Cleared Traditional

K922581 - BARTELS RUBELLA IGM EIA

K922581 is the FDA 510(k) clearance for BARTELS RUBELLA IGM EIA by Baxter Diagnostics, Inc.. It is a Class 2 Microbiology device (product code LFX) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K922581 · Baxter Diagnostics, Inc. · Microbiology device
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Sep 1992
Decision
113d
Days
Class 2
Risk

K922581 is an FDA 510(k) clearance for the BARTELS RUBELLA IGM EIA. Classified as Enzyme Linked Immunoabsorbent Assay, Rubella (product code LFX), Class II - Special Controls.

Submitted by Baxter Diagnostics, Inc. (Bellevue, US). The FDA issued a Cleared decision on September 17, 1992 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3510 - 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 K922581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1992
Decision Date September 17, 1992
Days to Decision 113 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
11d slower than avg
Panel avg: 102d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3510
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 - LFX Enzyme Linked Immunoabsorbent Assay, Rubella

All 62
Devices cleared under the same product code (LFX) and FDA review panel - the closest regulatory comparables to K922581.
ACCESS RUBELLA IGG
K954687 · Bio-Rad Laboratories, Inc. · Apr 1996
RUBELLA IGG ELISA TEST
K941624 · Gull Laboratories, Inc. · Aug 1995
IMX RUBELLA IGM ANTIBODY ASSAY
K931059 · Abbott Laboratories · Dec 1994
BARTELS RUBELLA IGG EIA
K922586 · Baxter Diagnostics, Inc. · Sep 1992
RUBELLA IGM ELISA TEST SYSTEM
K914028 · Zeus Scientific, Inc. · Apr 1992
RUBELLA IGG ELISA TEST
K915893 · Gull Laboratories, Inc. · Mar 1992