510(k) · Cleared
ClearedElitech Clinical Systems Creatinine Pap SL, Elical 2, Elitrol I and Elitrol II, Urine Control BI-Level
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elitechgroup · JFY Enzymatic Method, Creatinine
Cleared on Jan 3, 2014 as substantially equivalent to K024098 (Roche Diagnostics Corp., 2002) and 3 other predicates after a 155-day review. Its family tree reaches back 3 generations to 1981.
- Decided
- Jan 3, 2014
- Review
- 155 days
- Class
- Class II
- Product code
- JFY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K811832 (1981). 9 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 deviceK132399 Elitech Clinical Systems Creatinine Pap SL, Elical 2, Elitrol I and…Elitechgroup · 2014
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) | K132399 | Elitech Clinical Systems Creatinine Pap SL, Elical 2, Elitrol I and Elitrol… | Elitechgroup | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 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? (4)
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…Clinical Chemistry 21 CIFR 826.1660 5. Predicate Device: k024098 Roche Diagnostics Creatinine plus v… | 2002 |
| * | K033501 | Modification to Calibrator for Automatic Systems (Cfas)Summary page 1…Roche Diagnostics Creatinine plus ver 2 k033501 Roche Diagnostics Calibrator for Au… | 2003 |
| * | K041227 | Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal Control SeraSummary page 1…Roche Diagnostics Calibrator for Automated Systems (C.f.a.s.) k041227 Roche Diagnostics Precinorm and Pre… | 2004 |
| * | K020817 | Liquichek Urine Chemistry ControlSummary page 2…EtiTech Clinical Systems k02081 7 BlO-RAD Liquichelk Urine Chem… | 2002 |
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 33 years and passes through 3 companies; a new generation was cleared every 9.6 years on median.
- 2 of the 9 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. 2014, 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 determiniation of creatinine in human serum, plasma and urine on ELiTech Clinical Systems Selectra Pro Series Analyzers. It is not intended for use inPoint of Care settings. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. ELITech…
Read the full statement (171 words)
ELiTech Clinical Systems CREATININE PAP SL is intended for the quantitative in vitro diagnostic determiniation of creatinine in human serum, plasma and urine on ELiTech Clinical Systems Selectra Pro Series Analyzers. It is not intended for use inPoint of Care settings.
Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
ELITech Clinical Systems ELICAL 2 is a multi-paramnetric calibrator for in vitro diagnostic use in the calibration of quantitative ELiTech Clinical Systems methods on ELiTech Clinical Systems Selectra Pro Series Analyzers.
ELITecli Clinical Systetms ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELiTech Clinical Systems Selectra Pro Series Analyzers.
ELITech Clinical Systems URINE CONTROL BI- LEVEL is a set of 2 levels of urine controls used for in vitro diagnostic in the quality control of quantitative ELITech Clinical Systems methods on ELiTech Clinical Systems Seletra Prto Series Analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132399 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132399: Elitech Clinical Systems Creatinine Pap SL, Elical 2, Elitrol I and Elitrol II, Urine Control BI-Level.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132399
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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