# K023141: Modification to Standard Human Plasma

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jan 16, 2003 after 118 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- 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 K924393 (1992). 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)
- K924393: Standard Human Plasma, Behring Diagnostics, Inc. (1992) 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
For the calibration of the following tests: 1. Prothrombin time (PT) 2. Fibrinogen 3. Coagulation factors II, V, VII, VIII, wWf, IX, X, XI, XI1 and XIII* 4. Inhibitors: Antithrombin Ill, Protein C, Protein S , a2-antiplasmin, C1-inhibitor* 5. Total complement activity* 6. Plasminogen * Not available in the U.S.

Source page: https://510kreport.com/device/K023141
Methodology: https://510kreport.com/methodology