# K013168: Imubind Plasma Pai-1 Elisa,Model 822

- Pathway: 510(k) (Traditional)
- Applicant: American Diagnostica, Inc.
- Decided: Mar 7, 2002 after 167 days
- Product code: GGP (Test, Qualitative And Quantitative Factor Deficiency)
- Device class: 2
- Regulation: 21 CFR 864.7290
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K960438 (1996). 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)
- K960438: Tintelize Pai-1 Kit, Medical Diagnostic Technologies, Inc. (1996) Summary page 1.

## Recalls of this device
- Mar 5, 2010 · Not classified · Z-1426-2010: Unacceptable microwell to microwell variation in the section of the plate that is typically used for the calibrators

## Indications for use
The IMUBIND® Plasma PAI-1 ELISA is an enzyme-linked immunosorbent assay for the measurement of human Plasminogen Activator Inhibitor Type-1 (PAI-1) antigen in plasma. This kit is for in vitro diagnostic use. High levels of PAI-1 antigen are known to be associated with deep vein thrombosis and myocardial infarction.

Source page: https://510kreport.com/device/K013168
Methodology: https://510kreport.com/methodology