# K042209: Control Plasma N and Control Plasma P

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Oct 21, 2004 after 66 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 K001256 (2000). 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.
- K023312: Control Plasma P, Dade Behring, Inc. (2002) 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, a2 -antiplasmin 8. Plasminogen 9. Lupus anticoagulants Control Plasma P is an assayed control for use in monitoring the performance of the following parameters in the pathological range: 1. Prothrombin time (PT) 2. Activated partial thromboplastin time (aPTT) 3. Fibrinogen (Clauss method) 4. Coagulation factors II, V, VII, VIII, vWF, IX,X, XI, XII 5. Inhibitors: Antithrombin III, protein C, protein S, t2 -antiplasmin 6. Plasminogen

Source page: https://510kreport.com/device/K042209
Methodology: https://510kreport.com/methodology