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.

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.

Summary

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K032461
pz-142

510(k) Summary of Safety and Effectiveness

OCT 03 2003

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Introduction

According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

Submitter name, Address, and Contact

Lin-Zhi International, Inc. 687 North Pastoria Avenue Sunnyvale, CA 94085 Phone: (408) 732-3856 (408) 732-3849 Fax:

Cheng-I Lin, Ph.D. Contact: President

Device Name and Classification

Classification Name:	Enzymatic method, Alcohol Dehydrogenase, UltravioletClass II, DMT (21 CFR 862.3040)(91 Toxicology),
Common Name:	Ethyl Alcohol Enzymatic assay for the determination of EthylAlcohol levels in human serum, plasma or urine.
Proprietary Name:	None

Legally Marketed Predicate Device(s)

Lin-Zhi International, Inc.'s Ethyl Alcohol Enzymatic Assay is substantially equivalent to the Ethyl Alcohol Assay (By DRI/Microgenics Corp.), cleared under premarket notification K923783.

LZI's Ethyl Alcohol Enzymatic Assay is identical or similar to its predicate in terms of intended use, method principle, device components, and clinical performance.

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

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(ADH) that can detect ethyl alcohol in human urine, serum, plasma with minimal crossreactivity to various, common prescription drugs and abused drugs.

ADH NADH + Acetaldehyde Ethyl Alcohol + NAD

Intended Use

The Ethyl Alcohol Enzymatic Assay is a homogeneous enzymatic assay with 0, 100 mg/dL calibrators. The assay is intended for quantitative analyses of for the determination of Ethyl Alcohol levels in human serum, plasma or urine.

Comparison to Predicate Device

LZI's Ethyl Alcohol Enzymatic Assay is substantially equivalent to other products in commercially distribution intended for similar use. Most notably it is substantially equivalent to the currently, commercially marketed Ethyl Alcohol Assay (K923783) by DRI/Microgenics Corporation.

The following table compares LZI's Ethyl Alcohol Enzymatic Assay with the predicate device, Ethyl Alcohol Assay by DRI/Microgenics Corp.

Similarities:

. Both assays are for quantitative determination of Ethyl Alcohol levels in human serum, plasma or urine
Both assays use the same method principle, and device components. ●

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(Comparison to Predicate Device, continued)

Performance Characteristics

Feature	DRI's Ethyl Alcohol Test			LZI's Ethyl Alcohol Enzymatic Assay
	Mean (mg/dL)	SD	% CV	Mean (mg/dL)	SD	% CV
Within Run Precision:	100 mg/dL50 mg/dL300 mg/dL	100.348.6290.2	1.21.31.9	1.22.70.6	50 mg/dL100 mg/dL200 mg/dL300 mg/dL	50.099.1194.8281.6	0.590.771.473.21	1.10.80.81.1
Run-To-Run Precision:	50 mg/dL250 mg/dL	50.7253.7	4.56.7	9.02.6	50 mg/dL100 mg/dL200 mg/dL300 mg/dL	50.599.2200.5280.0	2.30.568.38.26	4.60.584.122.95
Sensitivity:	10 mg/dL			3 mg/dL
Accuracy:	Urine specimens:LZI = 1.003 DRI-0.95, ( $r^2$ =0.9998)Serum Samples:LZI = 0.991 DRI-11.03, ( $r^2$ =0.9952)			LZI = 1.003 DRI-0.95, ( $r^2$ =0.9998)LZI = 0.991 DRI-11.03, ( $r^2$ =0.9952)
Analytical Recovery:	No data available			Average 95.0% recovery at 18.75 mg/dLAverage 98.3% recovery at 37.5 mg/dLAverage 102.4% recovery at 75 mg/dLAverage 97.9% recovery at 150 mg/dLAverage 96.9% recovery at 300mg/dLAverage 95% recovery at 600 mg/dL
Specificity:	See attached DRI's Ethyl Alcohol Assay			Comparable to the predicate device

Conclusion

LZI's Ethyl Alcohol Enzymatic Assay was evaluated for several performance characteristics including precision, sensitivity, accuracy, analytical recovery, and specificity. All the studies showed acceptable results when compared to the predicate device.

