# K981178: Thrombolytic Assessment System Low Range Heparin Management Test Controls

- Pathway: 510(k) (Traditional)
- Applicant: Cardiovascular Diagnostics, Inc.
- Decided: Apr 27, 1998 after 26 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 HMT controls (CVDI): named in the summary without a submission number

## Indications for use
The new TAS LHMT Controls are intended to be used with the TAS Analyzer and the TAS LHMT card 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 TAS LHMT results. The controls are substantially equivalent in intended use to other controls used in coagulation assays.

Source page: https://510kreport.com/device/K981178
Methodology: https://510kreport.com/methodology