(40 days)
A drug of abuse assay intended for use in clinical toxicology laboratories, physicians' offices, drug-of-abuse clinics and law enforcement agencies is an in-vitro diagnostic test for the qualitative identification of any addictive narcotic pain relieving opiate drug, in urine. An opiate is any natural or synthetic drug that has morphine-like pharmaco-logical actions. The opiates include drugs such as morphine, heroin, codeine, nalorphine,meperidine and morphine glucuronide. Measurements that are obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.
The QuickScreenTM One Step Opiates Test utilizes colloidal gold as the label like other commercially available immunoassays for drug of abuse (Opiates) test kits, to qualitatively measure the presence of opiates by visual color sandwich one step immunoassay technology.
The provided information describes the Phamatech QuickScreen™ One Step Opiate Screening Test, an immunoassay for the qualitative detection of opiates in urine.
Here's an analysis based on your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sensitivity | > 95% | > 95% (specifically 116/116 for clinical samples vs. EMIT II) |
| Specificity | > 99% | > 99% (specifically 35/35 for clinical samples vs. EMIT II) |
| Accuracy | > 97% | > 97% (specifically 151/151 for clinical samples vs. EMIT II) |
Note: The acceptance criteria are implied from the "Performance" section which states the device "produced a sensitivity of >95%, specificity of >99% and accuracy >97%". This suggests these values were the targets for demonstrating substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "clinical specimens" producing 116/116 sensitive results, 35/35 specific results, and 151/151 accurate results. This suggests a total of 151 clinical samples were used in the correlation study against the predicate device.
- Data Provenance:
- Country of Origin: USA (Phamatech is located in San Diego, California, and clinical testing sites are in San Diego, CA).
- Retrospective or Prospective: The document does not explicitly state whether the study was retrospective or prospective. However, it refers to "clinical sample correlation study," which often implies analysis of existing samples, but without further detail, it's not definitively one or the other.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for the test set. Instead, it states that the performance was evaluated against a predicate device, the Syva EMIT II immunoassay, and tests were conducted "in the hands of professional laboratory technicians."
4. Adjudication Method for the Test Set
No adjudication method (e.g., 2+1, 3+1) is described for the test set. The comparison was directly against the Syva EMIT II immunoassay.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was performed or described. This device is an in-vitro diagnostic test, and the performance evaluation focuses on direct comparison to a predicate assay, not on human reader performance with or without AI assistance.
6. Standalone Performance
Yes, standalone performance was done. The entire performance section describes the algorithm's (the immunoassay's) performance characteristics (sensitivity, specificity, accuracy) when compared to a predicate device. This is a standalone evaluation demonstrating the device's ability to detect opiates in urine without human interpretation beyond reading the visual color change.
7. Type of Ground Truth Used
The ground truth used was the results from a predicate device, the Syva EMIT II immunoassay. This is a common method for establishing substantial equivalence for new IVD devices, comparing their performance to an established, legally marketed device.
8. Sample Size for the Training Set
The document does not explicitly mention a separate "training set" or its sample size. Immunoassays are typically developed and validated using a different paradigm than AI/machine learning models which require distinct training and testing sets. The performance study refers to clinical validation rather than machine learning training.
9. How the Ground Truth for the Training Set was Established
As no separate training set is mentioned in the context of machine learning, this question is not applicable in the way it would be for an AI device. The development and optimization of the immunoassay itself would have involved internal validation and calibration using known positive and negative samples, but these are not described as a "training set" in the context of the 510(k) summary. The "ground truth" for the clinical performance evaluation (test set) was the predicate device's results.
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).