(43 days)
HemoTrol® Duo is an assayed quality control material for professional use to verify the performance characteristics of the HemoCue® Hb 301 and the HemoCue® Hb 801 System. HemoTrol® Duo is intended for the quantitative determination of hemoglobin.
HemoTrol® Duo is an assayed hemoglobin quality control material intended for professional use in the verification of the performance characteristics of the HemoCue® 301 and HemoCue® 801 systems. HemoTrol® Duo contains stroma-free bovine hemolysate with hemoglobin in cyanmethemoglobin (CNMetHb) form and a bioburden-controlling agent. For daily quality control, three physiological relevant levels are available.
HemoTrol® Duo solutions are filled in reclosable plastic primary containers. Each bottle contains 1.0 ml of HemoTrol® Duo solution. The primary containers are equipped with colored polypropylene caps. Cap color depends on the concentration of hemoglobin (Low: red cap; High: blue cap). Two (2) bottles of the same level are placed in a plastic blister and packed in a product box together with the combined instructions for use (IFU) and value sheet. Both the primary containers and product box are labeled.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a formal table separate from the performance results. Instead, for "Expected values and Value Assignment," it details "Production acceptance range on Hb301" for batch release and "Label range" calculated from the measured mean. For precision/reproducibility and stability, the acceptance criteria are implied by the reported results being "within the defined acceptance criteria."
Implicit Acceptance Criteria and Reported Device Performance:
| Study Category | Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Precision/Reproducibility | Standard Deviation (SD) & Coefficient of Variation (CV) | "Total precision was within the defined acceptance criteria." Specific numerical criteria for SD/CV are not presented. | HemoCue Hb301 System: |
- Low: Mean 70.2 g/L, SD 2.0 g/L, CV 2.9%
- Normal: Mean 129.8 g/L, SD 3.2 g/L, CV 2.4%
- High: Mean 168.6 g/L, SD 3.8 g/L, CV 2.2%
HemoCue Hb801 System: - Low: Mean 65.0 g/L, SD 1.1 g/L, CV 1.7%
- Normal: Mean 117.0 g/L, SD 1.5 g/L, CV 1.2%
- High: Mean 154.5 g/L, SD 1.6 g/L, CV 1.0% |
| Open Vial Stability | Duration (days) at 30°C | "is stable for 31 days when stored at 30℃." (This is both the criterion and the result based on the study). | 31 days stable when stored at 30°C. |
| Closed Vial Stability | Duration (days) at 2-8°C | "is stable for 336 days when stored at 2-8ºC." (This is both the criterion and the result based on the study). | 336 days stable when stored at 2-8°C. |
| Value Assignment (Batch Release for Hb301) | Mean value (g/L) | - Low: 70.0 ± 2.5 g/L - Normal: 130.0 ± 2.5 g/L
- High: 170.0 ± 2.5 g/L | Not explicitly reported as device performance for new batches, but the method for achieving this is described. The batch "can be released for value assignment" if it meets these ranges. |
| Value Assignment (Label Range for Hb801) | Label range (g/L) | - Low: Measured mean ± 12 - Normal: Measured mean ± 21
- High: Measured mean ± 27 | Not explicitly reported as a performance metric, but rather a calculation method for the assigned value and range. |
2. Sample Size Used for the Test Set and Data Provenance
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Precision/Reproducibility:
- Sample Size: Three batches of control material for each of the three levels (Low, Normal, High), tested with five replicates per day over five operating days on 3 sites. This totals to 3 batches * 3 levels * 5 replicates * 5 days * 3 sites = 675 individual measurements per analyzer system (Hb301 and Hb801).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the study was conducted to demonstrate device performance, implying a prospective study design for this submission.
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Open Stability:
- Sample Size: Nine batches (3 batches of each level), monitored at three time points for a total of 34 days.
- Data Provenance: Not explicitly stated.
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Closed Stability:
- Sample Size: 21 batches of control material (3 batches of the three HemoTrol Duo levels "9 in total" suggests 9 batches tested, 3 per level, which were then monitored to determine shelf life, potentially across different production runs?). The phrasing "21 batches of a quality control were monitored" and then "Three (3) batches of the three HemoTrol Duo levels (9 in total)" is a bit conflicting. It safely confirms at least 9 batches (3 per level) were used, monitored up to 337 days.
- Data Provenance: Not explicitly stated.
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Value Assignment (Batch Release):
- Sample Size: Three samples of control materials (presumably from a batch being assessed) evaluated on three HemoCue Hb301 Systems, with three batches of microcuvettes. Each sample is measured once per microcuvette batch, providing 27 replicates per analyzer being qualified. This is a batch release process, not a test set for the device's overall performance.
- Data Provenance: Not explicitly stated; refers to ongoing production processes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This device is a quality control material for an analyzer system (HemoCue Hb 301 and Hb 801). The "ground truth" (or target values) for the control material is established through objective laboratory measurements on the respective analyzer systems, not through expert consensus on qualitative data or imaging. Therefore, no experts in the conventional sense (e.g., radiologists) are involved in establishing the ground truth of the control material itself.
4. Adjudication Method
N/A. As the ground truth is established by objective measurements on the specified analyzer systems, there is no need for an adjudication method by human experts. The process for "Value Assignment" described (mean of 27 measurements) serves a similar purpose of establishing a reliable target value.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No. An MRMC study is typically used for diagnostic devices that involve human interpretation (e.g., medical imaging). This device is a quality control material, which is measured objectively by an automated or semi-automated analyzer.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, implicitly. The performance data for precision/reproducibility and stability are measurements of the control material's characteristics when analyzed by the HemoCue Hb 301 and Hb 801 systems, which are objective measurement devices. Human involvement is primarily in operating the system and recording results, not in interpreting qualitative data, making this essentially a standalone performance assessment of the control material with the specified analyzers.
7. Type of Ground Truth Used
The ground truth for HemoTrol® Duo is established through objective, quantitative measurements of hemoglobin concentration using the HemoCue® Hb 301 and HemoCue® Hb 801 Systems. This is akin to a reference measurement or instrument-generated data, where the analyzer itself defines the 'truth' for the control material within its operational parameters.
8. Sample Size for the Training Set
N/A. This device is a quality control material and is not an AI/ML algorithm that requires a training set. The descriptions of "batches" refer to manufacturing lots of the control material, not data used for training an algorithm.
9. How the Ground Truth for the Training Set Was Established
N/A. As above, this device does not involve an AI/ML algorithm or a training set.
§ 864.8625 Hematology quality control mixture.
(a)
Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).(b)
Classification. Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.