# K062025: Aspirinworks Test Kit (11-Dehydro Thromboxane B2), Model 12136

- Pathway: 510(k) (Traditional)
- Applicant: Corgenix, Inc.
- Decided: May 29, 2007 after 315 days
- Product code: OBW (11-Dehydro Thromboxane B2 Kit, Urinary)
- Device class: 2
- Regulation: 21 CFR 864.5700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K830749 (1983). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042423: Verifynow-Aspirin Assay, Accumetrics, Inc. (2004) Summary page 1.

## Indications for use
The AspirinWorks® Test Kit is an enzyme-linked immunoassay (ELISA) to determine levels of 11-Dehydro Thromboxane B 2 (I1 dhTxB 2) in human urine, which aids in the qualitative detection of aspirin effect in apparently healthy individuals post ingestion. For professional use only. The AspirinWorks® Test Kit is intended for use in clinical (hospital and reference) laboratories. The AspirinWorks® Test Kit is an enzyme-linked immunoassay (ELISA) to determine levels of 11-Dehydro Thromboxane B2 (1ldhTxB 2) in human urine, which aids in the qualitative detection of aspirin effect in apparently healthy individuals post ingestion. For professional use only. The AspirinWorks® Test Kit is intended for use in clinical (hospital and reference) laboratories.

Source page: https://510kreport.com/device/K062025
Methodology: https://510kreport.com/methodology