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510(k) Data Aggregation
(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 < 100 ng/dL testosterone | Interference for all concentrations of interferent tested at < 100 ng/dL of testosterone. No visibly hemolyzed or cloudy (lipemic) samples should be used. |
| Cross-reactivity | ||
| 5-α-DHT | No significant cross-reactivity | No significant cross-reactivity |
| Androstenediol | Magnitude < 4% | Magnitude < 4% |
| 19-Norethisterone Acetate | Magnitude < 4% | Magnitude < 4% |
| Comparative Testing vs. Established Methods | ||
| Serum (N=135) | Slope: ~1.0, Y-intercept: ~0, r²: ~1.0 | Slope: 1.054, y-intercept: 6.5, r² = 0.914 |
| Lithium Heparin Plasma vs Serum (N=60) | Slope: ~1.0, Y-intercept: ~0, r²: ~1.0 | Slope: 0.992, y-intercept: -8.0, r² = 0.987 |
| K2 EDTA Plasma vs Serum (N=67) | Slope: ~1.0, Y-intercept: ~0, r²: ~1.0 | Slope: 0.998, y-intercept: -10.9, r² = 0.996 |
Study Details
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Sample sizes used for the test set and the data provenance:
- Serum: N = 135
- Lithium Heparin Plasma: N = 60
- K2 EDTA Plasma: N = 67
- Data Provenance: The document does not specify the country of origin. It indicates the studies were "conducted in-house" which typically implies internal testing by the manufacturer. It does not state whether the data was retrospective or prospective, but clinical validation studies for in-vitro diagnostics are generally prospective or use carefully selected archived samples that mimic prospective collection.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not mention the use of experts to establish ground truth for the test set. For quantitative immunoassays, the "ground truth" is typically established by comparative testing against an established, legally marketed method or a reference method. The comparison study uses the results from the predicate device (FastPack® Testo Immunoassay K021972) or other "established methods" as the reference for comparison, not expert consensus. -
Adjudication method for the test set:
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for qualitative or imaging-based diagnostics where human interpretation of results is involved and there might be discrepancies. For quantitative laboratory assays, the result is a numerical value, and the comparison is statistical against a reference method. -
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is an in-vitro diagnostic immunoassay for quantitative determination of testosterone, not an imaging device or an AI-assisted diagnostic tool that involves human readers. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, this is essentially a standalone device performance study. The FastPack® Testo Immunoassay is an automated immunoassay system. Its performance (accuracy, precision, linearity, interference) is evaluated intrinsically, independent of human interpretation or assistance beyond operating the device. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The ground truth was established by comparison to "Established Methods" and the predicate device (FastPack® Testo Immunoassay K021972) for serum samples, and comparison to serum results for plasma samples. This means the clinical performance of the device was assessed by correlating its quantitative measurements with those obtained from already accepted, legally marketed, or gold-standard laboratory methods. -
The sample size for the training set:
The document does not explicitly state the sample size for a "training set." For an immunoassay like this, method development and optimization would occur internally, potentially using numerous samples, but it's not typically referred to as a "training set" in the context of device approval unless machine learning/AI is involved. The listed sample sizes (N=135, N=60, N=67) are for the validation or test sets to demonstrate performance characteristics. -
How the ground truth for the training set was established:
Not applicable, as a distinct "training set" with ground truth established in a formal, reported manner (like for an AI algorithm) is not mentioned or relevant for this type of immunoassay device submission. Method development and optimization would rely on established laboratory practices to ensure reagents and assay parameters lead to accurate and precise measurements.
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