Cleared Traditional

BIOMERIEUX HEMOLAB AT III (K934156) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K934156 · Biomerieux Vitek, Inc. · Microbiology device
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Dec 1994
Decision
482d
Days
Class 2
Risk

K934156 is an FDA 510(k) clearance for the BIOMERIEUX HEMOLAB AT III. Classified as Antithrombin Iii Quantitation (product code JBQ), Class II - Special Controls.

Submitted by Biomerieux Vitek, Inc. (Hazelwood, US). The FDA issued a Cleared decision on December 22, 1994 after a review of 482 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 864.7060 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Biomerieux Vitek, Inc. devices

Submission Details

510(k) Number K934156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1993
Decision Date December 22, 1994
Days to Decision 482 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
380d slower than avg
Panel avg: 102d · This submission: 482d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JBQ Antithrombin Iii Quantitation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7060
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 - JBQ Antithrombin Iii Quantitation

All 55
Devices cleared under the same product code (JBQ) and FDA review panel - the closest regulatory comparables to K934156.
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COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS
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COAMATIC AT-400
K022195 · Instrumentation Laboratory CO · Aug 2002