(44 days)
The DSL ACTIVE™ I-PTH Coated Bead IRMA assay is intended for the quantitative determination of I-PTH in human serum. This assay is intended for in vitro diagnostic use. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.
The DSL 9300 ACTIVE™ I-PTH Coated Bead IRMA kit was developed for the quantitative measurement of the intact molecule PTH in human serum. This Coated Bead IRMA format is a capture assay. Goat polyclonal antibody to PTH is immobilized to the surface of the coated bead. I-PTH in the standards or serum samples is "sandwiched" between this polyclonal antibody and the anti-I-PTH goat polyclonal antibody radiolabeled for detection with I-125.
Here's a summary of the acceptance criteria and study details for the DSL 9300 ACTIVE™ I-PTH Coated Bead IRMA Kit, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device: DSL 8000 ACTIVE™ I-PTH IRMA. The study aimed to demonstrate that the new device measures I-PTH levels with a strong correlation and similar performance to the established predicate device, using patient samples that span the expected range of I-PTH values. | Linear regression analysis of results from 97 patient samples comparing the DSL 9300 ACTIVE™ I-PTH Coated Bead IRMA kit (Y) to the DSL 8000 ACTIVE™ I-PTH IRMA (X) yielded the equation: Y = 0.93(X) + 33.81 with a correlation coefficient (r) = 0.97. |
Study Details:
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Sample Size used for the test set and data provenance:
- Sample Size: 97 patient samples.
- Data Provenance: Not explicitly stated whether retrospective or prospective, nor the country of origin. However, the samples were "patient samples" chosen to represent low, intermediate, and high I-PTH levels.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth for this equivalence study was the measurement obtained from the predicate device (DSL 8000 ACTIVE™ I-PTH IRMA), not expert interpretation of the samples themselves.
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Adjudication method for the test set:
- Not applicable. The study compares quantitative measurements from two devices rather than expert adjudication.
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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:
- No. This was a device-to-device equivalence study, not an MRMC study involving human readers or AI assistance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense. The study evaluated the performance of the DSL 9300 ACTIVE™ I-PTH Coated Bead IRMA kit itself against another device (the predicate). There is no "human-in-the-loop" component in the direct measurement of I-PTH by these IRMA kits.
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The type of ground truth used:
- Comparative Ground Truth: The measurements obtained from the predicate device, the DSL 8000 ACTIVE™ I-PTH IRMA. The assumption is that the predicate device provides accurate measurements of I-PTH.
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The sample size for the training set:
- Not applicable. This document describes a validation study for substantial equivalence, not the development or training of the assay itself. The assay is a "Coated Bead IRMA kit," which implies a biochemical measurement system, not a machine learning algorithm requiring a "training set."
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How the ground truth for the training set was established:
- Not applicable, as there was no explicit "training set" for the assay described in this document. The assay's underlying principles are based on immunoradiometric assay technology.
§ 862.1545 Parathyroid hormone test system.
(a)
Identification. A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.(b)
Classification. Class II.