# K091284: Visucal-F Frozen Calibrator Plasma and Visucon-F Frozen Normal and Abnormal Control Plasma

- Pathway: 510(k) (Traditional)
- Applicant: Affinity Biologicals, Inc.
- Decided: Oct 28, 2009 after 180 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
Longest line of descent: 2 generations back to K001256 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952622: Cryo Check Normal Human Reference Plasma, Precision Biologicals, Inc. (1995) Summary page 1.
- K023141: Modification to Standard Human Plasma, Dade Behring, Inc. (2003) Summary page 1.
- K013708: Reference Check, Catalog Number-RCN-10, Precision Biologic (2001) Summary page 3.
- K952624: Cryo Check Abnormal Reference Check I & II, Precision Biologicals, Inc. (1995) Summary page 5.

## Indications for use
The VisuCal-F Frozen Calibrator plasma is intended for use in the calibration of coagulation and fibrinolysis assays including the following: fibrinogen (Clauss Method), coagulation factors II, V, VII, VIII, IX,X, XI, XII, antithrombin activity, alpha-2-antiplasmin, plasminogen, Protein C activity and antigen, Protein S activity and total antigen and von Willebrand factor antigen and Ristocetin Cofactor. The VisuCon-F Frozen Abnormal Control plasma is intended for use in the quality control of coagulation assays in the borderline pathological range for the following parameters: fibrinogen (Clauss Method), coagulation factors II,V, VII, VIII, IX,X, XI, XII, antithrombin activity, Protein C activity and Protein S activity. The VisuCon-F Frozen Normal Control plasma is intended for use in the quality control of coagulation assays in the normal range for the following parameters: fibrinogen (Clauss Method), coagulation factors II, V, VII, VIII, IX,X, Xi, XII, antithrombin activity, Protein C activity and Protein S activity.

Source page: https://510kreport.com/device/K091284
Methodology: https://510kreport.com/methodology