We trust the information provided in this Premarket Notification [510(k)] submission will support a determination of substantial equivalence of the LZI's Ethyl Alcohol Enzymatic Assay to other Ethyl Alcohol Assay systems currently marketed in the United States.

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510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Introduction

According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

Submitter name, Address, and Contact

Lin-Zhi International, Inc. 687 North Pastoria Avenue Sunnyvale, CA 94085 Phone: (408) 732-3856 (408) 732-3849 Fax: -

Cheng-I Lin, Ph.D. Contact: President

Device Name and Classification

Classification Name:	Calibrators, Drug Mixture;Class II, DKB (91 Toxicology), 21 CFR 862.3200
Common/Usual Name:	Ethyl Alcohol Calibrators and Controls
Proprietary Name:	None

Legally Marketed Predicate Device(s)

Lin-Zhi International, Inc.'s Ethyl Alcohol Calibrators and Controls are substantially equivalent to EMIT Ethyl Alcohol Calibrators and Controls (Syva Co., now Dade Behring Limited), cleared under premarket notifications (K903152).

Device Description

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. The various concentrations of ethyl alcohol in the calibrator and controls are summarized as follows:

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	Ethyl Alcohol Assay
Material	Ethanol
Negative Calibrator	0 mg/dL
Calibrator	100 mg/dL
Control Level 1	45-55 mg/dL
Control Level 2	270-330 mg/dL

Intended Use

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

Comparison to Predicate Device

LZI's Ethyl alcohol Calibrators and Controls are similar in intended use, matrix, and performance to the Syva's EMIT Ethyl Alcohol Calibrators and Controls.

Similarities:

Both are for the calibration and validation of ethyl alcohol assay to measure ethyl alcohol . in human urine, serum or plasma.
Both assays use two point calibration, negative and 100 mg/dL calibrators. ●
The nominal concentrations of the analyte in the calibrators and controls are determined ● and confirmed by GC/MS.
. Storage condition is the same, at 2℃ to 8℃.

Conclusion

The information provided in the premarket notification demonstrates that the LZI's Ethyl Alcohol Calibrators and Controls are substantially equivalent to previously approved predicate devices, notably the Syva's EMIT Ethyl Alcohol Calibrators and Controls, and safe and effective for its intended use.

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Performance Characteristics

Reproducibility (Precision)

Multiple vials each of the Calibrators and Controls were used during the evaluation of performance of the LZI's Ethyl Alcohol Enzymatic Assay. The reproducibility, description of the assay principle, and assay procedure can be found on the assay reagent package insert.

The following table illustrates the precision of calibrators and controls. Twelve vials each of calibrators and controls were used in the assay. The enzyme rates of the calibrators from each run and the concentrations of the controls determined from the calibration curves from the same run were summarized. Data were collected on the Hitachi 717 Analyzer.

(N = 12)	Neg. Cal	Calibrator
	negative	100 mg/dL
Ave. Rate (mA/min)	2.2	64.3
Stdev	0.21	4.00
%CV	9.44	0.22

Ethyl Alcohol Enzymatic Assay

(N =12)	Contl L1	Contl L2
	45-55 mg/mL	270-330 mg/dL
Ave. Conc. (mg/dL)	50.47	279.88
Stdev	2.30	8.26
% CV	4.56	2.95

Accuracy

The concentrations of the Ethyl Alcohol Calibrators and Controls were determined and confirmed with gas chromatography/mass spectroscopy (GC/MS) technique. The observed concentration of the analyte in each calibrator or control, and its expected value are as follows:

	Ethanol (mg/dL)
	Expected	GC/MS
Calibrator	100	100
Level 1 Control	45-55	50
Level 2 Control	270-330	310

Ethanol was purchased from Sigma and Aldrich, St. Louis, MO 63178 (Traceable to NIST standard.).

