Cleared Traditional

COATEST(R) ANTITHROMBIN III, MODIFICATION (K931420) - FDA 510(k) Clearance

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

K931420 · Kabi Pharmacia Hepar, Inc. · Hematology device
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May 1994
Decision
419d
Days
Class 2
Risk

K931420 is an FDA 510(k) clearance for the COATEST(R) ANTITHROMBIN III, MODIFICATION. Classified as Antithrombin Iii Quantitation (product code JBQ), Class II - Special Controls.

Submitted by Kabi Pharmacia Hepar, Inc. (Franklin, US). The FDA issued a Cleared decision on May 2, 1994 after a review of 419 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7060 - 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 Kabi Pharmacia Hepar, Inc. devices

Submission Details

510(k) Number K931420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1993
Decision Date May 02, 1994
Days to Decision 419 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
306d slower than avg
Panel avg: 113d · This submission: 419d
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 Hematology devices follow this clearance model.

Regulatory Peers - JBQ Antithrombin Iii Quantitation

All 55
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