(21 days)
The Hemo-Control Hemoglobin Measurement System is indicated for the quantitative determination of hemoglobin in arterial, venous, or capillary blood.
The microcuvettes part number 3000-3012-0765 are indicated for use in the Hemo-Control Hemoglobin Measurement System and compatible measurement systems. The microcuvettes are intended to be used only once and must be disposed of after use as potentially infectious waste.
Estimation of hematocrit as a function of Hemoglobin is performed for normal hemoglobin ranges only (120 to 180 g/liter or 12.0 to 18.0 g/deciliter). The estimated hematocrit is not indicative of disease states such as anemia and abnormal values will not be reported.
For In Vitro Diagnostic Use Only
The Hemo-Control Hemoglobin Measurement System is comprised of a Hemo-Control Hemoglobin Measurement Photometer and Hemo-Control Microcuvettes. The scope of this 510(k) is limited to a modification of the microcuvettes.
The Hemo-Control Microcuvettes are single-use microcuvettes filled with dry reagents. A modified azide methemoglobin method is used. The use of microcuvettes with short light pathways makes it possible to analyze undiluted blood. The filled microcuvette is inserted into the Hemo-Control Hemoglobin Measurement Photometer, the color produced by the chemical reaction in the microcuvette is measured, and the Hb level is calculated and displayed. Light emitting diodes (LED's) are used as light sources with a photodiode to detect the light.
The plastic microcuvette consists of a clear body with a cavity which takes up approximately 10 µL of blood which combines with the dry reagent chemistry. The optical distance between the microcuvette walls is fixed and permits photometric determination of the hemoglobin in undiluted blood samples using the Lambert-Beers Law. The microcuvette optical and chemical characteristics are unchanged by the modification.
The Hemo Control Hemoglobin Measurement System with the microcuvette modification employs the identical fundamental scientific technology as the predicate device(s).
The provided documentation describes the acceptance criteria and a study demonstrating that the modified Hemo_Control Microcuvettes meet these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The study primarily focuses on precision and correlation with a reference method. The acceptance criteria can be inferred from the reported precision (low CV%) and strong correlation (high R^2).
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria (Implied) | Reported Device Performance (Hemo_Control modified microcuvette) |
|---|---|---|---|
| Precision | Within-Run CV% | Low CV% (e.g., 0.95) | 0.9955 (compared to CLSI H15-A3 reference method) |
| Linearity/Bias | Regression slope | Close to 1.0 (e.g., 0.95-1.05) | 1.0086 |
| Regression intercept | Close to 0.0 | 0.2929 |
Note: The acceptance criteria are "implied" as specific numeric thresholds are not explicitly stated as "acceptance criteria" but rather as "results obtained" that demonstrate substantial equivalence.
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: 100 samples
- Data Provenance: The document does not explicitly state the country of origin. The test used venous blood samples. It is a retrospective analysis in the sense that the samples were already collected and then tested. The study design appears to be a laboratory evaluation (non-clinical test).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This study is a non-clinical laboratory test comparing a device's performance to a reference method, not an interpretative study requiring human expert ground truth.
- Number of Experts: Not applicable, as the ground truth was established by a reference method.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
Not applicable. This was a direct comparison to a reference method, not an interpretative study requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is a non-clinical laboratory evaluation of a modified medical device against a reference standard, not an AI-assisted diagnostic tool involving human readers.
6. Standalone Performance Study
Yes, a standalone performance study was done. The precision and correlation data presented represent the performance of the modified microcuvette with the Hemo_Control device, without human interpretation as part of the measurement process. It's a "device only" performance evaluation.
7. Type of Ground Truth Used
The ground truth was established by a reference method, specifically the CLSI H15-A3 standard for the quantitative determination of hemoglobin in blood.
8. Sample Size for the Training Set
Not applicable. This device is a measurement system, and the study described is a validation study for a device modification, not a machine learning model that requires a training set. The "device" already has its algorithm embedded.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for a machine learning model was used.
§ 864.5620 Automated hemoglobin system.
(a)
Identification. An automated hemoglobin 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.(b)
Classification. Class II (performance standards).