(28 days)
The ST AIA-PACK C-Peptide II Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK C-Peptide II assay.
2 x 1 mL ST AIA-PACK C-Peptide II Calibrator (1) 0 ng/mL Protein matrix containing no detectable concentration of C-peptide with sodium azide as a preservative (Liquid).
2 x 1 mL ST AIA-PACK C-Peptide II Calibrator (2) 0.5 ng/mL (approx.)
ST AIA-PACK C-Peptide II Calibrator (3) 2 ng/mL (approx.)
ST AIA-PACK C-Peptide II Calibrator (4) 6 ng/mL (approx.)
ST AIA-PACK C-Peptide II Calibrator (5) 15 ng/mL (approx.)
ST AIA-PACK C-Peptide II Calibrator (6) 33 ng/mL (approx.)
Protein matrix containing the assigned concentration of C-peptide (described on each vial) (Lyophilized).
The ST AIA-PACK C-Peptide II Calibrator Set is designed specifically for use on the Tosoh AIA Svstem Analyzers which have been previously cleared as a family of instruments under K971103. Only materials obtained from Tosoh should be used. Materials obtained elsewhere should not be substituted since assay performance is characterized based strictly on Tosoh materials.
The ST AIA-PACK C-Peptide II Calibrator Set is designed for use with ST AIA-PACK C-Peptide II, ST AIA-PACK C-Peptide Sample Diluting Solution, AIA-PACK C-Peptide Control Set.
Here's an analysis of the provided text regarding the ST AIA-PACK C-Peptide II Calibrator Set, focusing on acceptance criteria and supporting studies.
Based on the provided 510(k) Summary, this document primarily discusses the substantial equivalence of a calibrator set, not a diagnostic device with performance metrics like accuracy, sensitivity, or specificity in relation to a disease state. Therefore, many standard questions about AI device performance (like MRMC studies, standalone performance, training set details, expert qualifications for ground truth, etc.) are not applicable to this type of submission.
The "acceptance criteria" and "device performance" in this context refer to the stability and reproducibility of the calibrator set itself, not its diagnostic accuracy in patients.
1. Table of Acceptance Criteria and Reported Device Performance
This calibrator set's "performance" is assessed based on its stability and reproducibility rather than diagnostic accuracy.
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Shelf-Life Stability | Recovery: 100 ± 10% | Recovery: Within 100 ± 10% |
| (Unopened vial, 2-8°C) | Reproducibility (CV%): ≤ 10% | Reproducibility (CV%): ≤ 10% at 13 months |
| In-Use Stability | Recovery: 100 ± 10% | Recovery: Met criteria for 2 days at refrigerator temperature |
| (Opened/Reconstituted vial, | Reproducibility (CV%): ≤ 10% | Reproducibility (CV%): Met criteria for 2 days at refrigerator temperature |
| 2-8°C) |
The conclusions from these studies allowed the manufacturer to set:
- Shelf-life: 12 months at 2-8°C (based on 13-month data meeting criteria)
- In-use stability: 1 day (24 hours) after reconstitution at 2-8°C (based on 2-day data meeting criteria)
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Stability Studies) Sample Size:
- Shelf-Life Stability: Three different lots of calibrator set. Each specimen (presumably from each lot at each time point) was assayed in 5 replicates. This refers to the number of lots tested, not patient samples.
- In-Use Stability: One lot of calibrator material. Three sets of calibrator material were opened and reconstituted. Urine, serum, and EDTA plasma specimens were chosen for this study. Each specimen was assayed in 5 replicates. The number of patient specimens (urine, serum, EDTA plasma) is not explicitly stated, only that such specimens were chosen.
- Data Provenance: Not specified, but generally for such in-vitro diagnostic (IVD) calibrators, the studies are conducted internally by the manufacturer. The text does not mention country of origin or whether the studies were external. The nature of the study (stability of a reagent) suggests it's prospective testing in a lab setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This device is a calibrator set, not a diagnostic device requiring expert interpretation of results to establish a "ground truth" for clinical performance. Its "ground truth" (assigned C-peptide concentrations) is established through an analytical traceability chain to international standards (WHO 1ª IRP 84/510).
4. Adjudication Method for the Test Set
- Not applicable. There is no "adjudication" in the context of stability and reproducibility testing for a calibrator. The performance is assessed against predefined recovery and CV% criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is not an AI-powered diagnostic device, and thus MRMC studies are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
- No. This is a calibrator product for an in-vitro diagnostic assay, not an algorithm.
7. The Type of Ground Truth Used
- Analytical Traceability to International Standard complemented by Internal Referencing: The assigned value of C-peptide in the primary reference material (which is then used to assign values to the calibrators) was based on WHO 1ª IRP 84/510. This is an internationally recognized reference preparation for C-peptide. Subsequent secondary reference materials and product calibrators are assigned values using Tosoh AIA instruments, comparing measured results with those obtained with previous lots or a primary reference.
8. The Sample Size for the Training Set
- Not applicable. This is a calibrator set, not an AI or machine learning model that requires a training set. The values are assigned based on analytical methods and traceability, not learned from data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set." The "ground truth" for the calibrator values is established through the analytical traceability described in point 7.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.