(99 days)
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,
No
The summary describes a qualitative urine test strip and contains no mention of AI, ML, image processing, or any related concepts.
No
This device is intended for detection and not for treatment or therapy. It is a diagnostic tool.
Yes
The device is intended to qualitatively detect metabolites of Amphetamine, which is a diagnostic function used to identify the presence of substances in a patient's system.
No
The 510(k) summary describes a "Micro-Strip" intended to detect metabolites in urine. This strongly suggests a physical test strip, which is a hardware component, not a software-only device. The lack of information about software further supports this conclusion.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed to "qualitatively detect the metabolites of Amphetamine and Amphetamine-like drugs in urine." Urine is a biological sample taken from the human body.
- In Vitro: The detection is performed in vitro, meaning outside of the living body, on the urine sample.
- Diagnostic: The detection of drug metabolites in urine is a diagnostic test used to determine the presence of these substances, which can be indicative of drug use.
Therefore, the device fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Microdiagnostics, Inc. Micro-Strip for Amphetamine Metabolites is intended to qualitatively detect the metabolites of Amphetamine and Amphetamine-like drugs in urine.
Product codes
DKZ
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
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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
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Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. 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, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
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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 consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 20 1998
Roy Chung President Microdiagnostics, Inc. 28062 Forbes Road, Suite B Laquna Niquel, California 92677
Re: K974611 Micro-Strip for Amphetamine Metabolites Requlatory Class: II Product Code: DKZ Dated: February 24, 1998 Received: March 2, 1998
Dear Mr. Chung:
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 The general controls provisions of the Act 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. 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 In addition, FDA may publish further announcements action. 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.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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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Micro-Strip for Amphetamine Metabolites Indications For Use:
The Microdiagnostics, Inc. Micro-Strip for Amphetamine Metabolites is intended to qualitatively detect the metabolites of Amphetamine and Amphetamine-like drugs in urine.
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
rescription Use er 21 CFR 801.1091
ાર
Over-The-Counter Use_
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Dental Devices
510(k) Number: K974611