510(k) · Cleared

Cleared

Hemosil LA Positive Control & Hemosil LA Negative Control

K113211510(k) TraditionalCleared Jan 4, 201265-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

Instrumentation Laboratory CO · GGN Plasma, Coagulation Control

Cleared on Jan 4, 2012 as substantially equivalent to K110031 (Instrumentation Laboratory CO, 2011) after a 65-day review. Its family tree reaches back 3 generations to 1993.

Decided: Jan 4, 2012
Review: 65 days
Class: Class II
Product code: GGN
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K922156 (1993). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK922156 Lucor Confirmatory ReagentGradipore, Ltd. · 1993
2 generations backK990302 IL Test Lac Screen (Claims Added to Acl Futura), IL Test Lac Confirm…Instrumentation Laboratory CO · 1999
1 generation backK110031 Hemosil Drvvt Screen & Hemosil Drvvt ConfirmInstrumentation Laboratory CO · 2011
This deviceK113211 Hemosil LA Positive Control & Hemosil LA Negative ControlInstrumentation Laboratory CO · 2012

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K922156	Lucor Confirmatory Reagent	Gradipore, Ltd.	1993	—
−2	K990302	IL Test Lac Screen (Claims Added to Acl Futura), IL Test Lac Confirm (Claims…	Instrumentation Laboratory CO	1999	—
−1	K110031	Hemosil Drvvt Screen & Hemosil Drvvt Confirm	Instrumentation Laboratory CO	2011	—
0 (this device)	K113211	Hemosil LA Positive Control & Hemosil LA Negative Control	Instrumentation Laboratory CO	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0

FIG. 1 — Lineage of K113211, 1993–2012Source: 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

Get a 510(k) Report

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
*	K110031	Hemosil Drvvt Screen & Hemosil Drvvt Confirm Summary page 2 …slL LA Negative Control applicant is Substantially Equivalent to its predicate, the HemoslL LA Negative Control that was cleared under K110031, in intended use, fundamental scientific technology, and product composition. The…	Instrumentation Laboratory CO	2011	—

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 2 companies; a new generation was cleared every 6.0 years on median.
None of the 4 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. 2012, 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?

HemosiL LA Positive Control is intended for use as an LA Positive Quality Control of Lupus Anticoagulant assays (Hemo5IL dRWVT Screen/dRVVT Confirm, Hemosl LAC Screen/LAC Confirm and H-emosiL Silica Clotting Time Screen and Confirm) on IL Coagulation systems [ACL TOP* Family; ACL ELITE /ELITE PRO/8/9/10000; ACL Futura/ACL Advance; ACL Classic (100-7000)]. H-emosiL LA Negative Control is intended for use as an IA Negative Quality Control of Lupus…

Read the full statement (102 words)

H-emosiL LA Negative Control is intended for use as an IA Negative Quality Control of Lupus Anticoagulant assays (HemoslL dRVVT Screen/dRVVT Confirm, HemoslL LAC Screen/LAC Confirm and HemoslL Silica Clotting Time Screen and Confirm) on IL Coagulation systems [ACL TOPO Family; ACI ELITE /ELITE PRO/8/9/10000; ACI Futura/ACL Advance; AdL Classic (100-7000)].

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K113211 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113211: Hemosil LA Positive Control & Hemosil LA Negative Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113211

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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