510(k) · Cleared
ClearedDiazyme Creatinine Liquid Reagents Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diazyme Laboratories · JFY Enzymatic Method, Creatinine
Cleared on Apr 23, 2007 as substantially equivalent to K003261 (Roche Diagnostics Corp., 2000) and 1 other predicate after a 273-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Apr 23, 2007
- Review
- 273 days
- Class
- Class II
- Product code
- JFY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K002852 (2000). 8 ancestors in all, the oldest K992858 (1999). No later device cites it as a predicate yet.
- Root · 3 generations backK002852 N/T Protein Control SLDade Behring, Inc. · 2000
- 2 generations backK012468 Modification to N/T Protein Control SLDade Behring, Inc. · 2001
- 1 generation backK063206 Dimension Vista Hcys Flex Reagent Cartridge; Protein 1 Calibrator…Dade Behring, Inc. · 2006 · Recalled
- This deviceK062105 Diazyme Creatinine Liquid Reagents AssayDiazyme Laboratories · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002852 | N/T Protein Control SL | Dade Behring, Inc. | 2000 | — |
| −2 | K012468 | Modification to N/T Protein Control SL | Dade Behring, Inc. | 2001 | — |
| −1 | K063206 | Dimension Vista Hcys Flex Reagent Cartridge; Protein 1 Calibrator; Protein 1… | Dade Behring, Inc. | 2006 | 3 |
| 0 (this device) | K062105 | Diazyme Creatinine Liquid Reagents Assay | Diazyme Laboratories | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2006 | 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? (2)
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…cate Device: For the Creatinine test system, we are claiming equiva- lence [807.92(a) (3) to CREATININE PLUS (k003261) manufactured by Roche Diagnostics GmbH, D-68298 Ma… | 2000 |
| * | K063206 | Dimension Vista Hcys Flex Reagent Cartridge; Protein 1 Calibrator; Protein 1 Control… Cleared while this submission was under review Summary page 1…eatinine control which is a single (specified) analyte controls (assayed), the predicate is k063206 16 Pre-ma… | 2006 |
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 9 months on median.
- 5 of the 8 ancestors have a recall of any class.
- 5 other devices also cite its predicate K003261.
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?
Diazyme Creatinine Liquid Reagents Assay, in conjunction with Diazyme Creatinine Calibrator, is intended for the quantitative determination of creatinine in serum 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. For in vitro diagnostic use only.
Diazyme Creatinine Control is an assayed QC material for use in quantitative in vitro diagnostic determination of creatinine in human serum and urine. It is intended as a reference sample for monitoring the Diazyme Creatinine Liquid Reagents Assay for gross systematic errors. For in vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062105 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062105: Diazyme Creatinine Liquid Reagents Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062105
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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