# K051472: Biophen LMWH Control, LMWH Control Low, Ufh Control, Heparin Calibrator & Ufh Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Hyphen Biomed
- Decided: Dec 23, 2005 after 203 days
- Product code: GGN (Plasma, Coagulation Control)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002400 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030965: Control Plasma LMW Heparin, Instrumentation Laboratory CO (2003) Summary page 1.
- K943520: Heparin Control Kit, American Bioproducts Co. (1995) Summary page 1.
- K030964: Calibration Plasma LMW Heparin, Instrumentation Laboratory CO (2003) Summary page 3.
- K042941: Dade Behring Heparin Calibrator and Controls, Dade Behring, Inc. (2004) Summary page 3.

## Recalls of this device
- Jun 28, 2022 · Class III · Z-1743-2022: Incorrect product labeling was included in the package.
- Mar 19, 2019 · Class III · Z-1189-2019: The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
- Mar 19, 2019 · Class III · Z-1190-2019: The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
- Mar 19, 2019 · Class III · Z-1188-2019: The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.

## Indications for use
Biophen Low Molecular Weight Heparin (LMWH), Low Molecular Weight Heparin Low (LMWH Low) and Unfractionated Heparin (UFH) control are set of control plasmas for the quality control of Low Molecular weight Heparin(LMWH) and Unfractionated Heparin(UFH) measurements using anti Xa colorimetric assays (Biophen Heparin 3 & 6). These control plasmas are within the usual therapeutic range recommended for the low molecular weight heparin (LMWH) and Unfractionated Heparin (UFH). Biophen Heparin & Unfractionated heparin (UFH) Calibrators are set of calibration plasmas for the measurement of Low molecular weight heparin (LMWH) and Unfractionated heparin, using anti-Xa colorimetric assays.

Source page: https://510kreport.com/device/K051472
Methodology: https://510kreport.com/methodology