# K062306: Plasmacon N, Plasmacon L-1, Plasmacon L-2

- Pathway: 510(k) (Traditional)
- Applicant: R2 Diagnostics, Inc.
- Decided: Mar 16, 2007 after 220 days
- Product code: GGC (Control, Plasma, Abnormal)
- 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 K895262 (1989). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895262: Normal Coagulation Control Plasma (NCCP), Medical Diagnostic Technologies, Inc. (1989) Summary page 1.
- K895260: Abnormal Coagulation Control Plasma-1 (Accp-1), Medical Diagnostic Technologies, Inc. (1989) Summary page 1.
- K895261: Abnormal Coagulation Control Plasma-2 (Accp-2), Medical Diagnostic Technologies, Inc. (1989) Summary page 1.

## Indications for use
PlasmaCon N is a human-lyophilized plasma control intended for use as a normal control with citrated plasma to monitor the performance of the prothrombin time (PT) and activated partial thromboplastin time (aPTT) tests. PlasmaCon L-1I is a human lyophilized plasma control intended for use as a mid-level abnormal control with citrated plasma to monitor the performance of the prothrombin time (PT) and activated partial thromboplastin time (aPTT) tests. PlasmaCon L-2 is a human lyophilized plasma control intended for use as a high level abnormal control with citrated plasma to monitor the performance of the prothrombin time (PT) and activated partial thromboplastin time (aPTT) tests.

Source page: https://510kreport.com/device/K062306
Methodology: https://510kreport.com/methodology