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510(k) Data Aggregation
(120 days)
The Opiate Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analyses of opiates in human urine.
The Opiate 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.
LZI's Opiate Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibody that can detect opiates in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs.
The assay is based on competition between morphine labeled with glucose-6-phosphate dehydrogenase (G6PDH) enzyme, and free drug from the urine sample for a fixed amount of specific antibody. In the absence of free drug from the urine sample the specific antibody binds to the drug labeled with G6PDH enzyme causing a decrease in enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically at 340 nm by measuring its ability to covert nicotinamide adenine dinucleotide (NAD) to NADH.
Here's a breakdown of the acceptance criteria and study information for the Lin-Zhi International, Inc.' Opiate Enzyme Immunoassay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to the predicate device and the stated "acceptable results." Since this is a 510(k) submission for an in-vitro diagnostic, the primary "acceptance criterion" is often substantial equivalence to a legally marketed predicate. The reported performance of the new device is directly compared to the predicate's performance or presented as standalone performance that is considered acceptable.
| Performance Characteristic | Predicate Device Performance (DRI® Opiate EIA) | LZI's Opiate EIA Performance (New Device) | Acceptance Criteria (Implied) |
|---|---|---|---|
| Within Run Precision (Qualitative) | Comparable to predicate device; low %CVs. | ||
| Negative | - (Not reported directly, but implied low) | Mean Rate: 291.6, SD: 2.19, %CV: 0.75 | |
| 225 ng/mL | Mean Rate: 374, SD: 2.2, %CV: 0.6 | Mean Rate: 374.4, SD: 3.01, %CV: 0.80 | |
| 300 ng/mL | Mean Rate: 401, SD: 2.3, %CV: 0.6 | Mean Rate: 399.8, SD: 3.42, %CV: 0.86 | |
| 375 ng/mL | Mean Rate: 421, SD: 2.4, %CV: 0.6 | Mean Rate: 421.8, SD: 3.20, %CV: 0.76 | |
| 1000 ng/mL | - (Not reported) | Mean Rate: 530.8, SD: 5.17, %CV: 0.97 | |
| Within Run Precision (Semi-quantitative) | Comparable to predicate device; low %CVs. | ||
| 225 ng/mL | Mean Conc: 226, SD: 6.0, %CV: 2.7 | Mean Conc: 218.6, SD: 5.96, %CV: 2.73 | |
| 300 ng/mL | Mean Conc: 303, SD: 8.1, %CV: 2.7 | Mean Conc: 298.0, SD: 9.84, %CV: 3.30 | |
| 375 ng/mL | Mean Conc: 379, SD: 15.1, %CV: 4.0 | Mean Conc: 373.3, SD: 11.18, %CV: 3.00 | |
| Run-To-Run Precision (Qualitative) | Comparable to predicate device; low %CVs. | ||
| Negative | - (Not reported directly, but implied low) | Mean Rate: 292.8, SD: 1.81, %CV: 0.62 | |
| 225 ng/mL | Mean Rate: 374, SD: 2.6, %CV: 0.7 | Mean Rate: 375.8, SD: 3.61, %CV: 0.96 | |
| 300 ng/mL | Mean Rate: 401, SD: 3.2, %CV: 0.8 | Mean Rate: 400.8, SD: 3.34, %CV: 0.83 | |
| 375 ng/mL | Mean Rate: 421, SD: 3.0, %CV: 0.7 | Mean Rate: 421.1, SD: 2.87, %CV: 0.68 | |
| 1000 ng/mL | - (Not reported) | Mean Rate: 528.6, SD: 4.84, %CV: 0.92 | |
| Run-To-Run Precision (Semi-quantitative) | Comparable to predicate device; low %CVs. | ||
| 225 ng/mL | Mean Conc: 226, SD: 8.2, %CV: 3.6 | Mean Conc: 223.8, SD: 9.45, %CV: 4.22 | |
| 300 ng/mL | Mean Conc: 303, SD: 9.4, %CV: 3.1 | Mean Conc: 301.0, SD: 9.15, %CV: 3.04 | |
| 375 ng/mL | Mean Conc: 379, SD: 15.9, %CV: 4.2 | Mean Conc: 377.8, SD: 7.53, %CV: 1.99 | |
| Sensitivity | 6 ng/mL | 15 ng/mL | Adequate sensitivity for intended use (difference noted, but deemed acceptable for substantial equivalence). |
| Accuracy | Vs. GC/MS: Positive Samples: 100% agreement, Negative Samples: 90% agreement | Vs. DRI® Opiate EIA (n = 216): Positive Samples: 97.1% agreement, Negative Samples: 93.8% agreement | Comparable to predicate device. |
| Analytical Recovery (Qualitative) | No data available | 100% accuracy on positive vs. negative tests | Acceptable performance. |
| Analytical Recovery (Semi-quantitative) | No data available | Quantitates within ±10% of nominal concentration between 60-900 ng/mL. | |
| Average 97.7% recovery at 225 ng/mL (Cutoff - 25%) | |||
| Average 96.7% recovery at 375 ng/mL (Cutoff + 25%) | Acceptable performance. | ||
| Interference | See predicate package insert | Compounds tested are comparable; results in specificity table | Comparable to predicate device. |
| Specificity | See predicate package insert | Comparable to the predicate device | Comparable to predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Accuracy Test: The accuracy study comparing the LZI device to the DRI® Opiate EIA used n = 216 samples.
- Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Accuracy Study: For the accuracy study against the predicate device, it's not clear that "experts" established a separate ground truth. The comparison was against the results of the DRI® Opiate EIA, which itself is a diagnostic test.
- The predicate device's accuracy was established against GC/MS (Gas Chromatography/Mass Spectrometry), which is typically considered the gold standard for drug quantification. The document does not specify the number or qualifications of experts involved in the GC/MS analysis.
4. Adjudication Method for the Test Set
- The document does not describe any adjudication method (e.g., 2+1, 3+1) for the test set. The comparison for accuracy was directly against the predicate device's results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is an in-vitro diagnostic test, not an imaging or interpretive AI system that typically involves human readers.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
- Yes, the performance characteristics (precision, sensitivity, accuracy, analytical recovery, interference, specificity) described are for the device (immunoassay) operating in a standalone manner, providing analytical results without human real-time intervention during the analytical process itself. The interpretation of these results for clinical decisions would involve human judgment.
7. Type of Ground Truth Used
- For the LZI device's accuracy study, the "ground truth" was effectively the results from the predicate device (DRI® Opiate EIA).
- For the predicate device, its accuracy was established against GC/MS (Gas Chromatography/Mass Spectrometry), which serves as a definitive analytical "ground truth" for drug levels.
8. Sample Size for the Training Set
- The document does not specify a training set sample size. Immunoassays are not "trained" in the typical machine learning sense with a distinct training dataset. Their performance is inherent in their chemical and biological design. The "studies" described are validation studies (testing) of the final device.
9. How the Ground Truth for the Training Set Was Established
- As there is no "training set" in the machine-learning sense for this immunoassay, this question is not applicable. The assay's performance characteristics are determined by its formulation and manufacturing, not by learning from a trained dataset.
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