(31 days)
The Liquid Stable Hemoglobin A1c Control is intended for use as a quality control material to monitor the performance of laboratory testing procedures for HbA1c quantitation. The control is designed for use with lon exchange HPLC assays, Immunoassay based analyses and Boronate Affinity based assays.
The use of quality control materials is indicated as an objective assessment of the precision and bias of methods and techniques in use and is an integral part of good laboratory practices. The two levels of controls allow performance monitoring within the clinical range.
The controls are for in vitro diagnostic use only and should not be used past the expiry date.
The Liquid Stable HbA1c Control is a bi-level liquid HbA1c control that is prepared from human red cells. The control should be treated the same as patient specimens and tested following the instructions included with the instrument, kit or reagent being used.
The provided text describes a 510(k) summary for a "Liquid Stable HbA1c Control" device. This device is a quality control material, not an AI-powered diagnostic tool. Therefore, many of the typical acceptance criteria and study elements associated with AI diagnostic devices (such as sensitivity, specificity, MRMC studies, ground truth establishment by experts, and training/test sets) are not applicable here.
Instead, the "acceptance criteria" for a quality control material primarily revolve around its stability and performance characteristics in monitoring laboratory testing procedures. The study described focuses on validating these stability claims.
Here's an adaptation of the request to fit the context of a quality control material:
1. Table of Acceptance Criteria (or Performance Claims) and Reported Device Performance
| Feature/Claim | Acceptance Criteria or Predicate Device Performance | Reported Device Performance |
|---|---|---|
| Open Vial Stability | 30 days at 2°-8°C (Same as predicate) | Validated as 30 days at 2°-8°C |
| Closed Vial Stability | 18 months at 2°-8°C (Same as predicate) | Validated as 18 months at 2°-8°C |
| Intended Use | Monitor HbA1c quantitation performance | Intended for use with specified assay types (HPLC, Immunoassay, Boronate Affinity) |
2. Sample size used for the test set and the data provenance
- Test Sample: The "test set" in this context refers to the Liquid Stable HbA1c Control material itself, which was subjected to stability testing. The document does not specify a "sample size" in terms of individual patient samples or measurements beyond the stability data.
- Data Provenance: The document does not specify the country of origin for any human data, as it's a quality control material. The data provenance relates to the stability testing done on the control material itself.
- Specificity: Stability studies were performed on various laboratory instruments (Bio-Rad Variant, Bayer DCA200, Roche Hitachi 917, Primus CLC385, Bayer DCA2000). The context implies these were conducted in a laboratory setting by the manufacturer, Canterbury Scientific Ltd.
- Retrospective or Prospective: The stability studies were prospective, as they involved real-time and accelerated (20°-25°C) testing over time to determine shelf life.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable for a quality control material. "Ground truth" in the context of diagnostic AI typically refers to a definitive diagnosis or measurement for a patient sample. For a quality control material, its "truth" is its stability and its ability to consistently perform within expected ranges when used to monitor assays. The "truth" is established through documented laboratory methods and instrument validations.
4. Adjudication method for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of patient data (e.g., medical images). For stability testing of a control material, the results are quantitative measurements against predefined criteria, not subjective interpretations requiring adjudication.
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 device is a quality control material, not an AI-powered diagnostic tool, and it does not involve human readers interpreting cases or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI device. It's a laboratory reagent.
7. The type of ground truth used
- For the stability studies, the "ground truth" implicitly refers to the established scientific principles of chemical and biological stability and the performance of the control material over time when stored under specified conditions and tested on validated laboratory instruments. The "truth" is that the material retains its expected properties (e.g., target HbA1c values) within acceptable variation over the claimed stability period.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that uses training sets.
9. How the ground truth for the training set was established
- Not applicable. No training set exists for this device.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.