Cleared Traditional

BARTELS RUBEOLA IGM EIA (K922335) - FDA 510(k) Clearance

Class I Microbiology device.

K922335 · Baxter Diagnostics, Inc. · Microbiology device
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Sep 1992
Decision
112d
Days
Class 1
Risk

K922335 is an FDA 510(k) clearance for the BARTELS RUBEOLA IGM EIA. Classified as Enzyme Linked Immunoabsorbent Assay, Rubeola Igg (product code LJB), Class I - General Controls.

Submitted by Baxter Diagnostics, Inc. (Bellevue, US). The FDA issued a Cleared decision on September 2, 1992 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3520 - 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 K922335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1992
Decision Date September 02, 1992
Days to Decision 112 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 102d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJB Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3520
Definition The Qualitative Detection Of Measles Specific Igg Antibodies In Serum Or Plasma.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.