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510(k) Data Aggregation
(29 days)
LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS
The Cocaine Metabolite Enzyme Immunoassay is intended for the qualitative and semiquantitative determination of benzoylecgonine in human urine, at the cutoff value of 150 ng/mL. 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 Cocaine Metabolite Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Cocaine Metabolite Enzyme Immunoassay at a cutoff value of 150 ng/mL.
The Cocaine Metabolite Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the Cocaine Metabolite Enzyme Immunoassay at a cutoff value of 150 ng/mL.
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 liquid 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 Cocaine Metabolite assay is a homogeneous enzyme immunoassay with 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, benzoylecgonine-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 benzoylecgonine-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.
The Cocaine Metabolite Enzyme Immunoassay is a kit comprised of two reagents, an R, and R2 which are bottled separately but sold together within the kit.
The Ri solution contains a mouse monoclonal anti-benzoylecgonine antibody, glucose-6phosphate (G6P) nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09%) as a preservative. The R2 solution contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with benzoylecgonine in buffer with sodium azide (0.09%) as preservative.
The Cocaine Metabolite Enzyme Immunoassay calibrators and controls designated for use at the 150 ng/mL cutoff contain 0, 75, 112.5, 150, 187.5, 300, and 1000 ng/mL of benzoylecgonine in human urine with sodium azide (0.09%) as preservative. These five calibrators and two controls are sold as individual bottles.
Here's a breakdown of the acceptance criteria and the study details for the Cocaine Metabolite Enzyme Immunoassay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state acceptance criteria in terms of numerical thresholds for each performance characteristic. However, it presents the performance data in a way that implies these results are deemed acceptable for demonstrating substantial equivalence to the predicate device. For qualitative analysis, the goal is typically high agreement with GC/MS, especially around the cutoff.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision (Semi-Quantitative) | Low %CV values, especially at and around the cutoff, indicating reproducibility. | Total Precision (%CV): |
| - 0 ng/mL: 156.9% | ||
| - 37.5 ng/mL: 10.8% | ||
| - 75 ng/mL: 7.4% | ||
| - 112.5 ng/mL: 4.3% | ||
| - 150 ng/mL: 4.7% | ||
| - 187.5 ng/mL: 4.0% | ||
| - 225 ng/mL: 4.1% | ||
| - 267.5 ng/mL: 3.4% | ||
| - 300 ng/mL: 3.7% | ||
| Qualitative Agreement (Clinical Samples vs. GC/MS) | High percentage agreement for both positive and negative samples compared to the confirmatory method. | Semi-Quantitative Data: 90% agreement with positive, 98% agreement with negative samples |
| Qualitative Data: 90% agreement with positive, 95% agreement with negative samples | ||
| Qualitative Positive/Negative Results (Concentration vs. Cutoff) | Consistent negative results for samples below the cutoff, consistent positive results for samples above the cutoff, with some variability expected at the cutoff. | Total Precision Immunoassay Result: |
| - 0, 37.5, 75, 112.5 ng/mL: 88 Negative | ||
| - 150 ng/mL: 15 Pos/73 Neg (Qualitative), 29 Pos/59 Neg (Semi-Qualitative) | ||
| - 187.5, 225, 267.5, 300 ng/mL: 88 Positive | ||
| Linearity | High correlation coefficient (r^2) with good agreement between observed and target values. | y = 1.0488x -0.5229, r^2 = 0.9992 |
| Endogenous Compound Interference & Specificity & Cross-Reactivity | No significant interference from common endogenous compounds or cross-reactants. | No significant undesired cross-reactants or endogenous substance interference was observed. |
2. Sample Size Used for the Test Set and Data Provenance
- Precision/Qualitative Positive/Negative Results: The test set used for precision studies consisted of
N=88determinations at each specified concentration level. - Method Comparison - Clinical Samples:
Eighty (80)clinical unaltered samples were used. - Data Provenance: The document does not explicitly state the country of origin or whether the samples were retrospective or prospective. It only mentions "clinical unaltered samples."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the document. For an immunoassay of this type, the "ground truth" for clinical samples is typically established by Mass Spectrometry (GC/MS or LC/MS), which is an analytical method and doesn't require human expert interpretation in the same way an imaging study would.
4. Adjudication Method for the Test Set
- This information is not applicable and therefore not provided. The "adjudication method" typically refers to how disagreements among multiple human readers (e.g., radiologists) are resolved. For an immunoassay, the confirmatory method (GC/MS or LC/MS) establishes the objective truth.
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
- This information is not applicable and therefore not provided. This device is an immunoassay, not an AI-powered diagnostic imaging system that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Yes, this study is inherently a standalone performance evaluation of the immunoassay device. The results (e.g., precision, linearity, qualitative agreement against GC/MS) represent the performance of the device itself, without human interpretation of the assay result in a way that would modify the instrument's output. The output of the immunoassay is a numerical value or a positive/negative determination.
7. The Type of Ground Truth Used
- The ground truth for the clinical samples was established using a "more specific alternative chemical method," specifically Gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS). This is explicitly stated as the "preferred confirmatory method."
8. The Sample Size for the Training Set
- This information is not applicable and therefore not provided. Immunoassays are not "trained" in the typical machine learning sense with a training dataset. Their performance is inherent to their chemical and biological design. The "calibration" mentioned refers to adjusting the instrument to known standard concentrations, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable as there is no "training set" in the context of a machine learning algorithm. The "Cocaine Metabolite Drugs of Abuse (DAU) Calibrators" are used for calibration, and their "ground truth" (i.e., their known concentrations) is established through controlled manufacturing processes and analytical verification.
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