDAS LYME SCREEN II
K943812 · Biomerieux Vitek, Inc. · Jun 1995
IMMUNODOT BORRELIA (LYME) TEST
K911627 · General Biometrics, Inc. · Apr 1992
IMMUNOWELL LYME (P39 RECOMBINANT) TEST
K911599 · General Biometrics, Inc. · Dec 1991
IMMUNOWELL BORRELIA (LYME)TEST
K911590 · General Biometrics, Inc. · Dec 1991