(91 days)
ST AIA-PACK Testosterone is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific TOSOH AIA System analyzers. Measurement of testosterone is used to aid in the diagnosis and management of conditions involving excess or deficiency of this androgen. This device is intended "For Professional Use" only.
The ST AIA-PACK Testosterone is a competitive immunoenzymometric assay which is performed entirely in the AIA-PACK. Testosterone present in the test sample competes with enzyme-labeled testosterone for a limited number of binding sites on a testosterone-specific monoclonal antibody, immobilized on a magnetic solid phase. The magnetic beads are washed to remove urbound enzyme-labeled testosterone and are then incubated with a fluorogenic substrate, 4methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled testosterone that binds to the beads is inversely proportional to the testosterone concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve.
Here's a breakdown of the acceptance criteria and study information for the ST AIA-PACK Testosterone device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a numerical or categorical format for specific metrics. Instead, it presents performance characteristics and compares them to a predicate device to establish substantial equivalence.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ST AIA-PACK Testosterone) |
|---|---|---|
| Comparative Analysis | ||
| Slope | Close to 1.0 (relative to predicate) | 0.9562 |
| Intercept | Close to 0.0 (relative to predicate) | -0.7375 |
| Correlation Coefficient | High (e.g., >0.95 relative to predicate) | 0.979 |
| Sample Range | Comparable to predicate | 0.0 - 1107 ng/dL |
| Precision | ||
| Intra-run precision %CV | Low | 5.3% or less |
| Inter-run precision %CV | Low | 5.9% or less |
| Recovery | ||
| Spiked samples recovery | Acceptable range | 85.5% to 113.4% |
| Diluted samples recovery | Acceptable range | 91.5% to 113.5% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 71 serum samples
- Data Provenance: Not explicitly stated, but given the context of a 510(k) submission to the FDA, it is highly likely that the data was collected in a prospective manner for the purpose of demonstrating device performance. The country of origin for the data is also not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" for a quantitative diagnostic assay like this is typically established by the results of a validated reference method (in this case, the predicate device, DPC Coat-A-Count Total Testosterone assay) or a highly accurate laboratory standard, rather than expert consensus on interpretive tasks.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (like 2+1 or 3+1) are common in studies involving human interpretation (e.g., imaging studies) where there might be disagreement among experts. For a quantitative assay, the "adjudication" is inherent in the direct measurement and comparison to a reference.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for devices that assist human readers in making interpretations, such as medical imaging AI. The ST AIA-PACK Testosterone is a standalone quantitative assay device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, a standalone study was done. The entire comparative analysis and performance characteristics (precision, recovery) described are for the ST AIA-PACK Testosterone assay functioning as a standalone device, directly measuring testosterone in serum. There is no human interpretative component that the device assists.
7. The Type of Ground Truth Used
The ground truth was established by comparison to a predicate device, the DPC Coat-A-Count Total Testosterone assay. This technically represents a "comparative ground truth" where the reference standard is another legally marketed and accepted diagnostic test, rather than a gold standard like pathology or long-term outcomes data.
8. The Sample Size for the Training Set
The document does not specify a separate training set. For in vitro diagnostic assays, especially those based on immunoassay principles, the development and optimization (which could be considered analogous to "training") typically involve iterative design, reagent formulation, and analytical validation experiments using characterized samples, but not necessarily a distinct "training set" in the machine learning sense. The 71 serum samples mentioned are for the comparative analysis (test set) against the predicate.
9. How the Ground Truth for the Training Set Was Established
Since a distinct "training set" is not explicitly mentioned in the context of this 510(k) summary, the method for establishing its "ground truth" is not available in the provided text. The development of the assay itself would have relied on established biochemical principles and extensive internal validation to ensure accuracy and precision, using well-characterized calibrators and controls.
§ 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.