(100 days)
The Hgb Pro Professional Hemoglobin Testing System™ consists of a portable, battery operated meter and single-use test strips for the quantitative measurement of total hemoglobin from capillary or venous (EDTA) whole blood. The Hgb Pro Professional Hemoglobin Testing System is designed for near patient testing in a professional facility. The Hgb Pro Professional Hemoglobin Testing System is not intended for home use.
For In Vitro Diagnostic Use Only
The Hgb Pro Professional Hemoglobin Testing System™ consists of a portable, battery operated meter and single-use test strips for the quantitative measurement of total hemoglobin from capillary or venous (EDTA) whole blood. The Hgb Pro Professional Hemoglobin Testing System is designed for near patient testing in a professional facility. The Hgb Pro Professional Hemoglobin Testing System is not intended for home use.
The Hgb Pro meter utilizes optical reflectance for determination of total hemoglobin. The test strip, containing a membrane preloaded with a dried reagent containing a red cell lysing agent, is inserted into the meter. A drop of whole blood is applied to the test location on the strip after a baseline reading is taken. Blood immediately disperses within the membrane, resulting in lysis of red blood cells and release of hemoglobin. The meter's optical detectors automatically measure the change in membrane reflectance.
The meter calculates and displays the total hemoglobin concentration in grams/deciliter (s/dL, equivalent to percent) or millimole/L) based on a mathematical conversion table, which is programmed into the instrument. Minor adjustments may be made to the conversion on a lot-by-lot basis based on variation of the raw materials and process to ensure accuracy with the laboratory system. The test result will be displayed in 30 seconds or less.
Here's a breakdown of the acceptance criteria and study information for the ITC Hgb Pro Professional Hemoglobin Testing System, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the "Summary of Performance Data, Linearity and Precision" section, where the device's performance is compared against known standards and other devices. While explicit "acceptance criteria" are not formally listed with specific thresholds as such, the reported performance demonstrates "substantial equivalence" to a standard clinical laboratory instrument (Coulter MD8) and "clinical equivalence" to the Hemocue Test System.
Table of Performance Data:
| Performance Metric | Implied Acceptance Criteria / Standard | Reported Device Performance (Hgb Pro) | Notes |
|---|---|---|---|
| Linearity | Linear between 4.0 to 24.0 g/dl within 5% of the estimated linear regression line at a 95% confidence level (per NCCLS guideline EP6-P) | Linear between 4.0 to 24.0 g/dl within 5% of the estimated linear regression line at a 95% confidence level. Regression: Y=0.974x+0.264, r=0.99 | Assessed with one lot of strips and 7 hemoglobin concentrations (single normal donor). |
| Precision (Commercial Controls) | Assessed using NCCLS EP5-T2 guidelines (no explicit threshold given, but values are reported) | Level I (Mean=6.86 g/dL): Within SD=0.17, %CV=2.41; Total SD=0.18, %CV=2.66 | |
| Level II (Mean=11.33 g/dL): Within SD=0.20, %CV=1.73; Total SD=0.25, %CV=2.17 | |||
| Level III (Mean=15.63 g/dL): Within SD=0.18, %CV=1.14; Total SD=0.29, %CV=1.86 | Tested repeatedly for 20 days with commercial controls (Streck, Para 4®) using 4 instruments and 2 strip lots. | ||
| Precision (Whole Blood Samples) | Assessed by comparing with Coulter MD8 Laboratory instrument (no explicit threshold given, but values are reported) | Level I (Range 6.0-6.4 g/dL, Mean=6.30): SD=0.14, %CV=2.25 | |
| Level II (Range 13.0-13.4 g/dL, Mean=13.44): SD=0.32, %CV=2.35 | |||
| Level III (Range 19.4-19.9 g/dL, Mean=19.88): SD=0.39, %CV=1.97 | Tested with freshly prepared whole blood samples (normal donor blood) over 3 days, using 9 instruments and 3 unique strip lots. Hemoglobin levels confirmed with Coulter MD8. | ||
| Accuracy (Hgb Pro vs. HemoCue) | Substantial equivalence (demonstrated by high correlation coefficient 'r' and regression equation close to y=x) | All ages combined: y=1.02x - 0.71, r=0.99 (venous samples) | |
| Adults only: y=1.01x - 0.62, r=0.99 (venous samples) | |||
| Neonate / Pediatric: y=1.02x - 0.68, r=0.99 (venous samples) | |||
| Fingerstick (Hgb Pro vs. HemoCue): y=0.78x + 3.01, r=0.78 | Comparison with HemoCue, another CLIA Waived "point of care" system. | ||
| Accuracy (Hgb Pro vs. Coulter) | Substantial equivalence (demonstrated by high correlation coefficient 'r' and regression equation close to y=x) | All ages combined: y=1.01x - 0.37, r=0.99 (venous samples) | |
| Adults only: y=1.05x - 0.89, r=0.98 (venous samples) | |||
| Neonate / Pediatric: y=0.99x - 0.25, r=0.99 (venous samples) | |||
| Fingerstick (Hgb Pro vs. Coulter): y=0.96x + 1.18, r=0.84 | Comparison with Coulter MD8 (standard clinical laboratory instrument). |
Study Information:
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Sample Size Used for the Test Set and Data Provenance:
- Linearity Study: 7 hemoglobin concentrations prepared from a single normal donor. Multiple Hgb Pro instruments (n=5) were tested twice at each concentration.
