# K043451: Biophen Normal and Abnormal Control Plasma; Biophen Plasma Calibrator

- Pathway: 510(k) (Abbreviated)
- Applicant: Hyphen Biomed
- Decided: Mar 17, 2005 after 93 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 K941737 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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 2.
- K020878: Lyphochek Hemostasis, Models 798, 799, Bio-Rad (2002) Summary page 2.

## Indications for use
Biophen Plasma Calibrator is normal citrated human plasma used as the calibrator in the assay methods for coagulation factors Antithrombin III and Protein C. The following table shows various parameters which are measured using the assays from Hyphen BioMed or from other manufacturers as per the instructions in the package insert. The Biophen Plasma Calibrator is tested for the absence of Lupus Anticoagulant and can be used for this investigation. Biophen Normal and Abnormal Control Plasma is a set of 12 vials each of normal citrated human plasma used as quality control of some coagulation factors. The following table shows the various parameters which are measured using assays from Hyphen Biomed or from other manufacturers, and as per the package inserts. DWtest, DWconfirm are registered trade marks from American Diagnostica Inc. The Biophen Normal and Abnormal Control Plasma are tested for the absence of Lupus Anticoagulant and can be used as a negative control for this investigation. This control plasma is also tested for the absence of Activated Protein C resistance (Act PC-r). When the APTT is performed with or without Activated Protein C (APC), the ratio obtained (APTT + APC/APTT) is ≥2.00 for the Normal Control Plasma.

Source page: https://510kreport.com/device/K043451
Methodology: https://510kreport.com/methodology