# K973274: Accucolor High Calibrator (A3089)

- Pathway: 510(k) (Traditional)
- Applicant: Sigma Diagnostics, Inc.
- Decided: Oct 31, 1997 after 59 days
- Product code: GIZ (Plasma, Control, Normal)
- 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 Product A7432: named in the summary without a submission number

## Indications for use
Sigma Diagnostics ACCUCOLOR™ High Calibrator is for use with the Sigma Diagnostics ACCUCOLOR™ Antithrombin 1ll (AT-I1) to determine the plasma level of antithrombin Il (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin Iit).

Source page: https://510kreport.com/device/K973274
Methodology: https://510kreport.com/methodology