(51 days)
Not Found
No
The description focuses on a standard enzymatic assay and spectrophotometric measurement, with no mention of AI, ML, or related concepts.
No
This device is an in vitro diagnostic assay used for the quantitative analysis of ethyl alcohol in human specimens, not for treating or diagnosing a disease.
Yes
The device is an "in vitro diagnostic assay" used for the quantitative analysis of ethanol in human biological samples, which provides information for diagnosis.
No
The device description clearly states it is an "in vitro diagnostic assay" based on an "enzymatic reaction" and measures "absorbance change that can be measured spectrophotometrically." This indicates a chemical and optical process requiring physical reagents and a spectrophotometer, which are hardware components, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states the assay is used for the "quantitative analysis of ethyl alcohol (ethanol) in human serum, plasma, or urine." This is a classic definition of an in vitro diagnostic test, as it analyzes biological samples outside of the body to provide information about a person's health status (in this case, the presence and amount of ethanol).
- Device Description: The description clearly states "Ethanol is an in vitro diagnostic assay".
- Mechanism: The assay uses an enzymatic reaction to measure a substance in a biological sample, which is a common method for IVD tests.
The information provided strongly indicates that this device is intended for use in a laboratory setting to diagnose or monitor a condition (ethanol levels) by analyzing biological specimens.
N/A
Intended Use / Indications for Use
The Ethanol assay is used for the quantitative analysis of ethyl alcohol (ethanol) in human serum, plasma, or urine. The Ethanol assay should be exclusively used to detect ethanol and not other alcohols such as isopropanol or methanol. Reactivity with compounds structurally unrelated to ethanol has not been observed.
Product codes
DML
Device Description
Ethanol is an in vitro diagnostic assay for the quantitative analysis of ethyl alcohol (ethanol) in human serum, plasma, or urine. The assay is based on an enzymatic reaction. Active enzyme converts NAD to NADH, resulting in an absorbance change that can be measured spectrophotometrically. The increase in absorbance at 340 nm is proportional to the concentration of alcohol in the specimen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Comparative performance studies were conducted using the AEROSET® System. The Ethanol assay method comparison yielded acceptable correlation with the Emit® II Plus Ethyl Alcohol assay on the SYVA 30R Analyzer. For serum, the correlation coefficient = 0.996, slope = 1.00, and the Y-intercept = - 1.87 mg/dL. For urine the correlation coefficient = 0.997, slope = 1.01, and the Y-intercept = -4.85 mg/dL. Precision studies were conducted using the Ethanol assay. A within-run study was performed using three levels of control material. The total %CV for the low control is 5.1%, 100 mg/dL calibrator/control is 2.8%, and the high control is 1.7%. The Ethanol assay range is 10 to 600 mg/dL. The limit of quantitation (sensitivity) of the Ethanol assay is 5 mg/dL. These data demonstrate that the performance of the Ethanol assay is substantially equivalent to the performance of the Emit II Plus Ethyl Alcohol assay on the SYVA-30R Analyzer.
Key Metrics
For serum, the correlation coefficient = 0.996, slope = 1.00, and the Y-intercept = - 1.87 mg/dL. For urine the correlation coefficient = 0.997, slope = 1.01, and the Y-intercept = -4.85 mg/dL. The total %CV for the low control is 5.1%, 100 mg/dL calibrator/control is 2.8%, and the high control is 1.7%. The Ethanol assay range is 10 to 600 mg/dL. The limit of quantitation (sensitivity) of the Ethanol assay is 5 mg/dL.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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510(k) Summary
Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive MS 8-21 Irving, Texas 75038
Contact Person Alicia Simpson Senior Regulatory Affairs Specialist Regulatory Affairs (972) 518-7864 Fax (972) 518-6533
| Date of Preparation of this Summary: | October 23, 2001 |
|---|---|
| Device Trade or Proprietary Name: | Ethanol |
| Device Common/Usual Name or Classification Name: | Ethyl Alcohol |
| Classification Number/Class: | DML/Class II |
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.
The assigned 510(k) number is: K013538_
Test Description:
Ethanol is an in vitro diagnostic assay for the quantitative analysis of ethyl alcohol (ethanol) in human serum, plasma, or urine. The assay is based on an enzymatic reaction. Active enzyme converts NAD to NADH, resulting in an absorbance change that can be measured spectrophotometrically. The increase in absorbance at 340 nm is proportional to the concentration of alcohol in the specimen.
