Medicon Hellas Albumin, Calcium, Creatinine, Urea Nitrogen, Glucose, Total Bilirubin, Direct Bilirubin
by Medicon Hellas S.A EUDAMED510(k)
Active
510(k) K200898
Overview
This device is a Bromcresol Green Dye-Binding test system for quantitative measurement of albumin, calcium, creatinine, glucose, total bilirubin, direct bilirubin, and urea nitrogen in human serum or urine. It falls under the clinical chemistry category and is designed to support diagnostic evaluation of liver, kidney, metabolic, and carbohydrate-related conditions by providing precise biochemical analysis.
The test systems are supplied as single-use reagents for in vitro diagnostic use, adhering to FDA 510(k) clearance and IVDR compliance. They are intended for laboratory settings and require proper storage as per manufacturer instructions. Each product is assigned specific registration numbers and product codes for regulatory tracking, ensuring traceability and adherence to clinical chemistry standards.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK200898 | Date21 Sep 2021 | StatusActive |
| European Union | CE/IVDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- Full name
- Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin
- 510(k) Number
- FDA Product Code
- CIX
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1035
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Medicon Hellas S.A
Questions
What specific biochemical parameters can this test system measure, and how does it support clinical decision-making?
This test system measures albumin, calcium, creatinine, glucose, total bilirubin, direct bilirubin, and urea nitrogen in human serum or urine using the Bromcresol Green dye-binding method. It helps clinicians evaluate liver function (e.g., bilirubin levels), kidney function (e.g., creatinine and urea nitrogen), metabolic health (e.g., calcium and glucose), and overall protein status (e.g., albumin). These measurements aid in diagnosing and monitoring conditions like diabetes, liver disease, kidney dysfunction, and metabolic disorders.
Are these reagents single-use only, and if so, why is this important for laboratory workflow?
Yes, these reagents are supplied as single-use only, as explicitly stated in the device description. This design ensures accuracy and reliability by preventing cross-contamination between samples, reducing the risk of inaccurate results from repeated use. Single-use also aligns with best practices for in vitro diagnostics, minimizing the need for reprocessing and maintaining consistency in test performance.
How should these reagents be stored, and what happens if storage instructions aren’t followed?
The manufacturer’s instructions specify proper storage conditions, though exact details (e.g., temperature, light exposure) aren’t provided in the data. Deviating from these guidelines—such as exposing reagents to improper temperatures or light—could compromise their stability, accuracy, or sterility. Since these are single-use in vitro diagnostics, improper storage may lead to invalid results, potential contamination, or loss of efficacy, impacting diagnostic reliability.
What regulatory pathways does this device follow, and how does that affect its use in clinical settings?
This device is cleared under FDA 510(k) (with a *Substantially Equivalent* determination) and complies with the In Vitro Diagnostic Regulation (IVDR). The FDA clearance confirms it meets U.S. safety and performance standards for clinical chemistry tests, while IVDR compliance ensures adherence to EU requirements for accuracy, traceability, and risk management. Clinicians can rely on these pathways to validate the device’s regulatory standing and its suitability for diagnostic use in their respective regions.
Are there multiple product models, and if so, how do I identify the correct one for my lab’s needs?
Yes, this family of products includes separate reagents for each parameter (e.g., Medicon Hellas Albumin, Medicon Hellas Creatinine, etc.), each with unique registration numbers (e.g., 3004192065 for Albumin) and product codes (all listed under *CIX*). To select the correct one, match your lab’s specific biochemical test requirements—e.g., if you need to measure glucose, use the *Medicon Hellas Glucose* reagent (registration #1000305841). The distinct identifiers ensure traceability and compatibility with your lab’s existing systems.