# K023309: Control Plasma N

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Nov 1, 2002 after 29 days
- Product code: GIZ (Plasma, Control, Normal)
- 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 K001256 (2000). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001256: Control Plasma N, Dade Behring, Inc. (2000)

## Most influential descendants
- K042333: Control Plasma N, Proc Control Plasma (2004), 0 descendants of its own
- K042209: Control Plasma N and Control Plasma P (2004), 0 descendants of its own

## Indications for use
Control Plasma N is assayed for use as an accuracy control 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 I I , V, VII, VIII, vWF, IX, X , XI, and XI1 7. Inhibitors: Antithrombin Ill, Protein C, Protein S , az-antiplasmin, 8. Plasminogen 9. Lupus anticoagulants * Not for BI=TTMII analyzer

Source page: https://510kreport.com/device/K023309
Methodology: https://510kreport.com/methodology