# K013492: Imubind Tpa Elisa, Model 860

- Pathway: 510(k) (Traditional)
- Applicant: American Diagnostica, Inc.
- Decided: Mar 13, 2002 after 142 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
IMUBIND® tPA ELISA is an enzyme-linked immunosorbent assay for the measurement of human tissue-type Plasminogen Activator (tPA) antigen in plasma. This kit is for in vitro diagnostic use. Levels of tPA in plasma are known to be elevated in late stage pregnancy, myocardial infarction, atherosclerosis, and stroke.

Source page: https://510kreport.com/device/K013492
Methodology: https://510kreport.com/methodology