# K013708: Reference Check, Catalog Number-RCN-10

- Pathway: 510(k) (Traditional)
- Applicant: Precision Biologic
- Decided: Dec 10, 2001 after 32 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
Longest line of descent: 1 generation back to K001256 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001256: Control Plasma N, Dade Behring, Inc. (2000) Summary page 1.

## Most influential descendants
- K091284: Visucal-F Frozen Calibrator Plasma and Visucon-F Frozen Normal and Abnormal Control Plasma (2009), 0 descendants of its own

## Indications for use
Reference Check is recommended for use in controlling the accuracy of quantitative hemostasis assays in the normal range. Reference Check is an assayed control for the following parameters in the normal range: Fibrinogen Factor il Factor V Factor VIi Factor VIII:C VvWF: antigen VWF: Ristocetin Cofactor Factor IX Factor X Factor XI Factor Xl Factor Xili Prekallikrein Protein C: antigen Protein C: activity Protein S: activity Protein S: total Protein S: free Antithrombin: activity Antithrombin: antigen Alpha-2-antiplasmin Plasminogen

Source page: https://510kreport.com/device/K013708
Methodology: https://510kreport.com/methodology