Cleared Traditional

HEMOLAB (K931992) - FDA 510(k) Clearance

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

K931992 · Biomerieux Vitek, Inc. · Hematology device
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Dec 1994
Decision
608d
Days
Class 2
Risk

K931992 is an FDA 510(k) clearance for the HEMOLAB. Classified as Instrument, Coagulation, Automated (product code GKP), 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 608 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5400 - the FDA hematology 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 Hematology submissions.

View all Biomerieux Vitek, Inc. devices

Submission Details

510(k) Number K931992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1993
Decision Date December 22, 1994
Days to Decision 608 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
495d slower than avg
Panel avg: 113d · This submission: 608d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKP Instrument, Coagulation, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5400
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 Hematology devices follow this clearance model.

Regulatory Peers - GKP Instrument, Coagulation, Automated

All 48
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