(170 days)
Reagents: The ARCHITECT HbA1c assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of percent hemoglobin A1c (HbA1c) in human whole blood on the ARCHITECT i System. Percent HbA1c measurements are used for monitoring long term glycemic control in diabetic patients. Calibrators: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of percent haemoglobin A1c (HbA1c) in human whole blood.
The ARCHITECT HbA1c assay is a two-step pre-treatment immunoassay for the quantitative determination of percent haemoglobin A1c (% HbA1c) in human whole blood using CMIA technology, with flexible assay protocols, referred to as Chemiflex. Sample is incubated with pre-treatment reagent to lyse the red blood cells. Pre-treated sample is the incubated with magnetic microparticles with a silica surface. Hemaglobin and HbA1c in the sample bind to the silica surface of the microparticles. Following a wash cvcle, anti-HbA1c acridinium-labeled conjugate is added to create a reaction mixture. Following another wash cycle, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). The haemoglobin and HbA1c that are bound to the surface of the microparticles represents the total percentage present in the sample however, only the HbA1c result is required to determine the % HbA1c in the sample. A direct relationship exists between the amount of HbA1c in the sample and the RLUs detected by the ARCHITECT i System optics.
The information provided describes the ARCHITECT HbA1c Reagents and ARCHITECT HbA1c Calibrators, an in-vitro diagnostic device. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on establishing substantial equivalence to a predicate device (AxSYM HbA1c). Therefore, the "acceptance criteria" are implied to be performance comparable to the predicate device, demonstrated through specific statistical metrics.
| Acceptance Criteria (Implied) | Reported Device Performance (ARCHITECT HbA1c vs. AxSYM HbA1c) |
|---|---|
| Slope close to 1.0 | Slope: 1.04 (95% CI: 0.97 to 1.12) |
| Intercept close to 0 | Intercept: -0.07 (95% CI: -0.67 to 0.37) |
| High Correlation Coefficient | Correlation Coefficient (r): 0.95 (95% CI: 0.93, 0.96) |
| Adequate Sensitivity | Demonstrated "substantially equivalent performance" in sensitivity (no specific numerical criteria or performance for sensitivity reported) |
| Adequate Precision | Demonstrated "substantially equivalent performance" in precision (no specific numerical criteria or performance for precision reported) |
| Adequate Measurement Range | Demonstrated "substantially equivalent performance" in measurement range (linearity) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 127 samples.
- Data Provenance: The document does not explicitly state the country of origin. It indicates the study was a "method comparison study" and does not specify if it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For in-vitro diagnostic devices, the "ground truth" is typically established by comparative analysis against a recognized reference method or a legally marketed predicate device, rather than by human expert review of images or clinical cases.
4. Adjudication Method for the Test Set
This information is not applicable and not provided for this type of device and study. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert interpretation (e.g., radiology studies) to establish a consensus ground truth. Here, the comparison is between two quantitative assays.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study involves multiple human readers interpreting cases, often with and without AI assistance, and is relevant for devices that aid human interpretation (e.g., in medical imaging). This submission is for an in-vitro diagnostic assay that provides a direct quantitative measurement.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the performance described is a standalone (algorithm only) performance. The ARCHITECT HbA1c assay is an automated chemiluminescent microparticle immunoassay (CMIA) run on the ARCHITECT i System. The performance metrics presented (slope, intercept, correlation) compare the results obtained directly from this automated system against results from the predicate automated system, without any human-in-the-loop interpretation being evaluated.
7. The Type of Ground Truth Used
The "ground truth" in this context is the results obtained from the legally marketed predicate device (AxSYM HbA1c assay). The study is a method comparison, aiming to show that the new device produces results comparable to an already accepted method.
8. The Sample Size for the Training Set
The document does not specify a separate "training set" or its sample size. For an in-vitro diagnostic assay like the ARCHITECT HbA1c, the development process likely involves internal validation and optimization, but the submission primarily details the performance evaluation study against the predicate device.
9. How the Ground Truth for the Training Set Was Established
Since a dedicated "training set" with established ground truth as typically understood in AI/ML contexts is not explicitly mentioned, this information is not provided. The development of the assay itself would have involved establishing accurate calibrators and quality control materials, which form the basis for accurate measurement, but this is distinct from a "ground truth" used for training an AI algorithm.
§ 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).