(101 days)
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No
The summary describes a simple immunochromatographic assay for qualitative detection, which is a standard chemical test and does not mention any computational or learning components.
No
This device is a diagnostic test kit for detecting amphetamines in urine, not a device used to provide therapy or treatment.
Yes
The device is described as an "immunochromatographic assay for rapid, qualitative detection of amphetamines in urine," which directly falls under the definition of a diagnostic device as it detects a substance to identify a condition (presence of amphetamines).
No
The device is described as an "immunochromatographic assay" and a "Test Kit," which are physical components used for chemical analysis of urine. This indicates it is a hardware-based diagnostic device, not software only.
Based on the provided information, the dBest Amphetamines Test Kit is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "rapid, qualitative detection of amphetamines in urine." This involves testing a sample taken from the human body (urine) outside of the body (in vitro) to provide diagnostic information (detection of amphetamines).
- Sample Type: It uses urine, which is a biological sample.
- Purpose: The purpose is to detect a substance (amphetamines) in the sample, which is a diagnostic activity.
The fact that it's for "professional and laboratory use only" further supports its classification as an IVD, as these are typical settings for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
dBest Amphetamines Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of amphetamines in urine with cutoff of 1000 ng/ml. The dBest Amphetamines Test Kits are for professional and laboratory use only.
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
professional and laboratory use
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract design of three human figures.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
6 1398 AUG
K.C. Yee, Ph.D. President & CEO AmeriTek, Inc. 7030 35th Avenue, N.E. Seattle, Washington 98115
Re : K981504 dBest AMP Test Kit Requlatory Class: II Product Code: DKZ Dated: June 21, 1998 Received: June 29, 1998
Dear Dr. Yee:
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, Druq, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗೆ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set wire 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 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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Page of
510 (K) Number (if known): 981504
Device Name: dBest Amphetamines Test Kits
Indications For Use:
dBest Amphetamines Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of amphetamines in urine with cutoff of 1000 ng/ml. The dBest Amphetamines Test Kits are for professional and laboratory use only.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 1981504
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PATE IF NEEDEN)
Prescription Use
OR
Over-The -Counter Use (Optional Format 1-2-96)