Cleared Traditional

K922578 - BARTELS LYME DISEASE IGM EIA

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

K922578 · Baxter Diagnostics, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 50
Devices cleared under the same product code (LSR) and FDA review panel - the closest regulatory comparables to K922578.
QUANTA LITE LYME IGM ELISA
K984234 · Inova Diagnostics, Inc. · Apr 1999
APTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBODY ELISA TEST SYSTEM
K984138 · Zeus Scientific, Inc. · Mar 1999
VIDAS LYME SCREEN II
K943812 · Biomerieux Vitek, Inc. · Jun 1995
LYME-SPOT IF KIT
K910230 · Vitek Systems, Inc. · Aug 1991
LYME IGM ELISA TEST
K903013 · Gull Laboratories, Inc. · Jun 1991
LYME DISEASE MICROASSAY
K910899 · Diamedix Corp. · Jun 1991