510(k) · Cleared
Recalled · Class I · 2015Spotchem II Chemistry Basic 1 and Chemistry Basic 2 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 Mar 24, 2006 after a 108-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Mar 24, 2006
- Review
- 108 days
- Class
- Class II
- Product code
- CIC
- Recalls
- 1 (1 Class I)
- 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.
1 device in this family has a Class I recall. 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? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 18, 2015 | Class I | Z-0631-2016 | Component design/selection | One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip are being recalled due to a lowered reaction rate in the reagent pad for glucose. The affected lots will display a result of… |
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 IIChemistry Basic 1 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 Chemistry Basic I Blood Urea Nitrogen (BUN) test is intended to measure the concentration of urea nitrogen in…
Read the full statement (448 words)
The SPOTCHEM IIChemistry Basic 1 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 Chemistry Basic I 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.
The SPOTCHEM II Chemistry Basic 1 Glucose test is intended to measure the concentration in serum, plasma, and whole blood. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
The SPOTCHEM II Chemistry Basic 1 Albumin test is intended to measure the concentration in serum, plasma, and whole blood. Measurements of albumin are used in the diagnosis and treatment of numerous diseases involving the liver or kidneys.
The SPOTCHEM I!Chemistry Basic I 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 Chemistry Basic 2 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.
The SPOTCHEM II Chemistry Basic 2 Total Bilirubin test is intended to measure the levels of bilirubin in serum, plasma, and whole blood. Measurements of the levels of bilirubin are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
The SPOTCHEM II Chemistry Basic 2 Total Protein test is intended to measure total protein in serum, plasma, and whole blood. Measurements of total protein are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow, as well as other metabolic and nutritional disorders.
The SPOTCHEM 1I Chemistry Basic 2 AST test is intended to measure AST activity in serum, plasma, and whole blood. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
The SPOTCHEM II Chemistry Basic 2 ALT test is intended to measure ALT activity in serum, plasma, and whole blood. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K053401 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053401: Spotchem II Chemistry Basic 1 and Chemistry Basic 2 Tests.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053401
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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