(66 days)
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.
Alcohol Reagent Set
This document is a 510(k) clearance letter from the FDA for an "Alcohol Reagent Set." It does not contain information about acceptance criteria or a study proving device performance in the way typically seen for AI/ML-driven medical devices.
The letter indicates that the device is substantially equivalent to a pre-amendment device, which means it likely passed based on performance characteristics similar to those already on the market, rather than a new clinical study with detailed acceptance criteria and performance metrics.
Therefore, I cannot provide the requested information from the provided text. The document is a regulatory approval notice, not a scientific report detailing a device's performance study.
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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
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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 _
§ 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.