(187 days)
The Abbott ARCHITECT™ Glycated Hemoglobin assay is a boronate affinity binding assay intended to measure glycated hemoglobin in human anticoagulated whole blood. Measurement of glycated hemoglobin is used for the management of diabetes mellitus.
The ARCHITECT™ Glycated Hemoglobin assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of glycated hemoglobin in human anticoagulated whole blood (EDTA, lithium heparin, or sodium heparin). The ARCHITECTTM Glycated Hemoglobin assay is calibrated with Abbott ARCHITECT™ Glycated Hemoglobin Calibrators. Abbott ARCHITECT™ Glycated Hemoglobin Controls are assayed for the verification of the accuracy and precision of the Abbott ARCHITECT™ i System.
Here's a breakdown of the acceptance criteria and the study details for the Abbott ARCHITECT™ Glycated Hemoglobin assay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Abbott ARCHITECT™ Glycated Hemoglobin assay are implicitly defined by its demonstration of substantial equivalence to the Bio-Rad DIAMAT™ Glycosylated Hemoglobin Analyzer System (K851636). The performance metrics used for this comparison were based on regression analysis.
| Acceptance Criteria (Implied) | Reported Device Performance (ARCHITECT™ Glycated Hemoglobin vs. Bio-Rad DIAMAT™) |
|---|---|
| Correlation (r): High correlation to predicate device | 0.961 |
| Slope (Least Squares): Close to 1.0 | 0.96 (95% CI: 0.93, 1.00) |
| Intercept (Least Squares): Close to 0 | 0.42 (95% CI: 0.15, 0.68) |
| Slope (Passing-Bablok): Close to 1.0 | 1.00 (95% CI: 1.00, 1.06) |
| Intercept (Passing-Bablok): Close to 0 | 0.20 (95% CI: -0.27, 0.20) |
| Measurement Range Coverage: Equivalent to predicate device | Specimens ranged from 4.3 to 14.3 %A1c eq (ARCHITECT™) and 4.4 to 14.5 %A1c (Bio-Rad DIAMAT™) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 249
- Data Provenance: Not explicitly stated (e.g., country of origin). The study involved human anticoagulated whole blood specimens. It is retrospective in the sense that existing specimens were analyzed and compared.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. This study does not rely on human experts to establish ground truth in the traditional sense of image interpretation or diagnostic review.
- Qualifications of Experts: Not applicable. The "ground truth" is established by the predicate device's measurements.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This is a comparison study between two quantitative laboratory assays. There is no human adjudication process involved; the comparison is statistical.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This is a comparison of two laboratory devices, not a study involving human readers' diagnostic performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Yes, the entire study is focused on the standalone performance of the Abbott ARCHITECT™ Glycated Hemoglobin assay. It's a fully automated in vitro diagnostic device, and its performance is evaluated independently of human intervention in the measurement process.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this study is effectively established by the results obtained from the legally marketed predicate device, the Bio-Rad DIAMAT™ Glycosylated Hemoglobin Analyzer System. The goal is to demonstrate that the new device's measurements correlate strongly and are in agreement with those of the established predicate device.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The provided text describes a validation study for a medical device (an in vitro diagnostic assay), not a machine learning algorithm that requires a training set. The device's calibration and control systems are mentioned, but these are distinct from a "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no "training set" in the context of this device's validation as presented. The device is calibrated using Abbott ARCHITECT™ Glycated Hemoglobin Calibrators, but the method for establishing the ground truth of these calibrators is not detailed in the provided summary.
§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).