(117 days)
The Genie Cup™ Integrated Screening Device is a professional use, rapid, multiple immunoassay tool for the qualitative detection of the major metabolites of the following drugs of abuse in urine at the SAMHSA specified (except for methamphetamines) cutoff concentrations.
Not Found
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving a device meets them. The document is a 510(k) clearance letter from the FDA for the "Genie Cup™ Integrated Screening Device."
While it mentions the intended use and cutoff concentrations for certain substances, it does not include:
- A table of acceptance criteria and reported device performance. It lists cutoff concentrations but not the performance metrics against those cutoffs (e.g., sensitivity, specificity).
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method.
- Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
- Details about standalone algorithm performance.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample size and ground truth establishment for the training set.
The document primarily focuses on the FDA's determination of substantial equivalence to a legally marketed predicate device, allowing the manufacturer to market the device. It refers to "established economics of the major metabolites of Sep" and SAMHSA specified cutoff concentrations, suggesting that the device's design aligns with existing standards, but it doesn't present the specific rigorous study data you're asking for.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 9 1998
Dr. Richard Roblin Chief Scientific Officer Point of Care Technologies, Inc. 6 Taft Court, Suite 150 Rockville, Maryland 20850
Re : K980836 Genie Cup™ Integrated Screening Device Requlatory Class: II Rogarat Code: LDJ, DIO, DJG, DKZ, LCM Dated: May 22, 1998 Received: May 22, 1998
Dear Dr. Roblin:
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 requlations 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 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 leqally 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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N 480056.171
Page_of_of_of_
长980836 510(k) Number (if known):
Genie Cup™ Integrated Screening Device Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Intended Use
The Genie Cup™ Integrated Screening Device is a professional use, rapid, The Gene Cup - Integrator established economics of the major metabolites of Sep of Sep multiple inimulioasay tool for are more at the SAMHSA specified (except for ~ methamphetamines) cutoff concentrations.
| And and the many of the many of the first of the first ofmphetamines) cutoff concentrations.amphetaminescocaineopiatesphencyclidine (PCP)cannabinoids (THC) | 1000 ng/ml300 ng/ml300 ng/ml25 ng/ml50 ng/ml | .;: 上一篇:لم العامل المنتدى القرب المنتدى القرب القريب المنتجات المنتجات المنتجات المنتجات المنتجات التقابل المنتجات المنتجات المنتجات المنتجات المنتجات المنتجات المنتجات المنتجات الم | 2រីភﯾﮧ ﮐﮯ ﮐﮧ్రాలు------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ20 | ្រី A/ HUGO/0 DE/DAC |
|---|---|---|---|---|
| methamphetamines | 500 ng/ml |
Genie Cup™ Integrated Screening Device provides only a preliminary analytical test result. A more Gente Cup - Integrated Screening Dors be used in order to obtain a confirmed analytical i Clici Specific aller nate chemical metry (GC/MS) is the preferred confirmatory method. Clinical Gas chi onliness apliyations on indigement should be applied to any drug of abuse test result, consider attorrand 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) | Alfred Montgome |
|---|---|
| (Division Sign-Off) | Cawl Denam |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K980836 |
| Prescription Use | OR | Over-The-Counter Use_ |
|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
8K-29
§ 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).