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510(k) Data Aggregation
(64 days)
The Cocaine Metabolite Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of benzoylecgonine (cocaine metabolite) in human urine.
The Cocaine Metabolite 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 Cocaine Metabolite Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibody that can detect benzovlecgonine (cocaine metabolite) in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs.
The assay is based on competition between benzoylecgonine labeled with glucose-6phosphate 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 convert nicotinamide adenine dinucleotide (NAD) to NADH.
Here's an analysis of the provided text regarding the Lin-Zhi International, Inc.'s Cocaine Metabolite Enzyme Immunoassay, broken down by your requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" as pass/fail thresholds against which the new device was measured. Instead, it presents performance characteristics of the new device and compares them to a legally marketed predicate device (DRI's Cocaine Metabolite EIA). The implicit acceptance criterion is that the new device's performance should be "comparable" or "acceptable" relative to the predicate, demonstrating substantial equivalence.
| Performance Characteristic | Acceptance Criteria (Implicit - based on predicate) | Reported Device Performance (LZI's Cocaine Metabolite EIA) |
|---|---|---|
| Within Run Precision (Qualitative) | Comparable to DRI's (e.g., %CV < 1.0) | Negative: 0.37 %CV |
| 225 ng/mL: 0.50 %CV | ||
| 300 ng/mL: 0.48 %CV | ||
| 375 ng/mL: 0.56 %CV | ||
| 3000 ng/mL: 0.36 %CV | ||
| Within Run Precision (Semi-quantitative) | N/A (DRI had no data) | 225 ng/mL: 1.45 %CV |
| 300 ng/mL: 1.53 %CV | ||
| 375 ng/mL: 1.37 %CV | ||
| Run-To-Run Precision (Qualitative) | Comparable to DRI's (e.g., %CV < 1.5) | Negative: 0.36 %CV |
| 225 ng/mL: 0.67 %CV | ||
| 300 ng/mL: 0.93 %CV | ||
| 375 ng/mL: 0.53 %CV | ||
| 3000 ng/mL: 0.49 %CV | ||
| Run-To-Run Precision (Semi-quantitative) | N/A (DRI had no data) | 225 ng/mL: 1.41 %CV |
| 300 ng/mL: 1.65 %CV | ||
| 375 ng/mL: 1.83 %CV | ||
| Sensitivity | Comparable to DRI's (40 ng/mL) | 4 ng/mL |
| Accuracy (vs. Commercial EIA) | 100% Sensitivity, 100% Specificity | 100% Sensitivity, 100% Specificity |
| Analytical Recovery (Qualitative) | N/A (DRI had no data) | 100% accuracy on positive vs. negative tests |
| Analytical Recovery (Semi-quantitative) | N/A (DRI had no data) | Quantitate within ±10% of nominal concentration between 30 ng/mL and 2100 ng/mL. Average 100.6% recovery at 225 ng/mL, 97.3% recovery at 375 ng/mL. |
| Specificity | Comparable to predicate device | Comparable to the predicate device |
| Cutoff Level | 300 ng/mL | 300 ng/mL |
| Assay Range | 0 to 1000 ng/mL (DRI's current) / 0 to 3000 ng/mL (DRI's previous) | 0 to 3000 ng/mL |
Study Proving Acceptance Criteria (Substantial Equivalence):
The submission functions as the study report. It aims to demonstrate substantial equivalence to the predicate device (DRI/Microgenics Corp.'s Cocaine Metabolite Enzyme Immunoassay, K960187) by comparing various performance characteristics. The conclusion states: "LZI's Cocaine Metabolite Enzyme Immunoassay was evaluated for several performance characteristics including precision, sensitivity, accuracy, analytical recovery, and specificity. [These] showed acceptable results when compared to the predicate device."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The sample sizes are not explicitly stated for individual tests beyond the "Mean Rate," "SD," and "%CV" values, which imply multiple runs or measurements. For precision studies, there are multiple data points for "Within Run" and "Run-To-Run" precision for different concentration levels (Negative, 225, 300, 375, 3000 ng/mL). The specific number of replicates or runs for each condition is not provided.
- Data Provenance: Not specified. It's likely an internal study conducted by Lin-Zhi International, Inc. The document does not indicate country of origin for test data or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a new in-vitro diagnostic, it would typically involve prospective testing to generate the performance data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not provided in the document. For an enzyme immunoassay testing for a drug metabolite, the "ground truth" would typically be established by preparing samples with known concentrations of the analyte (benzoylecgonine) or by confirming the presence/absence and concentration using a highly accurate reference method like GC/MS. The document mentions GC/MS as the preferred confirmatory method for preliminary positive results, but it doesn't detail how known concentrations were prepared or verified for the internal test set.
4. Adjudication Method for the Test Set
- Not applicable/Not specified. This refers to consensus-building amongst experts for diagnostic ground truth. For this type of IVD, the ground truth is established through chemical analysis methods (e.g., preparing spiked samples with known concentrations, or using a reference method like GC/MS).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices or those requiring human interpretation. This device is an automated enzyme immunoassay, so human interpretation is not the primary measure of performance in the same way. The comparison is between the performance metrics of the new assay and the predicate assay.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
- Yes, the provided data represents standalone performance. The "device" is the enzyme immunoassay kit itself, which provides an analytical result (rate or concentration) without human intervention in the result generation process beyond operating the analyzer. The precision, sensitivity, accuracy, and recovery data are measures of the assay's performance on its own.
7. Type of Ground Truth Used
- The ground truth for evaluating the device's performance (precision, sensitivity, analytical recovery) appears to be based on known concentrations of benzoylecgonine. This is achieved by either:
- Creating samples with precisely prepared, spiked concentrations of benzoylecgonine.
- Using samples previously characterized by a reference method (like the mentioned GC/MS).
- For accuracy, the "ground truth" was established by comparing the LZI assay's results against a commercial EIA (presumably the predicate device or another established method) and reporting 100% sensitivity and specificity, indicating agreement with a widely accepted method.
8. Sample Size for the Training Set
- This information is not provided. This device is an enzyme immunoassay, not a machine learning algorithm that typically requires a large "training set" in the same sense. The development of such an assay involves formulation and optimization, but the document doesn't detail the experimental scale of that development process. The term "training set" is more common in AI/ML contexts.
9. How the Ground Truth for the Training Set Was Established
- Since there's no explicitly mentioned "training set" in the AI/ML sense, this question isn't directly applicable. If interpreted as how the assay was developed and optimized, the ground truth would have been established through a series of experiments using known concentrations of benzoylecgonine in urine samples to optimize reaction conditions, antibody concentrations, and enzyme activity, ensuring accurate detection across the intended range. However, these specific details are not elaborated upon in the 510(k) summary.
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