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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:

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