(66 days)
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No
The summary describes a chemical reagent set for quantitative analysis, with no mention of AI or ML technologies.
No
The device is described as an "alcohol reagent set" used for the quantitative determination of ethyl alcohol, which is a diagnostic purpose rather than a therapeutic one.
Yes
The device is used for the quantitative determination of ethyl alcohol to aid in the differential diagnosis of central nervous system depression, indicating a diagnostic purpose.
No
The device is described as an "Alcohol Reagent Set," which implies a chemical or biological reagent used in a laboratory test, not a software application. The description focuses on the intended use for quantitative determination of ethyl alcohol in serum or whole blood, which is a laboratory assay. There is no mention of software, algorithms, or digital processing.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative determination of ethyl alcohol in serum or whole blood." This involves testing biological samples in vitro (outside the body) to provide diagnostic information (aiding in the differential diagnosis of central nervous system depression).
- Device Description: The device is described as an "Alcohol Reagent Set," which are components used in laboratory tests performed in vitro.
The definition of an IVD generally includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device fits that description.
N/A
Intended Use / Indications for Use
The alcohol reagent set is for the quantitative determination of ethyl alcohol in serum or whole blood. Alcohol analysis is most frequently requested for emergency room patients to aid in the differential diagnosis of central nervous system depression, which can be due to alcohol intoxication. It is also requested for forensic medicine purposes.
Product codes (comma separated list FDA assigned to the subject device)
DIC
Device Description
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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
emergency room patients
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 shows the logo for the Department of Health & Human Services USA. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of a bird or eagle with three wing-like shapes extending upwards.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 2 5 ຼອງ
William F. Walters, Jr. Vice President, Technical Operations Pointe Scientific, Inc. 1025 John A. Papalas Drive Lincoln Park, Michigan 48146
K972725 Re: Alcohol Reagent Set Requlatory Class: II Product Code: DIC Dated: July 15, 1997 Received: July 21, 1997
Dear Mr. Walters:
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 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 reqistration, 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 Requlations, 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 Requlation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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" (21 CFR 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Steven Gutman
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): Unknown at this time
Device Name:_Alcohol Reagent Set
Indications for use:
The alcohol reagent set is for the quantitative determination of ethyl alcohol in serum or whole blood. Alcohol analysis is most frequently requested for emergency room patients to aid in the differential diagnosis of central nervous system depression, which can be due to alcohol intoxication. It is also requested for forensic medicine purposes.
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Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use_ OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Sign-Off) Division of Clinical 510(k) Number _