510(k) · Cleared
ClearedLupotek Correctin VL, Lupotek Detectin VL, Plasmacon LA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
R2 Diagnostics, Inc. · GIR Reagent, Russel Viper Venom
Cleared on Jun 25, 2010 as substantially equivalent to K061805 (Diagnostica Stago, Inc., 2006) and 1 other predicate after a 543-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Jun 25, 2010
- Review
- 543 days
- Class
- Class I
- Product code
- GIR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K922156 (1993). 5 ancestors in all. No later device cites it as a predicate yet.
- 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 backK061805 Sta - Staclot DRVV Screen; Sta - Staclot DRVV ConfirmDiagnostica Stago, Inc. · 2006
- This deviceK083878 Lupotek Correctin VL, Lupotek Detectin VL, Plasmacon LAR2 Diagnostics, Inc. · 2010
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 | K061805 | Sta - Staclot DRVV Screen; Sta - Staclot DRVV Confirm | Diagnostica Stago, Inc. | 2006 | — |
| 0 (this device) | 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 |
| 1994 | 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 |
|---|---|---|---|
| * | K061805 | Sta - Staclot DRVV Screen; Sta - Staclot DRVV ConfirmSummary page 1…PlasmaCon LA Classification Name: Abnormal control plasma (21CFR 864.5425, Product Code GUC) 3) Predicate Device(s) LupoTek Detectin VL: Diagnostica Stago DRVV Screen (K061 805) LupoTek Correctin VL: Diagnostica Stago DRVV Confirm (K06 1805) PlasmaCon LA: American Diagnostica LAtrol Abnormal Control (K93… | 2006 |
| * | K935254 | Dvvtest and Dvvconfirm Lupus Anticoagulant Normal and Abnormal Control PlasmaSummary page 1…VL: Diagnostica Stago DRVV Screen (K061 805) LupoTek Correctin VL: Diagnostica Stago DRVV Confirm (K06 1805) PlasmaCon LA: American Diagnostica LAtrol Abnormal Control (K93 5254) 4) Device Description(s) LupoTek Detectin VL and LupoTek Correctin VL use Vipera lebetina venom rather than Vipera russelit (… | 1994 |
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 17 years and passes through 4 companies; a new generation was cleared every 6.0 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All GIR devicesGIR Reagent, Russel Viper Venom: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
PlasmaCon LA is intended for use as an LA positive, abnormal quality control plasma to monitor the performance of diagnostic assays, performed in professional clinical laboratories, for the presence of lupus anticoagulants in citrated plasma.
LupoTek DetecTin VL, and CorrecTin VL test kits are qualitative tests intended to aid in the detection of lupus anticoagulants (LA) in citrated human plasma by the dilute Russell's viper venom method in professional clinical laboratories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083878 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083878: Lupotek Correctin VL, Lupotek Detectin VL, Plasmacon LA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083878
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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