# K200898: Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin

- Pathway: 510(k) (Traditional)
- Applicant: Medicon Hellas S.A
- Decided: Sep 21, 2021 after 536 days
- Product code: CIX (Bromcresol Green Dye-Binding, Albumin)
- Device class: 2
- Regulation: 21 CFR 862.1035
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K924964 (1992). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924368: Olympus Albumin Reagent, Olympus Corp. (1993) Summary page 5.
- K061575: Olympus Calcium Arsenazo Reagent, OSR60117, OSR61117, OSR65117, Olympus America, Inc. (2006) Summary page 5.
- K934361: Olympus Creatinine Reagent, Olympus Corp. (1993) Summary page 5.
- K944406: Olympus Glucose Reagent, Olympus America, Inc. (1995) Summary page 5.
- K022180: Direct Bilirubin, Abbott Laboratories (2002) Summary page 5.
- K924964: Olympus Total Bilirubin Reagent, Olympus Corp. (1992) Summary page 5.
- K944250: Urea Nitrogen Reagent, Olympus Corp of America (1995) Summary page 5.

## Most influential descendants
- K251157: Core Metabolic (2026), 0 descendants of its own

## Indications for use
Medicon Hellas Albumin: Reagent for the quantitative measurement of albumin in serum. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. Medicon Hellas Calcium: Reagent for the quantitative measurement of calcium in serum or urine. 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). Medicon Hellas Creatinine: Reagent for the quantitative measurement of creatinine in serum and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis. Medicon Hellas Glucose: Reagent for the quantitative measurement of glucose in serum and urine. 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. Medicon Hellas Direct Bilirubin; Reagent for the quantitative measurement of direct bilirubin (conjugated) in serum. Measurements of the level of direct bilirubin is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall blader block. Medicon Hellas Total Bilirubin; Reagent for the quantitative measurements of total bilirubin in serum. Measurements of the levels of total bilirubin is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block. Medicon Hellas Urea Nitrogen: Reagent for the quantitative measurement of urea nitrogen in serum and urine. Measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.

Source page: https://510kreport.com/device/K200898
Methodology: https://510kreport.com/methodology