Cleared Traditional

ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136 (K062025) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K062025 · Corgenix, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
315d
Days
Class 2
Risk

K062025 is an FDA 510(k) clearance for the ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136. Classified as 11-dehydro Thromboxane B2 Kit, Urinary (product code OBW), Class II - Special Controls.

Submitted by Corgenix, Inc. (Broomfield, US). The FDA issued a Cleared decision on May 29, 2007 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5700 - 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 Corgenix, Inc. devices

Submission Details

510(k) Number K062025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2006
Decision Date May 29, 2007
Days to Decision 315 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
202d slower than avg
Panel avg: 113d · This submission: 315d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OBW 11-dehydro Thromboxane B2 Kit, Urinary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5700
Definition The Test Kit Is An Enzyme-linked Immunoassay (elisa) To Determine Levels Of 11-dehydro Thromboxane B2 (11dhtxb2) In Human Urine, Which Aids In The Qualitative Detection Of Aspirin Effect In Apparently Healthy Individuals Post Ingestion. For Professional Use Only.
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.