The ETOH method is an in-vitro diagnostic test for the quantitative measurement of ethyl alcohol in human serum, plasma and urine. Ethyl alcohol test results may be used in the diagnosis and treatment of alcohol intoxication and poisoning.

Device Description

The Dimension Vista® ETOH Flex® reagent cartridge is a prepackaged in-vitro diagnostic test method that is specifically designed to be used on the Dade Behring Dimension Vista® System. The reagents contained in the Dimension Vista® ETOH Flex® reagent cartridge are: Reagent 1 which contains the buffering system and; Reagent 2 which contains alcohol dehydrogenase (ADH), the coenzyme nicotinamide adenine dinucleotide (NAD), buffer, preservatives, and stabilizers.

AI/ML Overview

The provided text describes a 510(k) submission for the Dimension Vista® Ethyl Alcohol (ETOH) Flex® Reagent Cartridge. This document is focused on establishing substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with defined performance metrics as might be found in an AI/ML device submission.

Therefore, many of the requested elements for an AI/ML device study, such as sample sizes for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this type of submission.

Here's a breakdown of what can be extracted based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in the way an AI/ML device study would. Instead, it demonstrates performance by comparing its features and principles to predicate devices and stating that comparative testing demonstrates substantial equivalent performance. Without specific thresholds or numerical acceptance criteria for performance metrics (e.g., accuracy, sensitivity, specificity), a direct comparison table as requested cannot be fully generated.

However, we can infer "performance" from the comparison to predicate devices, focusing on areas like measuring range, sample type, and principle.

Feature / Performance Metric	Acceptance Criteria (Inferred from Predicate Equivalence)	Reported Device Performance (Dimension Vista® ETOH Flex®)
Intended Use	Quantitative measurement of ethyl alcohol in human serum, plasma, and urine; diagnosis and treatment of alcohol intoxication and poisoning.	Meets the same intended use.
Sample Type	Supports serum, plasma, and urine. (Predicate 1 also supports supernatants from precipitated whole blood)	Supports plasma, serum, and urine.
Measuring Range	Expected to be comparable to or encompass the ranges of predicates (0-300 mg/dL for Predicate 1, 10-600 mg/dL for Predicate 2).	3 - 300 mg/dL
Sample Size	Comparable to predicates (3 µL or 4 µL).	4 µL
Measurement Principle	Enzymatic reaction / alcohol dehydrogenase (ADH) enzymatic procedure.	Based on an enzymatic reaction.
Substantial Equivalence	Demonstrated equivalent performance through comparative testing.	Conclusion: Substantially equivalent to predicates based on comparative testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size: Not specified. The document states "Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance," but does not detail the number of samples or cases used in this testing.
Data Provenance: Not specified.

3. 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):

Not applicable. This is a chemical assay, and "ground truth" would be established through reference methods or validated laboratory results, not expert consensus in the diagnostic imaging sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. As a chemical assay, adjudication methods are not relevant.

5. 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 laboratory diagnostic assay, not an AI-assisted diagnostic imaging device that involves human readers.

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

Not applicable in the AI/ML sense. This device is a reagent cartridge for an automated analyzer. Its performance is standalone in that it directly measures ethyl alcohol concentrations. However, this is not an "algorithm-only" performance as traditionally understood for AI/ML devices.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The ground truth for a chemical assay like this would typically be established using reference methods or highly accurate analytical techniques for ethyl alcohol concentration. The document does not explicitly state the specific reference method used but implies that the performance was compared to established predicate devices and internal validation protocols.

8. The sample size for the training set:

Not applicable. This is a chemical reagent cartridge, not a machine learning model that undergoes a "training phase" in the conventional sense. Its development relies on chemical and biological principles and optimization, not data-driven training as in AI/ML.

9. How the ground truth for the training set was established:

Not applicable, as there is no "training set" in the AI/ML context for this device.

Summary

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JUN 1 3 2007

. . . . . . . . . . . . . .

510(k) Summary of Safety and Effectiveness for the Dimension Vista® Ethyl Alcohol (ETOH) Flex® Reagent Cartridge (K5022)

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.

