(47 days)
The Ethyl Alcohol Clinical Standard Solutions are intended for use in the calibration and standardization caruments and methods for the determination of ethyl alcohol in whole blood or serum. The Standard tions may also be used for validation of the laboratory's routine standards and/or control materials.
Not Found
This document is a 510(k) clearance letter from the FDA for "Ethyl Alcohol Clinical Standard Solutions." It does not contain information about acceptance criteria or a study proving device performance in the way described in the request. The letter confirms substantial equivalence to a legally marketed predicate device, but it doesn't detail performance metrics or studies.
Therefore, I cannot extract the requested information from the provided text. The document is regulatory approval, not a performance study report.
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OCT - 1 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Anna G. Bentley . Director Regulatory and Quality Affairs EM Science 480 S. Democrat Road Gibbstown, NJ 08027
K973054/S1 Re : Ethyl Alcohol Clinical Standard Solutions Requlatory Class: II Product Code: DNN Dated: September 16, 1997 Received: September 17, 1997
Dear Ms. Bentley:
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 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 Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 requlatory 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 requlation (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.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
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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jk) Number (if Known):
ice Name: Ethyl Alcohol Clinical Standard Solutions
rations for Use:
The Ethyl Alcohol Clinical Standard Solutions are intended for use in the calibration and standardization caruments and methods for the determination of ethyl alcohol in whole blood or serum. The Standard tions may also be used for validation of the laboratory's routine standards and/or control materials.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
scription Use
21 CFR 801.109
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number.
K093054
§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.