# K981255: Sigma Diagnostics Accuclot Control Iii

- Pathway: 510(k) (Traditional)
- Applicant: Sigma Diagnostics, Inc.
- Decided: Apr 29, 1998 after 23 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) Sigma Diagnostics Coagulation Control, Level III (Cat. No. 9916): named in the summary without a submission number

## Indications for use
Sigma Diagnostics ACCUCLOT™ CONTROL III is a human plasma control that is suitable for use as an abnormal control with patient citrated plasma in the one-stage prothrombin time (PT), in the activated partial thromboplastin time (APTT), the chromogenic Antithrombin III (AT-III) assay and in fibrinogen determinations using a clotting method. Plasma controls are routinely used in the coagulation laboratory as a means of quality control for coagulation testing

Source page: https://510kreport.com/device/K981255
Methodology: https://510kreport.com/methodology