510(k) · Cleared
ClearedCreatinine (Enzymatic)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermofisher Scientific OY · JFY Enzymatic Method, Creatinine
Cleared on Dec 3, 2007 as substantially equivalent to K024098 (Roche Diagnostics Corp., 2002) after a 252-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Dec 3, 2007
- Review
- 252 days
- Class
- Class II
- Product code
- JFY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003261 (2000). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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? (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 |
|---|---|---|---|
| * | K024098 | Cobas Integra Creatinine Plus Ver.2 AssaySummary page 3…ics Corporation, model COBAS Integra 700 Roche Diagnostics Corporation item: COBAS Integra Creatinine plus ver.2 (K024098). G. Substantial equivalence -similarities CREATININE (Enzymatic) is subst… | 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 7 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
- 2 of the 2 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. 2007, 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?
The CREATIN1NE (Enzymatic) is intended for quantitative in-vitro diagnostic determination of creatinine concentration in human serum, plasma (Li-heparin) or urine using T60 Clinical Chemistry Analyzers. Measurement of creatinine levels aids in the diagnosis and treatment of certain renal disease, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. For in vitro diagnostic use on T60 analyzer. sCal is used as a…
Read the full statement (176 words)
The CREATIN1NE (Enzymatic) is intended for quantitative in-vitro diagnostic determination of creatinine concentration in human serum, plasma (Li-heparin) or urine using T60 Clinical Chemistry Analyzers.
Measurement of creatinine levels aids in the diagnosis and treatment of certain renal disease,
in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
For in vitro diagnostic use on T60 analyzer.
sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy.
For in vitro diagnostic use for quantitative testing on T60 analyzer.
Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet. The given values are valid for T60 Clinical Chemistry Analyzers using methods defined by Thermo Fisher Scientific Oy.
For in vitro diagnostic use for quantitative testing on T60 analyzer.
Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet. The given values are valid for T60 Clinical Chemistry Analyzers using methods defined by Thermo Fisher Scientific Oy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070824 · printed Nov 5, 2026
Cite this page
510(k) Report. “K070824: Creatinine (Enzymatic).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070824
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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