Cleared Special

K033775 - HEMOSIL LIQUID ANTITHROMBIN XL

K033775 is an FDA 510(k) clearance for HEMOSIL LIQUID ANTITHROMBIN XL, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Hematology device with product code JBQ cleared through the Special 510(k) pathway after a 30-day FDA review.

K033775 · Instrumentation Laboratory CO · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
30d
Days
Class 2
Risk

K033775 is an FDA 510(k) clearance for the HEMOSIL LIQUID ANTITHROMBIN XL. 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 January 2, 2004 after a review of 30 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.

FDA 510(k) Submission Details - K033775

510(k) Number K033775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2003
Decision Date January 02, 2004
Days to Decision 30 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
83d faster than avg
Panel avg: 113d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 52
Devices cleared under the same product code (JBQ) and FDA review panel - the closest regulatory comparables to K033775.
HEMOSIL ANTITHROMBIN
K070301 · Instrumentation Laboratory CO · Feb 2007
HEMOSIL LIQUID ANTITHROMBIN
K062431 · Instrumentation Laboratory CO · Sep 2006
BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102
K043007 · Hyphen Biomed · Nov 2005
CHROMOCHECK ANTITHROMBIN 25
K023991 · Precision Biologic · Apr 2003
COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS
K022550 · Instrumentation Laboratory CO · Aug 2002
COAMATIC AT-400
K022195 · Instrumentation Laboratory CO · Aug 2002
K033775 · HEMOSIL LIQUID ANTITHROMBIN XL
Download PDF FDA Summary Instrumentation Labor…