510(k) · Cleared
ClearedSpotchem II Calcium, Magnesium, and Blood Urea Nitrogen Tests
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arkray, Inc. · CIC Cresolphthalein Complexone, Calcium
Cleared on Feb 15, 2005 after a 34-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Feb 15, 2005
- Review
- 34 days
- Class
- Class II
- Product code
- CIC
- 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 CIC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 CIC devicesCIC Cresolphthalein Complexone, Calcium: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CIC
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · CIC
Too few CIC 510(k)s in any year since 2007 to give a median.
Recalls per year · CIC
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CIC
10in 2025
MAUDE reports naming product code CIC, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 3 | 5 |
| 2010 | 0 | — | 2 | 83 |
| 2011 | 0 | — | 0 | 29 |
| 2012 | 0 | — | 0 | 10 |
| 2013 | 1 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 1 | 30 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 42 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SpotChem II Calcium test is intended to measure the concentration of calcium in serum, plasma and whole blood. Serum calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). The SpotChem II Magnesium test is intended to measure the concentration of magnesium in serum, plasma and whole blood. Magnesium measurements…
Read the full statement (131 words)
The SpotChem II Calcium test is intended to measure the concentration of calcium in serum, plasma and whole blood. Serum calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
The SpotChem II Magnesium test is intended to measure the concentration of magnesium in serum, plasma and whole blood. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).
The SpotChem II Blood Urea Nitrogen (BUN) test is intended to measure the concentration of urea nitrogen in serum, plasma and whole blood. Blood urea nitrogen measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K050077 · printed Nov 5, 2026
Cite this page
510(k) Report. “K050077: Spotchem II Calcium, Magnesium, and Blood Urea Nitrogen Tests.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050077
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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