(29 days)
The AIA-PACK C-Peptide Control Set is intended for In Vitro Diagnostic Use Only for performing quality control procedures with the ST AIA-PACK C-Peptide II assay.
2 x 2 mL AIA-PACK C-Peptide Control Level 1 Buffered bovine serum albumin containing approximately 2 nq/mL of C-peptide (Lyophilized). See the vial label for the assigned concentration range. AIA-PACK C-Peptide Control Level 2 2 x 2 mL Buffered bovine serum albumin containing approximately 20 ng/mL of C-peptide (Lyophilized). See the vial label for the assigned concentration range. The AIA-PACK C-Peptide Control Set contains buffered bovine serum albumin with assigned levels of C-peptide. The C-peptide controls shall be run at the beginning of each day on which C-peptide assays are scheduled.
This document describes the TOSOH BIOSCIENCE, INC. AIA-PACK C-Peptide Control Set, a quality control material. The provided text primarily focuses on demonstrating substantial equivalence to a predicate device and summarizing stability and value assignment studies. It does not contain information about a study proving the device meets clinical acceptance criteria for diagnostic performance, as it is a control set, not a diagnostic device itself.
Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance) are not applicable or discussed for this type of device (a quality control material).
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Criteria | Reported Performance |
|---|---|---|
| Stability (Shelf Life) | Recovery within 100 ± 10%. Reproducibility (CV%) ≤ 10%. | 6, 12, and 13 months after manufacture: Recovery was within 100 ± 10% and reproducibility (CV%) was ≤ 10%. |
| Conclusion: Shelf life set at 12 months at 2-8°C. | ||
| Stability (In-Use, Reconstituted) | Recovery within 100 ± 10%. Reproducibility (CV%) ≤ 10%. | 15 days at refrigerator temperature (2-8°C) after reconstitution: Recovery and reproducibility met acceptance criteria. |
| Conclusion: In-use stability set at 14 days after reconstitution, provided vials are kept tightly sealed and refrigerated (2-8°C). | ||
| Value Assignment (Control Set) | Mean values fell within the value range. All CV% fell within pre-determined acceptance criteria. Assigned control value range is ± 20% of the target value. Target levels: approximately 2 ng/mL and 20 ng/mL of C-peptide. | For 2 lots of control levels 1 and 2, using two AIA 2000 analyzers: Measurements in 5 replicates showed mean values fell within the value range and all CV% fell within pre-determined acceptance criteria. The assigned concentration range is determined lot-by-lot to provide target control levels of approximately 2 and 20 ng/mL of C-peptide, with a range of +/- 20% of the target value. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size:
- Stability Studies: Three different lots of the AIA-PACK C-Peptide Control Set were used as samples for the study.
- In-Use Stability: A single lot of control set was used. Each specimen was assayed in 5 replicates.
- Value Assignment: Two lots for control levels 1 and 2 were used. Measurements were made in 5 replicates.
- Data Provenance: Not explicitly stated, but clinical laboratory studies involving control materials are typically conducted internally by the manufacturer or by contract labs in the country where the manufacturer is based (USA in this case, based on the address provided). The studies described appear to be prospective studies specifically designed to assess the performance of the control set under various conditions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is a quality control material. Its performance is assessed against defined analytical criteria (recovery, reproducibility) rather than by expert clinical interpretation. The "ground truth" for the assigned values is established through a traceable process using reference materials, not expert consensus on diagnostic images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is a quality control material. Its performance is based on analytical measurements against pre-defined quantitative criteria.
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 and not an AI-powered diagnostic device or a system intended for human reader assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a quality control material; it does not involve an algorithm for diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the stability and in-use studies, the "ground truth" is the expected original concentration of C-peptide in the control material, against which recovery and reproducibility are measured.
- For value assignment, the ground truth for the primary reference material was assigned based on C-Peptide of Human Insulin, International Reference Reagent (WHO International Reference Reagent). The secondary reference material and the control set values were then assigned using this primary reference material as a calibrator, following a hierarchical traceability scheme.
8. The sample size for the training set
- Not applicable. This is a quality control material; it does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable. There is no training set for this type of 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.