510(k) · Cleared

Cleared

Hemosil LA Positive Control

K102552510(k) TraditionalCleared Apr 5, 2011210-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 · GGC Control, Plasma, Abnormal

Cleared on Apr 5, 2011 as substantially equivalent to K935254 (American Diagnostica, Inc., 1994) after a 210-day review. Its family tree reaches back 1 generation to 1994.

Decided: Apr 5, 2011
Review: 210 days
Class: Class II
Product code: GGC
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K935254 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK935254 Dvvtest and Dvvconfirm Lupus Anticoagulant Normal and Abnormal…American Diagnostica, Inc. · 1994
This deviceK102552 Hemosil LA Positive ControlInstrumentation Laboratory CO · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K935254	Dvvtest and Dvvconfirm Lupus Anticoagulant Normal and Abnormal Control Plasma	American Diagnostica, Inc.	1994	—
0 (this device)	K102552	Hemosil LA Positive Control	Instrumentation Laboratory CO	2011	—

FIG. 1 — Lineage of K102552, 1994–2011Source: 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
*	K935254	Dvvtest and Dvvconfirm Lupus Anticoagulant Normal and Abnormal Control Plasma Summary page 1 …s 11 Product Code: GGN 21 CER 864.5425 Negative Control: Class Il Product Code: GIZ 21 CFR 864.5425 Predicate Devices: K93 5254 LAtrol Abnormal Control and LAtrol Normal Control (Manufacturer: American Diagnosti…	American Diagnostica, Inc.	1994	—
†	K990302	IL Test Lac Screen (Claims Added to Acl Futura), IL Test Lac Confirm (Claims Addad to…	Instrumentation Laboratory CO	1999	—
†	K050221	Hemosil Silica Clotting Time	Instrumentation Laboratory CO	2005	—

Also cleared against K935254: 1 other device →

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?

Its one ancestor has no recall.
1 other device also cites its predicate K935254.

How does its category compare?

All GGC devices

GGC Control, Plasma, Abnormal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

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?

HemosiL LA Positive Control For use as an LA Positive Quality Control of Lupus Anticoagulant assays (HemoslL LAC Screen/LAC Confirm; HemoslL Silica Clotting Time) on IL Coagulation systems [ACL TOP® Family; ACL ELITE®/ELITE PRO/8/9/10000; ACL Futura/ACL Advance; ACL Classic (100-7000)]. The control assesses the precision and accuracy of Lupus Anticoagulant (LA) tests performed on IL Coagulation Systems using HemoslL LA assays. HemoslL LA Negative Control…

Read the full statement (122 words)

HemosiL LA Positive Control

For use as an LA Positive Quality Control of Lupus Anticoagulant assays (HemoslL LAC Screen/LAC Confirm; HemoslL Silica Clotting Time) on IL Coagulation systems [ACL TOP® Family; ACL ELITE®/ELITE PRO/8/9/10000; ACL Futura/ACL Advance; ACL Classic (100-7000)].

The control assesses the precision and accuracy of Lupus Anticoagulant (LA) tests performed on IL Coagulation Systems using HemoslL LA assays.

HemoslL LA Negative Control

For use as an LA Negative Quality Control of Lupus Anticoagulant assays (HemoslL LAC Screen/LAC Confirm; HemoslL Silica Clotting Time) on IL Coagulation systems [ACL TOP® Family; ACL ELITE®/ELITE PRO/8/9/10000; ACL Futura/ACL Advance; ACL Classic (100-7000)].

The control assesses the precision and accuracy of Lupus Anticoagulant (LA) tests performed on IL Coagulation Systems using HemosiL LA assays.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K102552 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102552: Hemosil LA Positive Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102552

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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