# K142132: Pool Norm

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostics Stago S.A.S.
- Decided: Dec 12, 2014 after 130 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 K952623 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061803: Sta - Control LA 1+2, Diagnostica Stago, Inc. (2006) Summary page 4.
- (no number) Pooled Normal Plasma: named in the summary without a submission number

## Indications for use
The Pool Norm is a normal human plasma pool intended for use as a normal control for the activated partial thromboplastin time (APTT) and dilute Russell's viper venom time (dRVVT) assays carried out with the following tests: – APTT: STA® - PTT A (REF 00595) on STA-R®, STA Compact® and STA Satellite® analyzers – dRVVT: STA® - Staclot® dRVV Screen (REF 00339, 00333), STA® - Staclot® dRVV Confirm (REF 00334) on STA-R® and STA Compact® analyzers. This reagent is to be used in clinical laboratories by certified medical laboratory personnel. For in vitro diagnostic use only. For prescription use.

Source page: https://510kreport.com/device/K142132
Methodology: https://510kreport.com/methodology