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The Ethyl Alcohol Enzymatic Assay is a homogeneous enzymatic assay with 0 and 100 mg/dL (0.1%) alcohol calibrators. The assay is intended for use in the quantitative analyses of ethyl alcohol in human urine, serum or plasma. The assay is designed for professional use with a number of automated clinical chemistry analyzers.

Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.

The Ethyl Alcohol Calibrators are intended for in vitro diagnostic use for the calibration of the Ethyl Alcohol Enzymatic Assay to determine the ethyl alcohol concentration in human urine, serum or plasma.

The Ethyl Alcohol Controls are intended for in vitro diagnostic use for the validation of the Ethyl Alcohol Enzymatic Assay to determine ethyl apphol in human urine, serum or plasma.

Device Description

LZI's Ethyl Alcohol Enzymatic Assay is a ready-to-use, liquid reagent, homogeneous enzymatic assay. The assay uses ethyl alcohol specific enzyme, alcohol dehydrogenase (ADH) that can detect ethyl alcohol in human urine, serum, plasma with minimal crossreactivity to various, common prescription drugs and abused drugs.

The assay is based on alcohol dehydrogenase (ADH) enzyme uses ethyl alcohol as enzyme substrate. In the presence of nicotinamide adenine dinucleotide (NAD), ADH turns the ethyl alcohol to acetaldehyde and converts the NAD to NADH. The ADH enzyme activity is then determined spectrophotometrically at 340 nm by measuring its ability to covert nicotinamide adenine dinucleotide (NAD) to NADH.

Ethyl Alcohol Calibrators and Controls are aqueous phosphate buffer-based liquid, and ready to use. These Calibrators and Controls do not have any especially unique technical characteristics. Each contains a known concentration of ethanol.

The Negative Calibrator is a drug-free phosphate buffer matrix with preservative. The Ethyl Alcohol Calibrator (100 mg/dL) and Controls are prepared by spiking known concentrations of ethyl alcohol into the Negative Calibrator matrix.

AI/ML Overview

Here's an analysis of the provided 510(k) summary for the Lin-Zhi International, Inc.'s Ethyl Alcohol Enzymatic Assay, Calibrators, and Controls, focusing on the acceptance criteria and supporting studies.

Important Note: This document describes a chemical assay, not an AI/ML powered device. Therefore, many of the requested categories like "sample sized used for the test set and the data provenance," "number of experts used to establish the ground truth," "adjudication method," and "MRMC comparative effectiveness study" are not applicable. The information provided focuses on the analytical performance of a diagnostic test.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to a legally marketed predicate device (DRI/Microgenics Corp.'s Ethyl Alcohol Assay, K923783). The performance characteristics are presented as a direct comparison, aiming to show that the new device performs comparably or better.

Here's a table summarizing the performance characteristics presented, with the "Acceptance Criteria" inferred as being "comparable to or better than the predicate device" and "Reported Device Performance" as the LZI device's results.

