# K973869: Trace Reagent Line for the Cobas Mira

- Pathway: 510(k) (Traditional)
- Applicant: Trace America, Inc.
- Decided: Jan 7, 1998 after 105 days
- Product code: CKA (Nadh Oxidation/Nad Reduction, Alt/Sgpt)
- Device class: 1
- Regulation: 21 CFR 862.1030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have 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.

## Most influential descendants
- K072115: Abx Pentra Creatinine 120 CP, Total Protein 100 CP, Multical, N and P Controls, and Urine Control L/H (2007), 0 descendants of its own

## Indications for use
intended for the the In Vitro, quantitative determination of ALT (L-Alanine;2-Oxoglutarate Aminotransferase EC2.6.1.2) in human serum on the Cobas MIRA ® clinical chemistry system. This alanine aminotransferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine aminotransferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g. viral hepatitus and cirrhosis) and heart diseases. CFR 862.1030 intended for the the In Vitro, quantitative determination of XAMYLASE (1,4-X- D glucan glucanohydrolase EC3.2.1.1) in human serum and urine on the Cobas MIRA ® clinical chemistry system. This Amylase test system is a device intended to measure the activity of the enzyme Amylase in serum and urine . Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas) CFR 862.1070 Intended for the the In Vitro, quantitative determination of AST (Aspartate aminotransferase EC2.6.1.1) in human serum on the Cobas MIRA ® clinical chemistry system. This "aspartate aminotransferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate aminotransferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liverand heart disease.” CFR 862.1100 Intended for the the In Vitro, quantitative determination of Direct Bilirubin in human serum on the Cobas MIRA ® clinical chemistry system. This "Direct Bilirubin test system is a device intended to measure the levels of bilirubin (direct) in plasma or serum. Measurements of levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, if used in the diagnosis and treatment of the liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block." CFR 862.1110 Intended for the the In Vitro, quantitative determination of Total Bilirubin in human serum on the Cobas MIRA ® clinical chemistry system. This "Total Bilirubin test system is a device intended to measure the levels of bilirubin (Total) in plasma or serum. Measurements of levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, if used in the diagnosis and treatment of the liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block." CFR 862.1110 Intended for the the In Vitro, quantitative determination of Calcium in human serum or urine on the Cobas MIRA ® clinical chemistry system. This “Calcium test system is a device intended to measure the total calcium level in 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” CFR 862.1145 Intended for the the In Vitro, quantitative determination of Total CO2 in human serum on the Cobas MIRA ® clinical chemistry system. This " bicarbonate/ carbon dioxide test system is a device intended to measure the total bicarbonate/carbon dioxide plasma, serum and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid base balance. * CFR 862.1160 Intended for the the In Vitro, quantitative determination of Chloride in human serum on the Cobas MIRA ® clinical chemistry system. This " Chioride test system is a device intended to measure the Chloride in plasma, serum, sweat and urine. Chioride measurements are used in the diagnosis and treatment of electrolyte and metaboiic disorders such as cystic fibrosis and diabetic acidosis. " CFR 862.1170 Intended for the the In Vitro, quantitative determination of Cholesterol in human serum on the Cobas MIRA ® clinical chemistry system. This " Cholesterol test system is a device intended to measure the Cholesterot in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. " CFR 862.1175 Intended for the the In Vitro, quantitative determination of Creatinine in human serum and urine on the Cobas MIRA ® clinical chemistry system. This " Creatinine test system is a device intended to measure the Creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases,in monitoring renal dialysis, and a calculation basis for measuring other urine analytes. " CFR 862.1225 Intended for the the In Vitro, quantitative determination of Glucose in human serum and urine on the Cobas MIRA ® clinical chemistry system. This " Glucose test system is a device intended to measure the Glucose levels in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus,neonatal hypoglycemia , idiopathic hypoglycemia and pancreatic islet cell carcinoma. “ CFR 862.1360 intended for the the In Vitro, quantitative determination of Iron in human serum on the Cobas MIRA ® clinical chemistry system. This " Iron (non-heme) test system is a device intended to measure Iron (non-heme)in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia , hemochromatosis ( a disease associated with widespread deposit in the tissues of two iron containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin) and chronic renal disease. " CFR 862.1410 Intended for the the In Vitro, quantitative determination of Magnesium in human serum and urine on the Cobas MIRA ® clinical chemistry system. This " Magnesium test system is a device intended to measure magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnasemia (abnormally high levels of magnesium). " CFR 862.1495 Intended for the the In Vitro, quantitative determination of Inorganic Phosphorus in human serum or urine on the Cobas MIRA ® clinical chemistry system. This " Phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases , and vitamin D imbalance. " CFR 862.1580 Intended for the the In Vitro, quantitative determination of Total Protein in human serum on the Cobas MIRA ® clinical chemistry system. This " Total Protein test system is a device intended to measure Total protein(s) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney or bone marrow as well as other metabolic or nutritional disorders " CFR 862. 1635 intended for the the In Vitro, quantitative determination of Triglycerides in human serum on the Cobas MIRA ® clinical chemistry system. This " Triglyceride test system is a device intended to measure Triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders. " CFR 862.1705 Intended for the the In Vitro, quantitative determination of Urea Nitrogen in human serum or urine on the Cobas MIRA ® clinical chemistry system. This " urea nitrogen test system is a device intended to measure urea nitrogen (an end product of nitrogen metabolism) in whole blood, serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases. " CFR 862.1770 intended for the the In Vitro, quantitative determination of Unbound lron-Binding Capacity (UIBC) in human serum on the Cobas MIRA ® clinical chemistry system. This " Iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. lron-binding capacity measurements are used in the diagnosis and treatment of anemia. " CFR 862.1415 Intended for the the In Vitro, quantitative determination of Uric Acid in human serum or urine on the Cobas MIRA ® dlinical chemistry system. This " Uric Acid test system is a device intended to measure uric acid in serum, plasma or urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs. " CFR 862.1775

Source page: https://510kreport.com/device/K973869
Methodology: https://510kreport.com/methodology