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The Simultaneous Cocaine-Amphetamines-Morphine-Phencyclidine Multiple Analyte Enzyme Immunoassay is a homogeneous enzyme immunoassay with 300 ng/mL cutoff for cocaine metabolite, 1000 ng/mL cutoff for amphetamines, 300 ng/mL cutoff for opiates, and 25 ng/mL cutoff for phencyclidine. 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 identify which drug is present. The assay is solely intended for the qualitative screening of human urine for these analytes. Measurements obtained by this device are used in the diagnosis and treatment of individuals who have used cocaine, amphetamines, opiates, or phencyclidine. The assay is designed for professional use with a number of automated clinical chemistry analyzers,

The Simultaneous Cocaine-Amphetamines-Morphine-Phencyclidine Multiple Analyte Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method for the individual drugs must be used to obtain a confirmed analytiral 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 preliminary positive results are used.

LZI's Simultaneous Cocaine-Amphetamines-Morphine-Phencyclidine Multiple Analyte Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibodies that can detect cocaine metabolite, amphetamines, opiate r ic assay uses specific analo rine 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 I he ussay is based on componities and free drug from the urine sample for a fixed amount of ucific antibody. In the absence of free drug from the urine sample the specific antibody specific antiboury. In the dobtDH 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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the LZI's Simultaneous Cocaine-Amphetamines-Morphine-Phencyclidine Multiple Analyte Enzyme Immunoassay (CAMP):

The provided document describes a 510(k) premarket notification for a new device, comparing it to existing predicate devices. It focuses on demonstrating substantial equivalence rather than setting new, specific acceptance criteria for each performance characteristic of the new device in isolation. Instead, the "acceptance criteria" are implied to be comparable performance to the predicate devices. The study aims to show that the new multi-analyte assay performs as well as, or equivalently to, the individual previously cleared assays.

Let's break down the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit, quantitative acceptance criteria for all performance metrics are not clearly defined as distinct thresholds for the new device. Instead, the document consistently states "100% agreement" or "Comparable to the predicate device" as the desired outcome for performance characteristics (accuracy, analytical recovery, specificity) when compared to either the individual LZI predicate EIAs or commercial EIAs (which are implicitly the standard). For precision, specific CV% values are provided for both the new and predicate devices, which can be interpreted as demonstrating "comparable" precision.

Here's the table, inferring acceptance criteria based on the comparison to predicate devices:

Note: The reported performance for the CAMP EIA consistently shows similar (and often identical) precision values to the individual LZI predicate EIAs, demonstrating that the multi-analyte assay maintains the precision characteristics of its single-analyte counterparts. Accuracy, Analytical Recovery, and Specificity are all reported as 100% agreement or "Comparable to the predicate device," indicating the new device meets the implied acceptance criterion of equivalence.

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

The document focuses on the performance characteristics of the new assay compared to its predicate devices, primarily based on laboratory testing rather than large-scale patient test sets.

• Precision Studies:

  • Within Run Precision: n=21 replicates for each concentration level tested (for each of the four analytes).
  • Run-To-Run Precision: n=12 replicates (presumably per concentration over multiple runs) for each analyte.
  • The document does not specify the provenance (country of origin, retrospective/prospective) of the samples used for these precision studies, but they are typically controlled laboratory samples spiked with known concentrations of analytes.

• Accuracy, Analytical Recovery, Specificity:

  • The document states "100% agreement" for accuracy and analytical recovery when comparing the LZI CAMP EIA to the individual LZI predicate EIAs. It doesn't break down the specific number of samples for these direct comparisons.
  • For the predicate devices, accuracy compared to a commercial EIA and GC/MS/HPLC showed varying numbers of samples (e.g., for Opiate EIA, 97.1% agreement vs. commercial EIA and 100% vs. GC/MS/HPLC, implies a specific number of samples used in that predicate study).
  • The document does not provide a specific sample size for a "test set" of clinical samples for the LZI CAMP EIA's overall accuracy, analytical recovery, or specificity against "ground truth" using a confirmatory method like GC/MS/HPLC. The primary evidence presented is the comparison to the already-cleared predicate devices.
  • Data Provenance: Not specified, but generally, these types of IVD studies are conducted in a laboratory setting, sometimes with clinical samples, but the source details are omitted here. These appear to be retrospective comparisons against established methods.

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

• No human "experts" are explicitly mentioned as establishing ground truth in this context. For in vitro diagnostic (IVD) devices like this, the ground truth for drug testing is typically established by:
  • Analytical Chemistry Methods: The gold standard is Gas Chromatography/Mass Spectrometry (GC/MS) or High-Performance Liquid Chromatography (HPLC), which are objective analytical methods, not dependent on human expert interpretation.
  • Comparison to a Predicate Device: The performance is benchmarked against a legally marketed device that has already established its accuracy, sensitivity, and specificity.
• Therefore, the concept of "number of experts" and "qualifications of experts" does not apply directly to how ground truth was established for this type of chemical assay.

4. Adjudication Method for the Test Set

• Since the ground truth is established by objective analytical methods (GC/MS/HPLC for predicate device claims, and the predicate devices themselves for the new device), there's no human adjudication method (like 2+1, 3+1 consensus) involved as there might be for image-based diagnostic AI, for example. The results are compared quantitatively and qualitatively (positive/negative agreement).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. This type of study (comparing human reader performance with and without AI assistance) is relevant for diagnostic imaging AI devices where human interpretation is the primary method. This device is an in-vitro diagnostic assay for detecting drugs in urine; it does not involve human "readers" interpreting results in the same way as an imaging device, and there is no AI component.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Yes, this is a standalone device in the context of an IVD. The "LZI's Simultaneous Cocaine-Amphetamines-Morphine-Phencyclidine Multiple Analyte Enzyme Immunoassay" is the algorithm/device itself. Its performance is measured directly by analyzing urine samples and producing a detectable signal, which is then interpreted as positive or negative based on a defined cutoff. There is no "human-in-the-loop" to enhance or modify the device's analytical output. The "algorithm" here refers to the chemical assay itself and its spectrophotometric measurement rather than a machine learning algorithm.

7. The Type of Ground Truth Used

• The ground truth used for demonstrating the performance of the predicate devices was primarily:
  • Commercial EIAs: Other commercially available enzyme immunoassays.
  • Confirmatory Analytical Methods: Gas Chromatography/Mass Spectrometry (GC/MS) and High-Performance Liquid Chromatography (HPLC). These are objective, highly precise chemical analytical techniques considered the gold standard for drug confirmation.
• For the LZI's CAMP EIA (the new device), the primary "ground truth" against which its performance was demonstrated for the purpose of the 510(k) submission was the individual LZI predicate enzyme immunoassays themselves. The new device showed "100% agreement" with these already-cleared devices for accuracy and analytical recovery.

8. The Sample Size for the Training Set

• This device is an immunoassay (chemical assay), not an AI/machine learning device. Therefore, the concept of a "training set" in the context of machine learning (where an algorithm learns from data) does not apply.
• The "training" for such a chemical assay typically involves optimizing the reagent concentrations, reaction conditions, and assay parameters during product development and manufacturing. This is an engineering and chemistry process, not a computational "training set" like that used for AI.

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

• As explained above, there is no "training set" in the AI sense for this chemical immunoassay. The development and optimization of the assay rely on established biochemical principles, analytical chemistry validation, and quality control procedures, rather than on a labeled training dataset.

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