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The Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene (BMBP) Multiple Analyte Enzyme Immunoassay is a homogeneous enzyme immunoassay. The assay is solely intended for use in the qualitative screening human urine samples for the presence of barbiturates, methadone. benzodiazepines, and propoxyphene drugs. . The assay will produce a positive result if any of the four analyte are present at a concentration at or above their respective cutoffs but will not its its is is is is drug is present. The assay is solely intended for the qualitative screening of human writer for these analytes. Measurements obtained by this device are used in the diagnosis and treatment of in divisiouals who have used barbiturates, methadone, benzodiazepines, and propoxyphene druation on mourvis designed for professional use with a number of automated clinical chemistry arralyzes.

The Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene Multiple Analyte Enzyme Immunoassay provides only a preliminary analytical test result. The assay will not identify which drug is present in the positive urine sample. All screening positive samples shall subject to minist assays to identify the drug in the sample before alternative confirmation. Gas chromations withings spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, when preliminary positive results are used.

LZI's Simultaneous Barbiturate-Methadone-Benzodiazepine-Propoxyphene Multiple Analyte Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibodies that can detect barbiturates, methadone, benzodiazepines, and propoxyphene drugs in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs.

The assay is based on competition between drug 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 enzymc 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 convert nicotinamide adenine dinucleotide (NAD) to NADH.

Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary for the BMBP Enzyme Immunoassay:

Acceptance Criteria and Device Performance for BMBP Enzyme Immunoassay

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state numerical "acceptance criteria" for precision or sensitivity in the same way it defines cutoffs. Instead, it presents performance data for the new BMBP EIA and compares it to predicate devices. The implicit acceptance criteria appear to be substantial equivalence to the predicate devices and demonstrating acceptable precision and accuracy.

Note: The accuracy for the BMBP EIA is reported relative to the LZI individual EIAs, while the predicate EIAs' accuracy is often reported against a "commercial EIA" or GC/MS/HPLC, indicating a different primary comparative method in some cases.

2. Sample Size Used for the Test Set and Data Provenance

• Precision (within-run): n=21 replicates at each concentration level (Negative, 100/225 ng/mL, 200 ng/mL, 300/375 ng/mL, 1000 ng/mL) for each analyte.
• Precision (run-to-run): n=12 replicates at each concentration level for each analyte.
• Accuracy: The document states "Positive Samples: 100 % agreement" and "Negative Samples: [various percentages] agreement" but does not specify the number of samples used for the accuracy assessment against the predicate devices.
• Data Provenance: Not explicitly stated. Given the context of a 510(k) submission for a diagnostic device, these would typically be laboratory-generated or spiked urine samples. Country of origin is not mentioned but assumed to be from within the company's testing facilities (likely US based on the submission to FDA). The study is prospective in the sense that controlled experiments were performed to gather this data for the submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

N/A. This is an in-vitro diagnostic (IVD) device for drug detection. The "ground truth" for the test set is established by the known concentrations of the target analytes in the samples, or by results from a reference method like GC/MS or a commercial EIA (for the predicate device's ground truth). Human expert interpretation is not part of establishing the ground truth for this type of test.

4. Adjudication Method for the Test Set

N/A. As this is an IVD device measuring analyte concentrations, there is no expert adjudication process for the test results. The results are quantitative (mA/min) and then interpreted qualitatively (positive/negative) based on a defined cutoff.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

N/A. This is an automated immunoassay for drug detection, not an imaging device or a test requiring human interpretation. Therefore, an MRMC study is not applicable. The device operates standalone.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

Yes, this is a standalone device. The BMBP Enzyme Immunoassay performs the detection of drugs in urine automatically. Its performance characteristics (precision, sensitivity, accuracy, analytical recovery, and specificity) are evaluated as a standalone system. The stated intended use is for "qualitative screening human urine samples" with results interpreted automatically against defined cutoffs. It is intended for "professional use with a number of automated clinical chemistry analyzers."

7. Type of Ground Truth Used

The ground truth used for performance validation includes:

• Known concentrations: For precision and sensitivity studies, samples with predefined concentrations of the target drugs were likely used.
• Comparison to predicate devices: For accuracy, the results from the new BMBP EIA were compared to results obtained from the individual LZI predicate EIAs.
• Reference Methods (for predicate's accuracy): The predicate devices themselves sometimes reference GC/MS/HPLC or other commercial EIAs for their own accuracy establishment. For example, the LZI Methadone EIA's positive sample accuracy is 100% agreement "vs. GC/MS /HPLC".

8. Sample Size for the Training Set

Not explicitly mentioned in the provided text. For enzyme immunoassays, there isn't a "training set" in the machine learning sense. Instead, the assay's operational parameters (e.g., reagent concentrations, reaction times, spectrophotometer readings, and cutoff values) are developed and optimized during the research and development phase using a range of experimental samples. The document focuses on the validation of the final device, not its initial development.

9. How the Ground Truth for the Training Set Was Established

Not applicable in the context of "training set" for an enzyme immunoassay. The development process would involve:

• Known spiked samples: Urine samples spiked with precise concentrations of target analytes and potential interfering substances.
• Clinically characterized samples: Real patient samples with known drug status (confirmed by a reference method like GC/MS).
  The ground truth would be established by these known concentrations or confirmed reference method results, which are then used to optimize and set the assay's parameters, including its cutoff.

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