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

Device Description

The Dimension® ETOH Flex® reagent cartridge is a prepackaged in-vitro diagnostic test method that is specifically designed to be used on the Dade Behring Dimension® Clinical Chemistry System. The reagents contained in the Dimension® 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) premarket notification for the Dimension® Ethyl Alcohol (ETOH) Flex® Reagent Cartridge (DF22), asserting its substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a detailed study proving its performance against those criteria as would be found in a clinical trial report.

However, based on the information provided, we can infer some aspects and highlight the lack of others. The core of the submission is to demonstrate substantial equivalence to existing devices.

Here's an attempt to answer your questions based on the provided text, noting where information is explicitly not available in the provided document.

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

The document does not explicitly state "acceptance criteria" in the format of a table with specific thresholds for performance metrics (e.g., accuracy, precision, limits of detection) that the new device needed to meet. Instead, it relies on demonstrating comparative performance to predicate devices to establish substantial equivalence.

The table below summarizes the comparative features and stated performance that are used to assert equivalence, rather than a direct acceptance criteria table.

Feature / Performance Aspect	Acceptance Criteria (Inferred from Predicate Equivalence)	Reported Device Performance
Intended Use	Quantitative measurement of ethyl alcohol (ethanol) in human serum, plasma, and urine for diagnosis and treatment of alcohol intoxication and poisoning (similar to predicates).	The ETOH method is an in-vitro diagnostic test for the quantitative measurement of ethyl alcohol (ethanol) in human serum, plasma and urine on the Dimension® System. Ethyl alcohol test results may be used in the diagnosis and treatment of alcohol intoxication and poisoning.
Sample Type	Plasma, serum, and urine (similar to predicates).	Plasma, serum, and urine.
Measuring Range	Within a clinically acceptable range, comparable to or improving upon predicates (Predicates: 0-300 mg/dL and 10-600 mg/dL).	3-300 mg/dL
Sample Size	Practical and efficient (Predicates: 3 µL and 4 µL).	9 µL
Measurement Principle	Enzymatic reaction using alcohol dehydrogenase (ADH) and NAD (similar to predicates).	Bichromatic rate, based on an enzymatic reaction.
Substantial Equivalence	Performance comparable to Dimension® ALC Flex® (K904302) and Syva® Emit® II Plus Ethyl Alcohol Assay (K010960).	"Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance." (Specific data not provided in this summary).

Note on "Acceptance Criteria": For an in-vitro diagnostic device like this, acceptance criteria would typically involve specific assay characteristics such as:

Analytical Sensitivity: Limit of Detection (LoD), Limit of Quantitation (LoQ).
Analytical Specificity: Interference studies, cross-reactivity.
Precision: Repeatability (within-run) and Reproducibility (between-run, between-lot, between-instrument).
Accuracy: Method comparison studies against a reference method or legally marketed device, often assessed by regression analysis and bias.
Linearity/Measuring Range.
Stability.

This 510(k) summary only states that "Comparative testing demonstrated substantial equivalent performance," implying these types of studies were conducted and met predetermined criteria, but the specific criteria and results are not detailed in the provided text.

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 for Test Set: Not specified in the provided text. The document states "Comparative testing described in the protocol included in this submission," but no details about the number of samples or subjects are given.
Data Provenance: Not specified. There is no information about the country of origin of the data or whether the study was retrospective or prospective.

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)

This type of device (clinical chemistry reagent cartridge for ethyl alcohol measurement) typically establishes "ground truth" through:

Reference methods: Highly accurate and precise laboratory methods (e.g., Gas Chromatography-Mass Spectrometry, enzymatic methods traceable to certified reference materials).
Legally marketed predicate devices: The new device's results are compared to the results obtained from established, cleared devices.

No human experts are typically involved in establishing "ground truth" for the quantitative measurement of ethanol in this context. The "ground truth" refers to the true concentration of ethyl alcohol, which is determined by analytical methods, not by expert interpretation.

