# K013305: Enoxaparin Test Card

- Pathway: 510(k) (Traditional)
- Applicant: Cardiovascular Diagnostics, Inc.
- Decided: Aug 23, 2002 after 323 days
- Product code: KFF (Assay, Heparin)
- Device class: 2
- Regulation: 21 CFR 864.7525
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K925433 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925433: The Stachrom Heparin Assay Kit, American Bioproducts Co. (1995) Summary page 2.

## Indications for use
The RapidpointTMCoagEnoxaparin Test card (ENOX) is a qualitative test intended for exclusive use with the Rapidpoint Coag analyzer to detect the anticoagulant effects, 2 1.O IU/ml, of the low molecular weight heparin (LMWH), LovenoxWClexaneB (enoxaparin sodium)’, in arterial citrated whole blood from patients with unstable angina (UA)/non-ST segment elevation myocardial infarction (NSTEMI) who may transition to percutaneous intervention (PCI). The ENOX test is intended for use at either the point of care or in the central laboratory. The device does not discriminate between values of enoxaparin below 1.O IU/ml and the absence of drug. The test provides information on the patient’s citrated arterial whole blood response to enoxaparin by measurement of the clotting time using a factor Xa activated clotting method and should be interpreted in conjunction with other clinical data available to the clinician.

Source page: https://510kreport.com/device/K013305
Methodology: https://510kreport.com/methodology