(25 days)
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No
The summary describes a qualitative immunoassay for drug screening, which is a chemical detection method and does not typically involve AI/ML. There are no mentions of AI, ML, image processing, or data sets for training/testing.
No
This device is an immunoassay for detecting drugs of abuse in urine, which is a diagnostic tool, not a therapeutic one. It assists in screening but does not provide treatment.
Yes
The device is described as an "Immunoassay for the qualitative detection of amphetamine, THC metabolites, methamphetamine, opiates, and phencyclidine in human urine to assist in screening of drugs of abuse samples." This indicates it's used to identify specific substances in a biological sample, which is a diagnostic purpose.
No
The description clearly indicates an immunoassay for detecting substances in human urine, which is a laboratory test involving physical reagents and samples, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's an "Immunoassay for the qualitative detection of amphetamine, THC metabolites, methamphetamine, opiates, and phencyclidine in human urine to assist in screening of drugs of abuse samples." This involves testing a sample taken from the human body (urine) in vitro (outside the body) to provide information about a person's health status (presence of drugs of abuse).
- Anatomical Site: The sample is "human urine," which is a biological specimen.
- Professional Use: It's indicated for "Professional Use," which is typical for IVDs used in clinical or laboratory settings.
These characteristics align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes.
N/A
Intended Use / Indications for Use
Immunoassay for the qualitative detection of amphetamine, THC metabolites, methamphetamine, opiates, and phencyclidine in human urine to assist in screening of drugs of abuse samples. The detecting cut-off concentrations are as follows:
| AMP | Amphetamine | 1000 ng/mL |
|---|---|---|
| THC | 11-nor-A9-9-carboxylic acid | 50 ng/mL |
| COC | Benzoylecgonine | 300 ng/mL |
| MET | D-Methamphetamine | 1000 ng/mL |
| OPI | Morphine | 300 ng/mL |
| PCP | Phencyclidine | 25 ng/mL |
Product codes
DKE, DIO, LAG, DJG, LCM, 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
human urine
Indicated Patient Age Range
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Intended User / Care Setting
Professional Use: X Prescription Use: X
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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 U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "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 the human form.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 18 1999
Jemo Kang, Ph.D., M.B.A. Director Princeton BioMeditech Corporation 4242 U.S. Route 1 Monmouth Junction, New Jersey 08852-1905
Re: K991751
Trade Name: Status Cup™ - AMP/THC/COC/MET/OPI/PCP Regulatory Class: II Product Code: DKE, DIO, LAG, DJG, LCM, DKZ Dated: May 15, 1999 Received: May 24, 1999
Dear Dr. Kang:
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 legally marketed predicate 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 Regulations, 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 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 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/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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
Page_of_of_of_________________________________________________________________________________________________________________________________________________________________
2(k) Number (if known): _ 1 9 1 75
Device Name:__Status Cup
Indications For Use:
Immunoassay for the qualitative detection of amphetamine, THC metabolites, methamphetamine, opiates, and phencyclidine in human urine to assist in screening of drugs of abuse samples. The detecting cut-off concentrations are as follows:
| AMP | Amphetamine | 1000 ng/mL |
|---|---|---|
| THC | 11-nor-A9-9-carboxylic acid | 50 ng/mL |
| COC | Benzoylecgonine | 300 ng/mL |
| MET | D-Methamphetamine | 1000 ng/mL |
| OPI | Morphine | 300 ng/mL |
| PCP | Phencyclidine | 25 ng/mL |
JeanCooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K991751
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Professional Use:_X Prescription Use:_X 'Per 21 CFR 801.109)
OR
(Optional Format 1-2-96)