(47 days)
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No
The document describes clinical standard solutions for calibrating instruments, with no mention of AI or ML.
No
The device is described as "Ethyl Alcohol Clinical Standard Solutions" intended for calibration and standardization in determining ethyl alcohol in blood/serum, which is a diagnostic/analytical purpose, not a therapeutic one.
No
The device is described as "Ethyl Alcohol Clinical Standard Solutions" intended for calibration and standardization of instruments used to determine ethyl alcohol in blood or serum, and for validation of laboratory standards/control materials. It does not directly diagnose a condition but rather supports the accuracy of diagnostic measurements.
No
The device is described as "Ethyl Alcohol Clinical Standard Solutions," which are physical solutions used for calibration and standardization. This indicates a chemical or physical product, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the solutions are for "calibration and standardization of instruments and methods for the determination of ethyl alcohol in whole blood or serum." This involves testing biological samples (whole blood or serum) in vitro (outside the body) to obtain information about a person's health status (specifically, their blood alcohol level).
- Anatomical Site: The specified anatomical site is "whole blood or serum," which are biological specimens collected from the body for in vitro analysis.
- Intended User / Care Setting: The intended user is a "laboratory," which is the typical setting for performing in vitro diagnostic tests.
The definition of an IVD generally includes reagents, calibrators, control materials, and other devices intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for diagnosis, monitoring, or treatment. The Ethyl Alcohol Clinical Standard Solutions fit this description as they are calibrators used in the process of determining ethyl alcohol levels in biological specimens.
N/A
Intended Use / Indications 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.
Product codes
DNN
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
whole blood or serum
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
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§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized eagle symbol. The eagle is depicted with three swooping lines, representing the department's commitment to health and well-being. The text is in all caps and arranged in a circular pattern.
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
2
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