(58 days)
Technical Chemicals and Products, Inc.'s One Step™ Urine Drug of Abuse: Benzodiazepine assay is a rapid, qualitative, competitive binding immunoassay for the determination of Benzodiazepine in urine at the cutoff level of 200 ng/ml. The test provides only preliminary data that 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. Technical Chemicals and Products, Inc.'s One Step™ Urine Drug of Abuse: Benzodiazepine Test is not intended to monitor drug levels, but only to screen urine for the presence of Benzodiazepine and its metabolites.
Technical Chemicals and Products. Inc.'s One Step™ Urine Drug of Abuse: Benzodiazepine 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 200 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 information for the One Step™ Urine Drug of Abuse: Benzodiazepine Test, based on the provided document:
Acceptance Criteria and Device Performance
| Criteria | Acceptance Criteria (Implied by comparison) | Reported Device Performance (Clinical Trial) | Reported Device Performance (In-house Testing) |
|---|---|---|---|
| Agreement within positive samples | Not explicitly stated | 100% | 100% |
| Agreement within negative samples | Not explicitly stated | 95.42% | 97.40% |
| Accuracy | Not explicitly stated | 97.69% | 98.54% |
| No false negatives | Yes (Implied for safety) | 0 | 0 |
Note: The document states that "By non-parametric testing, the results are significantly different from one another" when comparing the clinical trial data to Emit II 200®. This suggests that while the One Step™ test performed well, there were statistical differences in its results compared to the predicate device. The document clarifies that the false positives from Emit II® were due to drug levels below the 200 ng/ml cutoff, confirmed by GC/MS.
Study Details
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Sample sizes used for the test set and the data provenance:
- Clinical Trial Test Set: 303 samples.
- In-house Test Set: Not explicitly stated, but results are given for "positive samples of 1000" and "negative samples of 0.9740" (likely a typo, intended to refer to a percentage of negatives, or related to the number of negative samples if positive samples were 1000) and "accuracy of 98.54%".
- Data Provenance: Not explicitly stated, but given it's a 510(k) submission to the FDA, it's typically for the US market. The mention of "clinical trial" suggests prospective data collection in a clinical setting. "In-house testing" would be retrospective data from the manufacturer.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The ground truth was established by comparison to Syva EMIT II 2200® for initial screening, and then confirmed by GC/MS 200. No mention of expert review as the primary ground truth establishment.
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Adjudication method for the test set:
- The primary method of adjudication was confirmation of all positive samples (by either the One Step™ test or Syva EMIT II 2200®) using Gas Chromatography/Mass Spectrometry (GC/MS 200). For ambiguous or discrepant results (e.g., Emit II® false positives), GC/MS served as the definitive arbiter.
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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 device is a qualitative diagnostic test for drug detection in urine, not an AI-assisted diagnostic imaging device. Therefore, an MRMC study with human readers and AI assistance is not applicable.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the device itself is a standalone qualitative test. Its performance statistics (agreement within positives/negatives, accuracy) were measured independently against reference methods (EMIT II and GC/MS). There is no "human-in-the-loop" component in the interpretation of the test result other than a visual reading of the color bands.
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The type of ground truth used:
- The gold standard for ground truth was Gas Chromatography/Mass Spectrometry (GC/MS 200), which was used to confirm all positive samples from either screening method. The Syva EMIT II 2200® was used as a comparative screening method, but GC/MS was the definitive validation.
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The sample size for the training set:
- Not specified. As this is a chromatographic absorbent device (immunoassay), it's not a machine learning model, and thus there isn't a traditional "training set" in the computational sense. The device's components and chemical reactions are designed rather than trained.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set in the context of a machine learning model for this type of device. The device's operational characteristics (e.g., cutoff levels, chemical sensitivities) are established through research, development, and calibration using known concentrations of benzodiazepines and their metabolites.
§ 862.3170 Benzodiazepine test system.
(a)
Identification. A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.(b)
Classification. Class II (special controls). A benzodiazepine 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).