510(k) · Cleared
ClearedSpotchem II Creatinine, Amylase & Alp Tests
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arkray, Inc. · CGX Alkaline Picrate, Colorimetry, Creatinine
Cleared on Apr 6, 2005 after a 23-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 6, 2005
- Review
- 23 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 SPOTCHEM II Creatinine test is intended to measure the concentration of creatinine in serum, plasma, and whole blood. 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. The SPOTCHEM II Amylase test is intended to measure amylase activity in serum, plasma, and whole blood. Amylase measurements are used primarily for the…
Read the full statement (116 words)
The SPOTCHEM II Creatinine test is intended to measure the concentration of
creatinine in serum, plasma, and whole blood. 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.
The SPOTCHEM II Amylase test is intended to measure amylase activity in serum,
plasma, and whole blood. Amylase measurements are used primarily for the diagnosis
and treatment of pancreatitis (inflammation of the pancreas).
The SPOTCHEM II ALP test is intended to measure ALP activity in serum, plasma, and
whole blood. Measurements of alkaline phosphatase or its isoenzymes are used in the
diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K050652 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050652: Spotchem II Creatinine, Amylase & Alp Tests.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050652
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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