# K053401: Spotchem II Chemistry Basic 1 and Chemistry Basic 2 Tests

- Pathway: 510(k) (Traditional)
- Applicant: Arkray, Inc.
- Decided: Mar 24, 2006 after 108 days
- Product code: CIC (Cresolphthalein Complexone, Calcium)
- Device class: 2
- Regulation: 21 CFR 862.1145
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Dec 18, 2015 · Class I · Z-0631-2016: 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 l

## Indications for use
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.

Source page: https://510kreport.com/device/K053401
Methodology: https://510kreport.com/methodology