(43 days)
The Cannabinoid Urine Drugs of Abuse (DAU) Calibrators are intended for in vitro diagnostic use for the calibration of the Cannabinoid Enzyme Immunoassay to detect cannabinoids (THC) in human urine.
The Cannabinoid Urine Drugs of Abuse (DAU) Controls are intended for in vitro diagnostic use for the validation of the Cannabinoid Enzyme Immunoassay to detect cannabinoids (THC) in human urine.
All of the Cannabinoid Urine DAU Calibrators and Controls are human urine-based liquid, and ready to use. These Calibrators and Controls do not have any especially unique technical characteristics. They each contain a known concentration of 11-nor-A -THC-9-Carboxylic Acid.
All of the Cannabinoid Urine DAU Calibrators and Controls are prepared by spiking known concentrations of 11-nor-A -THC-9-Carboxylic Acid into the Negative DAU Calibrator. which is a processed, drug-free human urine-based matrix. The nominal concentrations of the analyte in the calibrators and controls are determined and confirmed by GC/MS.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Lin-Zhi International, Inc. Cannabinoid Urine Drugs of Abuse Calibrators and Controls:
This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a previously legally marketed predicate device, rather than proving a device meets specific, pre-defined acceptance criteria through a full-scale clinical trial. Therefore, much of the requested information (like sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance studies, and detailed ground truth for training sets) is not applicable or not provided in this type of submission.
The "study" undertaken here is essentially a comparison study to the predicate device to demonstrate similar performance characteristics.
Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" in this context refers to demonstrating that the new device performs similarly to the predicate device in key areas like precision, accuracy, and stability, using established methods (GC/MS for nominal concentrations). The FDA's acceptance is based on the claim of substantial equivalence.
| Acceptance Criteria (Implied by Equivalence Claim) | Reported Device Performance (as claimed by manufacturer) |
|---|---|
| Intended Use Equivalence: | Similar intended use: calibration and validation of Cannabinoid Enzyme Immunoassay to detect cannabinoids (THC) in human urine. |
| Matrix Type: | Both are urine-based liquids. |
| Analyte Identification: | Both contain 11-nor-A-THC-9-Carboxylic Acid. |
| Concentration Determination: | Nominal concentrations determined and confirmed by GC/MS (stated for both predicate and new device). |
| Cut-off Concentration(s): | Same cut-off concentrations, including the 50 ng/mL SAMHSA recommendation. |
| Storage Conditions: | Same storage condition: 2℃ to 8℃. |
| Performance Characteristics (General): | Performance characteristics on precision, accuracy, and stability are similar (stated for both predicate and new device). Specific quantitative data not provided in summary. |
Additional Information based on the 510(k) Summary
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Sample size used for the test set and the data provenance:
- Not explicitly provided in this 510(k) summary. A 510(k) summary typically doesn't detail the specific sample sizes of the internal verification and validation studies. The studies are assumed to be internal to the manufacturer for demonstrating performance characteristics like precision, accuracy, and stability, with results compared to the predicate.
- Data provenance: Not specified, but generally, such studies are conducted by the manufacturer in a laboratory setting. Prospective or retrospective is not relevant as it's not a clinical study on human subjects in the usual sense.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. The "ground truth" for calibrators and controls is established by precise chemical methods (GC/MS in this case) to determine the exact concentration of the analyte, not by expert interpretation. Experts are not typically involved in establishing the ground truth for these types of in vitro diagnostic devices.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/None. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which is not the case for these chemical calibrators and controls.
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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:
- Not applicable. This device is a chemical calibrator/control, not an AI-powered diagnostic system or a device for human reader interpretation. No MRMC study was performed.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable in the context of AI algorithms. However, if interpreted as "device performance on its own," the underlying performance of precision, accuracy, and stability would have been evaluated in a standalone manner by the manufacturer, but the details are not provided in this summary. The device's "performance" is its ability to provide known, accurate concentrations for calibration and control.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Chemical/Quantitative Measurement. The "ground truth" for the concentration of 11-nor-A-THC-9-Carboxylic Acid in the calibrators and controls is established by Gas Chromatography/Mass Spectrometry (GC/MS), which is a highly accurate analytical chemistry technique.
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The sample size for the training set:
- Not applicable/Not provided. This is not an AI-driven device that requires a training set in the machine learning sense. The device is a chemical reagent.
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How the ground truth for the training set was established:
- Not applicable. As above, no training set in the machine learning sense. The concentrations are established by precise chemical methods (GC/MS).
§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). 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.