# K083729: Hemoclot Quanti- V-L, Factor V-L Calibrator, Biophen V-L Cal (Undiluted), Biophen Act. PC-R Control Plasma and Biophen

- Pathway: 510(k) (Traditional)
- Applicant: Aniara Diagnostica, LLC
- Decided: May 8, 2009 after 143 days
- Product code: GGW (Test, Time, Partial Thromboplastin)
- Device class: 2
- Regulation: 21 CFR 864.7925
- 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 K945940 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963111: Coatest Apc (TM) Resistance V/Coatest Apc (TM) Resistance V S, Chromogenix AB (1996) Summary page 1.

## Indications for use
HEMOCLOT Quanti VL is an in vitro diagnostic test for the quantitative determination of Factor V Leiden (FVL) activity in human citrated plasma, using automated or manual methods, by its resistance to the action of Activated Protein C (APC). Patients with the Factor V-L (mutation R5060). are exposed to an increased thrombotic risk. Biophen V-L CAL (undiluted), at defined Factor V-Leiden (FV-L) concentrations, for the calibration of Factor V-Leiden activity on human plasma, using the Hemoclot Quanti V-L kit. Factor V-L Calibrator, pre diluted (1:20) human plasmas. at defined Factor V-Leiden (FV-L) concentrations, for the calibration of Factor V-L activity on human plasma using Hemoclot Quanti V-L Kit. Biophen Act PC-r Control Plasma contains human plasma, presenting an Activated Protein C Resistance (APC-R) is used as quality control plasma for the testing of Activated Protein C resistance (APC-R) on human plasma using Hemoclot Quanti V-L kit. (Updated) BIOPHEN Normal Control Plasma is a set of 12 vials of normal citrated human plasma for the 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 according to the package inserts: Assays: ATIII; Protein C; aPC resistance (FV Leiden); Lupus Anticoagulant. Reagents: Biophen ATII; Biophen Protein C; Hemoclot Quanti V-L; DVVtest®/DVVconfirm®. Manufacturers: Hyphen Biomed; Hyphen Biomed; Hyphen Biomed; American Diagnostica. Reference: 221102/221105; 221202/221205; CK065K; 810/815/815L. DWtest, DVVconfirm are registered trademarks from American Diagnostica, Inc. The BIOPHEN Normal Control Plasma is 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/AP'T) is >2.00.

Source page: https://510kreport.com/device/K083729
Methodology: https://510kreport.com/methodology