510(k) · Cleared
ClearedIL Test Lac Screen (Claims Added to Acl Futura), IL Test Lac Confirm (Claims Addad to Acl Futura)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · GIR Reagent, Russel Viper Venom
Cleared on Apr 8, 1999 as substantially equivalent to K922156 (Gradipore, Ltd., 1993) and 1 other predicate after a 66-day review. Its family tree reaches back 1 generation to 1993. 7 later devices descend from it.
- Decided
- Apr 8, 1999
- Review
- 66 days
- Class
- Class I
- Product code
- GIR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K922156 (1993). 2 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK922156 Lucor Confirmatory ReagentGradipore, Ltd. · 1993
- This deviceK990302 IL Test Lac Screen (Claims Added to Acl Futura), IL Test Lac Confirm…Instrumentation Laboratory CO · 1999
- Descendant · cites it directly · 2 of its ownK050221 Hemosil Silica Clotting TimeInstrumentation Laboratory CO · 2005
- Descendant · 2 generations on · 1 of its ownK160445 HemosIL Silica Clotting TimeInstrumentation Laboratory CO · 2016
- Descendant · cites it directly · 1 of its ownK110031 Hemosil Drvvt Screen & Hemosil Drvvt ConfirmInstrumentation Laboratory CO · 2011
- Descendant · cites it directly · 1 of its ownK061805 Sta - Staclot DRVV Screen; Sta - Staclot DRVV ConfirmDiagnostica Stago, Inc. · 2006
- Descendant · 3 generations on · 0 of its ownK253957 HemosIL Silica Clotting TimeInstrumentation Laboratory (IL) Co. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K050221Hemosil Silica Clotting TimeInstrumentation Laboratory CO · 2005 · cites it directly2descendants
- K160445HemosIL Silica Clotting TimeInstrumentation Laboratory CO · 2016 · 2 generations on1descendant
- K110031Hemosil Drvvt Screen & Hemosil Drvvt ConfirmInstrumentation Laboratory CO · 2011 · cites it directly1descendant
- K061805Sta - Staclot DRVV Screen; Sta - Staclot DRVV ConfirmDiagnostica Stago, Inc. · 2006 · cites it directly1descendant
- K253957HemosIL Silica Clotting TimeInstrumentation Laboratory (IL) Co. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922156 | Lucor Confirmatory Reagent | Gradipore, Ltd. | 1993 | — |
| 0 (this device) | K990302 | IL Test Lac Screen (Claims Added to Acl Futura), IL Test Lac Confirm (Claims… | Instrumentation Laboratory CO | 1999 | — |
| +1 | K050221 | Hemosil Silica Clotting Time | Instrumentation Laboratory CO | 2005 | — |
| +2 | K160445 | HemosIL Silica Clotting Time | Instrumentation Laboratory CO | 2016 | — |
| +1 | K110031 | Hemosil Drvvt Screen & Hemosil Drvvt Confirm | Instrumentation Laboratory CO | 2011 | — |
| +1 | K061805 | Sta - Staclot DRVV Screen; Sta - Staclot DRVV Confirm | Diagnostica Stago, Inc. | 2006 | — |
| +3 | K253957 | HemosIL Silica Clotting Time | Instrumentation Laboratory (IL) Co. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2026 | 1 | 0 |
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 GIR? 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
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 | Decided |
|---|---|---|---|
| * | K922156 | Lucor Confirmatory ReagentSummary page 1…f reagent onto the ACL Futura) Classification name(s): 864.8950 Russell Viper Venom Reagent 81GIR Reagent, Russell Viper Venom Identification of predicate device(s): K922156 LUPO-TEST II Reagent (included ACL Series performance data) K922326 LUCOR Confirmatory Reagent (included ACL Series performance… | 1993 |
| * | K922326 | Lupo-Test RegeantSummary page 1…ell Viper Venom Reagent 81GIR Reagent, Russell Viper Venom Identification of predicate device(s): K922156 LUPO-TEST II Reagent (included ACL Series performance data) K922326 LUCOR Confirmatory Reagent (included ACL Series performance data) Description of the device/intended use(s): IL Test™ LAC Screen… | 1993 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K050221 (Instrumentation Laboratory CO, 2005) has gone furthest, with 2 descendants of its own.
How does its category compare?
All GIR devicesGIR Reagent, Russel Viper Venom: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GIR
2in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · GIR
Too few GIR 510(k)s in any year since 2007 to give a median.
Recalls per year · GIR
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GIR
3in 2018
MAUDE reports naming product code GIR, 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 | 0 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 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 | — | 0 | — |
What is it indicated for?
IL Test™ LAC Screen and IL Test™ LAC Confirm are in vitro diagnostic products for the detection of lupus anticoagulants (a type of phospholipid interfering antibody) in human citrated plasma on IL Coagulation Systems. These tests are indicated for use with patients who have prolonged APTT test of undetermined origin.
This 510(k) is intended to extend the use of these reagents onto another member in the IL family of coagulation analyzers, the ACL Futura (K951891).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990302 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990302: IL Test Lac Screen (Claims Added to Acl Futura), IL Test Lac Confirm (Claims Addad to Acl Futura).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990302
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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