(58 days)
The ARCHITECT LH Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of human luteinizing hormone (LH) in human serum and plasma.
The ARCHITECT LH Calibrator kit contains 6 bottles (4.0 mL each) of ARCHITECT LH Calibrators A, B, C, D, E, and F. Calibrators A through F contain phosphate buffer with protein (bovine) stabilizers. Calibrators B through F also contain different concentration levels of luteinizing hormone (from human pituitary). Preservatives: ProClin 300, ProClin 950.
This submission is for a medical device called "ARCHITECT LH Calibrators," which is a secondary calibrator for quantitative determination of human luteinizing hormone (LH). This type of device does not typically undergo the same kind of "performance studies" as an in-vitro diagnostic test that directly measures a biological marker or an AI-powered diagnostic tool. Instead, the "acceptance criteria" and "study" for a calibrator largely revolve around demonstrating its ability to accurately and precisely calibrate the instrument it's intended for, and that it is substantially equivalent to a previously approved device.
Based on the provided information, the 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense (e.g., sensitivity, specificity for disease detection).
Here's an interpretation of "acceptance criteria" and "device performance" based on the provided document, even though it's structured as a comparison for substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
Instead of "acceptance criteria" against clinical metrics, the acceptance is based on demonstrating equivalency to a predicate device. The "performance" here refers to the characteristics and specifications of the new calibrator relative to the predicate.
| Attribute | "Acceptance Criteria" (Predicate Device Specification) | Reported Device Performance (New Device Specification) |
|---|---|---|
| Intended Use | For calibration of ARCHITECT i System for quantitative determination of LH in human serum and plasma. | Same |
| Instrumentation | ARCHITECT i System | Same |
| Range | 2 mIU/mL – 100 mIU/mL | 0.00 mIU/mL – 250.00 mIU/mL |
| LH Calibrator Levels | 2 levels (2 and 100 mIU/mL) | 6 levels (0.00, 1.00, 3.50, 15.00, 50.00, 250.00 mIU/mL) |
| Calibrator Matching | Calibrators must be used with matched reagents and controls per labeling. | Matching of calibrators with reagents and controls is not required. |
| Composition (LH Source) | Luteinizing hormone (from human pituitary) | Luteinizing hormone (from human pituitary) - changed vendor code |
| Composition (Diluent) | Calf serum | Phosphate buffer with protein stabilizers (bovine) |
| Composition (Preservative) | Sodium Azide | ProClin 300, ProClin 950 |
| Standardization | Referenced to WHO LH Human, Pituitary 2nd International Standard 80/552 at each concentration. | Referenced to WHO LH Human, Pituitary 2nd International Standard 80/552. Note: Calibrators B-F are manufactured by dilution. |
Interpretation of "Acceptance": The "acceptance" (or determination of substantial equivalence by the FDA) is based on the argument that despite differences (e.g., expanded range, more calibrator levels, different diluent/preservatives), the fundamental principles of the calibrator, its intended use, and its traceability to an international standard remain consistent with a legally marketed predicate device, and these differences do not raise new questions of safety or effectiveness. The FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent..."
Since this is a calibrator and the submission is focused on substantial equivalence rather than a new diagnostic claim, many of the typical performance study questions for AI/diagnostic devices are not directly applicable. However, I will address them based on the context of the provided document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given 510(k) summary. For a calibrator, the "test set" would typically refer to the experiments conducted to validate its performance (e.g., accuracy, precision, linearity within the specified range) on the intended instrument. This kind of detailed study data is usually included in the full 510(k) submission but summarized only at a high level or by reference in the public summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable and not provided. Calibrators are characterized chemically and biologically; their "ground truth" is established through analytical validation processes against recognized standards (like the WHO standard mentioned), not by expert consensus on clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable and not provided. Adjudication methods are relevant for subjective interpretations (e.g., image reading) where disagreement among experts needs resolution to establish ground truth.
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
This is not applicable. An MRMC study is relevant for diagnostic devices, particularly those involving human interpretation (e.g., radiologists, pathologists) often assisted by AI. This device is a calibrator, not a diagnostic tool or an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a biochemical calibrator, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the calibrators themselves is established by referencing them to the World Health Organization (WHO) Luteinizing Hormone (LH) Human, Pituitary 2nd International Standard 80/552. This is a highly standardized biological standard used to ensure comparability and accuracy of LH measurements worldwide. The concentrations of LH in the calibrators are derived from this international standard.
8. The sample size for the training set
This information is not applicable and not provided. There is no "training set" in the context of a calibrator for an immunoassay system. This concept is relevant for machine learning or AI algorithms.
9. How the ground truth for the training set was established
This is not applicable. As stated above, there is no "training set" for this type of device.
§ 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.