(252 days)
The ARCHITECT 2nd Generation Testosterone assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of testosterone in human serum and plasma. Measurements 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.
The ARCHITECT 2nd Generation Testosterone Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of testosterone in human serum and plasma.
The ARCHITECT 2nd Generation Testosterone Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of testosterone in human serum and plasma.
The ARCHITECT 2nd Generation Testosterone Reagent Kit consists of 100 (1 x 100) or 400 (4 x 100) tests. Each kit contains 1 or 4 bottle(s) each of Microparticles. Conjugate. Assay Specific Diluent, and Specimen Diluent.
Microparticles 1 or 4 Bottle(s) (6.6 mL) Anti-Testosterone (sheep, monoclonal) coated . microparticles in BIS Tris buffer with protein (bovine) stabilizer. Minimum concentration: 0.1% solids. Preservative: ProClin 300.
. Conjugate -1 or 4 Bottle(s) (6.9 mL) Testosterone acridinium-labeled conjugate in BIS Tris buffer with surfactant stabilizer. Minimum concentration: 6.5 nmol/L. Preservative: ProClin 300.
. Assay Specific Diluent - 1 or 4 Bottle(s) (25.0 mL) Testosterone Assay Diluent containing phosphate and glycine in citrate buffer. Preservative: ProClin 300.
. Specimen Diluent - 1 or 4 Bottle(s) (12.2 mL) Testosterone Specimen Diluent containing PBS buffer. Preservative: ProClin 300.
Each ARCHITECT 2nd Generation Testosterone Calibrator Kit contains 6 Bottles (4.0 mL each) of ARCHITECT 2nd Generation Testosterone Calibrators A-F. Calibrator A contains PBS buffer. Calibrators B through F contain testosterone in PBS buffer. All calibrators contain a protein (bovine) stabilizer. Preservative: ProClin 300.
Each ARCHITECT 2nd Generation Testosterone Control Kit contains 3 Bottles (8.0 mL each) of ARCHITECT 2nd Generation Testosterone Controls. The Low, Medium, and High Controls contain testosterone in PBS buffer with a protein (bovine) stabilizer. Preservative: ProClin 300.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Device: ARCHITECT 2nd Generation Testosterone assay, Calibrators, and Controls.
1. A table of acceptance criteria and the reported device performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance (ARCHITECT 2nd Generation Testosterone) |
|---|---|---|
| Precision | Within-laboratory (total) imprecision of ≤ 10% CV for samples with testosterone concentrations ≥ 14.4 ng/dL to 1009 ng/dL. | All reported within-laboratory (total) %CV values were ≤ 5.2%, well within the ≤ 10% CV acceptance criterion for the control levels (9.02-229.95 ng/dL) and the human serum panel (60.72-62.35 ng/dL) tested. Specific values range from 2.6% to 5.2%. |
| Limit of Quantitation (LoQ) | LoQ of ≤ 4.33 ng/dL with an inter-assay imprecision of 14.4 ng/dL. | Demonstrated linear range: 3.82 - 1862.27 ng/dL. This supports the claimed measuring interval. |
| Interference (Endogenous Substances) | Potential interference from bilirubin, hemoglobin, total protein, triglycerides, biotin, and SHBG to be |
§ 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.