Cleared Traditional

K922580 - BARTELS CYTOMEGALOVIRUS IGM EIA

K922580 is an FDA 510(k) clearance for BARTELS CYTOMEGALOVIRUS IGM EIA, manufactured by Baxter Diagnostics, Inc.. The device is a Class 2 Microbiology device with product code LKQ cleared through the Traditional 510(k) pathway after a 316-day FDA review.

K922580 · Baxter Diagnostics, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1993
Decision
316d
Days
Class 2
Risk

K922580 is an FDA 510(k) clearance for the BARTELS CYTOMEGALOVIRUS IGM EIA. Classified as Antibody Igm,if, Cytomegalovirus Virus (product code LKQ), Class II - Special Controls.

Submitted by Baxter Diagnostics, Inc. (Bellevue, US). The FDA issued a Cleared decision on April 8, 1993 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3175 - 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. Elevated predicate reliance profile. 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 - K922580

510(k) Number K922580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1992
Decision Date April 08, 1993
Days to Decision 316 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
214d slower than avg
Panel avg: 102d · This submission: 316d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKQ Device Classification - Class 2, Special Controls

Product Code LKQ Antibody Igm,if, Cytomegalovirus Virus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3175
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 - LKQ Antibody Igm,if, Cytomegalovirus Virus

All 15
Devices cleared under the same product code (LKQ) and FDA review panel - the closest regulatory comparables to K922580.
IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,
K100433 · Siemens Healthcare Diagnostics · May 2010
ACCURUN 146 CMV IGM POSITIVE CONTROL
K972884 · Boston Biomedica, Inc. · Aug 1997
VIDAS CMV IGM ASSAY
K933549 · Biomerieux Vitek, Inc. · Aug 1994
ELISA CMV IGM
K914789 · Sclavo, Inc. · Mar 1992
CMV-IGM IFA TEST SYSTEM
K900743 · Zeus Scientific, Inc. · Apr 1990
CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST)
K893465 · Immuno Concepts, Inc. · Jul 1989