(65 days)
The FastPack® Total Testosterone Immunoassay is a paramagnetic particle, chemiluminescence immunoassay for the in vitro quantitative determination of testosterone in human serum. The FastPack® Total Testosterone Immunoassay is designed for use with the FastPack® Analyzer 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® Total Testosterone Immunoassay is a competitive chemiluminescense assay.
• Primary incubation: Sample, calibrator, or control (100 µL) is added to the antibody solution (100 µL) to start the sequence. The reaction time is 5 minutes at 37° C
• Secondary incubation: The initial reaction mixture (200 uL) is transferred to the magnetic particles with bound testosterone and competition between the sample testosterone and the beads continues for an additional 2.5 minutes at 37°C.
• Removal of unbound materials: The paramagnetic particles are washed three times with wash buffer (0.2 mL/wash cycle) to remove unbound materials,
• Substrate addition and detection: Chemiluminogenic substrate [140 uL] is added to the solid phase bound complex to form a chemiluminescent glow, which is measured by the FastPack® Analyzer System at 37° C. The FastPack® Total Testosterone Immunoassay is a paramagnetic particle immunossay intended for the in vitro quantitative determination of total testosterone in human serum. The FastPack® Total Testosterone Immunoassay is designed for use with the FastPack® Analyzer System.
The Qualigen FastPack® Total Testosterone Immunoassay on the FastPack® Analyzer System (K021972) is a chemiluminescence immunoassay for the quantitative determination of total testosterone in human serum. The device performance was evaluated by comparing it to the Diagnostic Products Corporation's Coat-A-Count Total Testosterone RIA Kit (K964889).
Here's an overview of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
The submission does not explicitly state pre-defined acceptance criteria in a table format, but rather presents performance characteristics and compares them to the predicate device. For analytical performance, the "Predicate Device" column can be interpreted as a benchmark to demonstrate substantial equivalence.
| Feature | Predicate Device (DPC Coat-A-Count) | Qualigen FastPack® Total Testosterone Immunoassay |
|---|---|---|
| Precision | ||
| Intra-assay | Reported as a graph (4% CV to 7.5% CV over 1-16 ng/mL) | Between Run: Low 0.14 ng/mL, 0.06 SD, 10.3% CV; High 7.12 ng/mL |
| Inter-assay | Level Mean: Low 0.76 ng/mL, 0.09 SD; High 6.7 ng/mL, 6.0% CV | Between Analyzer: Low 0.14 ng/mL, 0.03 SD, 3.8% CV; High 7.12 ng/mL |
| Between Reagent Lot: Low 0.14 ng/mL, 0.01 SD; High 7.12 ng/mL, 0.1% CV | ||
| Analytical Sensitivity | 0.04 ng testosterone/mL (4 ng testosterone/dL) | 0.13 ng Testosterone/mL |
| Spike Recovery | 93 to 103% | 94 - 110% |
| Dilution Recovery | 96% to 108% | 99 - 132% |
| Method Comparison | (n=144, Range: 0 to 16.9 ng/mL) -> Reference Method | y = 1.065x - 0.004, r = 0.930 (Range: 0 to 18.4 ng/mL) |
| Interfering Substances | Bilirubin: No interference up to 25 mg/dL; Hemoglobin: No interference up to 600 mg/dL; Triglycerides: No interference up to 3000 mg/dL | Bilirubin: No interference up to 40 mg/dL; Hemoglobin: No interference up to 1000 mg/dL; Triglycerides: No interference up to 1000 mg/dL |
| Specificity | Similar cross-reactivity profiles to the predicate, with some differences (e.g., 19-Nor Testo) | Various materials tested (e.g., 5-α-DHT, Androstenedione, Estradiol) with reported % Cross-reactivity. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Method Comparison (Test Set): n = 144
- Data Provenance: Not explicitly stated (e.g., country of origin). The submission does not specify if the data was retrospective or prospective, but clinical studies for such IVD devices are typically prospective or involve retrospective analysis of collected clinical samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the 510(k) summary. For immunoassay devices, ground truth is typically established by comparative analysis with a well-characterized reference or predicate method, rather than expert interpretation of results. The predicate "DPC Coat-A-Count® Total Testosterone" serves as the reference method here.
4. Adjudication Method for the Test Set:
Not applicable. For quantitative diagnostic assays, ground truth is established by the results of a reference method, not by expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC study was not done. This type of study is typically relevant for interpretative diagnostic devices (e.g., imaging AI) where multiple human readers assess cases, and their performance is compared with and without AI assistance. This device is a quantitative immunoassay system.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, the performance characteristics (Precision, Analytical Sensitivity, Spike Recovery, Dilution Recovery, Method Comparison, Interfering Substances, Specificity) are all standalone performance metrics of the FastPack® Total Testosterone Immunoassay system itself. The system provides quantitative results without human interpretation in the loop.
7. The Type of Ground Truth Used:
The ground truth for the method comparison study was established by comparing the results of the FastPack® Total Testosterone Immunoassay with the DPC Coat-A-Count® Total Testosterone RIA Kit (K964889), which served as the predicate/reference method.
8. The Sample Size for the Training Set:
The 510(k) summary does not explicitly state a "training set" sample size in the context of machine learning. For traditional immunoassay development, the "training" aspect would relate to the assay's development and optimization, which isn't typically quantified with a sample size in the same way as a machine learning model. The provided data focuses on the validation of the final assay.
9. How the Ground Truth for the Training Set Was Established:
Not applicable in the context of a machine learning "training set". For the development and optimization of an immunoassay, the "ground truth" (or target values) for calibrators and controls would be established through a rigorous process of reference material characterization, often involving comparison to established reference methods or orthogonal techniques.
§ 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.