(55 days)
ABI SureStep, Syntron Bioresearch Methamphetamine Test
Not Found
No
The device description and performance studies indicate a standard immunoassay technology, with no mention of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is an in-vitro diagnostic test for qualitative identification of methamphetamine, used in diagnosis and treatment, but it does not directly provide therapy.
Yes
The "Intended Use" section explicitly states that the measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose, identifying it as an in-vitro diagnostic test.
No
The device description clearly indicates it is an immunoassay test kit utilizing colloidal gold and visual color detection, which are physical components and processes, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative identification of methamphetamine... in urine." This is a test performed on a sample taken from the human body (in vitro).
- Purpose: The measurements are used in the "diagnosis and treatment of methamphetamine use or overdose." This aligns with the definition of an IVD, which is used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: It describes an "Immunoassay for the Qualitative Detection of Methamphetamine in Urine," which is a common type of IVD test.
- Sample Type: The test is performed on "urine," which is a biological specimen.
The information provided clearly indicates that this device is designed to be used outside of the body (in vitro) to analyze a human specimen (urine) for diagnostic purposes.
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 methamphetamine, a central nervous system stimulating drug, in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.
Product codes
LAF
Device Description
Immunoassay for the Qualitative Detection of Methamphetamine in Urine. The QuickScreenTM One Step Methamphetamine Test utilizes colloidal gold as the label like other commercially available immunoassays for drug of abuse (methamphetamine) test kits, to qualitatively measure the presence of methamphetamine by visual color sandwich one step immunoassay technology.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urine
Indicated Patient Age Range
Not Found
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
The product performance characteristics of the QuickScreen™ One Step Methamphetamine Test was evaluated in a clinical sample correlation study and a blind labeled methamphetamine study.
Correlation studies, using clinical specimens, produced a sensitivity of >95%, specificity of >99% and accuracy >97% when compared to the Syva EMIT II (San Jose, CA 95161).
Two clinical laboratory studies were performed, the Phamatech QuickScreen™ exhibited excellent sensitivity (84/86), specificity (39/39), and accuracy (123/125) in the hands of professional laboratory technicians.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical sample correlation study, blind labeled methamphetamine study.
Sample Size: Not explicitly stated, but clinical studies involved 86 (sensitivity), 39 (specificity), and 125 (accuracy) samples.
Key Results: The results of these studies demonstrate the Phamatech QuickScreen™ One Step Methamphetamine Test to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of methamphetamine in urine.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: >95% (compared to Syva EMIT II), 84/86 (clinical laboratory studies)
Specificity: >99% (compared to Syva EMIT II), 39/39 (clinical laboratory studies)
Accuracy: >97% (compared to Syva EMIT II), 123/125 (clinical laboratory studies)
Predicate Device(s)
ABI SureStep, Syntron Bioresearch Methamphetamine Test
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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
SEP - 2 1997
10972556
510(k) SUMMARY As Required By Section 807.92(c)
QuickScreen™ One Step Methamphetamine Test
Immunoassay for the Qualitative Detection of Methamphetamine in Urine
| Name of Product: | QuickScreen™ One Step Methamphetamine Test |
|---|---|
| Name Of Packager: | Phamatech |
| 9265 Activity Road #112 | |
| San Diego, California 92126 | |
| USA | |
| Name Of Manufacturer: | Phamatech |
| 9520 Padgett Street #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: 011
1
510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
Identification: OuickScreen TM One Step Methamphetamine Screening Test (9065)
Description: Immunoassay for the Qualitative Detection of Methamphetamine in Urine
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 methamphetamine, a central nervous system stimulating drug, in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose
The QuickScreenTM One Step Methamphetamine Test utilizes colloidal Technology: gold as the label like other commercially available immunoassays for drug of abuse (methamphetamine) test kits, to qualitatively measure the presence of methamphetamine 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 Methamphetamine Test (Vista, CA 92083). All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / Methamphetamine / antibody / complexes.
Performance: The product performance characteristics of the QuickScreen™ One Step Methamphetamine Test was evaluated in a clinical sample correlation study and a blind labeled methamphetamine study. The results of these studies demonstrate the Phamatech QuickScreen™ One Step Methamphetamine Test to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of methamphetamine in urine. Correlation studies, using clinical specimens, produced a sensitivity of >95%, specificity of >99% and accuracy >97% when compared to the Syva EMIT II (San Jose, CA 95161). Two clinical laboratory studies were performed, the Phamatech QuickScreen™ exhibited excellent sensitivity (84/86), specificity (39/39), and accuracy (123/125) in the hands of professional laboratory technicians.
Conclusion: For the reasons mentioned above, it may be concluded that the Phamatech QuickScreen™ One Step Methamphetamine ScreeningTest is substantially equivalent to a variety of qualitative methamphetamine tests currently in commercial distribution.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
SEP - 2 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Tuan H. Pham President Phamatech, Inc. 9265 Activity Road, Suite 112-113 San Diego, California 92126
K972556 Re: QuickScreen™ One Step Methamphetamine Test Requlatory Class: II Product Code: LAF Dated: July 7, 1997 Received: July 9, 1997
Dear Tuan H. Pham:
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 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 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 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 requlations.
3
Page 2
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 requlation (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
4
Fax:6196355843
INDICATIONS FOR USE
Applicant: Phamatech
510(k) Number (if known): 972556
Device Name. QuickScreen TM One Step Methamphetamine 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 in-vitro diagnostic test for the qualitative identification of methamphetamine, a central nervous system stimulating drug, in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.
PLEASE DO NOT WRITE BELOW THIS LINE
Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Denicas,
510(k) Number. 56
Division Sign-Off Division of Clinical Laboratory Devices 510(k) Number:
| Prescription Use: | |
|---|---|
| Per 21 CFR 801.109 |
Over the Counter OR