# K013549: Sigma Diagnostics Auto D-Dimer Calibrator, Model A7971

- Pathway: 510(k) (Traditional)
- Applicant: Sigma Diagnostics, Inc.
- Decided: Dec 26, 2001 after 63 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 K003267 (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)
- K003267: Sigma Diagnostics Auto D-Dimer, Model CRS126-a, Sigma Diagnostics, Inc. (2001) Summary page 1.

## Indications for use
Sigma Diagnostics AUTO D-Dimer Calibrator is a human plasma calibrator that is suitable for use as calibrator for the Sigma Diagnostics AUTO D-Dimer kit Procedure CRS126 for the quantitative determination of fibrin degradation products containing D- dimer in citrated human plasma in D-dimer agglutination assays.

Source page: https://510kreport.com/device/K013549
Methodology: https://510kreport.com/methodology