(28 days)
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No
The device description and performance studies indicate a standard immunoassay technology, with no mention of AI or ML.
No
This device is an in-vitro diagnostic test for identifying substances in urine, which aids in diagnosis and treatment, but does not itself provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements that are obtained by this device are used in the diagnosis and treatment of cocaine use or overdose." This directly indicates its diagnostic purpose.
No
The device description explicitly states it is an "in-vitro diagnostic test" that "utilizes colloidal gold as the label" and "visual color sandwich one step immunoassay technology," indicating it is a physical test kit with chemical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states it's "an in-vitro diagnostic test for the qualitative identification of cocaine and the cocaine metabolite benzoylecgonine, in urine." It also mentions that the measurements are used in the "diagnosis and treatment of cocaine use or overdose."
- Device Description: The description reiterates that it is "an in-vitro diagnostic test."
- Nature of the Test: The device analyzes a biological sample (urine) outside of the body to detect specific substances (cocaine and benzoylecgonine) for diagnostic purposes. This is the core definition of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
A drug of abuse assay intended for use in clinical toxicology laboratories, physicians' offices, drug-of-abuse clinics and law enforcement agencies is an in-vitro diagnostic test for the qualitative identification of cocaine and the cocaine metabolite benzoylecgonine, in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.
Product codes (comma separated list FDA assigned to the subject device)
DMN
Device Description
Immunoassay for the Qualitative Detection of Cocaine in Urine
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
clinical toxicology laboratories, physicians' offices, drug-of-abuse clinics and law enforcement agencies
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)
The product performance characteristics of the QuickScreenTM One Step Cocaine Test was evaluated in a clinical sample correlation study and a blind labeled cocaine study. The results of these studies demonstrate the Phamatech QuickScreenTM One Step Cocaine Test to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of Cocaine in urine. Correlation studies, using clinical specimens, produced a sensitivity of >99%, specificity of >99% and accuracy >99% when compared to the Syva EMIT II (San Jose, CA 95161) and the ABI Surestep (San Diego CA. 92121) Two clinical laboratory studies were performed, the Phamatech QuickScreen™ exhibited excellent performance in the hands of professional laboratory technicians.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
sensitivity of >99%, specificity of >99% and accuracy >99%
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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§ 862.3250 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).
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K972618
aug 8, 1997
510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
Identification: QuickScreenTM One Step Cocaine Screening Test (9080)
Immunoassay for the Qualitative Detection of Cocaine in Urine Description:
Name Of Manufacturer:
Phamatech 9265 Activity Road #112 / 113 San Diego, California 92126, USA
Intended Use: A drug of abuse assay intended for use in clinical toxicology laboratories, physicians' offices, drug-of-abuse clinics and law enforcement agencies is an in-vitro diagnostic test for the qualitative identification of cocaine and the cocaine metabolite benzoylecgonine, in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of cocaine use or overdose
The QuickScreen TM One Step Cocaine Test utilizes colloidal gold as the Technology: label like other commercially available immunoassays for drug of abuse (Cocaine) test kits, to qualitatively measure for the presence of Cocaine by visual color sandwich one step immunoassay technology. Examples of such predicate devices include the ABI SureStep (San Diego, CA 92121)and the Syntron Bioresearch Cocaine Test (Vista, CA 92083). All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / Cocaine / antibody / complexes.
The product performance characteristics of the QuickScreenTM One Step Performance: Cocaine Test was evaluated in a clinical sample correlation study and a blind labeled cocaine study. The results of these studies demonstrate the Phamatech QuickScreenTM One Step Cocaine Test to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of Cocaine in urine. Correlation studies, using clinical specimens, produced a sensitivity of >99%, specificity of >99% and accuracy >99% when compared to the Syva EMIT II (San Jose, CA 95161) and the ABI Surestep (San Diego CA. 92121) Two clinical laboratory studies were performed, the Phamatech QuickScreen™ exhibited excellent performance in the hands of professional laboratory technicians.
Conclusion: For the reasons mentioned above, it may be concluded that the Phamatech QuickScreenTM One Step Cocaine ScreeningTest is substantially equivalent to a variety of qualitative Cocaine tests currently in commercial distribution.
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510(k) SUMMARY As Required By Section 807.92(c)
QuickScreen ™ One Step Cocaine Screening Test
Immunoassay for the Qualitative Detection of Benzoylecgonine in Urine
| Name of Product: | QuickScreen™ One Step Cocaine Screening Test |
|---|---|
| Name Of Packager: | Phamatech |
| 9265 Activity Road #112 | |
| San Diego, California 92126 | |
| USA | |
| Name Of Manufacturer: | Phamatech |
| 9265 Activity Road #108 | |
| San Diego, California 92126 | |
| USA | |
| Site of Control Testing: | Phamatech |
| 9265 Activity Road #112 | |
| San Diego, California 92126 | |
| USA | |
| Sites of Clinical Testing: | Poison Laboratories |
| 7272 Clairemont Mesa Blvd. | |
| San Diego, CA 92111 | |
| Quest Diagnostics Incorporated | |
| 7470 Mission Valley Road | |
| San Diego, CA 92108 |
Regulatory Control Number: 010
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Image /page/2/Picture/3 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG - 8 1097
Mr. Carl Monqiovi · Director of Operations Phamatech 9520 Padgett Street, #108-110 San Diego, CA 92126
Re: K972618 QuickScreen™ One Step Cocaine Screening Test Requlatory Class: II Product Code: DMN Dated: July 8, 1997 Received: July 11, 1997
Dear Mr. Mongiovi:
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 able beated in the 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, qood 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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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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Paqe 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity (Sin oo), Chab 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 wor 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 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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INDICATIONS FOR USE
Applicant: Phamatech
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: QuickScreen TM One Step Cocaine Screening Test
Indications for Use:
A drug of abuse assay intended for use in clinical toxicology laboratories, physicians' offices, drug-of-abuse clinics and law enforcement agencies is an invitro diagnostic test for the qualitative or quantitative identification of cocaine and cocaine metabolite (benzoylecgonine), in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.
Concurrence of CDRH Office of Device Evaluation (ODE)
PLEASE DO NOT WRITE BELOW THIS LINE
(Division Sign-Off) Division of Clinical Labor 510(k) Number Division Sign-Off Division of Clinical Laboratory Devices 510(k) Number: Prescription Use: OR Over the Counter Per 21 CFR 801.109