Cleared Traditional

K023991 - CHROMOCHECK ANTITHROMBIN 25

Also marketed or referenced as:
CHROMOCHECK ANTITHROMBIN 50

K023991 is an FDA 510(k) clearance for CHROMOCHECK ANTITHROMBIN 25, manufactured by Precision Biologic. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K023991

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.

JBQ Device Classification - Class 2, Special Controls

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 48
Devices cleared under the same product code (JBQ) and FDA review panel - the closest regulatory comparables to K023991.
HEMOSIL LIQUID ANTITHROMBIN
K062431 · Instrumentation Laboratory CO · Sep 2006
BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102
K043007 · Hyphen Biomed · Nov 2005
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