# K013544: Sigma Diagnostics Auto D-Dimer Control, Level 2, Model A8096

- Pathway: 510(k) (Traditional)
- Applicant: Sigma Diagnostics, Inc.
- Decided: Nov 15, 2001 after 22 days
- Product code: DAP (Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 864.7320
- 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 K003329 (2001). 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)
- K003329: Sigma Dianostics Auto D-Dimer Control Level 2, Model A5217, Sigma Diagnostics, Inc. (2001) Summary page 1.

## Indications for use
Sigma Diagnostics ACCUMARK™ AUTO D-Dimer Control, Level 2 is a human plasma control that is suitable for use as an abnormal control with patient citrated plasma in D-dimer agglutination assays. Plasma controls are routinely used in the coagulation laboratory as a means of quality control.

Source page: https://510kreport.com/device/K013544
Methodology: https://510kreport.com/methodology