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

Not applicable. Adjudication methods (like 2+1, 3+1 consensus) are used for resolving disagreements among human readers/experts, typically in imaging or clinical assessment where subjective interpretation is involved. Since this device provides a quantitative measurement of alcohol, there is no human interpretation or adjudication process for its primary function.

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 an in-vitro diagnostic (IVD) device for quantitative measurement, not an AI-assisted diagnostic tool for human interpretation.
There are no "human readers" interpreting results in the way an MRMC study would evaluate, nor is there any AI component described.

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

Yes, in essence, this device operates as a "standalone" algorithm/system for quantitative measurement. The Dimension® ETOH Flex® Reagent Cartridge is designed to be used on the Dade Behring Dimension® Clinical Chemistry System, which performs the measurement automatically. The output is a numerical concentration of ethyl alcohol. Human involvement is in operating the instrument and interpreting the numerical result in a clinical context, but not in the analytical measurement itself. The "comparative testing" mentioned would have evaluated this standalone performance against predicate devices.

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

For this type of IVD device, the "ground truth" for establishing its analytical performance (accuracy, precision, linearity) would typically be:

Comparisons to legally marketed predicate devices: The Dimension® ALC Flex® reagent cartridge (K904302) and Syva® Emit® II Plus Ethyl Alcohol Assay (K010960).
Reference methods: Gold standard analytical methods for measuring ethyl alcohol, if used for calibration or method validation (though not explicitly stated in this summary, it's a standard practice).

It is not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable in the context of this device. This device is a reagent cartridge for a clinical chemistry analyzer, based on an enzymatic reaction. It is not an AI/machine learning model that requires a "training set" of data in the typical sense. The 'training' for such a system would involve validating the chemical reaction, reagent stability, and instrument calibration, which doesn't use a data-driven training set like AI models.

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

Not applicable. As explained in point 8, there is no "training set" for this type of IVD device.

Summary

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510(k) Summary of Safety and Effectiveness for the Dimension® Ethyl Alcohol (ETOH) Flex® Reagent Cartridge (DF22)

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: K071811

AUG 2 4 2007

B. Date of Preparation: June 29, 2007

C. Proprietary and Established Names:

Dimension® Ethyl Alcohol (ETOH) Flex® Reagent Cartridge (DF22)

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
1. Panel: Toxicology

G. Predicate Device:

The Dimension® 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).

H. Device Description:

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The ETOH method is an in-vitro diagnostic test for the quantitative G. Intended Use: measurement of ethyl alcohol (ethanol) in human serum, plasma and urine on the Dimension® System. 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® ETOHFlex® reagentcartridge	Dimension® ALCFlex® reagentcartridge(K904302)	Syva® Emit® II PlusEthyl Alcohol Assay(K010960)*
Intended Use	The Dimension® ETOHFlex® reagent cartridge isan in-vitro diagnostic testfor the quantitativemeasurement of ethylalcohol (ethanol) in humanserum, plasma, and urinein the Dimension®System. Ethyl alcohol testresults may 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. Ethylalcohol test results may beused in the diagnosis andtreatment of alcoholintoxication and poisoning.	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	9 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 SYVA30R Analyzer.

J. Conclusion:

The Dimension® 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services-PSA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-PSA" around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with its wings spread. The eagle is facing to the right.

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

AUG 2 4 2007

Re: K071811

Trade/Device Name: Dimension Ethyl Alcohol (ETOH) Flex Reagent Cartridge (DF22) Regulation Number: 21 CFR 862.3040 Regulation Name: Alcohol test system Regulatory Class: Class II Product Code: DIC Dated: July 2, 2007 Received: July 11, 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 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 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 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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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.

Sincerely yours,

Carol Benson for

Jean M. Cooper, M.S., D. 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 Konló। 510(k) Number (if known):

Device Name:

Dimension® ETOH Flex® Reagent Cartridge (DF22)

Indications for 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.

. . . . . . . .

Prescription Use X (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)

Carol Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

22(K) K071811

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.