(61 days)
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Not Found
No
The summary contains no mention of AI, ML, image processing, or any other indicators of AI/ML technology. The device is described as an in vitro diagnostic for ethanol in serum, which is typically a chemical analysis and not reliant on AI/ML.
No
This device is an in vitro diagnostic (IVD) device used for the quantitative determination of ethanol in serum, which means it diagnoses conditions but does not treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states "For IN VITRO diagnostic use.", which indicates it is a diagnostic device.
No
The summary describes an in vitro diagnostic device for determining ethanol in serum. This typically involves laboratory equipment and reagents, which are hardware components, not a software-only device.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: Explicitly states "For IN VITRO diagnostic use."
- Intended User / Care Setting: Also states "IN VITRO diagnostic use."
These statements clearly indicate that the device is intended to be used outside of the body to diagnose a condition or disease, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For the quantitative determination of ethanol in serum. For IN VITRO diagnostic use.
Ethanol (ethyl alcohol) is the most common toxic substance involved in medical-legal cases, Ethanol consumption is often a factor in all types of accidents and ethanol poisoning can be fatal. Ethanol testing of comatose patients aids in the differential diagnosis of the coma. (1)
Product codes
DIC
Device Description
Early methods for ethanol analysis depended on separation of the ethanol from the specimen. The method described here is an enzymatic procedure which does not require separation and is rapid and easily automated. This method is based on the first enzymatic method described by Bonnichsen and Theorelle (2) and later modified by other authors. (3) However, the current method is unique in that an aldehyde trap is no longer necessary in order to drive the reaction to completion. This is accomplished by the use of a co-factor with a high oxidizing potential. (4)
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" surrounding it. The text is written in a simple, sans-serif font.
Public Health Service
JAN 18 2000
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Karen Callbeck, R.T. B.Sc. Regulatory Affairs Coordinator Diagnostic Chemicals Limited 16 McCarville Street West Royalty Industrial Park Charlottetown, P.E.I., Canada
Re: K993920
Trade Name: Ethanol-L3K Assay, Catalogue Number 273-30, 273-17 Regulatory Class: II Product Code: DIC Dated: November 17, 1999 Received: November 18, 1999
Dear Ms. Callbeck:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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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 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 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
2
510(k) Number (if known): _
Device Name: Ethanol-L3K, Cat. No. 273-30, 273-17
Indications for Use:
For the quantitative determination of ethanol in serum. For IN VITRO diagnostic use.
Ethanol (ethyl alcohol) is the most common toxic substance involved in medical-legal cases, Ethanol consumption is often a factor in all types of accidents and ethanol poisoning can be fatal. Ethanol testing of comatose patients aids in the differential diagnosis of the coma. (1)
Early methods for ethanol analysis depended on separation of the ethanol from the specimen. The method described here is an enzymatic procedure which does not require separation and is rapid and easily automated. This method is based on the first enzymatic method described by Bonnichsen and Theorelle (2) and later modified by other authors. (3) However, the current method is unique in that an aldehyde trap is no longer necessary in order to drive the reaction to completion. This is accomplished by the use of a co-factor with a high oxidizing potential. (4)
Sean Cooper
Division Sign-Off vision of Clinical Laboratory Devices 9 91/10 510(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 (Per 21 CFR 801.109
OR
Over-The-Counter Use
(Optional Format 1-2-96)
.