Cleared Special

K062431 - HEMOSIL LIQUID ANTITHROMBIN

K062431 is the FDA 510(k) clearance for HEMOSIL LIQUID ANTITHROMBIN by Instrumentation Laboratory CO. It is a Class 2 Hematology device (product code JBQ) cleared through the Special 510(k) pathway after a 11-day FDA review.

K062431 · Instrumentation Laboratory CO · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
11d
Days
Class 2
Risk

K062431 is an FDA 510(k) clearance for the HEMOSIL LIQUID ANTITHROMBIN. Classified as Antithrombin Iii Quantitation (product code JBQ), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on September 1, 2006 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7060 - the FDA hematology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Instrumentation Laboratory CO devices

Submission Details

510(k) Number K062431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2006
Decision Date September 01, 2006
Days to Decision 11 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 113d · This submission: 11d
Pathway characteristics
Modification to existing cleared device.

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 31
Devices cleared under the same product code (JBQ) and FDA review panel - the closest regulatory comparables to K062431.
INNOVANCE Antithrombin
K242952 · Siemens Healthcare Diagnostic Products GmbH · Mar 2025
INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5
K081769 · Siemens Healthcare Diagnostics · May 2009
HEMOSIL ANTITHROMBIN
K070301 · Instrumentation Laboratory CO · Feb 2007
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