# K971519: Asserachrom Tpa Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: American Bioproducts Co.
- Decided: Aug 19, 1997 after 116 days
- Product code: GGP (Test, Qualitative And Quantitative Factor Deficiency)
- Device class: 2
- Regulation: 21 CFR 864.7290
- 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 K934314 (1994). 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)
- K934314: Tintelizer (R) Tpa, Biopool AB (1994) Summary page 1.

## Indications for use
The ASSERACHROM® tPA test kit is intended for the quantitative determination of tissue-type plasminogen activator (tPA) antigen in citrated plasma by the sandwich technique of enzyme immunoassay (EIA) known as enzyme-linked immunosorbent assay (ELISA). The quantitative determination of tPA is generally performed during the assessment of the fibrinolytic system of a patient, for instance, following a thrombotic episode. In addition, it has been reported that a high antigenic level of tPA is associated with a greater risk of myocardial infarction or vascular cerebral accident. Finally, quantitative tPA assays are useful in the detection of hypofibrinolytic and hyperfibrinolytic states.

Source page: https://510kreport.com/device/K971519
Methodology: https://510kreport.com/methodology