# K972796: Sigma Diagnostics Thrombomax with Calcium

- Pathway: 510(k) (Traditional)
- Applicant: Sigma Diagnostics, Inc.
- Decided: Oct 10, 1997 after 74 days
- Product code: GJS (Test, Time, Prothrombin)
- Device class: 2
- Regulation: 21 CFR 864.7750
- Recalls of this device: 1 (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. The FDA summary names its predicate without a number.
- (no number) Sigma Thromboplastin-XS: named in the summary without a submission number

## Recalls of this device
- Oct 27, 2004 · Not classified · Z-0261-05: Prolongation of Prothrombin times in patient samples, resulting in a falsely elevated INR value.

## Indications for use
Sigma Diagnostics ThromboMAX™ with Calcium is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway which involves the reaction between coagulation factors lil and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).

Source page: https://510kreport.com/device/K972796
Methodology: https://510kreport.com/methodology