# K960234: Tas HMT Controls

- Pathway: 510(k) (Traditional)
- Applicant: Cardiovascular Diagnostics, Inc.
- Decided: May 30, 1996 after 134 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) ACT-trol controls (Analytical Control Systems, ACS): named in the summary without a submission number

## Indications for use
The new TAS HMT controls are intended to be used with the TAS Analyzer and HMT cards, previously cleared to market by the FDA, 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 the HMT test results. The controls are substantially equivalent in intended use to other controls used in coagulation assays.

Source page: https://510kreport.com/device/K960234
Methodology: https://510kreport.com/methodology