# K971985: N-Assay Tia Plasminogen Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Crestat Diagnostics, Inc.
- Decided: Oct 20, 1997 after 144 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
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The N-Assay TIA Plasminogen Test Kit is 'intended to be used for the quantitation of plasminogen in in human plasma by immuno-turbidimetric assay. Decreased levels of plasminogen are of clinical importance. Low levels of plasminogen are usually due to liver disease with impaired synthesis, or to increased utilization associated with DIC(disseminated intravascular coagulation). Low levels could also occur in severe nephrosis. Measurement of plasminogen is helpful in the diagnosis of these conditions.

Source page: https://510kreport.com/device/K971985
Methodology: https://510kreport.com/methodology