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510(k) Data Aggregation
(27 days)
The Single Analyte Urine Drugs of Abuse (DAU) Calibrators are intended for in vitro diagnostic use for the calibration of their respective DAU enzyme immunoassays to detect phencyclidine, opiates, cocaine metabolite, or amphetamines in human urine.
The Single Analyte Urine Drugs of Abuse (DAU) Controls are intended for in vitro diagnostic use for the validation of their respective DAU enzyme immunoassays to detect phencyclidine, opiates, cocaine metabolite, or amphetamines in human urine.
All of the Single Analyte 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. When applicable, they contain known concentration of a specific drug analyte.
The Negative DAU Calibrator is a processed, drug-free human urine matrix. The Low, Cutoff, Intermediate, and High Calibrators, as well as the 2 levels of Controls are prepared by spiking known concentrations of drug analyte into the Negative DAU Calibrator matrix. The various concentrations of each drug analyte in their corresponding calibrators and controls are summarized as follows:
| Phencyclidine EIA | Opiate EIA | Cocaine Metabolite EIA | Amphetamines EIA | |
|---|---|---|---|---|
| Reference Material | Phencyclidine | Morphine | Benzoylecgonine | d-Methamphetamine |
| Low Calibrator | 12.5 ng/mL | 150 ng/mL | 150 ng/mL | 500 ng/mL |
| Cutoff Calibrator | 25 ng/mL | 300 ng/mL | 300 ng/mL | 1000 ng/mL |
| Intermediate Calibrator | 50 ng/mL | 600 ng/mL | 1000 ng/mL | 1500 ng/mL |
| High Calibrator | 100 ng/mL | 1000 ng/mL | 3000 ng/mL | 2000 ng/mL |
| Control Level 1 | 18 ng/mL | 225 ng/mL | 225 ng/mL | 750 ng/mL |
| Control Level 2 | 32 ng/mL | 375 ng/mL | 375 ng/mL | 1250 ng/mL |
The nominal concentrations of the analyte in the calibrators and controls are determined and confirmed by GC/MS.
The provided document describes a 510(k) premarket notification for "Single Analyte Urine Drugs of Abuse Calibrators and Controls". This device is a set of calibrators and controls used for in vitro diagnostic tests, rather than an AI-powered diagnostic device. As such, many of the requested categories in the prompt (e.g., AI performance, expert adjudication, MRMC studies, training set details) are not applicable.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" for the LZI device. Instead, it demonstrates substantial equivalence to a predicate device (DRI's Drugs of Abuse Urine Calibrators and Controls) by highlighting similarities in intended use, matrix, and performance characteristics. The performance characteristics mentioned as similar are precision, accuracy, and stability. However, specific numerical targets or benchmarks for these characteristics for the LZI device are not provided in this summary.
The table below summarizes the device's characteristics and how they compare to the predicate, which implicitly defines the performance expectations for equivalence.
| Characteristic | Predicate Device (DRI's DAU Urine Cals/Controls) | LZI's Single Analyte Urine DAU Cals/Controls | Acceptance Criteria / Performance |
|---|---|---|---|
| Intended Use | Calibration and validation of DAU immunoassays for phencyclidine, opiates, cocaine metabolite, or amphetamines in human urine. | Calibration and validation of DAU immunoassays for phencyclidine, opiates, cocaine metabolite, or amphetamines in human urine. | Similar (Intended use is the same) |
| Matrix | Urine-based liquids | Human urine-based liquids | Similar (Urine-based) |
| Cutoff Concentration | Same as SAMHSA recommendations | Same as SAMHSA recommendations | Similar (Matches SAMHSA guidelines) |
| Control Levels | 2 levels, ± 25% of cutoff per SAMHSA guideline | 2 levels, concentrations (18/32 ng/mL for PCP, 225/375 ng/mL for Opiate, 225/375 ng/mL for Cocaine, 750/1250 ng/mL for Amphetamines) set around cutoff | Similar (2 levels, concentrations set around cutoff per SAMHSA guideline implicitly met) |
| Analyte Concentration Confirmation | Confirmed by GC/MS | Confirmed by GC/MS | Similar (Uses GC/MS for nominal concentration confirmation) |
| Storage Condition | 2℃ to 8℃ | 2℃ to 8℃ | Similar (Same storage conditions) |
| Performance Characteristics (General) | Precision, accuracy, stability are similar to LZI's product | Precision, accuracy, stability are similar to DRI's product | Similar (General statement of similar precision, accuracy, and stability. Specific numerical data not provided in the summary.) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide details on sample size or data provenance for any "test set" in the context of device performance testing. The evaluation focused on demonstrating substantial equivalence to a predicate device based on characteristics and general performance attributes, rather than presenting a detailed clinical study with a test set. The nominal concentrations of analytes in the calibrators and controls are "determined and confirmed by GC/MS," which implies internal analytical testing, but specifics are not given.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. This device is a set of calibrators and controls for laboratory assays, not an AI or diagnostic device that requires expert ground truthing of clinical data for performance evaluation. The "ground truth" for the calibrators and controls is the precisely known concentration of drug analytes, which is confirmed by analytical methods like GC/MS.
4. Adjudication Method:
Not applicable for the reasons stated above.
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:
Not applicable. This is not an AI-powered device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI-powered device with an algorithm for standalone performance. The device itself (calibrators and controls) is a component used in an assay.
7. The Type of Ground Truth Used:
The ground truth for the device's characteristics is the precisely known (nominal) concentrations of drug analytes spiked into the urine matrix, which are confirmed by Gas Chromatography/Mass Spectrometry (GC/MS).
8. The Sample Size for the Training Set:
Not applicable. This is not an AI-powered device that requires a "training set." The development of calibrators and controls relies on precise chemical formulations and analytical validation.
9. How the Ground Truth for the Training Set was Established:
Not applicable. As there is no training set for this type of device, this question is not relevant. The "ground truth" for the product itself (known analyte concentrations) is established through analytical chemistry methods like GC/MS.
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