# P970025: Pro-Trac II Tacrolimus Elisa Kit

- Pathway: PMA
- Applicant: DiaSorin, Inc.
- Decided: Apr 27, 1999 after 666 days
- Product code: MLM (Enzyme Immunoassay, Tracrolimus)
- Device class: 2
- Regulation: 21 CFR 862.1678
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Mar 16, 2015 · Class II · Z-1464-2015: Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results.
- Apr 12, 2004 · Not classified · Z-0702-05: The software program written for use in the automated microtiter plate reader (Bio-Tek ELx800) for use with the Pro-Trac II Tacrolimus ELISA kit was found to be faulty. Assay software program did not 

Source page: https://510kreport.com/device/P970025
Methodology: https://510kreport.com/methodology