(161 days)
FRONTLINE® OPIATES is a homogeneous immunochromatographic assay for use in the qualitative analysis of opiates in human urine.
FRONTLINE® OPIATES is a homogeneous immunochromatographic assay for use in the qualitative analysis of opiates in human urine. The assay is based on Gold Labeled Optical-read Rapid Immuno Assay (GLORIA) technology. Each test strip contains monoclonal antibodies reactive to a morphine derivative labeled with colloidal gold (conjugate) and morphine polyhapten, bulking agents, stabilizers and preservatives (solid phase). When immersed in urine, the test strip absorbs the volume of fluid necessary for the chromatographic reaction to occur. By capillary action, the urine passes through a compartment containing soluble conjugate which specifically binds to the opiate analyte. Excess conjugate is retained by the solid phase in a separate compartment. Only that conjugate with bound opiate analyte passes to the detection pad where a red-colored conjugate-analyte complex is viewed. The color developed on the detection pad is compared visually with a scale provided on the test strip vial. The intensity of the color developed correlates with the concentration of the analyte in the sample and the user may classify the analyte sample as: negative or positive (≥200 ng/mL).
Here's a breakdown of the acceptance criteria and study information for the FRONTLINE® OPIATES device, based on the provided text:
Acceptance Criteria and Device Performance
A formal table of acceptance criteria is not explicitly stated in the provided text. However, the performance data presented within the "Comparison to EIA" and "Comparison to FPIA" sections implicitly define the device's performance relative to predicate methods and confirmation. The "Conclusion" states that the device is "substantially equivalent to other commercially available opiate test systems," which implies that its performance met a threshold for this determination.
Based on the provided data, we can infer the device's performance in comparison to the predicate methods and a confirmation method.
| Acceptance Criteria (Implied) | Reported Device Performance (vs. EIA & Confirmation) | Reported Device Performance (vs. FPIA & Confirmation) |
|---|---|---|
| Agreement with EIA/Confirmation | ||
| Number of positive samples | 244 (FRONTLINE® positive) | 191 (FRONTLINE® positive) |
| Number of negative samples | 482 (FRONTLINE® negative) | 318 (FRONTLINE® negative) |
| False Positives | 1 | 2 |
| Unavailable for confirmation | 1 | Not specified |
| Substantial Equivalence to Predicate Devices | Concluded to be substantially equivalent. | Concluded to be substantially equivalent. |
Note: The exact acceptance criteria (e.g., a minimum percentage agreement, sensitivity, or specificity) are not quantified in the provided text, but rather implied by the statement of "substantial equivalence" based on the observed comparison results.
Study Information
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size:
- Comparison to EIA: 728 metabolized urine samples
- Comparison to FPIA: 511 metabolized urine samples
- Data Provenance: The text does not explicitly state the country of origin. It mentions "three sites" for the EIA comparison and "two sites" for the FPIA comparison, suggesting a multi-site study. The study appears to be retrospective, as it involves evaluating "metabolized urine samples" against established methods, implying these samples were collected prior to the study for testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The text does not specify the number or qualifications of experts involved in establishing the ground truth. The ground truth appears to be established by comparison to the "confirmation method" which is not explicitly detailed but might involve gas chromatography-mass spectrometry (GC-MS) or a similar definitive method typically used for drug confirmation.
4. Adjudication method for the test set:
- The text does not describe an adjudication method for reconciling discrepancies. The comparison is made directly against "EIA and the confirmation method" or "FPIA and the confirmation method," suggesting a direct comparison without a formal adjudication process beyond the confirmation method serving as the ultimate truth.
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, an MRMC comparative effectiveness study was not done. The FRONTLINE® OPIATES device is described as a "noninstrumented assay" that requires "no user calibration" and involves visual comparison of a color developed on a detection pad with a scale. This is a standalone diagnostic test, not an AI-assisted tool for human readers. Therefore, the concept of improving human readers with AI assistance does not apply here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance assessment was conducted. The device itself is a "noninstrumented assay" where the user visually interprets the result by comparing the color intensity to a scale. The performance data presented (comparison to EIA/confirmation and FPIA/confirmation) reflects the direct performance of the FRONTLINE® OPIATES device in identifying opiate positives and negatives, without an explicit human-in-the-loop component beyond the visual reading. While a human performs the visual reading, the reported performance metrics are for the device's ability to produce that visual signal accurately relative to the ground truth.
7. The type of ground truth used:
- The ground truth was established using predicate device methods (Emit® d.a.u. Opiate Assay [EIA] and TDx® Opiates [FPIA]) in conjunction with a "confirmation method." The nature of the "confirmation method" is not detailed, but in drug screening, this typically refers to a highly sensitive and specific laboratory technique like Gas Chromatography-Mass Spectrometry (GC-MS) which is considered the gold standard for confirming the presence and concentration of drugs.
8. The sample size for the training set:
- The provided text does not mention a training set sample size. This information is typically relevant for machine learning algorithms or AI systems. As this device is an immunochromatographic assay based on chemical reactions and visual interpretation, it does not involve machine learning in the conventional sense that would require a separate training set. The development of such assays relies on biochemical optimization and validation, rather than algorithmic training.
9. How the ground truth for the training set was established:
- As no training set is mentioned or implied for this type of device, this information is not applicable.
§ 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).