510(k) · Cleared
ClearedHemosil Drvvt Screen & Hemosil Drvvt Confirm
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 Aug 24, 2011 as substantially equivalent to K990302 (Instrumentation Laboratory CO, 1999) after a 231-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it.
- Decided
- Aug 24, 2011
- Review
- 231 days
- Class
- Class I
- Product code
- GIR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K922156 (1993). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK922156 Lucor Confirmatory ReagentGradipore, Ltd. · 1993
- 1 generation backK990302 IL Test Lac Screen (Claims Added to Acl Futura), IL Test Lac Confirm…Instrumentation Laboratory CO · 1999
- This deviceK110031 Hemosil Drvvt Screen & Hemosil Drvvt ConfirmInstrumentation Laboratory CO · 2011
- Descendant · cites it directly · 0 of its ownK113211 Hemosil LA Positive Control & Hemosil LA Negative ControlInstrumentation Laboratory CO · 2012
Most influential descendants
Showing 1 of 1 · See all- K113211Hemosil LA Positive Control & Hemosil LA Negative ControlInstrumentation Laboratory CO · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922156 | Lucor Confirmatory Reagent | Gradipore, Ltd. | 1993 | — |
| −1 | K990302 | IL Test Lac Screen (Claims Added to Acl Futura), IL Test Lac Confirm (Claims… | Instrumentation Laboratory CO | 1999 | — |
| 0 (this device) | K110031 | Hemosil Drvvt Screen & Hemosil Drvvt Confirm | Instrumentation Laboratory CO | 2011 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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? (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 | Decided |
|---|---|---|---|
| * | K990302 | IL Test Lac Screen (Claims Added to Acl Futura), IL Test Lac Confirm (Claims Addad to…Summary page 2…sl [AC Screen & [AC HemosL dRVVT Screen & dRVVT Confirm Confirm K#t K990302 K(110031 Indications Hemosil- LAC Screen and HemoslL The HemoslL dRVVT Scr… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113211 | Hemosil LA Positive Control & Hemosil LA Negative Control | 2012 | 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?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 12.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K113211 (Instrumentation Laboratory CO, 2012) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K990302.
How does its category compare?
All GIR devicesGIR Reagent, Russel Viper Venom: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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?
The HemosiL dRVVT Screen and HemosL dRVVT Confirm assays are qualitative in-vitro diagnostic products to aid in the detection of lupus anticoagulants in human citrated plasma by the diluted Russell's Viper Venom method, on the ACL TOP Family. The HemoslL dRVVT Screen and Hemoslt dRVVT Confirm assays are intended to evaluate patients who have unexplained prolonged APTT test results The HemosiL dRVVT Screen and HemosL dRVVT Confirm assays should be used in parallel as an integrated test for Lupus Anticoagulant detection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110031 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110031: Hemosil Drvvt Screen & Hemosil Drvvt Confirm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110031
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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