(60 days)
The ARCHITECT® Insulin Calibrators are for the calibration of the ARCHTECT® i System when used for the quantitative determination of human insulin in human serum and plasma.
The ARCHITECT® Insulin Controls are for the verification of the accuracy and precision of the ARCHITECT® i System when used for the quantitative determination of human insulin in human serum or plasma.
The ARCHITECT® Insulin Calibrators are for the calibration of the ARCHITECT® i System when used for the quantitative determination of human insulin in human serum and plasma.
The ARCHITECT® Insulin Controls are for the verification of the accuracy and precision of the ARCHITECT® i System when used for the quantitative determination of human insulin in human serum and plasma.
This is a 510(k) premarket notification for in vitro diagnostic calibrators and controls used with the ARCHITECT® i System for quantitative determination of human insulin. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria for device performance as would be expected for a diagnostic algorithm. Therefore, many of the requested fields are not applicable or cannot be extracted from the provided text.
Here's the information that can be extracted, along with explanations for the missing data:
Acceptance Criteria and Device Performance
This submission does not define specific performance metrics like sensitivity, specificity, accuracy, or AUC for an algorithm. Instead, it demonstrates similarity in intended use, methodology, binding protein, assay protocols, and traceability/standardization to legally marketed predicate devices. The "acceptance criteria" are implicitly met by demonstrating these similarities and the fact that the FDA granted substantial equivalence.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated Equivalence Aspects) | Reported Device Performance (ARCHITECT® Insulin Calibrators & Controls) |
|---|---|
| Calibrators | |
| Intended Use | For calibration of ARCHITECT® i System for quantitative determination of human insulin in human serum and plasma. |
| Methodology | CMIA (Chemiluminescent Microparticle Immunoassay) |
| Binding Protein | Insulin |
| Assay Protocols | Direct, quantitative immunoassay |
| Traceability/Standardization | Relative Light Unit (RLU) matched to Primary Calibrators. Referenced to World Health Organization (WHO) Insulin 1st. International Reference Preparation, 66/304. |
| Controls | |
| Intended Use | For verification of accuracy and precision of ARCHITECT® i System for quantitative determination of human insulin in human serum or plasma. |
| Methodology | CMIA (Chemiluminescent Microparticle Immunoassay) |
| Binding Protein | Insulin |
| Assay Protocol | Direct, quantitative immunoassay |
| Levels | 3 levels: Low, Medium, and High (targets: 8, 40, 120 μU/mL). |
Note: The "performance" here refers to the characteristics that make the device equivalent to existing devices, not clinical performance metrics typical of a diagnostic AI.
Additional Information
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Sample size used for the test set and the data provenance:
- This document does not specify a "test set" in the context of an algorithm evaluation. The submission relies on demonstrating substantial equivalence through comparison of technological characteristics and intended use, not through a performance study on a specific dataset. Therefore, N/A.
- There is no mention of specific data provenance (e.g., country of origin, retrospective/prospective) because individual patient data samples are not the focus of this type of submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This type of submission (for in vitro diagnostic calibrators and controls) does not involve establishing ground truth from experts for a diagnostic algorithm.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. Not applicable for this type of medical device submission.
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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:
- N/A. This device is a calibrator and control for an automated immunoassay system, not an AI-assisted diagnostic algorithm that involves human reader interpretation. Therefore, no MRMC study or effect size related to human reader improvement is relevant or performed.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The "device" itself (calibrators and controls) is used to ensure the performance of an automated immunoassay system (ARCHITECT® i System). The performance of the calibrators and controls is inherently "standalone" in that they are materials used by an instrument, not an algorithm being evaluated for clinical diagnostic interpretation. However, the concept of "standalone performance" as it applies to a diagnostic algorithm is N/A here.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For calibrators, the "ground truth" implicitly refers to the accuracy of the assigned values, which are traceable to the World Health Organization (WHO) Insulin 1st. International Reference Preparation, 66/304. This is a reference standard.
- For controls, the "ground truth" refers to the expected values (targets of 8, 40, 120 μU/mL) used to verify accuracy and precision, which are established against primary controls. This is a reference standard/primary control assignment.
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The sample size for the training set:
- N/A. This submission is for calibrators and controls, not a machine learning model. There is no concept of a "training set" in this context.
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How the ground truth for the training set was established:
- N/A. As there is no training set, this question is not applicable.
§ 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.