(18 days)
Immunoassay for the qualitative detection of amphetamine or methamphetamine, opiates, evcaine metabolites, THC metabolites, and phencyclidine in human urine to assist in screening of drugs of abuse samples. The detecting cut-off concentrations are as follows:
THC 11-nor-Δ9-9-carboxylic acid 50 ng/mL
OPI Morphine 300 ng/mL
COC Benzoylecgonine 300 ng/mL
AMP Amphetamine 1000 ng/mL
MET D-Methamphetamine 1000 ng/mL
PCP Phencyclidine 25 ng/mL
Not Found
I am sorry, but the provided text does not contain information regarding rejection criteria or studies that prove the device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a drug screening device, outlining the device's substantial equivalence to predicate devices and its intended use. It does not include performance data, study design details, or acceptance criteria tables.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide the associated table, sample sizes, expert qualifications, or other study-specific details.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - 1784" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or waves.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL - 6 1999
Jemo Kang, Ph.D., M.B.A. Director Princeton BioMeditech Corporation 4242 U.S. Route 1 Monmouth Junction, New Jersey 08852-1905
Re: K992068
Trade Name: Status Stik™ (THC/OPI/COC/AMP or MET/PCP) Regulatory Class: DKE, DJG, DIO, DKZ, DJC, LCM Product Code: II Dated: June 15, 1999 Received: June 18, 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/cdrl/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
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Page of of ___________________________________________________________________________________________________________________________________________________________________
0(k) Number (if known): K992068
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Immunoassay for the qualitative detection of amphetamine or methamphetamine, opiates, evcaine metabolites, THC metabolites, and phencyclidine in human urine to assist in screening of drugs of abuse samples. The detecting cut-off concentrations are as follows:
| THC | 11-nor-Δ9-9-carboxylic acid | 50 ng/mL |
|---|---|---|
| OPI | Morphine | 300 ng/mL |
| COC | Benzoylecgonine | 300 ng/mL |
| AMP | Amphetamine | 1000 ng/mL |
| MET | D-Methamphetamine | 1000 ng/mL |
| PCP | Phencyclidine | 25 ng/mL |
(Divisio Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K992068
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANYTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
| Professional Use: | X |
|---|---|
| Prescription Use: | X |
| (Per 21 CFR 801.109) |
OR
Over The Counter Use: ________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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).