(277 days)
The FastPack® Testo Immunoassay is a paramagnetic particle immunoassay for the invitro quantitative determination of total testosterone in human serum or plasma. The FastPack® Testo Immunoassay is designed for use with the FastPack® System. It is intended strictly for in-vitro diagnostic use as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.
The FastPack® Testo Immunoassay for the quantitative determination of testosterone in human serum, lithium heparin plasma and K2 EDTA plasma is designed for use on the FastPack® Analyzer. The FastPack® Testo Immunoassay Reagents are contained in a disposable pack (FastPack®). Each FastPack® contains the following four components: Paramagnetic Particles, Testosterone Antibody Solution, Wash Buffer, and Substrate. The FastPack® Testo Immunoassay is a competitive chemiluminescence assay.
Here's a breakdown of the acceptance criteria and study information for the Qualigen FastPack® Testo Immunoassay, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
The acceptance criteria for this device are implicitly tied to demonstrating equivalence to the predicate device (FastPack® Testo Immunoassay K021972), particularly for the new sample types (lithium heparin plasma and K2 EDTA plasma). The performance data below reflects the device meeting these criteria by achieving comparable results to the predicate, and demonstrating linearity and acceptable precision.
| Characteristic | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (FastPack® Testo Immunoassay Serum or Plasma) |
|---|---|---|
| Measuring Range | 23 ng/dL to 1600 ng/dL | 23 ng/dL to 1600 ng/dL |
| Precision (High Sample) | Total imprecision 10.9% CV at 712 ng/dL | Total imprecision 10.9% CV at 712 ng/dL |
| Precision (Low Sample) | Total imprecision 0.07 SD at 14 ng/dL | Total imprecision 0.07 SD at 14 ng/dL |
| Linearity | Assay linear throughout dynamic range | Assay linear throughout dynamic range |
| Interfering Substances | ||
| Bilirubin | No interference up to 10 mg/dL | No interference up to 10 mg/dL |
| Hemoglobin | No interference up to 250 mg/dL | No interference up to 250 mg/dL |
| Triglyceride | Interference |
§ 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.