A. 510(k) Number: KO70853

B. Date of Preparation: March 26, 2007

C. Proprietary and Established Names:

Dimension Vista® Ethyl Alcohol (ETOH) Flex® Reagent Cartridge (K5022)

D. Applicant: Dade Behring Inc., P.O. Box 6101, Newark, DE 19714-6101 Victor M. Carrio, Regulatory Affairs and Compliance Manager Office: (302) 631-0376 Fax: (302) 631-6299

F. Regulatory Information:

1. Regulation section: 21 CFR § 862.3040 Clinical toxicology test system
1. Classification: Class II
1. Product Code: DIC Alcohol Dehydrogenase, Specific Reagent for Ethanol Enzyme Method

4. Panel: Toxicology

G. Predicate Device:

H. Device Description:

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G. Intended Use: The ETOH method is an in-vitro diagnostic test for the quantitative measurement of ethyl alcohol in human serum, plasma and urine, Ethyl alcohol test results may be used in the diagnosis and treatment of alcohol intoxication and poisoning.

I. Substantial Equivalence Information:

The Dimension Vista® ETOH Flex® reagent cartridge and the predicates, Dimension® ALC Flex® reagent cartridge and Syva® Emit® II Plus Ethyl Alcohol Assay, were compared. A comparison of the important similarities and differences between the device and the predicates is provided in the following table:

Feature	Dimension Vista®ETOH Flex®reagent cartridge	Dimension® ALCFlex® reagentcartridge(K904302)	Syva® Emit® II PlusEthyl Alcohol Assay(K010960)*
Intended Use	The Dimension Vista®ETOH Flex® reagentcartridge is an in-vitrodiagnostic test for thequantitative measurementof ethyl alcohol in humanserum, plasma, and urine.Ethyl alcohol test resultsmay be used in thediagnosis and treatment ofalcohol intoxication andpoisoning.	The ALC method used in theDimension® clinicalchemistry system is an invitro diagnostic test intendedto measure ethyl alcohol inhuman serum andsupernatants fromprecipitated whole blood andto qualitatively detect ethylalcohol in urine.	The EMIT® II Plus EthylAlcohol Assay is intendedfor use in the quantitativeanalysis of ethyl alcohol(ethanol) in human urine,serum, or plasma.
Sample Type	Plasma, serum, and urine.	Serum, supernatants fromprecipitated whole blood andurine.	Plasma, serum, and urine.
MeasuringRange	3 -300 mg/dL	0 - 300 mg/dL	10-600 mg/dL
Sample Size	4 µL	3 µL	4 µL
Measurement	Bichromatic rate	Bichromatic endpoint	Bichromatic rate
Principle	The ETOH method isbased on an enzymaticreaction.	The ethyl alcohol (ALC)method is a modification ofthe alcohol dehydrogenase(ADH) enzymatic procedure.	The Emit®II Plus EthylAlcohol Assay is based onan enzymatic reaction.

*Tested on the Roche/Hitachi 717 Analyzer.

J. Conclusion:

The Dimension Vista® ETOH Flex® reagent cartridge is substantially equivalent to the Dimension® ALC Flex® reagent cartridge (K904302) and to the Syva® Emit® II Plus Ethyl Alcohol Assay (K010960). Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dade Behring, Inc. Glasgow Business Community c/o Mr. Victor Carrio RA/QS Compliance Manager P.O. Box 6101, M/S 514 Newark, DE 19714-6101

JUN 1 3 2007

Re: K070853

Trade/Device Name: Dimension Vista ETOH Flex Reagent Cartridge, Model K5022 Regulation Number: 21 CFR 862.3040 Regulation Name: Alcohol test system. Regulatory Class: Class II Product Code: DIC Dated: March 26, 2007 Received: March 28, 2007

Dear Mr. Carrio:

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 Amendmonts, 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 11 The general controls provisions of the Act include requirements for annual registiation, into 1.0.7 devices, good manufacturing practice, labeling, and prohibitions against misbrandi, nound adulteration.

If your 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 Degiter.

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 protice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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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 (240) 276-0490. 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 tolli ine (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jean M. Cooper, M.S., D.V.M.

Sean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications For Use Statement

510(k) Number (if known): K070853

Device Name:

Dimension Vista® ETOH Flex® Reagent Cartridge (K5022)

Indications for Use:

Prescription Use な (Per 21 CFR 801 Subpart D) AND/OR

Over-the-counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of -In Vitro Diagnostic Devices (OIVD)

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Office of In Vitro Diagnostic Device valuation and Safe

K070853

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.