(70 days)
Not Found
Not Found
No
The description focuses on a rapid immunochromatography assay, which is a chemical detection method, and does not mention any computational analysis or learning algorithms.
No.
The device is described as an in vitro diagnostic assay (a test) for the detection of drugs and/or their metabolites, providing only a preliminary analytical test result. It is not designed to treat or alleviate a disease or condition.
Yes
The device is a rapid immunochromatography assay designed for the detection of various substances in urine, providing a preliminary analytical test result which is then confirmed by a more specific chemical method. This process of identifying the presence of specific markers to infer a condition or state (drug use) is characteristic of a diagnostic device.
No
The device description clearly states it is an "immunochromatography assay," which is a physical test kit, not software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that DRUG CHECK is an "in vitro test intended for professional use."
- Nature of the Test: The description details a "rapid immunochromatography assay designed for the simultaneous qualitative detection of cocaine, amphetamines, THC, morphine, PCP, and/or their metabolites in urine." This is a classic description of an in vitro diagnostic test that analyzes biological samples (urine) outside of the body to detect specific substances.
The other sections (Device Description, Mentions image processing, etc.) being "Not Found" or "Not Applicable" do not negate the clear statement in the Intended Use that it is an in vitro test.
N/A
Intended Use / Indications for Use
DRUG CHECK is a rapid immunochromatography assay designed for the simultaneous qualatative detection of cocaine, amphetamines, THC, morphine, PCP, and/or their metabolites in urine. It is an in vitro test intended for professional use.
The DRUG CHECK assay provides only a preliminary analytical test result. A more specific alterate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MC) is the preferred confirmatory method. (1) Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Product codes
DIO, LDJ, DKZ, DPK, LCM
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
Not Found
Intended User / Care Setting
professional 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 (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.
Not Found
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human services.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 2 7 1998
Charles W. Gill Director, Research & Development Texas Immunology, Inc. 5400 Spur 248 University Business Park, Bldg. 2, Suite 6 Tyler, Texas 75707
K980153 Re : Drug Check Regulatory Class: II Product Code: DIO, LDJ, DKZ, DPK, LCM Dated: January 14, 1998 Received: January 16, 1998
Dear Mr. Gill:
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 qeneral 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. ਕੇ 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 Reqister. 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 qeneral 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
510(k) Number (if known):
DRUG CHECK TEST Device Name:
Indications For Use:
DRUG CHECK is a rapid immunochromatography assay designed for the simultaneous qualatative detection of cocaine, amphetamines, THC, morphine, PCP, and/or their metabolites in urine. It is an in vitro test intended for professional use.
The DRUG CHECK assay provides only a preliminary analytical test result. A more specific alterate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MC) is the preferred confirmatory method. (1) Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K980153
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)