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510(k) Data Aggregation
(25 days)
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(14 days)
A home drug screening, and if needed, confirmation service. This kit provides a preliminary result for the detection/presence of the following drugs of abuse in urine: PCP
Immunoassay for the qualitative detection of PCP in urine. The At Home Drug Test, like many commercially available drug screening test kits, qualitatively measures the presence of target drugs or their metabolites by visual color sandwich one step immunoassay technology.
The Phamatech At Home Drug Test (Model 9133) for PCP in urine was evaluated through a clinical sample correlation study, a blind labeled spiked study, and a consumer study.
1. Acceptance Criteria and Reported Device Performance:
The document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds. However, it implies that the device's performance should be "substantially equivalent to the reported performance characteristics of other commercially available tests" and should demonstrate "excellent overall accuracy."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices | In clinical specimen correlation studies, produced a >98% correlation when compared to Behring EMIT II and GC/MS methodology. |
| Clinical studies with professional users exhibited excellent overall accuracy (>97%). | |
| Excellent overall accuracy in the hands of professional users | >97% |
| Excellent overall accuracy in the hands of lay users | Overall accuracy in consumer study: 4557/4715 correct or 96.65%. |
| Specific to PCP test interpretation by consumers: 464/499 or 93%. |
2. Sample Size and Data Provenance:
- Test Set (Clinical Sample Correlation Study):
- Sample Size: Not explicitly stated, but it involved "clinical specimens."
- Data Provenance: Not explicitly stated, but "clinical specimens" typically originate from various patient populations. The studies were performed at "two independent laboratories," suggesting a broader scope, but specific country of origin is not mentioned. It is a retrospective study using existing clinical samples.
- Test Set (Blind Labeled Spiked Study):
- Sample Size: Not explicitly stated.
- Data Provenance: Not explicitly stated. "Spiked study" implies controlled laboratory conditions, so the origin of the base samples would be controlled.
- Test Set (Consumer Study):
- Sample Size: 4715 total interpretations for overall accuracy; 499 interpretations specifically for PCP.
- Data Provenance: Not explicitly stated regarding the origin of the consumers or their urine samples. The study involved "lay users," implying a diverse, real-world user population. It would likely be a prospective study.
3. Number of Experts and Qualifications:
- Clinical Sample Correlation Study & Clinical Studies with Professional Users: The document mentions "professional users" in clinical studies but does not specify the number of experts or their exact qualifications (e.g., "radiologist with 10 years of experience"). For the correlation to Behring EMIT II and GC/MS, it is implied that experts capable of performing and interpreting these reference methods were involved.
- Blind Labeled Spiked Study: No information provided on expert involvement.
- Consumer Study: No experts were used to establish ground truth for this specific study; the purpose was to assess lay user interpretation. However, the ground truth definitions for accuracy were based on laboratory methods like EMIT II and GC/MS.
4. Adjudication Method:
The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for establishing ground truth in any of the studies mentioned. Ground truth was established through reference methods (Behring EMIT II and GC/MS) and spiked samples.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned that evaluates the effect size of human readers improving with AI vs. without AI assistance. This device is a standalone immunoassay kit, not an AI-assisted diagnostic tool.
6. Standalone Performance Study:
Yes, a standalone performance study was done. The entire evaluation describes the performance of the "At Home Drug Test" algorithm/device itself in detecting PCP in urine, without human intervention as part of the detection mechanism, although human interpretation of the visual result is part of its intended use. The "clinical sample correlation study," "blind labeled spiked study," and the "consumer study" all assessed the device's standalone ability to provide a result.
7. Type of Ground Truth Used:
- Clinical Sample Correlation Study: The ground truth was established by comparison to the Behring EMIT II (an enzymatic immunoassay) and GC/MS methodology (Gas Chromatography/Mass Spectrometry), which is a definitive confirmatory method.
- Blind Labeled Spiked Study: The ground truth was based on known concentrations of PCP "spiked" into samples, allowing for precise determination of true positive and true negative results.
- Consumer Study: The ground truth for evaluating consumer interpretation accuracy was presumably derived from the results obtained from the reference methods (EMIT II/GC/MS) or spiked concentrations that the consumers were then asked to interpret.
8. Sample Size for the Training Set:
The document does not mention a separate "training set" or "validation set" in the context of machine learning. The studies described are performance evaluations of the final device, not an algorithm being developed or trained. This is a traditional immunoassay device, not an AI/ML-based device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as this is not an AI/ML device requiring a training set in the conventional sense.
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