Cleared Traditional

K043007 - BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102

Also marketed or referenced as:
BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105

K043007 is an FDA 510(k) clearance for BIOPHEN ANTITHROMBIN 2.5, manufactured by Hyphen Biomed. The device is a Class 2 Hematology device with product code JBQ cleared through the Traditional 510(k) pathway after a 371-day FDA review.

K043007 · Hyphen Biomed · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
371d
Days
Class 2
Risk

K043007 is an FDA 510(k) clearance for the BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102. Classified as Antithrombin Iii Quantitation (product code JBQ), Class II - Special Controls.

Submitted by Hyphen Biomed (Mason, US). The FDA issued a Cleared decision on November 7, 2005 after a review of 371 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Hyphen Biomed devices

FDA 510(k) Submission Details - K043007

510(k) Number K043007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2004
Decision Date November 07, 2005
Days to Decision 371 days
Submission Type Traditional
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
258d slower than avg
Panel avg: 113d · This submission: 371d
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 47
Devices cleared under the same product code (JBQ) and FDA review panel - the closest regulatory comparables to K043007.
INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5
K081769 · Siemens Healthcare Diagnostics · May 2009
HEMOSIL ANTITHROMBIN
K070301 · Instrumentation Laboratory CO · Feb 2007
HEMOSIL LIQUID ANTITHROMBIN
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