(30 days)
The HemoPoint® H2 Hemoglobin Measurement System is indicated for the quantitative determination of hemoglobin in arterial, venous, or capillary blood.
The microcuvettes part number 3010-100 are indicated for use in the HemoPoint® H2 Hemoglobin Measurement System and the Hemocue® measurement system. 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 HemoPoint® H2 Hemoglobin Measurement System is comprised of a HemoPoint® H2 Hemoglobin Photometer and HemoPoint® H2 Cuvettes. A modified azide methemoglobin method is used in the HemoPoint® H2 system. In the HemoPoint® H2, the use of microcuvettes with short light pathways makes it possible to analyze undiluted blood. The filled cuvette is inserted into the HemoPoint® H2 photometer, the color produced by the chemical reaction in the cuvette is measured, and the Hb level is calculated and displayed. In the HemoPoint® H2 photometer the light transmitted through the cuvette sample is measured. Light emitting diodes (LED's) are used as light sources and a photodiode to detect the light. The light emitting diodes utilize the central wavelengths 570 nm (for measurement) and 880 nm (for turbidity compensation).
Here's an analysis of the acceptance criteria and study details for the HemoPoint® H2 Hemoglobin Measurement System based on the provided 510(k) summary:
Acceptance Criteria and Device Performance for HemoPoint® H2 Hemoglobin Measurement System
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a separate section with specific numerical targets for all parameters. However, it presents "Comparison to Predicate Device" that implies the acceptance criteria are met if the device's performance is "equivalent" to the predicate or within acceptable clinical ranges. For precision and correlation, specific numerical results are provided.
| Metric / Parameter | Acceptance Criteria (Implied by Predicate Comparison or Performance Goal) | Reported HemoPoint® H2 Device Performance (HemoPoint® H2 cuvette measured in HemoPoint® H2 device) | Reported HemoPoint® H2 Device Performance (HemoPoint® H2 cuvette measured in HemoCue device) |
|---|---|---|---|
| Precision (Within-run imprecision) | ≤ 2% (overall stated goal) | ||
| Hemoglobin/high (15.7 g/dL) | (Not explicitly stated as a target, but compared) | Swr 0.087 g/dL, CV 0.5% | Swr 0.102 g/dL, CV 0.7% |
| Hemoglobin/low (11.8 g/dL) | (Not explicitly stated as a target, but compared) | Swr 0.070 g/dL, CV 0.6% | Swr 0.105 g/dL, CV 0.9% |
| Hemoglobin/normal (8.0 g/dL) | (Not explicitly stated as a target, but compared) | Swr 0.058 g/dL, CV 0.7% | Swr 0.068 g/dL, CV 0.8% |
| Precision (Total Precision) | (Not explicitly stated as a target, but compared) | ||
| Hemoglobin/high (15.7 g/dL) | (Not explicitly stated as a target, but compared) | ST 0.1747 g/dL, CV 1.1% | ST 0.302 g/dL, CV 1.9% |
| Hemoglobin/low (11.8 g/dL) | (Not explicitly stated as a target, but compared) | ST 0.162 g/dL, CV 1.4% | ST 0.198 g/dL, CV 1.6% |
| Hemoglobin/normal (8.0 g/dL) | (Not explicitly stated as a target, but compared) | ST 0.122 g/dL, CV 1.5% | ST 0.158 g/dL, CV 1.9% |
| Correlation Coefficient (vs. NCCLS H15-A3 reference) | ≥ 0.998 (for comparison to predicate) or high correlation for self-system | 0.999 (R=0.999) | Not applicable (this comparison is for HemoPoint H2 system vs. reference) |
| Correlation Coefficient (vs. HemoCue System) | > 0.995 (for HemoPoint® H2 cuvettes on HemoCue) | 0.995 (R=0.995) (for HemoPoint® H2 system vs. HemoCue) | 0.997 (R=0.997) (for HemoPoint® H2 cuvettes in HemoCue device vs. HemoCue) |
| Measurement range | 0 - 25.6 g/dL (Equivalent to predicate) | 0 - 25.6 g/dL | Equivalent (same as HemoPoint H2 self-system) |
| Specified accuracy | ± 0.3 g/dL at ≈ 14 g/dL (Equivalent to predicate) | ± 0.3 g/dL at ≈ 14 g/dL | Equivalent (same as HemoPoint H2 self-system) |
| Sample material | venous, arterial or capillary human blood (Equivalent to predicate) | venous, arterial or capillary human blood | Equivalent (same as HemoPoint H2 self-system) |
| Measuring time | Approximately 30 - 60 sec (Equivalent to predicate) | Approximately 30 - 60 sec | Equivalent (same as HemoPoint H2 self-system) |
