# K971748: Tas PT-Nctest Controls

- Pathway: 510(k) (Traditional)
- Applicant: Cardiovascular Diagnostics, Inc.
- Decided: May 29, 1997 after 17 days
- Product code: GGN (Plasma, Coagulation Control)
- Device class: 2
- Regulation: 21 CFR 864.5425
- 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. The FDA summary names its predicate without a number.
- (no number) TAS PT Controls: named in the summary without a submission number

## Indications for use
The new TAS PT-NC Controls are intended to be used with the TAS Analyzer and PT-NC test cards to provide a method for quality control of the system. The controls produce clotting times which must be within accepted, standard ranges, to indicate that the analyzer and test cards are functioning properly and thereby help assure the accuracy of PT-NC test card results. These controls were designed to allow CVDI's point-of-care tests to maintain accepted laboratory standards and requirements. These controls also can be used to determine system (TAS Analyzer and PT-NC test cards) precision. The controls are substantially equivalent in intended use to other control materials used in coagulation tests.

Source page: https://510kreport.com/device/K971748
Methodology: https://510kreport.com/methodology