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510(k) Data Aggregation
(36 days)
The Benzodiazepine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 200 ng/mL and/or 300 ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analyses of benzodiazepines in human urine. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Benzodiazepine Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when the preliminary positive results are used.
LZI's Benzodiazepine Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibody that can detect benzodiazepines in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs.
The assay is based on competition between benzodiazepine 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 G6PDH enzyme causing a decrease in enzyme activity. It is therefore the drug concentration is proportional to the enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically at 340 nm by measuring its ability to covert nicotinamide adenine dinucleotide (NAD) to NADH.
The provided document describes the LZI's Benzodiazepine Enzyme Immunoassay and its performance evaluation against a predicate device (Syva EMIT® II Plus Benzodiazepine Assay) to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as a separate list with pass/fail thresholds. Instead, it presents performance characteristics of both the predicate device and the LZI device side-by-side, implying that performance comparable to or better than the predicate device constitutes acceptable performance for substantial equivalence.
Based on the "Performance Characteristics" table and the "Conclusion" section, here's a reconstructed table:
| Performance Characteristic | Acceptance Criteria (Implied: Comparable to Predicate Device) | LZI's Benzodiazepine EIA Performance |
|---|---|---|
| Within Run Precision (Qualitative) | Coefficient of Variation (% CV) similar to or better than predicate. | Negative: 0.9% CV |
| 100 ng/mL: 0.8% CV | ||
| 200 ng/mL: 0.8% CV | ||
| 300 ng/mL: 0.7% CV | ||
| 400 ng/mL: 0.7% CV | ||
| 1000 ng/mL: 0.7% CV | ||
| Within Run Precision (Semi-quantitative) | Coefficient of Variation (% CV) similar to or better than predicate. | 100 ng/mL: 7.2% CV |
| 200 ng/mL: 2.9% CV | ||
| 300 ng/mL: 3.9% CV | ||
| 400 ng/mL: 4.1% CV | ||
| Run-To-Run Precision (Qualitative) | Coefficient of Variation (% CV) similar to or better than predicate. | Negative: 0.7% CV |
| 100 ng/mL: 0.6% CV | ||
| 200 ng/mL: 0.4% CV | ||
| 300 ng/mL: 0.5% CV | ||
| 400 ng/mL: 0.6% CV | ||
| 1000 ng/mL: 0.6% CV | ||
| Run-To-Run Precision (Semi-quantitative) | Coefficient of Variation (% CV) similar to or better than predicate. | 100 ng/mL: 6.7% CV |
| 200 ng/mL: 3.4% CV | ||
| 300 ng/mL: 5.3% CV | ||
| 400 ng/mL: 3.9% CV | ||
| Sensitivity | Functional sensitivity of 15 ng/mL (as per predicate). | 15 ng/mL (functional) |
| Accuracy (Positive Samples) | Percentage agreement with commercial EIA similar to predicate (95.6%). | 89.4% agreement with Syva |
| Accuracy (Negative Samples) | Percentage agreement with commercial EIA similar to predicate (99%). | 100% agreement with Syva |
| Analytical Recovery (Qualitative) | 100% accuracy on positive vs. negative tests. | 100% accuracy on positive vs. negative tests. |
| Analytical Recovery (Semi-quantitative) | Quantitates within ±15% of nominal concentration between 40-900 ng/mL. | Quantitates within ±10% of nominal concentration between 20-800 ng/mL. |
| Specificity | Comparable to the predicate device. | Comparable to the predicate device. |
Note on Accuracy: While LZI's positive sample agreement (89.4%) is lower than the predicate's (95.6%), the FDA's acceptance of the 510(k) suggests this was deemed "acceptable results when compared to the predicate device" in the context of substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- For Accuracy testing against the predicate device (Syva), a sample size of n=116 was used ("Vs. Syva (n=116)").
- For precision studies (Within Run and Run-To-Run), specific sample sizes are not explicitly stated, but the data includes Mean, SD, and %CV, which are derived from repeated measurements. The control levels used (e.g., Negative, 100 ng/mL, 200 ng/mL, etc.) represent different test points within the assay's range.
- Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. It is implied to be laboratory-generated data from Lin-Zhi International, Inc. for the purpose of demonstrating device performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of information is not applicable to this device. This is an in vitro diagnostic device (immunoassay) for detecting benzodiazepines in urine. Ground truth for such assays is typically established by:
- Using known concentrations of analytes (e.g., spiked samples, reference materials) for precision and analytical recovery.
- Comparing results directly to a reference method (e.g., Gas Chromatography/mass spectrometry (GC/MS) mentioned as the preferred confirmatory method) or a legally marketed predicate device (which the Syva EMIT® II Plus Benzodiazepine Assay serves as in this submission).
There are no human "experts" in the traditional sense (e.g., radiologists interpreting images) establishing "ground truth" for individual test cases in this context.
4. Adjudication Method for the Test Set
Not applicable. As this is an in vitro diagnostic test, adjudication methods involving expert consensus (like 2+1 or 3+1) are not used to establish the "truth" for individual samples. Performance is assessed based on direct comparison to known values, a reference method, or a predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is typically conducted for diagnostic imaging devices where multiple human readers interpret images. This document describes an in vitro diagnostic immunoassay, not an imaging device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, the performance data presented (precision, sensitivity, accuracy, analytical recovery, specificity) are all standalone performance data for the LZI's Benzodiazepine Enzyme Immunoassay. The device itself (the immunoassay) performs the measurement and provides a result (qualitative or semi-quantitative). Although a human performs the test and interprets the result in a clinical setting, the performance characteristics described directly relate to the analytical capabilities of the assay itself. The term "algorithm only" is more commonly associated with software-based AI, but in the context of an immunoassay, the "device only" performance is what's being evaluated.
7. The Type of Ground Truth Used
The ground truth used for this study appears to be a combination of:
- Known concentrations: For precision, sensitivity, and analytical recovery studies, the results are compared against samples with pre-defined, known concentrations of benzodiazepines.
- Comparison to a legally marketed predicate device: For accuracy, the LZI assay's results were compared against the Syva EMIT® II Plus Benzodiazepine Assay for n=116 samples. The predicate device's results serve as the "ground truth" or reference for this comparison.
- Implied reference methods: While not explicitly used to establish ground truth for reported metrics, the document states that "Gas Chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method," indicating it's the gold standard for confirming results, especially preliminary positive ones.
8. The Sample Size for the Training Set
The document does not provide information regarding a "training set." This is an immunoassay, not a machine learning or AI model that requires a discrete training phase with data. The components of the assay (antibodies, enzyme conjugates, reagents) are developed through chemical and biochemical processes, not by "training" on a dataset in the way an AI algorithm is trained.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As a traditional immunoassay, there is no "training set" or "ground truth for the training set" in the context of machine learning. The assay's parameters (e.g., reagent concentrations, antibody specificity) are established through biochemical research and development, not data-driven training.
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