The Bayer ADVIA IMS Ethanol (ETOH) assay is an in vitro diagnostic device intended to quantitatively measure ethanol concentration in human serum or plasma (Lithium Heparin). Measurement of ethanol is used in the diagnosis of ethanol (alcohol) toxicity and overdose.

Device Description

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AI/ML Overview

The Bayer ADVIA® IMS™ Ethanol assay is an in vitro diagnostic device intended to quantitatively measure ethanol concentration in human serum or plasma (Lithium Heparin). This assay is used in the diagnosis of ethanol (alcohol) toxicity and overdose.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Predicate Device TDx)	Reported Device Performance (ADVIA® IMS™ Ethanol)
Imprecision (Total CV%)
Level ~40 mg/dL	5.9%	5.3% (at 22.0 mg/dL)
Level ~100 mg/dL	3.2%	2.2% (at 88.9 mg/dL)
Level ~250 mg/dL	3.2%	1.8% (at 289.5 mg/dL)
Correlation (vs. Predicate TDx - Serum)
Regression Equation	Not explicitly stated, but high R-value expected	Y = 0.964x - 0.04
Syx (mg/dL)	Not explicitly stated	4.8
R	Not explicitly stated, but close to 1 expected	0.999
Sample Range (mg/dL)	Not explicitly stated	22.9 to 433.0
Correlation (Plasma vs. Serum - ADVIA IMS)
Regression Equation	Not explicitly stated	Y = 1.005x - 1.75
Syx (mg/dL)	Not explicitly stated	2.99
R	Not explicitly stated, but close to 1 expected	1.000
Sample Range (mg/dL)	Not explicitly stated	10.0 to 516.2
Interfering Substances	Minimal interference (< ~10% change)
Bilirubin (unconjugated, 25 mg/dL)	Not explicitly stated	+1.2% (at 98.2 mg/dL Ethanol)
Bilirubin (conjugated, 25 mg/dL)	Not explicitly stated	+1.6% (at 98.3 mg/dL Ethanol)
Hemoglobin (1000 mg/dL)	Not explicitly stated	+2.7% (at 94.9 mg/dL Ethanol)
Lipids (Triglycerides, 1000 mg/dL)	Not explicitly stated	+2.0% (at 95.8 mg/dL Ethanol)
Analytical Range	Not explicitly stated	0.7 to 500 mg/dL

2. Sample Sizes Used for the Test Set and Data Provenance

Correlation (Serum vs. Abbott/TDx): 54 samples (N=54)
Correlation (Plasma vs. Serum using ADVIA IMS): 50 samples (N=50)

The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given the context of a 510(k) submission for a diagnostic device, it is typically expected that studies are prospective or, if retrospective, well-controlled with banked samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This is an in vitro diagnostic device measuring a chemical analyte (ethanol concentration). The "ground truth" for such measurements is established by validated reference methods or predicate devices, not by expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the "ground truth" is a quantitative measurement, not a subjective interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study (MRMC) is typically used for imaging-based diagnostic devices where human readers interpret images. For an in vitro diagnostic assay, the comparison is made against a predicate device or reference method's quantitative output.

6. Standalone Performance Study

Yes, in essence. The imprecision, interfering substances, and analytical range studies assess the algorithm's (or assay's) performance independently of human interpretation.
The correlation studies also demonstrate the standalone performance of the ADVIA IMS Ethanol assay in comparison to a predicate device and also for different sample types (plasma vs serum) using the ADVIA IMS system itself.

7. Type of Ground Truth Used

The ground truth for the performance studies was established by:

Predicate Device Comparison: The Abbott/TDx system served as the comparison system for the serum correlation study.
Internal Comparison: For the plasma versus serum correlation, the ADVIA IMS itself was used to compare ethanol levels in matched plasma and serum samples.
Known Concentrations: For imprecision and interfering substances studies, known concentrations of ethanol and interfering substances would have been used.

8. Sample Size for the Training Set

The document does not specify a separate "training set" sample size. For an in vitro diagnostic assay, development and validation typically involve extensive internal testing before final performance studies are conducted. The provided data represents validation studies, not typically a "training set" in the machine learning sense. Statistical models or algorithms within such devices are generally based on established chemical principles rather than iterative machine learning from large datasets.

9. How the Ground Truth for the Training Set was Established

Not explicitly stated or applicable in the conventional machine learning sense. The "ground truth" for developing such a chemical assay would involve:

Chemical Principles: The assay is based on known biochemical reactions for ethanol detection.
Reference Materials: Using validated reference materials with known ethanol concentrations for calibration and quality control.
Method Optimization: Through extensive laboratory experimentation and optimization, ensuring that the assay accurately measures ethanol across its intended range.
Comparison to Established Methods: During development, the assay would be compared to existing, well-validated methods to ensure accuracy and precision.

Summary

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NOV 1 8 2002

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Ethanol method for ADVIA® IMSTM

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

The assigned 510(k) number is: 5023184

1. Intended Use

2. Predicate Device

Product Name		Reagent Part # Calibrator Part #
TDx/Ethanol	તે રેતા રેતા રાજ્યના પાકની ખેતી કરવામાં આવે છે. આ ગામમાં પ્રાથમિક શાળા, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી	8545

3. Device / Method

Product Name		Reagent BAN Calibrator BAN
Comments of Address of Acres Company Complete Company La Province La Province La Pro-Bayer ADVIA® IMSTM Ethanol.	01482481	08648547

Imprecision

ADVIA IMS	TDx
Level (mg/dL)	Total CV(%)	Level (mg/dL)	Total CV(%)
22.0	5.3	40	5.9
88.9	2.2	100	3.2
289.5	1.8	250	3.2

Correlation (Y=ADVIA IMS, X=comparison system) =

Specimen type	Comparison System (X)	N	Regression Equation	Syx (mg/dL)	R	Sample Range (mg/dL)
Serum	Abbott/TDx	54	$0.964 x - 0.04$	4.8	0.999	22.9 to 433.0
Plasma(y), Serum(x)	ADVIA IMS	50	$1.005 x - 1.75$	2.99	1.000	10.0 to 516.2

Interfering Substances

Interfering Substance	Interfering Sub.Conc. (mg/dL)	Ethanol Conc(mg/dL)	Effect(% change)
Bilirubin (unconjugated)	25	98.2	+1.2
Bilirubin (conjugated)	25	98.3	+1.6
Hemoglobin	1000	94.9	+2.7
Lipids (Triglycerides)	1000	95.8	+2.0

Analytical Range

Serum/Plasma(Lithium heparine): 0.7 to 500 mg/dL

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Kenneth. Clark

11/6/02
Date

Kepalli T. Edids
Regulatory Aniars
Bayer Corporation 511 Benedict Avenue
Tarrytown, New York 10591-5097

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its head facing left and three stripes forming its wing. 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

NOV 1 8 2002

Kenneth T. Edds, Ph.D. Manager, Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, NY 10591-5097

Re: K023184 Trade/Device Name: Ethanol Assay for the ADVIA® IMS™ Regulation Number: 21 CFR 862.3040 Regulation Name: Alcohol test system Regulatory Class: Class II Product Code: DIC; JIX Dated: September 20, 2002 Received: September 24, 2002

Dear Dr. Edds:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrl/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number:

Device Name: Ethanol Assay for the ADVIA® IMSTM

Indications for Use:

The Bayer ADVIA IMS Ethanol method is an in vitro diagnostic device intended to quantitatively measure ethanol (alcohol) levels in human serum or plasma (Lithium heparin). Such measurements are used in the diagnosis of ethanol toxicity and overdose.

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K023184

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-CounterUse

(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.