(14 days)
Syntron's QuikStrip One Step Opiates assay is a rapid, qualitative. competitive binding immunoassay for the determination of Opiates in urine at the cutoff level of 2000 ng/ml. The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated6. Syntron's QuikStrip One Step Opiates Test is not intended to monitor drug levels, but only to screen urines for the presence of Opiates and its metabolites.
Syntron's QuikStrip One Step Opiates Test consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody:antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the detection level of 2000 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly.
Here's a breakdown of the acceptance criteria and study details for the QuikStrip One Step Opiates Test, based on the provided 510(k) submission:
Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Relative Sensitivity (Positive Samples) | High agreement (e.g., approach 1.000 or 100%) | 1.000 / 100% |
| Relative Specificity (Negative Samples) | High agreement (e.g., approach 1.000 or 100%) | 1.000 / 100% |
| Accuracy | High accuracy (e.g., approach 100%) | 100% |
| False Positives | Zero | Zero |
| False Negatives | Zero | Zero |
Note: The document doesn't explicitly state numerical "acceptance criteria" but rather presents the achieved performance. Based on the 100% agreement and accuracy reported, it can be inferred that these values met or exceeded the internal acceptance criteria set by the manufacturer.
Study Information
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: 829 samples in clinical trials.
- Data Provenance: Not explicitly stated, but "In-house testing" and "Clinical trials" are mentioned. Given the sponsor is located in Carlsbad, California, it's highly probable the in-house testing was in the USA. The clinical trials' location is also not specified but likely within the USA. The data is retrospective, as it involves testing previously collected urine samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not explicitly state the number or qualifications of experts involved in establishing the ground truth. The ground truth was established by "Syva EMIT® II or GC/MS run at 2000 ng/ml" for screening, with all positive samples confirmed by GC/MS. This indicates a reliance on established laboratory methods rather than human expert interpretation of the test results themselves for ground truth.
4. Adjudication method for the test set:
- Not applicable in the traditional sense of human adjudication. The ground truth was established by comparison to other analytical methods (EMIT® II and GC/MS). All samples positive by either screening method were then confirmed by GC/MS. This acts as a definitive, objective confirmation rather than an adjudication between human readers.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a diagnostic device for qualitative testing of Opiates in urine, not an AI-powered image analysis tool or a device requiring human interpretation in a MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, this is a standalone device. The QuikStrip One Step Opiates Test is a chromatographic absorbent device that produces a visible color band. Its performance is evaluated as a standalone test system compared to reference methods. While a human reads the final result (presence/absence of color band), the performance metrics (sensitivity, specificity, accuracy) relate to the device's inherent ability to detect the Opiates. The "algorithm" here is the biochemical reaction within the strip itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Laboratory Reference Methods: The primary ground truth was established using
- Syva EMIT® II (Enzyme Multiplied Immunoassay Technique)
- Gas Chromatography/Mass Spectrophotometry (GC/MS)
- All positive samples by either EMIT® II or the QuikStrip test were confirmed by GC/MS. GC/MS is generally considered the "gold standard" for drug confirmation in forensic and clinical toxicology.
8. The sample size for the training set:
- Not explicitly stated. The document mentions "In-house testing" yielding 1.000 sensitivity, specificity, and 100% accuracy, and then "clinical trials" with 829 samples. It's common for device development to involve internal testing and optimization (akin to a training/development phase) before larger clinical trials (test set), but the exact size of any such developmental "training set" isn't detailed.
9. How the ground truth for the training set was established:
- Similar to the test set, the ground truth for any "in-house testing" (which would serve as an internal training/development set) was established by comparison to Syva EMIT® II and confirmed by GC/MS for positive samples.
§ 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).