510(k) · Cleared
ClearedSynermed Creatinine Reagent Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synermed Intl., Inc. · CGX Alkaline Picrate, Colorimetry, Creatinine
Cleared on Feb 24, 1998 after a 55-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Feb 24, 1998
- Review
- 55 days
- Class
- Class II
- Product code
- CGX
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CGX? 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 CGX device
- #1 K242685 Atellica® CH Creatinine_3 (Crea3)score 12.1 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All CGX devicesCGX Alkaline Picrate, Colorimetry, Creatinine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CGX
25in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGX
2in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGX
34in 2025
MAUDE reports naming product code CGX, 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 | 4 | 25 | 0 | 15 |
| 2008 | 0 | — | 1 | 27 |
| 2009 | 1 | — | 2 | 5 |
| 2010 | 0 | — | 2 | 5 |
| 2011 | 0 | — | 1 | 32 |
| 2012 | 1 | — | 2 | 13 |
| 2013 | 1 | — | 0 | 24 |
| 2014 | 2 | — | 0 | 13 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 1 | — | 2 | 3 |
| 2017 | 0 | — | 0 | 21 |
| 2018 | 0 | — | 0 | 14 |
| 2019 | 0 | — | 0 | 25 |
| 2020 | 0 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 13 |
| 2022 | 1 | — | 0 | 23 |
| 2023 | 0 | — | 0 | 19 |
| 2024 | 2 | — | 0 | 32 |
| 2025 | 1 | — | 0 | 34 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Synermed® Creatinine reagent is intended for use in the quantitative determination of creatinine in serum by manual and automated methods. Creatinine concentration is increased when the glomerutar filtration is decreased. Blood urea rises more steeply than creatinine as renal function declines; with dialysis, urea levels fall more rapidly than creatinine concentration. With severe, permanent renal impairment, urea levels continue to climb while…
Read the full statement (108 words)
The Synermed® Creatinine reagent is intended for use in the quantitative determination of creatinine
in serum by manual and automated methods.
Creatinine concentration is increased when the glomerutar filtration is decreased. Blood urea rises
more steeply than creatinine as renal function declines; with dialysis, urea levels fall more rapidly
than creatinine concentration. With severe, permanent renal impairment, urea levels continue to
climb while creatinine levels tend to plateau.
Serum creatinine concentration is low in subjects with relatively small muscle mass, patients with
muscle disease, amputees, and cachetic patients. A serum creatinine level that would usually be
considered normal does not rule out the presence of impaired renal function.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974909 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974909: Synermed Creatinine Reagent Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974909
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026