510(k) · Cleared
ClearedSta - Staclot DRVV Screen; Sta - Staclot DRVV Confirm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostica Stago, Inc. · GIR Reagent, Russel Viper Venom
Cleared on Dec 6, 2006 as substantially equivalent to K990302 (Instrumentation Laboratory CO, 1999) after a 162-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it.
- Decided
- Dec 6, 2006
- Review
- 162 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 deviceK061805 Sta - Staclot DRVV Screen; Sta - Staclot DRVV ConfirmDiagnostica Stago, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK083878 Lupotek Correctin VL, Lupotek Detectin VL, Plasmacon LAR2 Diagnostics, Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K083878Lupotek Correctin VL, Lupotek Detectin VL, Plasmacon LAR2 Diagnostics, Inc. · 2010 · 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) | K061805 | Sta - Staclot DRVV Screen; Sta - Staclot DRVV Confirm | Diagnostica Stago, Inc. | 2006 | — |
| +1 | K083878 | Lupotek Correctin VL, Lupotek Detectin VL, Plasmacon LA | R2 Diagnostics, Inc. | 2010 | — |
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 |
|---|---|---|
| 2010 | 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 1…(21 cfr 864.8950, Product Code GF@~) 6>FO c) Predicate Device LAC Screen and Confirm manufactured by Instrumentation Laboratories (K9903 02). d) Intended Use/Device Description The STAt~-Staclot® dRVV Screen and STA®-Staclot®O dRVV Confirm kits arc intende… | 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 |
|---|---|---|---|
| K083878 | Lupotek Correctin VL, Lupotek Detectin VL, Plasmacon LA | 2010 | 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 13 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K083878 (R2 Diagnostics, Inc., 2010) 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.
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 STA®-Staclot®dRVV Screen and STA®-Staclot® dRVV Confirm kits are intended for the detection of lupus anticoagulants (LA) in plasma by the dilute Russell's viper venom method (1) performed with analyzers of the STA® line suitable to these reagents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061805 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061805: Sta - Staclot DRVV Screen; Sta - Staclot DRVV Confirm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061805
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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