510(k) · Cleared
ClearedElitech Clinical Systems Creatinne Pap SL Model CRSL-0250, Clitech Clinical Systems Elical 2 Model Cali-0580, Elitech CL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seppim S.A.S. · JFY Enzymatic Method, Creatinine
Cleared on Nov 18, 2011 as substantially equivalent to K024098 (Roche Diagnostics Corp., 2002) and 2 other predicates after a 366-day review. Its family tree reaches back 3 generations to 1981.
- Decided
- Nov 18, 2011
- Review
- 366 days
- Class
- Class II
- Product code
- JFY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K811832 (1981). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK811832 Precinorm U & Precipath U Human SerumBoehringer Mannheim Corp. · 1981
- 2 generations backK992900 Precinorm Universal and Precipath Universal Control SeraRoche Diagnostics Corp. · 1999
- 1 generation backK041227 Modification to:Roche Diagnostics Precinorm Universal and Precipath…Roche Diagnostics Corp. · 2004
- This deviceK103376 Elitech Clinical Systems Creatinne Pap SL Model CRSL-0250, Clitech…Seppim S.A.S. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K811832 | Precinorm U & Precipath U Human Serum | Boehringer Mannheim Corp. | 1981 | — |
| −2 | K992900 | Precinorm Universal and Precipath Universal Control Sera | Roche Diagnostics Corp. | 1999 | — |
| −1 | K041227 | Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal… | Roche Diagnostics Corp. | 2004 | — |
| 0 (this device) | K103376 | Elitech Clinical Systems Creatinne Pap SL Model CRSL-0250, Clitech Clinical… | Seppim S.A.S. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 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 JFY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JFY device
- #1 K252619 Qscheck Uisacrscore 12.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K024098 | Cobas Integra Creatinine Plus Ver.2 AssaySummary page 1…Creatinine test system (Sec.862.1225) Product code JFY- Enzymatic method, Creatinine Predicate device Roche Diagnostics Creatinine plus ver.2 (K024098) Device description The device for this submission is available as kit only. It consists of 2… | 2002 |
| * | K033501 | Modification to Calibrator for Automatic Systems (Cfas)Summary page 4…JIX- Calibrator, multi-analyte mixture Predicate device Roche Diagnostics Calibrator for Automated Systems (Cf as) (K033501) Device description ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on… | 2003 |
| * | K041227 | Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal Control SeraSummary page 6…862.1660) Product code JJY- Multi-analyte controls - all kinds Predicate device Roche Diagnostics Precinorm U (K041227) Roche Diagnostics Precipath U (K041227) Device description ELITech Clinical Systems ELITROL… | 2004 |
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 30 years and passes through 3 companies; a new generation was cleared every 7.5 years on median.
- 2 of the 7 ancestors have a recall of any class.
- 4 other devices also cite its predicate K024098.
How does its category compare?
All JFY devicesJFY Enzymatic Method, Creatinine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · JFY
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · JFY
59in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JFY
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JFY
61in 2025
MAUDE reports naming product code JFY, 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 | 8 | 193 | 0 | 1 |
| 2008 | 4 | 170 | 2 | 4 |
| 2009 | 3 | 59 | 3 | 22 |
| 2010 | 0 | — | 3 | 22 |
| 2011 | 2 | — | 0 | 42 |
| 2012 | 0 | — | 0 | 24 |
| 2013 | 0 | — | 1 | 39 |
| 2014 | 2 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 1 | — | 0 | 16 |
| 2017 | 1 | — | 0 | 16 |
| 2018 | 2 | — | 0 | 34 |
| 2019 | 2 | — | 0 | 56 |
| 2020 | 0 | — | 0 | 34 |
| 2021 | 2 | — | 0 | 57 |
| 2022 | 0 | — | 0 | 9 |
| 2023 | 0 | — | 0 | 36 |
| 2024 | 0 | — | 0 | 34 |
| 2025 | 0 | — | 0 | 61 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
ELiTech Clinical Systems CREATININE PAP SL is intended for the quantitative in vitro diagnostic determination of creatinine in human serum and plasma on Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Creatinine measurements are used in the diagnosis and treatment of renal diseases, and in monitoring renal dialysis. ELiTech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic…
Read the full statement (166 words)
ELiTech Clinical Systems CREATININE PAP SL is intended for the quantitative in vitro diagnostic determination of creatinine in human serum and plasma on Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings.
Creatinine measurements are used in the diagnosis and treatment of renal diseases, and in monitoring renal dialysis.
ELiTech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELiTech Clinical Systems methods on Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzers.
ELiTech Clinical Systems ELITROL I is a multi-parametric control serum for in vitro diagnostic use in accuracy control of quantitative ELiTech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer.
ELITech Clinical Systems ELITROL 11is a multi-parametric control serum for in vitro diagnostic use in accuracy control of quantitative ELiech Clinical Systems methods on the Vital Scientific Selectra Junior analyzer and the Vital Scientific Flexor Junior analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103376 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103376: Elitech Clinical Systems Creatinne Pap SL Model CRSL-0250, Clitech Clinical Systems Elical 2 Model Cali-0580, Elitech CL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103376
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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