510(k) · Cleared

Cleared

Pool Norm

K142132510(k) TraditionalCleared Dec 12, 2014130-day reviewClass II21 CFR 864.5425

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Diagnostics Stago S.A.S. · GGN Plasma, Coagulation Control

Cleared on Dec 12, 2014 as substantially equivalent to K061803 (Diagnostica Stago, Inc., 2006) after a 130-day review. Its family tree reaches back 2 generations to 1995.

Decided: Dec 12, 2014
Review: 130 days
Class: Class II
Product code: GGN
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K952623 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK952623 Cryo Check Lupus PlasmaPrecision Biologicals, Inc. · 1995
1 generation backK061803 Sta - Control LA 1+2Diagnostica Stago, Inc. · 2006
This deviceK142132 Pool NormDiagnostics Stago S.A.S. · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K952623	Cryo Check Lupus Plasma	Precision Biologicals, Inc.	1995	—
−1	K061803	Sta - Control LA 1+2	Diagnostica Stago, Inc.	2006	—
0 (this device)	K142132	Pool Norm	Diagnostics Stago S.A.S.	2014	—

FIG. 1 — Lineage of K142132, 1995–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GGN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K061803	Sta - Control LA 1+2 Summary page 4 …te Devices: - Pooled Normal Plasma - Pre-amendment device George King Bio-Medical, INC - STA® - Control LA 1 - K061803 Diagnostica Stago Device Intended Use: The Pool Norm is a normal human plasma pool intended for…	Diagnostica Stago, Inc.	2006	—
*	—	Pooled Normal Plasma Named without a submission number			—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 10.7 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All GGN devices

GGN Plasma, Coagulation Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · GGN

4in 2017

2007high 4 (2017) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GGN

96in 2017

2007high 441 (2013) · low 23 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GGN

1in 2019

2007high 4 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GGN

4in 2018

2007high 37 (2009) · low 0 (2007)2025

MAUDE reports naming product code GGN, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	3	47	0	0
2008	1	—	0	0
2009	2	—	0	37
2010	3	23	4	17
2011	2	—	1	30
2012	1	—	0	10
2013	3	441	3	9
2014	2	—	0	5
2015	0	—	0	10
2016	2	—	0	9
2017	4	96	0	11
2018	0	—	0	4
2019	0	—	1	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	2	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K142132 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142132: Pool Norm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142132

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026