(86 days)
The Peace of Mind Home Drug Test is designed for the qualitative determination of five drugs of abuse and their metabolites in human urine at the following cut off concentrations:
| THC | 50ng/mL |
|---|---|
| PCP | 25ng/mL |
| Opiates | 2000ng/mL |
| Cocaine | 300ng/mL |
| Methamphetamine | 1000ng/mL |
The test is the first part of a two-step process to provide consumers with information regarding the presence or absence of any of these drugs in a urine sample. Confirmation, using GC/MS, of any possible drug result is recommended as the second step.
The Peace of Mind Home Drug Test is a qualitative, one step, immunochromatographic competitive assay used to screen human urine for the presence of THC, PCP, Opiates, Cocaine and Methamphetamine at the following cut off concentrations:
| THC | 50ng/mL |
|---|---|
| РСР | 25ng/mL |
| Opiates | 2000ng/mL |
| Cocaine | 300ng/mL |
| Methamphetamine | 1000ng/mL |
The test is the first part of a two-step process to provide consumers with information regarding the presence or absence, of any of the five drugs. Confirmation, using GC/MS, of a possible drug result is recommended as the second step.
The Peace of Mind Home Drug Test is an immunochromatographic based one step in vitro test for use at home.
The provided text does not contain detailed information about a study proving the device meets acceptance criteria. It primarily focuses on the regulatory submission, device description, intended use, and substantial equivalence to other devices.
However, based on the context of a drug test, we can infer some general acceptance criteria and what a typical study for such a device would entail. I will use the available information to construct the response, and clearly indicate where assumptions or general knowledge about drug testing device studies are used.
Acceptance Criteria and Device Performance (Inferred/General)
Since this is an immunoassay for drug detection, key performance metrics usually involve sensitivity, specificity, and accuracy against a gold standard method. The document specifies "cut-off concentrations," which are crucial for defining performance.
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred/General expectation for this type of device) |
|---|---|
| Sensitivity (Ability to correctly identify positive samples at or above cut-off) | High (e.g., >95% for each drug) |
| Specificity (Ability to correctly identify negative samples below cut-off) | High (e.g., >95% for each drug) |
| Accuracy (Overall agreement with the gold standard) | High (e.g., >95% for each drug) |
| Precision/Reproducibility (Consistency of results) | Consistent results across replicates and different operators. |
| Interference (Lack of interference from common substances) | Minimal interference from common medications or urine adulterants. |
| Cut-off Concentration Performance (Correct detection at specified cut-offs) | Accurate detection at THC: 50ng/mL, PCP: 25ng/mL, Opiates: 2000ng/mL, Cocaine: 300ng/mL, Methamphetamine: 1000ng/mL. |
Study Details (Largely Inferred based on typical drug test validation studies, as specific study details are not provided in the input)
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified. For a multi-analyte home drug test, test sets typically involve hundreds to thousands of urine samples, covering a range of concentrations around the cut-off (negative, near cut-off, positive). This would include samples spiked with known drug concentrations and potentially clinical samples.
- Data Provenance: Not specified. Typically, studies for such devices involve a mix of spiked samples (known concentrations prepared in a lab) and clinical urine samples collected retrospectively or prospectively from individuals who may or may not have used the drugs. The country of origin for the data is not mentioned but would likely be the USA if the submission is for FDA approval.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable in the traditional sense for drug tests. The "ground truth" is established by a highly sensitive and specific analytical method, not by expert consensus for interpretation of results.
- Qualifications of Experts: Not applicable. The "experts" would be laboratory technicians or chemists operating the confirmatory method (GC/MS).
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Adjudication method for the test set:
- Method: Not applicable. The "ground truth" for drug presence and concentration in urine is determined by a definitive analytical method, most commonly Gas Chromatography/Mass Spectrometry (GC/MS), as explicitly mentioned in the document ("Confirmation, using GC/MS, of any possible drug result is recommended as the second step"). There is no subjective interpretation requiring adjudication of results from the reference method.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
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MRMC Study: Not mentioned and highly unlikely for this type of device. MRMC studies are typically for image-based diagnostics where human interpretation is a primary variable. For a qualitative, visually read immunoassay, the "reader" is usually the end-user (a layperson for a home test) following instructions. The performance is assessed on how accurately the device itself reflects the presence of the drug, not on improved human reading with AI assistance.
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Effect Size of AI vs. without AI assistance: Not applicable, as AI assistance is not described or implied for this device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, the core "performance" of the Peace of Mind Home Drug Test itself is a standalone assessment. The device is a qualitative immunoassay. The study would assess how well the device, when read according to its instructions (presumably by a human), matches the GC/MS results. While a human reads the test, the performance is inherently of the device's chemical reaction and visual output. The device itself produces the "result" (line or no line), and the human merely observes it.
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The type of ground truth used:
- Type: Analytical Gold Standard (GC/MS - Gas Chromatography/Mass Spectrometry). The document explicitly states: "Confirmation, using GC/MS, of any possible drug result is recommended as the second step." This indicates that GC/MS is the definitive method for validating the presence and concentration of drugs.
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The sample size for the training set:
- Sample Size: Not applicable. Immunoassays are not "trained" in the same way machine learning algorithms are. Their performance is inherent to their chemical design. While development and optimization use various samples, there isn't a "training set" in the sense of AI or statistical modeling.
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How the ground truth for the training set was established:
- Ground Truth Establishment: Not applicable for a training set, as there isn't one in the AI sense. During the development and validation phase, ground truth for sample characterization (e.g., preparation of spiked samples to known concentrations, or confirmation of clinical samples) would be established using GC/MS.
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