510(k) · Cleared

Cleared

Sta - Control LA 1+2

K061803510(k) TraditionalCleared Jul 28, 200631-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

Diagnostica Stago, Inc. · GGC Control, Plasma, Abnormal

Cleared on Jul 28, 2006 as substantially equivalent to K952623 (Precision Biologicals, Inc., 1995) after a 31-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.

Decided: Jul 28, 2006
Review: 31 days
Class: Class II
Product code: GGC
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K952623 (1995). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK952623 Cryo Check Lupus PlasmaPrecision Biologicals, Inc. · 1995
This deviceK061803 Sta - Control LA 1+2Diagnostica Stago, Inc. · 2006
Descendant · cites it directly · 0 of its ownK142132 Pool NormDiagnostics Stago S.A.S. · 2014

Most influential descendants

Showing 1 of 1 · See all

K142132Pool NormDiagnostics Stago S.A.S. · 2014 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0

FIG. 1 — Lineage of K061803, 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 GGC? 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? (1)

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
*	K952623	Cryo Check Lupus Plasma Summary page 1 …on Name: Lupus Control Plasmas Classification Name: Plasma, Control, Normal & Abnormal c) Predicate Device Cryocheck Lupus Positive Control (K952623) manufactured by Precision Biologic, Inc. Dartmouth, Nova Scotia, Canada. d) Intended Use/Device Description The STA…	Precision Biologicals, Inc.	1995	—

Also cleared against K952623: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K142132	Pool Norm	Diagnostics Stago S.A.S.	2014	0

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?

Its one ancestor has no recall.
Of its descendants, K142132 (Diagnostics Stago S.A.S., 2014) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K952623.

How does its category compare?

All GGC devices

GGC Control, Plasma, Abnormal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GGC

1in 2011

2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GGC

Too few GGC 510(k)s in any year since 2007 to give a median.

Recalls per year · GGC

No recall names GGC since 2007.

Adverse event reports per year · GGC

1in 2021

2007high 1 (2021) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	1	—	0
2008	0	—	0
2009	0	—	0
2010	1	—	0
2011	1	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	1
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The STA -R - Control LA 1+2 kit provides a lupus anticoagulant (LA) negative plasma

and a LA positive plasma. These plasmas are intended for the quality control of the tests

for LA detection carried out with the following tests:

STA® -Staclott dRVV Screen (#00339 & #00333)

STAR® -Staclot® dRVV

Confirm (#00334)

Staclot® LA (#00600, 00594)

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061803 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061803: Sta - Control LA 1+2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061803

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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