(45 days)
The DSL IGF-II IRMA assay is intended for the quantitative determination of IGF-II in human serum or plasma. The measurement of IGF-II is used For In Vitro Diagnostic Use in the evaluation of growth status.
The DSL 9100 IGF-II IRMA kit was developed for the quantitative measurement of IGF-II in human serum or plasma. The IRMA format is a non-competitive assay in which the analyte to be measured is "sandwiched" between two antibodies. The first antibody, goat anti-IGF-II, is immobilized to the inside wall of the test tube, the other antibody, mouse monoclonal anti-IGF-II is radiolabelled for detection. The analyte present is bound by both the antibodies to form a "sandwiched" complex. Unbound materials are removed be decanting and washing the tubes. The resultant is analyzed in a gamma counter for bounds counts per minute. The amount of bound IGF-II is directly proportional to the concentration of the IGF-II present in the sample.
This document is a Summary of Safety and Effectiveness for the DSL 9100 IGF-II IRMA Kit. It describes an In Vitro Diagnostic (IVD) device, specifically an immunoradiometric assay (IRMA) for quantitatively measuring Insulin-like Growth Factor-II (IGF-II) in human serum or plasma.
The provided document does not contain the information requested regarding acceptance criteria related to device performance in a clinical or diagnostic study involving patient data, nor does it describe a study that uses such data to prove the device meets acceptance criteria.
Instead, the document focuses on:
- The name and classification of the device.
- The submitter information.
- The assay principle (IRMA format, sandwich immunoassay with radiolabeled antibody).
- The intended use (in vitro diagnostic for evaluation of growth status).
- A statement of substantial equivalence to the DSL IGF-I IRMA.
Therefore, I cannot populate the table or answer the specific questions about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details because this information is not present in the provided text. The document is a regulatory submission summary, not a detailed clinical performance study report.
§ 862.1370 Human growth hormone test system.
(a)
Identification. A human growth hormone test system is a device intended to measure the levels of human growth hormone in plasma. Human growth hormone measurements are used in the diagnosis and treatment of disorders involving the anterior lobe of the pituitary gland.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.