510(k) · Cleared
Recalled · 2009Enzymatic Creatinine Assay (265 Series)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Chemicals, Ltd. · JFY Enzymatic Method, Creatinine
Cleared on Jun 22, 2007 as substantially equivalent to K003261 (Roche Diagnostics Corp., 2000) after a 133-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 22, 2007
- Review
- 133 days
- Class
- Class II
- Product code
- JFY
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003261 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK003261 Creatinine PlusRoche Diagnostics Corp. · 2000 · Recalled
- This deviceK070383 Enzymatic Creatinine Assay (265 Series)Diagnostic Chemicals, Ltd. · 2007
- Descendant · cites it directly · 1 of its ownK110137 Abx Pentra Enzymatic Creatinine CP, Abx Pentra Multical, Abx Pentra…Horiba Abx Sas · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK193649 Yumizen C1200 Creatinine PAPHoriba Abx Sas · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003261 | Creatinine Plus | Roche Diagnostics Corp. | 2000 | 1 |
| 0 (this device) | K070383 | Enzymatic Creatinine Assay (265 Series) | Diagnostic Chemicals, Ltd. | 2007 | — |
| +1 | K110137 | Abx Pentra Enzymatic Creatinine CP, Abx Pentra Multical, Abx Pentra N Control… | Horiba Abx Sas | 2011 | 2 |
| +2 | K193649 | Yumizen C1200 Creatinine PAP | Horiba Abx Sas | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2021 | 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? (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 |
|---|---|---|---|
| * | K003261 | Creatinine PlusSummary page 1…FDA Regulation Name: 862.1225 Creatinine Test System FDA Product Code: JFY Predicate Device: Roche Diagnostics Corp. Creatinine Plus (K003261) Device Description: The Enzymatic Creatinine Assay contains an in vitro diagnostic reagent system intended… | 2000 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110137 | Abx Pentra Enzymatic Creatinine CP, Abx Pentra Multical, Abx Pentra N Control, Abx… | 2011 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 12, 2009 | Not classified | Z-2326-2009 | Labeling Change Control | Labeled with extended expiration date (24 months instead of 18 months) |
| Feb 12, 2009 | Not classified | Z-2327-2009 | Labeling Change Control | Labeled with extended expiration date (24 months instead of 18 months) |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 Diagnostic Chemicals Limited Enzymatic Creatinine Assay is for the quantitative determination of creatinine in serum, plasma and urine. 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. This device is intended for professional use and INVITRO diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070383 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070383: Enzymatic Creatinine Assay (265 Series).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070383
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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