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The HemoCue® Hb 301 System is intended for quantitative determination of hemoglobin in primary care or blood donation settings.

The HemoCue® Hb 301 System is intended to be used to determine the hemoglobin concentration for adults, adolescents, children, and infants above 1 month old in primary care setting.

The HemoCue® Hb 301 System is intended to be used to determine the hemoglobin concentration for adults in blood donation setting.

The HemoCue® Hb 301 System is for professional in vitro diagnostic use only.

The HemoCue® Hb 301 System provides a direct reading of the hemoglobin concentration in a sample using specially designed, single use microcuvette and an analyzer. The system can be used by non-laboratory personnel.

The HemoCue® Hb 301 System consists of the following parts:

• An analyzer supporting the following features:
  • Photometric determination of hemoglobin
  • Presentation of results on a display
• Power supply by power adapter or four AA batteries
• Single use microcuvettes (test consumable)
• Labeling:
  • Operating Manual
  • Package Insert
  • Quick reference Guide
  • Labels

The microcuvette serves both as a pipette and as a measuring cuvette. No dilution or other preparation of the blood sample is required before filling of the microcuvette. A whole blood sample of approximately 10 µL is drawn into the cavity in the microcuvette by capillary action.

The measurement takes place in the analyzer, which measures the absorbance of whole blood at an Hb/ HbO2 isosbestic point. The measurement is performed directly on the whole blood through measurement of the transmitted and scattered light and using an algorithm for translation into the hemoglobin concentration of the sample.

The HemoCue® Hb 301 System is traceable to the hemiglobincyanide (HiCN) method, the international reference method according to ICSH for the determination of the hemoglobin concentration in blood.

Here's the breakdown of the acceptance criteria and the study for the HemoCue® Hb 301 System, based on the provided document:

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: 71 pediatric blood samples.
   • Data Provenance: Tested at one European clinical laboratory site. The data appears to be prospective as it describes a specific evaluation done to compare the device to the reference method and predicate device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not specify the number or qualifications of experts used to establish ground truth.

3. Adjudication method for the test set:

   • The document does not specify an adjudication method. The ground truth was established by a reference method (ICSH), which inherently has its own established protocol for measurement, rather than relying on expert consensus adjudication in this context.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, this is not applicable. The HemoCue® Hb 301 System is an automated hemoglobin analysis device, not an AI-assisted diagnostic tool that human readers would interpret. Therefore, an MRMC study related to human reader improvement with AI is irrelevant to this device.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, in essence. The study described is a direct comparison of the device's measurements (algorithmically determined hemoglobin concentration from photometric readings) against a reference method and a predicate device. The HemoCue® Hb 301 System itself performs the analysis without human interpretation of the final result. While "human-in-the-loop" isn't strictly defined for this type of device, the performance presented is of the automated system.

6. The type of ground truth used:

   • The primary ground truth used was the hemiglobincyanide (HiCN) method (ICSH reference method) for the determination of hemoglobin concentration.

7. The sample size for the training set:

   • The document does not explicitly state a sample size for a "training set" in the context of machine learning, as this device uses spectrophotometric measurements and an algorithm for translation into hemoglobin concentration, rather than a deep learning model that requires a distinct, large training set. The system is described as "factory calibrated."

8. How the ground truth for the training set was established:

   • The document states that "The HemoCue® Hb 301 System is traceable to the hemiglobincyanide (HiCN) method, the international reference method according to ICSH for the determination of the hemoglobin concentration in blood." This implies that the factory calibration (which is analogous to what might be considered a "training" or calibration phase for the device's internal algorithm) was established using the ICSH reference method as the gold standard. Specific details on the establishment of this ground truth for the factory calibration are not provided in this specific excerpt, beyond stating its traceability.

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