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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: amphetamine
Immunoassay for the qualitative detection of amphetamine in urine
The Phamatech At Home Drug Test (Model 9063) is a rapid, qualitative immunoassay for the detection of amphetamine in urine.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Amphetamine Detection Accuracy (Expert Users) | Not explicitly stated, but generally high accuracy is expected for medical devices. | >97% overall accuracy |
| Amphetamine Detection Accuracy (Lay Users) | Accuracy in the hands of lay users should be high enough to ensure safe and effective home use. | 97.2% (917/943 correct) |
| Correlation with Predicate Device (Behring EMIT II) | High correlation expected for substantial equivalence. | >98% correlation |
| Correlation with Confirmatory Method (GC/MS) | High correlation expected for reliable detection. | >98% correlation |
Note: The document implicitly assumes that "correlation" and "accuracy" are the primary indicators of performance for this type of test, and that a high percentage (e.g., >97-98%) is considered acceptable for substantial equivalence.
2. Sample Size and Data Provenance
- Test Set Sample Size: The document provides specific numbers for lay user studies (943 consumer interpretations for amphetamine specific, 4715 total interpretations across drugs). For professional users and correlation studies, it states "clinical specimens" but does not specify exact numbers.
- Data Provenance: The studies were performed in "two independent laboratories" and involved "clinical specimens" and "spiked study" data. The country of origin is not explicitly stated but can be inferred to be the USA, given the manufacturer's location and FDA submission. The studies were likely a combination of retrospective (clinical specimens) and prospective (blind labeled spiked study, consumer study).
3. Number of Experts and Qualifications for Ground Truth
- The document implies the use of "professional users" in some studies. However, it does not specify the exact number of experts, their qualifications (e.g., specific medical degrees, years of experience), or their role in establishing the ground truth for any of the studies.
- Clinical studies comparing the device to the Behring EMIT II and GC/MS were conducted, suggesting that the results of these established methods were considered the ground truth, which would have been interpreted by trained laboratory professionals.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method such as 2+1 or 3+1. Given that the ground truth for the clinical and correlation studies relied on established laboratory methods (Behring EMIT II and GC/MS), it's likely that a single, definitive result from these methods served as the ground truth. For the consumer study, the accuracy was measured against presumably pre-determined correct results, but the method of establishing those initial correct results (e.g., through a consensus of experts or a gold standard method) is not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study involving human readers improving with AI vs. without AI assistance was described. This device is a standalone in-vitro diagnostic test for home use, without an AI component in the described functionality.
6. Standalone Performance
Yes, a standalone performance study was done. The document reports the performance of the "At Home Drug Test" itself, both in the hands of professional users and lay users, and its correlation with predicate devices and GC/MS. This directly reflects the algorithm's (immunoassay's) standalone performance.
7. Type of Ground Truth Used
The ground truth used for the studies appears to be a combination of:
- Predicate Device Performance: Correlation studies were performed against the Behring EMIT II.
- Confirmatory Method: Correlation studies were performed against GC/MS methodology, which is a gold standard for drug detection.
- Pre-determined Correct Results: For the consumer study, the accuracy was reported against "correct" results, implying a comparison to an established ground truth, likely derived from the confirmatory methods or expert analysis.
8. Sample Size for the Training Set
The document does not provide information on a specific "training set" sample size. As an immunoassay, the device itself is not a machine learning algorithm that requires a training set in the conventional sense. The "training" for such devices typically involves the optimization of reagents and protocols during development, rather than a data-driven training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this device does not utilize a machine learning algorithm with a conventional training set. The development of the immunoassay involves chemical and biological optimization, not data-driven training.
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