| Measuring units | mol/L, g/dL, g/L (Equivalent to predicate) | mol/L, g/dL, g/L | Equivalent (same as HemoPoint H2 self-system) |
| Calibration | against NCCLS reference method (Equivalent to predicate) | against NCCLS reference method | Equivalent (same as HemoPoint H2 self-system) |
| Method | Azidemethemoglobin method (Vanzetti) (Equivalent to predicate) | Azidemethemoglobin method (Vanzetti) | Equivalent (same as HemoPoint H2 self-system) |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Test set sample size: For the correlation studies, the sample size was N=100 duplicate measurements for each comparison (HemoPoint H2 vs. NCCLS H15-A3, HemoPoint H2 vs. HemoCue, HemoPoint H2 cuvettes in HemoCue vs. HemoCue).
- Data provenance: The blood samples used were stated as venous blood. The country of origin is not specified in the provided summary, but the manufacturer is Stanbio Laboratory, located in Boerne, Texas, USA. The studies appear to be prospective as they are reported as experimental data for a device seeking 510(k) clearance, implying new testing was performed to support the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. This device is an automated hemoglobin measurement system. The "ground truth" is established through a recognized reference method (NCCLS H15-A3 standard) or comparison to an established predicate device (HemoCue System), rather than requiring expert qualitative assessment or interpretation.
4. Adjudication Method for the Test Set:
- None. As an automated quantitative measurement device, there is no need for an adjudication method in the context of expert review. The method for determining the reference values is through the specified chemical or instrumental reference methods.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is typically performed for devices that involve human interpretation, such as imaging systems or diagnostic aids. The HemoPoint® H2 is an automated quantitative measurement device and does not involve human interpretation of results that would necessitate an MRMC study.
6. Standalone Performance (Algorithm only without human-in-the-loop performance):
- Yes. The reported "Experimental Data" and "Precision" data represent the standalone performance of the device. The device provides a direct numerical output for hemoglobin concentration without requiring human intervention for interpretation beyond operating the instrument and collecting the sample. The comparisons are made against established reference methods or other automated devices.
7. Type of Ground Truth Used:
- The primary ground truth used is a reference method: NCCLS H15-A3. This is a recognized standard for total hemoglobin determination (cyanmethemoglobin method).
- Additionally, the device's performance (specifically the HemoPoint® H2 cuvettes) was compared against the HemoCue System, which serves as a predicate device and an established clinical standard for point-of-care hemoglobin measurement.
8. Sample Size for the Training Set:
- Not specified. The document does not provide details on a separate "training set" or how the device's algorithms (e.g., for calculating Hb from light absorbance) were developed or calibrated. The provided data focuses on validation and comparison to established methods. Automated systems like this are typically calibrated against known standards during manufacturing and do not usually have a "training set" in the machine learning sense that would be described in a 510(k) summary.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable / Not specified. As mentioned above, a "training set" in the typical machine learning context is not detailed. The ground truth for calibration would generally be established using internationally recognized hemoglobin standards and the NCCLS H15-A3 reference method, but this process is part of the device's design and manufacturing standards rather than a specific "training set" described in this summary. The device's calibration itself is stated to be "against NCCLS reference method."
§ 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).