510(k) · Cleared
Recalled · Class II · 2012Active Renin Irma Model Number DSL-25100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Systems Laboratories, Inc. · CIB Radioimmunoassay, Angiotensin I And Renin
Cleared on May 27, 1998 after a 22-day review. The FDA summary names its predicate without a number. It has been recalled once.
- Decided
- May 27, 1998
- Review
- 22 days
- Class
- Class II
- Product code
- CIB
- Recalls
- 1
- Predicates
- 0
The FDA summary names its predicate without a number.
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 CIB? 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 |
|---|---|---|---|
| * | — | Nichols Diagnostics ACTIVE Renin IRMA Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 20, 2012 | Class II | Z-0016-2013 | Nonconforming Material/Component | The recall was initiated because Beckman Coulter has confirmed that the Active Renin IRMA Test Kit may exhibit a decrease in stability of the coated tubes. As a result, quality control and patient sample results may be falsely elevated by… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All CIB devicesCIB Radioimmunoassay, Angiotensin I And Renin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CIB
2in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · CIB
Too few CIB 510(k)s in any year since 2007 to give a median.
Recalls per year · CIB
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CIB
No MAUDE report names CIB since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 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 DSL ACTIVE™ Renin Coated Tube IRMA assay is intended for the quantitative determination of Renin in human serum or plasma. This assay is intended for in vitro diagnostic use. Renin measurements are used in the diagnosis and treatment of certain types of hypertension.
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/K981607 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981607: Active Renin Irma Model Number DSL-25100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981607
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026