Substantial Equivalence:
The Ethanol assay is substantially equivalent to the Emit® II Plus Ethyl Alcohol assay (K993980) on the SYVA®-30R Analyzer.
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Both assays yield similar Performance Characteristics.
Similarities:
- Both assays are in vitro immunoassays. .
- Both assays can be used for the quantitative analysis of ethyl alcohol. .
- Both assays yield similar results. .
- Both assays are based on an enzymatic reaction. .
Differences:
- There is no difference. .
Intended Use:
The Ethanol assay is used for the quantitative analysis of ethyl alcohol (ethanol) in human serum, plasma, or urine.
Performance Characteristics:
Comparative performance studies were conducted using the AEROSET® System. The Ethanol assay method comparison yielded acceptable correlation with the Emit® II Plus Ethyl Alcohol assay on the SYVA 30R Analyzer. For serum, the correlation coefficient = 0.996, slope = 1.00, and the Y-intercept = - 1.87 mg/dL. For urine the correlation coefficient = 0.997, slope = 1.01, and the Y-intercept = -4.85 mg/dL. Precision studies were conducted using the Ethanol assay. A within-run study was performed using three levels of control material. The total %CV for the low control is 5.1%, 100 mg/dL calibrator/control is 2.8%, and the high control is 1.7%. The Ethanol assay range is 10 to 600 mg/dL. The limit of quantitation (sensitivity) of the Ethanol assay is 5 mg/dL. These data demonstrate that the performance of the Ethanol assay is substantially equivalent to the performance of the Emit II Plus Ethyl Alcohol assay on the SYVA-30R Analyzer.
ETHANOL 510(k) October 23, 2001 Ethan_5_R1.doc
Section II Page 13 0000012
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Conclusion:
The Ethanol assay is substantially equivalent to the Emit II Plus Ethyl Alcohol assay on the SYVA-30R Analyzer as demonstrated by results obtained in the studies.
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ETHANOL 510(k)
October 23, 2001 Ethan_5_R1.doc
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Section II Page 14 0000013
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Alicia Simpson Senior Regulatory Affairs Specialist Abbott Laboratories 1920 Hurd Drive Irving, TX 75038
DEC 1 4 2001
K013538 Re: Trade/Device Name: Ethanol Regulation Number: 21 CFR 862.3040 Regulation Name: Alcohol Test System Regulatory Class: Class II Product Code: DML Dated: October 23, 2001 Received: October 24, 2001
Dear Ms. Simpson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaren be (2) fee device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regars actual to the Medical Device Americal Partic Commerce provision of May 20, 1978, are oncernance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (110) that ao nov requent to the general controls provisions of the Act. The Tou may, merelove, manel of the Act include requirements for annual registration, listing of general controls provisions of assisted, 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 IT your device is classified (600 a00 rols. Existing major regulations affecting your device can may oc subject to back access as a 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 r lease oc advised that I Dris issuation that your device complies with other requirements of the Act that I Dri has intact a and regulations administered by other Federal agencies. You must or any I catal subdicalled and regaranents, including, but not limited to: registration and listing (21 comply with an the Not 811 CFR Part 801); good manufacturing practice requirements as set Of It in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by sections (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 I mis lower will and my of substantial equivalence of your device to a legally marketed notification. The I Drice 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 1 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, (201) 594-4639 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/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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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K013538 510(k) Number (if known): ___
Device Name: _________________________________________________________________________________________________________________________________________________________________ Ethanol
Indications For Use:
Ethan_5_R1.doc
The Ethanol assay is used for the quantitative analysis of ethyl alcohol (ethanol) in human serum, plasma, or urine. The Ethanol assay should be exclusively used to detect ethanol and not other alcohols such as isopropanol or methanol. Reactivity with compounds structurally unrelated to ethanol has not been observed.
Thomas A. Smith for Jean Cooper
(Division Sign-Of Division of Clinical Laboratory Devices 1-013538 510(k) Number.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use/ Over-The-Counter Use OR (Per 21 CFR 801.109) (Optional Format 1-2-96) ETHANOL 510(k) October 23, 2001
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