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510(k) Data Aggregation
(164 days)
The Opiate Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of opiates in human urine, at a cutoff value of 300 ng/mL when calibrated against morphine. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS or (2) permitting laboratories to establish quality control procedures."
The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or liguid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method). Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
The Opiate Enzyme Immunoasay is a homogeneous enzyme immunoassay ready-to-use liquid reagent. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent.
Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. In the absence of drug in the sample, morphine-labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when free drug is present in the sample, antibody would bind to free drug, the unbound morphine-labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at 340 nm.
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 performance characteristics presented and comparison to the predicate device. The primary performance metrics are precision and agreement with a confirmatory method (GC/MS or LC/MS).
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Semi-Quantitative Precision (ng/mL) | Consistent and low variability across the tested range, particularly around the 300 ng/mL cutoff. | Within Run: Mean and SD provided for concentrations from 0 ng/mL to 600 ng/mL. %CV for most concentrations is ≤ 2.7%. At 300 ng/mL, Mean = 297.5 ng/mL, SD = 6.3 ng/mL, %CV = 2.1%. |
Total Precision: Mean and SD provided. %CV for most concentrations is ≤ 2.9%. At 300 ng/mL, Mean = 297.5 ng/mL, SD = 7.3 ng/mL, %CV = 2.4%. | ||
| Qualitative Detection (Cutoff: 300 ng/mL) | Accurate classification (positive/negative) at and around the 300 ng/mL cutoff, with minimal false positives/negatives at concentrations far from the cutoff. | Within Run: |
- 0-225 ng/mL: 22 Negative (100%)
- 300 ng/mL: 6 Pos/16 Neg (27.3% Pos, 72.7% Neg)
- 375-600 ng/mL: 22 Positive (100%)
Total Precision: - 0-225 ng/mL: 88 Negative (100%)
- 300 ng/mL: 27 Pos/61 Neg (30.7% Pos, 69.3% Neg)
- 375-600 ng/mL: 88 Positive (100%) |
| Qualitative (mA/min) Detection (Cutoff: 300 ng/mL) | Similar to semi-quantitative qualitative detection. | Within Run: - 0-225 ng/mL: 22 Negative (100%)
- 300 ng/mL: 16 Pos/6 Neg (72.7% Pos, 27.3% Neg)
- 375-600 ng/mL: 22 Positive (100%)
Total Precision: - 0-225 ng/mL: 88 Negative (100%)
- 300 ng/mL: 51 Pos/37 Neg (58.0% Pos, 42.0% Neg)
- 375-600 ng/mL: 88 Positive (100%) |
| Method Comparison with Confirmatory Method (GC/MS or LC/MS) | High percentage agreement for both positive and negative clinical samples. | Semi-Quantitative Results: 98.3% agreement with positive, 95.9% agreement with negative samples (from 130 clinical samples).
Qualitative Results: 98.3% agreement with positive, 94.5% agreement with negative samples (from 130 clinical samples). |
| Limit of Detection (LoD) | Clearly defined lowest detectable concentration. | 20 ng/mL (95% confidence). |
| Linearity | Strong linear correlation across the analytical range. | 0 - 1000 ng/mL with a regression equation: y = 1.0619x - 2.3861, and r^2 = 0.9976. |
| Endogenous Compound Interference, Specific Gravity, & Specificity -Cross-Reactivity | No significant undesired cross-reactants or interference from endogenous substances. | "No significant undesired cross reactants or endogenous substance interference was observed." (Refer to product insert for list of compounds tested.) |
2. Sample Size Used for the Test Set and Data Provenance
- Precision Studies: N=88 for each concentration level (0, 75, 150, 225, 300, 375, 450, 525, 600 ng/mL) for both semi-quantitative and qualitative precision analyses. This involved 22 determinations within run and 88 total determinations.
- Method Comparison (Clinical Samples): A total of 130 clinical unaltered samples were used.
- Data Provenance: The document does not explicitly state the country of origin. It indicates that "clinical unaltered samples" were used, suggesting a prospective or collected retrospective real-world dataset. The studies were performed on a Hitachi 717 Analyzer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- For the method comparison study, the ground truth was established by a "more specific alternative chemical method," specifically Gas or Liquid Chromatography/Mass Spectrometry (GC/MS or LC/MS). These are instrumental methods, not expert human assessment.
- For the precision and linearity studies, the ground truth concentrations were prepared standard solutions of known concentrations.
- The document does not mention human experts establishing ground truth for any part of the device evaluation.
4. Adjudication Method for the Test Set
Not applicable, as the ground truth was established by objective analytical methods (GC/MS or LC/MS for clinical samples, and known concentrations for precision/linearity studies), not human judgment.
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 device is an automated in vitro diagnostic (IVD) immunoassay, not an AI-assisted diagnostic tool that involves human readers interpreting images or data. The "readers" are the automated clinical chemistry analyzers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies presented are all standalone performance studies for the immunoassay. The device itself is an automated system (the immunoassay reagents run on a Hitachi 717 Analyzer) designed to provide results without human interpretation of the primary signal; humans only interpret the final quantitative or qualitative result from the analyzer.
7. The Type of Ground Truth Used
- Method Comparison (Clinical Samples): Gold standard instrumental method, specifically Gas or Liquid Chromatography/Mass Spectrometry (GC/MS or LC/MS).
- Precision, Linearity, LoD: Prepared reference materials with known concentrations of opiates.
8. The Sample Size for the Training Set
Not applicable. This is an immunoassay, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "learning" for this type of device involves biochemical interactions and calibration curves, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for an immunoassay. The device relies on its biochemical reaction principles and established calibration against known standards.
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