# K150144: VisuCon-F Low Fibrinogen Control Plasma

- Pathway: 510(k) (Traditional)
- Applicant: Affinity Biologicals, Inc.
- Decided: Mar 6, 2016 after 409 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) Cryocheck Low Fibrinogen Control Plasma: named in the summary without a submission number

## Indications for use
The VisuCon-F Low Fibrinogen Control Plasma is an assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range. The VisuCon-F Low Fibrinogen Control Plasma may be used with mechanical instruments in conjunction with appropriate commercial reagents for determining fibrinogen levels in plasma by the clotting method of Clauss. This plasma is intended “For In Vitro Diagnostic Use”. The intended users of the VisuCon-F Low Fibrinogen Control Plasma are trained laboratory personnel working in clinical laboratories.

Source page: https://510kreport.com/device/K150144
Methodology: https://510kreport.com/methodology