Cleared Traditional

K924006 - BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY (FDA 510(k) Clearance)

Class I Microbiology device.

K924006 · Baxter Healthcare Corp · Microbiology device
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Dec 1992
Decision
141d
Days
Class 1
Risk

K924006 is an FDA 510(k) clearance for the BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY. Classified as Antigens, Cf (including Cf Control), Influenza Virus A, B, C (product code GNX), Class I - General Controls.

Submitted by Baxter Healthcare Corp (Issauah, US). The FDA issued a Cleared decision on December 29, 1992 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3330 - 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.

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Submission Details

510(k) Number K924006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1992
Decision Date December 29, 1992
Days to Decision 141 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
39d slower than avg
Panel avg: 102d · This submission: 141d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GNX Antigens, Cf (including Cf Control), Influenza Virus A, B, C
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3330
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.