Cleared Traditional

K023991 - CHROMOCHECK ANTITHROMBIN 25

Also marketed or referenced as:
CHROMOCHECK ANTITHROMBIN 50

K023991 is the FDA 510(k) clearance for CHROMOCHECK ANTITHROMBIN 25 by Precision Biologic. It is a Class 2 Hematology device (product code JBQ) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K023991 · Precision Biologic · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
146d
Days
Class 2
Risk

K023991 is an FDA 510(k) clearance for the CHROMOCHECK ANTITHROMBIN 25. Classified as Antithrombin Iii Quantitation (product code JBQ), Class II - Special Controls.

Submitted by Precision Biologic (Dartmouth, N.S., CA). The FDA issued a Cleared decision on April 28, 2003 after a review of 146 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Precision Biologic devices

Submission Details

510(k) Number K023991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2002
Decision Date April 28, 2003
Days to Decision 146 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
33d slower than avg
Panel avg: 113d · This submission: 146d
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 40
Devices cleared under the same product code (JBQ) and FDA review panel - the closest regulatory comparables to K023991.
HEMOSIL ANTITHROMBIN
K070301 · Instrumentation Laboratory CO · Feb 2007
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K062431 · Instrumentation Laboratory CO · Sep 2006
HEMOSIL LIQUID ANTITHROMBIN XL
K033775 · Instrumentation Laboratory CO · Jan 2004
COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS
K022550 · Instrumentation Laboratory CO · Aug 2002
COAMATIC AT-400
K022195 · Instrumentation Laboratory CO · Aug 2002
IL TEST LIQUID ANTITHROMBIN
K994238 · Instrumentation Laboratory CO · Jun 2000