510(k) · Cleared
ClearedReagent, Russel Viper Venom - LA Screen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dsrv, Inc. · GIR Reagent, Russel Viper Venom
Cleared on Jan 10, 2014 after a 184-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jan 10, 2014
- Review
- 184 days
- Class
- Class I
- Product code
- GIR
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All GIR devicesGIR Reagent, Russel Viper Venom: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
IFU Frozen Format LA Screen
Frozen Format LA Screen (FFLAS) and Frozen Format LA Confirm (FFLAC) are simplified DRWT reagents for detection of Lupus Anticoagulants (LA) in one-stage clotting tests.
Frozen Format LA Screen is a simplified DRVVT reagent to screen for the presence of Lupus Anicoagulants.
This product is for in-vitmo diagnostic use only.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K132130 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132130: Reagent, Russel Viper Venom - LA Screen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132130
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026