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510(k) Data Aggregation
(118 days)
The Amphetamines Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 1000 ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analyses of amphetamines in human urine.
The Amphetamines Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgement should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
L.ZI's Amphetamines Enzyme Immunoassay is a ready-to-use, liguid reagent, homogeneous enzyme immunoassay. The assay uses specific antibody that can detect amphetamine and/or methamphetamine in human urine with minimal cross-reactivity to other drugs of abuse, and common prescription drugs.
The assay is based on competition between amphetamines labeled with glucose-6phosphate dehydrogenase (G6PDH) enzyme, and free drugs from the urine sample for a fixed amount of specific antibody mixtures. In the absence of free drugs from the urine sample the specific antibodies bind to the drugs labeled with G6PDH enzyme causing a decrease in enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically at 340 mm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH.
Here's a summary of the acceptance criteria and study information based on the provided text, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Predicate Device K934891) | Reported Device Performance (LZI's Amphetamines EIA) |
|---|---|---|
| Within Run Precision: | ||
| - Qualitative Negative | Mean Rate: 312, SD: 1 | Mean Rate: 273.0, SD: 0.95, % CV: 0.35 |
| - Qualitative 750 ng/mL | Mean Rate: 418, SD: 2 | Mean Rate: 390.0, SD: 1.45, % CV: 0.37 |
| - Qualitative 1000 ng/mL | Mean Rate: 443, SD: 2 | Mean Rate: 415.7, SD: 1.41, % CV: 0.34 |
| - Qualitative 1250 ng/mL | Mean Rate: 468, SD: 2 | Mean Rate: 439.0, SD: 1.63, % CV: 0.37 |
| - Qualitative 2000 ng/mL | Mean Rate: 513, SD: 3 | Mean Rate: 480.5, SD: 1.42, % CV: 0.30 |
| - Semi-quantitative | No data available | 750 ng/mL: Mean Rec. 751.1, SD 9.83, % CV 1.31 |
| 1000 ng/mL: Mean Rec. 1008.6, SD 14.02, % CV 1.39 | ||
| 1250 ng/mL: Mean Rec. 1249.6, SD 17.24, % CV 1.38 | ||
| Run-To-Run Precision: | ||
| - Qualitative Negative | No data available | Mean Rate: 272.9, SD: 2.28, % CV: 0.84 |
| - Qualitative 750 ng/mL | No data available | Mean Rate: 390.5, SD: 2.88, % CV: 0.74 |
| - Qualitative 1000 ng/mL | No data available | Mean Rate: 415.9, SD: 3.04, % CV: 0.73 |
| - Qualitative 1250 ng/mL | No data available | Mean Rate: 439.1, SD: 3.60, % CV: 0.82 |
| - Qualitative 2000 ng/mL | No data available | Mean Rate: 479.6, SD: 3.47, % CV: 0.72 |
| - Semi-quantitative | No data available | 750 ng/mL: Mean Rec. 756.6, SD 14.81, % CV 1.96 |
| 1000 ng/mL: Mean Rec. 997.7, SD 25.01, % CV 2.51 | ||
| 1250 ng/mL: Mean Rec. 1265.2, SD 29.54, % CV 2.33 | ||
| Sensitivity | 10 ng/mL | 30 ng/mL |
| Accuracy (Positive) | 100% agreement (vs. commercially available EIA) | 100% agreement (vs. DRI's Amphetamines EIA) |
| Accuracy (Negative) | 100% agreement (vs. commercially available EIA) | 100% agreement (vs. DRI's Amphetamines EIA) |
| Analytical Recovery: | ||
| - Qualitative | No data available | 100% accurate on positive vs. negative tests |
| - Semi-quantitative | No data available | Quantitate within 10% of nominal concentration between 300 ng/mL and 1900 ng/mL. 104.2% recovery at 750 ng/mL, 101.2% recovery at 1250 ng/mL |
| Specificity | See attached DRI's package insert | Comparable to the predicate device |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: For the Accuracy study (comparison to predicate device), the sample size was n = 218.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It implies the data was collected for this comparative study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There were no experts used to establish ground truth in the traditional sense of medical image interpretation by human experts. The ground truth for the device's performance was established by comparing its results to a legally marketed predicate device (DRI's Amphetamines EIA) and by reference to nominal concentrations for precision and recovery studies.
4. Adjudication Method for the Test Set
Not applicable, as this is a chemical immunoassay, not a system requiring human adjudication of results. The comparison was directly against a predicate device's output.
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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a homogeneous enzyme immunoassay for chemical analysis, not an AI or imaging system involving human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone immunoassay. The performance characteristics (precision, accuracy, sensitivity, analytical recovery, specificity) are reported for the algorithm/device itself, without human interpretation as part of the primary test result. The "human-in-the-loop" equivalent would be a lab technician performing the test and reading the spectrophotometric output, not an interpretive process.
7. The Type of Ground Truth Used
The ground truth for the test set was established primarily through:
- Comparison to a Predicate Device: DRI's Amphetamines EIA (K934891) served as the reference for accuracy.
- Nominal Concentrations: For precision and analytical recovery studies, the "true" values were the known, spiked concentrations of amphetamines.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning. This device is a chemical immunoassay based on specific antibody-antigen reactions, not a machine learning model that undergoes training. Therefore, this information is not applicable.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for this type of medical device.
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