# K020109: Sigma Diagnostics Accuclot LA Control

- Pathway: 510(k) (Traditional)
- Applicant: Sigma Diagnostics, Inc.
- Decided: Feb 6, 2002 after 26 days
- Product code: GGC (Control, Plasma, Abnormal)
- 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
Longest line of descent: 1 generation back to K961370 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961370: LA Positive Control Plasma, Medical Diagnostic Technologies, Inc. (1996) Summary page 1.

## Indications for use
Sigma Diagnostics ACCUCLOT ™ LA Control is a human plasma control that is suitable for use as a positive control for lupus anticoagulant testing such as activated partial prothrombin time (APTT) and dilute Russell's viper venom time (dRVVT). Plasma controls are routinely used in the coagulation laboratory as a means of quality control.

Source page: https://510kreport.com/device/K020109
Methodology: https://510kreport.com/methodology