# K042333: Control Plasma N, Proc Control Plasma

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Dec 1, 2004 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 K945940 (1995). 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)
- K023309: Control Plasma N, Dade Behring, Inc. (2002) Summary page 1.
- K963111: Coatest Apc (TM) Resistance V/Coatest Apc (TM) Resistance V S, Chromogenix AB (1996) Summary page 1.

## Indications for use
Control Plasma N is an assayed control for use in monitoring performance of the following parameters in the normal range: 1. Prothrombin time (PT) 2. Activated partial thromboplastin time (APTT) 3. Thrombin time (TT) 4. Batroxobin time 5. Fibrinogen 6. Coagulation factors II,V, VII, VIII, vWF, IX, X, XI, XII 7. Inhibitors: Antithrombin III, protein C, protein S, c2 -antiplasmin 8. Plasminogen 9. Lupus anticoagulants 10. Factor V Leiden ProC® Control Plasma is an assayed control used to monitor the performance of Factor V Leiden assay in the pathological range.

Source page: https://510kreport.com/device/K042333
Methodology: https://510kreport.com/methodology