Acceptance Criteria (Inferred from Predicate)	Reported Device Performance (LZI Ethyl Alcohol Enzymatic Assay)
Ethyl Alcohol Enzymatic Assay	Ethyl Alcohol Enzymatic Assay
Within Run Precision:
100 mg/dL: Mean ~100.3, SD ~1.2, %CV ~1.2	100 mg/dL: Mean 99.1, SD 0.77, %CV 0.8
50 mg/dL: Mean ~48.6, SD ~1.3, %CV ~2.7	50 mg/dL: Mean 50.0, SD 0.59, %CV 1.1
300 mg/dL: Mean ~290.2, SD ~1.9, %CV ~0.6	300 mg/dL: Mean 281.6, SD 3.21, %CV 1.1
	200 mg/dL: Mean 194.8, SD 1.47, %CV 0.8
Run-To-Run Precision:
50 mg/dL: Mean ~50.7, SD ~4.5, %CV ~9.0	50 mg/dL: Mean 50.5, SD 2.3, %CV 4.6
250 mg/dL: Mean ~253.7, SD ~6.7, %CV ~2.6	100 mg/dL: Mean 99.2, SD 0.56, %CV 0.58
	200 mg/dL: Mean 200.5, SD 8.3, %CV 4.12
	300 mg/dL: Mean 280.0, SD 8.26, %CV 2.95
Sensitivity:	3 mg/dL
10 mg/dL
Accuracy (Correlation with Predicate):
Urine: LZI = 1.003 DRI - 0.95, (r² = 0.9998)	LZI = 1.003 DRI - 0.95, (r² = 0.9998)
Serum: LZI = 0.991 DRI - 11.03, (r² = 0.9952)	LZI = 0.991 DRI - 11.03, (r² = 0.9952)
Analytical Recovery:
No data available for predicate	Average 95.0% - 102.4% recovery across 18.75 mg/dL to 600 mg/dL
Specificity:	Comparable to the predicate device
(See attached DRI's Ethyl Alcohol Assay)
Ethyl Alcohol Calibrators & Controls
Reproducibility (Precision) (N=12)
Negative Calibrator: Comparable %CV	Ave. Rate 2.2, Stdev 0.21, %CV 9.44
100 mg/dL Calibrator: Comparable %CV	Ave. Rate 64.3, Stdev 4.00, %CV 0.22
Control Level 1: Comparable %CV	Ave. Conc. 50.47, Stdev 2.30, %CV 4.56
Control Level 2: Comparable %CV	Ave. Conc. 279.88, Stdev 8.26, %CV 2.95
Accuracy (as confirmed by GC/MS):
Calibrator 100 mg/dL: Matches GC/MS	Expected 100 mg/dL, GC/MS 100 mg/dL
Level 1 Control 45-55 mg/dL: Matches GC/MS	Expected 45-55 mg/dL, GC/MS 50 mg/dL
Level 2 Control 270-330 mg/dL: Matches GC/MS	Expected 270-330 mg/dL, GC/MS 310 mg/dL
Stability (Calibrators & Controls):
Ratio of RT to cold-stored rates ~1 (100%)	"Cold and RT rates are essentially the same" for 5+ months

Study Details:

Sample size used for the test set and the data provenance:
- Ethyl Alcohol Enzymatic Assay: The document does not explicitly state the total number of samples used for the precision, sensitivity, and accuracy studies.
  - Precision: "Within Run Precision" and "Run-To-Run Precision" tables show data for specific concentrations (50, 100, 200, 300 mg/dL), but the number of replicates (N) per run or total runs is not specified in this summary.
  - Accuracy: For accuracy, urine and serum specimens were used, but the exact number is not provided.
- Ethyl Alcohol Calibrators & Controls:
  - Reproducibility (Precision): "Twelve vials each of calibrators and controls were used in the assay," for N=12 data points.
  - Accuracy: The sample size for GC/MS confirmation is not explicitly stated beyond stating "the concentrations... were determined and confirmed."
- Data Provenance: The document does not specify the country of origin. It is a registration in the US, so it's presumed the studies align with standard practices for submission to an FDA 510(k). The studies appear to be prospective in nature, conducted specifically to evaluate the performance of the new device for this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- This is not applicable as this is a chemical assay, not an imaging device or diagnostic algorithm requiring expert interpretation of images/data for ground truth. The "ground truth" for alcohol concentration is established by quantitative chemical methodologies.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as this is a chemical assay, not an assessment requiring expert adjudication.
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:
- Not applicable. This is a standalone diagnostic IVD assay, not an AI-assisted diagnostic tool involving human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, this entire submission describes the standalone performance of the enzymatic assay and its associated calibrators and controls. The "algorithm" here is the chemical reaction and spectrophotometric measurement, which operates without human intervention in the result generation once the sample is loaded.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ethyl Alcohol Enzymatic Assay: The ground truth for comparative accuracy was the predicate device's measurements (DRI/Microgenics Corp.'s Ethyl Alcohol Assay). The predicate device itself would have relied on established analytical methods for its own validation.
- Ethyl Alcohol Calibrators & Controls: The ground truth for the concentrations of ethyl alcohol in the calibrators and controls was established using Gas Chromatography/Mass Spectroscopy (GC/MS) technique, which is a highly accurate and precise analytical method for quantifying substances. The ethanol used was traceable to a NIST standard.
The sample size for the training set:
- This concept is not directly applicable to this type of chemical assay. Chemical assays are developed using established biochemical principles and extensive R&D to optimize reagents and reaction conditions, rather than being "trained" on a dataset in the way a machine learning model is. The development process involves optimizing the assay's components and parameters to achieve desired performance characteristics.
How the ground truth for the training set was established:
- As explained above, the concept of a "training set" and associated "ground truth" for a chemical assay is different from that of an AI/ML model. The "ground truth" for optimizing the assay's performance would relate to accurately prepared reference standards, which, as mentioned for the calibrators and controls, involved highly accurate methods like GC/MS and traceability to NIST standards.

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