(45 days)
Meter Trax is an assayed whole blood control used in monitoring the precision of laboratory testing procedures for the analytes listed in this package insert.
Meter Trax Control is a suspension of stabilized human red blood cell components with added constituents of animal origin, chemicals, stabilizers, and preservatives. This product is provided in liquid form for convenience.
The provided text describes a 510(k) premarket notification for a medical device called "Meter Trax Control." This document focuses on establishing substantial equivalence to a predicate device, rather than presenting a study design with acceptance criteria for a new, innovative device that would typically involve clinical performance evaluation.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details, type of ground truth) are not applicable in this context as the submission is not for a performance study evaluating a diagnostic algorithm's accuracy against human interpretation or a specific clinical endpoint. The document is about a quality control material whose performance is assessed through stability studies.
Here's an attempt to answer the applicable questions based on the provided text:
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
The document focuses on stability claims as the primary performance metrics for the Meter Trax Control. The predicate device's performance already established the acceptable ranges for these analytes.
| Performance Metric | Acceptance Criteria (Claim) | Reported Device Performance |
|---|---|---|
| Open Vial Stability | ||
| Hematocrit | Stable for 31 days at 2°C to 8°C | Claims stability for 31 days at 2°C to 8°C |
| Glucose | Stable for 31 days at 2°C to 8°C or 18°C to 30°C | Claims stability for 31 days at 2°C to 8°C or 18°C to 30°C |
| Hemoglobin | Stable for 31 days at 2°C to 8°C or 18°C to 30°C | Claims stability for 31 days at 2°C to 8°C or 18°C to 30°C |
| Shelf Life Stability | ||
| All Analytes | Stable for 180 days at 2°C to 8°C (until expiration date unopened) | Claims stability for 180 days at 2°C to 8°C |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated. The stability studies would involve a series of measurements over time, but the number of unique "samples" (e.g., batches, vials) tested is not provided.
- Data Provenance: Not explicitly stated, but assumed to be internal laboratory data generated by Bio-Rad Laboratories. The studies are prospective in nature for stability testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This device is a quality control material, not a diagnostic device requiring expert interpretation for ground truth. The stability of the analytes is measured directly using laboratory equipment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
5. 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
- Not Applicable. This is a quality control material and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a quality control material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Analytical Measurement: The "ground truth" for stability studies is defined by the analytical measurements of glucose, hemoglobin, and hematocrit over time, compared against their initial values and pre-defined acceptable ranges for precision. The stability is demonstrated if the analytes remain within these acceptable ranges for the stated duration.
8. The sample size for the training set
- Not Applicable. This device uses stability studies for performance assessment, not a training set for an algorithm.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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.