- Precision (Commercial Controls): n=80 for each of the three levels of commercial controls.
- Precision (Whole Blood Samples): Level I: N=87; Level II: N=90; Level III: N=90. These were freshly prepared whole blood samples from normal donors.
- Accuracy (Hgb Pro vs. HemoCue / Coulter, venous samples):
- All ages combined: n=232 (Hgb Pro vs. HemoCue); n=226 (Hgb Pro vs. Coulter).
- Adults only: n=162.
- Neonate / Pediatric: n=70 (Hgb Pro vs. HemoCue); n=64 (Hgb Pro vs. Coulter).
- Accuracy (Hgb Pro vs. HemoCue / Coulter, fingerstick samples): n=87.
- Data Provenance: The document does not explicitly state the country of origin for the patient data. It mentions "Physician Office and Hospital Populations combined" and "normal donor" samples. It appears to be prospective for linearity and precision studies as samples were prepared and tested. For accuracy studies, it is implied to be clinical data from "Physician Office and Hospital Populations," which could be prospective or retrospective collections, but the wording suggests data collection for the purpose of the study.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The document does not mention the use of experts or their qualifications for establishing ground truth. The ground truth for quantitative hemoglobin measurements is typically established by reference laboratory instruments or validated methods, not by human expert opinion.
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Adjudication Method for the Test Set:
- No adjudication method is mentioned as this device measures a quantitative value and does not rely on subjective interpretation by multiple readers.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC study was done. This device provides quantitative measurements, not diagnostic images or interpretations that typically involve multiple readers. The comparison is against established laboratory instruments and other point-of-care devices.
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Standalone (i.e. algorithm only without human-in-the loop performance) Study:
- Yes, the performance data presented are for the standalone device (Hgb Pro system) measuring hemoglobin concentration. There is no mention of a "human-in-the-loop" component for interpretation; the device displays a numerical result. The accuracy studies compare the Hgb Pro's numerical output against other standalone devices (HemoCue and Coulter MD8).
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Type of Ground Truth Used:
- Reference Instrument/Method: The primary ground truth for accuracy and precision studies was established by comparing the Hgb Pro device's readings against a standard clinical laboratory instrument (Coulter MD8) and another commercial device, the Hemocue Test System. For precision with whole blood samples, the daily-prepared control hemoglobin levels were confirmed with the Coulter MD8 Laboratory instrument. For linearity, the ground truth was derived from prepared concentrations of hemoglobin, and the expectation was linearity relative to these known concentrations.
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Sample Size for the Training Set:
- The document does not specify a separate "training set" sample size. The Hgb Pro system is described as utilizing optical reflectance with a "mathematical conversion table, which is programmed into the instrument." It also states "Minor adjustments may be made to the conversion on a lot-by-lot basis based on variation of the raw materials and process to ensure accuracy with the laboratory system." This suggests that calibration and algorithm development might have used internal data, but these details are not provided as a distinct "training set." The performance data presented are primarily validation data.
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How the Ground Truth for the Training Set Was Established:
- As noted above, a distinct "training set" and its ground truth establishment are not explicitly described in the provided text. The implication is that the instrument's programmed conversion table and lot-by-lot adjustments are developed and validated to align with established laboratory methods (like the Coulter MD8).
§ 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).