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Stability

The Ethyl Alcohol Calibrators and Controls were evaluated according to the following established procedures and criteria.

Procedure:

1. All Calibrators and controls were aliquoted and stored at either 2-8°C or Room temperature (RT).
1. Reagents of the EIA used were all stored at 2-8 ℃.
1. At various time points, we evaluate the performance of the reagents using calibrators and controls stored at 2-8°C or RT, and comparing its performance (rate, mA/min.).

Stability Criteria:

1. The ratio of the enzyme rate from the RT-stored calibrators and controls vs. that of their respective 2-8°C-stored counter parts indicate the stability of the calibrators and controls.
1. A ratio of 1 (or 100%) indicated complete stability.
1. A ratio deviates from 1 for the negative (zero) calibrator would suggest instability of the buffer matrix.
Instability (decomposition or evaporation of the analyte, for example) of the 4. drug of abuse in the non-zero calibrators and controls stored at higher temperature (RT vs. recommended 2-8°C) should result in substantial decrease in enzyme rates when tested with EIA reagents. Consistent decrease should occur for the same set of drug calibrators and controls.

Days	0	5		21		55		106		167
mg/dL		Cold	RT	Cold	RT	Cold	RT	Cold	RT	Cold	RT
0	3.1	3.0	2.6	2.5	2.6	1.9	1.9	1.6	1.4	3.6	3.4
50	43.0	42.0	41.9	37.8	38.5	31.0	31.1	23.8	24.0	48.0	47.2
100	81.2	79.9	80.5	72.6	73.0	59.1	59.4	46.2	46.0	89.0	88.6
300	231.1	226.8	226.9	206.1	207.3	169.4	170.3	131.0	132.2	247.0	248.0

Calibrators/controls stability data (in mA/min. unit)

Note 1: The rate dropping is due to the reagent stability.

Note 2: Cold and RT rates are essentially the same.

Note 3: A new lot of reagent on day 167 was used. No difference between Cold and RT.

From the stability results, the calibrators and controls stored at RT performed equivalently to those stored at 2-8°C for at least 5 months (up to this writing). In other words, these calibrators and controls have shown 6 months RT stability. The calibrators used in this study were stored in a tightly capped 8-mL dropper type bottle with dropper tip and cap. Evaporation should not be a factor. At the present time, a recommended dating for 2-8℃ storage is made for 12 month. Real time stability at refrigerated temperature is being continued.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/7/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." arranged around the perimeter of the circle. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 03 2003

Cheng-I Lin, Ph.D. President Lin-Zhi International, Inc. 687 North Pastoria Avenue Sunnyvale, CA 94085

Re: K032461

Trade/Device Name: Ethyl Alcohol Enzymatic Assay, Calibrators and Controls Regulation Number: 21 CFR 862.3040 Regulation Name: Alcohol test system Regulatory Class: Class II Product Code: DIC; DKC; DNN Dated: August 6, 2003 Received: August 11, 2003

Dear Dr. Lin:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If vour device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Premarket Notification

Indications for Use Statement

510(k) Number (if known): KO32461

Device Name: Ethyl Alcohol Enzymatic Assay

Indications for Use:

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

Sean Cooper
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K03246

Concurrence of CDRH, Office of Device Evaluation (ODE)

scription Use

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

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Premarket Notification Supplement

Indications for Use Statement

510(k) Number (if known): ___ K032461

Device Name: Ethyl Alcohol Calibrators and Controls

Indications for Use:

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.

Sean Cooper
Division Sign-Off

Office of In Vitro Dic. nostic Device Evaluation and Safety

510(k)
K032461
Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.3040 Alcohol test system.

(a)
Identification. An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.(b)
Classification. Class II.