(82 days)
AxSYM® Testosterone is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of testosterone in human serum and plasma on the AxSYM System.
Testosterone monitoring is used clinically to diagnose and differentiate endocrine disorders. In males, these include hypogonadism, testicular failure, infertility, hypopituitarism and hyperprolactinemia. In females, polycystic ovary syndrome, adrenal hyperplasia, infertility, hirsutism, amenorrhea, obesity and virilization can cause changes in serum testosterone levels.
The AxSYM® Testosterone assay is used as an aid in the investigation of infertility in males and of hirsutism and virilization in females.
The AxSYM® Testosterone Standard Calibrators are for the standard calibration of the AxSYM system when used for the quantitative determination of testosterone in human serum and plasma.
Competition format. Microparticle Enzyme Immunoassay (MEIA) for use on Abbott AxSYM® system.
Assay procedure:
- Incubate the sample with the antibody-coated microparticles.
- Add testosterone alkaline phosphatase conjugate and incubate.
- Transfer to matrix cell.
- Wash to remove unbound substances.
- Add substrate.
- Measure fluorescent product.
Acceptance Criteria and Device Performance Study for AxSYM® Testosterone MEIA
This document describes the acceptance criteria and the supporting study for the AxSYM® Testosterone Microparticle Enzyme Immunoassay (MEIA) device, based on the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document compares the AxSYM® Testosterone immunoassay (Submission Device) to the Roche Elecsys® Testosterone assay (Predicate Device). The acceptance criteria are implicitly defined by the reported performance of the predicate device and the new device's performance demonstrating substantial equivalence. Given the nature of a 510(k) equivalency claim, the "acceptance criteria" for the new device are typically that its performance characteristics are comparable or superior to the predicate device within clinically acceptable ranges.
| Parameter | Acceptance Criteria (Implied by Predicate Device Performance) | Reported Device Performance (AxSYM® Testosterone) |
|---|---|---|
| Precision | Within-run CV of 0.9% to 4.6% | |
| Total CV of 1.6% to 7.4% (from 0.24 to 7.01 ng/mL) | Within-run CV of 3.9% to 8.3% | |
| Total CV of $\le$ 14% for samples with testosterone concentrations $\ge$ 0.85ng/ml and $\le$ 10% for samples $\ge$ 2.10ng/ml. | ||
| Functional Sensitivity | Not stated (for predicate device) | $\le$ 0.2ng/ml |
| Analytical Sensitivity | 0.02ng/ml | $\le$ 0.1ng/ml |
| Analytical Specificity | Cross-reactivity ranged from 0-10.4% for 12 potential cross-reactants tested at 40ng/mL. |
§ 862.1680 Testosterone test system.
(a)
Identification. A testosterone test system is a device intended to measure testosterone (a male sex hormone) in serum, plasma, and urine. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.(b)
Classification. Class I.