Automated Hemoglobin System

An Automated Hemoglobin System is a medical device designed to measure haemoglobin (Hb) levels in blood samples with high precision and efficiency. Haemoglobin is a crucial protein in red blood cells responsible for oxygen transport throughout the body. This system is commonly used in clinical laboratories, hospitals, and point-of-care settings for diagnosing and monitoring conditions such as anaemia, polycythemia, and other haematological disorders.

An automated haemoglobin system is a fully automated or semi-automated device which may or may not be part of a larger system. The generic type of device consists of the reagents, calibrators, controls, and instrumentation used to determine the hemoglobin content of human blood.

Intended Use: It is intended to be used for the quantitative determination of haemoglobin (Hb) concentrations in human blood.

Device Description: This device provides a direct haemoglobin concentration measurement using single-use micro cuvettes and a photometric analyzer. The analyzer features precise photometric detection, a clear result display, and versatile power options via adapter or batteries. The polystyrene micro cuvettes are designed for single use and contain no reagents or active ingredients, ensuring reliable and contamination-free testing. This device is intended for prescription use only and is designed exclusively for in-vitro diagnostic applications.

• Accuracy
• Precision (Reproducibility and Repeatability)
• Linearity
• Traceability
• Sensitivity and Specificity
• Limit of Detection (LoD), Limit of Quantitation (LoQ), and Limit of Blank (LoB)
• Internal method comparison
• Within Measurement Equivalence Tests
• Reference range
• Software verification and validation

The same is applicable for CE Marking under IVDR also.

Applicable for 510k submission and IVDR CE Marking