(159 days)
The Triage® Drugs of Abuse Panel Plus PPX is a competitive immunoassay used for the qualitative determination of the presence of the major metabolites of amphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, THC, tricyclic antidepressants, and propoxyphene in urine.
The Triage® Drugs of Abuse Panel Plus PPX is a competitive immunoassay used for the qualitative determination of the presence of the major metabolites of amphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, THC, tricyclic antidepressants, and propoxyphene in urine.
The provided text describes the Triage® Drugs of Abuse Panel Plus PPX, a competitive immunoassay for qualitative determination of various drug metabolites in urine. Here's a breakdown of the acceptance criteria and the study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes the "Summary of Performance Data" for the device, which essentially serves as the study proving the device meets its acceptance criteria. The acceptance criteria themselves are implied by the tests conducted and the statements of successful results.
| Study Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Interfering Substances | No interference with assay results from common urine substances. | "None of the substances tested caused interference with the assay results." This was evaluated by spiking samples with drug 20% above and 20% below the threshold concentration. |
| Specificity/Cross-reactivity | Device accurately identifies drugs and related substances. | "Drugs and related substances were added to drug-free urine and tested... to determine the concentration that produces a positive result. The results are described in the labeling." (Specific concentrations are not provided in this summary, but are stated to be in the labeling). |
| Imprecision | Consistent results around the threshold concentration. | "The precision results were consistent with the threshold validation results." Imprecision was determined by testing three contrived specimens (25% below, at, and 25% above threshold) ten times each by three individuals for three days. |
| Threshold Validation | Device able to detect drug concentrations near the established threshold and thresholds are appropriately set. | "The data indicated that the device is able to detect drug concentrations near the threshold and that the thresholds are set appropriately." This was confirmed by testing specimens spiked at 25% above and 25% below the previously established thresholds for each drug, in increments of 25%. |
2. Sample Size Used for the Test Set and Data Provenance
-
Sample Size for Test Set:
- Interfering Substances: Not explicitly stated, but "Substances that are commonly in human urine" were tested with samples spiked with drug 20% above and 20% below the threshold concentration. The number of unique samples or tests is not provided beyond this.
- Specificity/Cross-reactivity: Not explicitly stated how many different "Drugs and related substances" were tested or how many replicates per substance.
- Imprecision: For each drug, three contrived specimens (25% below, at, and 25% above threshold) were tested. Each specimen was evaluated ten times each day for three days by three individuals. This amounts to 3 specimens * 10 tests/day * 3 days * 3 individuals = 270 tests per drug panel for imprecision.
- Threshold Validation: For each drug, specimens containing concentrations at various increments (25% above and 25% below the threshold) were tested. The number of distinct concentrations and replicates for each is not specified.
-
Data Provenance: The studies used "human urine" and "drug-free urine" that were spiked with the substances. The country of origin is not mentioned, but given the submitter is Biosite Incorporated in San Diego, CA, it's highly probable the data originated in the USA. The studies appear to be prospective, designed specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The ground truth for this diagnostic device is based on analytical accuracy rather than expert interpretation of images or clinical data. Therefore, the concept of "experts establishing ground truth" as it applies to image interpretation or clinical diagnosis is not directly applicable here. The performance is assessed against known concentrations of analytes in a controlled environment.
However, three individuals were involved in evaluating specimens for imprecision. Their qualifications are not mentioned beyond "individuals." For the other studies, the "ground truth" (i.e., the presence and concentration of the drugs) was established by carefully spiking known quantities of drugs into drug-free urine, which is a laboratory-controlled method and does not require subjective expert consensus.
4. Adjudication Method for the Test Set
Adjudication methods like "2+1" or "3+1" are typically used when there is subjective interpretation involved, such as in radiology or pathology. This type of adjudication is not applicable to a quantitative/qualitative immunoassay like the Triage® Drugs of Abuse Panel Plus PPX, as the results are instrument-read detections based on chemical reactions. The "ground truth" is defined by the known concentration of spiked analytes.
For the imprecision study, "Three individuals evaluated each specimen ten times each day for three days," suggesting that their readings were aggregated or compared, but no formal adjudication process for conflict resolution is described as would be used in subjective assessments.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study assesses how human readers' performance changes with AI assistance versus without. The Triage® Drugs of Abuse Panel Plus PPX is a standalone diagnostic device, not an AI-assisted interpretation tool for human readers. Its primary output is a qualitative determination (present/absent) of drug metabolites.
6. Standalone Performance Study
Yes, a standalone performance study was done. The entire "Summary of Performance Data" describes the standalone performance of the algorithm/device. The device's ability to detect different drug concentrations (threshold validation), its specificity, its imprecision, and its resistance to interference were all assessed as a standalone system without human-in-the-loop interpretation.
7. The Type of Ground Truth Used
The type of ground truth used for this device's performance studies is analytical ground truth based on known concentrations of analytes.
- For interfering substances, specificity, and threshold validation, the ground truth was established by spiking known concentrations of drugs and related substances into drug-free urine. This allows for precise control over the presence and quantity of the target analytes.
- For imprecision, contrived specimens with known drug concentrations (25% below, at, and 25% above the threshold) were used.
8. The Sample Size for the Training Set
The document does not mention a training set or any machine learning/AI components that would require one. This device is described as a "competitive immunoassay," which is a traditional biochemical assay, not an AI-driven system. Therefore, the concept of a "training set" is not relevant here.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set, the establishment of ground truth for a training set is not applicable.
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).