Cleared Traditional

K922582 - BARTELS CYTOMEGALOVIRUS IGG EIA

K922582 is the FDA 510(k) clearance for BARTELS CYTOMEGALOVIRUS IGG EIA by Baxter Diagnostics, Inc.. It is a Class 2 Microbiology device (product code LFZ) cleared through the Traditional 510(k) pathway after a 316-day FDA review.

K922582 · Baxter Diagnostics, Inc. · Microbiology device
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Apr 1993
Decision
316d
Days
Class 2
Risk

K922582 is an FDA 510(k) clearance for the BARTELS CYTOMEGALOVIRUS IGG EIA. Classified as Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (product code LFZ), 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

Submission Details

510(k) Number K922582 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.

Device Classification

Product Code LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
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 - LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

All 42
Devices cleared under the same product code (LFZ) and FDA review panel - the closest regulatory comparables to K922582.
INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY
K955361 · Incstar Corp. · Jul 1996
IMMULITE CMV IGG
K950672 · Diagnostic Products Corp. · Jun 1996
OPUS CMV-G
K933389 · Pb Diagnostic Systems, Inc. · Jun 1994
CMV ELISA TEST SYSTEM
K924096 · Zeus Scientific, Inc. · Apr 1993
VIDAS CMV IGG ASSAY
K920661 · Vitek Systems, Inc. · Feb 1993
ENZYGNOST(R) ANTI-CMV IGG
K913910 · Behring Diagnostics, Inc. · Apr 1992