(41 days)
Not Found
Syva EMIT II
No
The device description and performance studies indicate a standard immunoassay technology, with no mention of AI or ML.
No
The device is an in-vitro diagnostic test for the qualitative identification of amphetamine in urine, used for diagnosis and monitoring, not for direct treatment of a disease or condition.
Yes
The intended use states that "Measurements that are obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose".
No
The device description clearly states it is an in-vitro diagnostic test kit that utilizes colloidal gold and visual color changes, indicating it is a physical test kit and not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's an "in-vitro diagnostic test for the qualitative identification of amphetamine... in urine." It also mentions the measurements are used in "diagnosis and treatment" and "monitoring levels."
- Device Description: The description details a test that analyzes a biological sample (urine) outside of the body to detect a specific substance (amphetamine).
- Performance Studies: The document describes clinical studies evaluating the device's performance in detecting amphetamine in urine samples, which is typical for IVDs.
The definition of an IVD generally involves tests performed on samples taken from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device clearly fits that description.
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 amphetamine, a central nervous system stimulating drug, in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.
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 amphetamine, a central nervous system stimulating drug, in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of amphetamine use and overdose.
Product codes
DIT
Device Description
Immunoassay for the Qualitative Detection of Amphetamine in Urine
The QuickScreenTM One Step Amphetamine Test utilizes colloidal gold as the label like other commercially available immunoassays for drug of abuse (amphetamine) test kits, to qualitatively measures the presence of amphetamine 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The product performance characteristics of the QuickScreen TM One Step Amphetamine Test was evaluated in a clinical sample correlation study and a blind labeled amphetamine study. The results of these studies demonstrate the Phamatech QuickScreenTM One Step Amphetamine Test to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of amphetamine in urine. Correlation studies, using clinical specimens, produced a >97% correlation when compared to the Syva EMIT II (San Jose, CA 95161) and the GC/MS methodology. Two clinical laboratory studies were performed, the Phamatech QuickScreen™ exhibited excellent sensitivity (83/84), specificity (40/40), and accuracy (123/124) in the hands of professional laboratory technicians.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
sensitivity (83/84), specificity (40/40), and accuracy (123/124)
Predicate Device(s)
ABI SureStep, Syntron Bioresearch Amphetamine Test
Reference Device(s)
Syva EMIT II
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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
KA72577
AUG 20 1997
510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
QuickScreenTM One Step Amphetamine Screening Test (9060) Identification:
Immunoassay for the Qualitative Detection of Amphetamine 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 amphetamine, a central nervous system stimulating drug, in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.
The QuickScreenTM One Step Amphetamine Test utilizes colloidal Technology: gold as the label like other commercially available immunoassays for drug of abuse (amphetamine) test kits, to qualitatively measures the presence of amphetamine 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 Amphetamine Test (Vista, CA 92083). All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / AMP / antibody / complexes.
The product performance characteristics of the QuickScreen TM Performance: One Step Amphetamine Test was evaluated in a clinical sample correlation study and a blind labeled amphetamine study. The results of these studies demonstrate the Phamatech QuickScreenTM One Step Amphetamine Test to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of amphetamine in urine. Correlation studies, using clinical specimens, produced a >97% correlation when compared to the Syva EMIT II (San Jose, CA 95161) and the GC/MS methodology. Two clinical laboratory studies were performed, the Phamatech QuickScreen™ exhibited excellent sensitivity (83/84), specificity (40/40), and accuracy (123/124) in the hands of professional laboratory technicians.
Conclusion: For the reasons mentioned above, it may be concluded that the Phamatech QuickScreen™ One Step AmphetamineTest is substantially equivalent to a variety of qualitative amphetamine tests currently in commercial distribution.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Carl A. Mongiovi Director of Operations Phamatech 9265 Activity Roads Suite 112-113 San Diego, California 92126 ... .....
AUG 20 1997
K972577 Re:
Trade Name: QuickScreen™ One Step Amphetamine Screening Test Requlatory Class: II Product Code: DIT Dated: July 7, 1997 Received: July 10, 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 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 requirement, 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 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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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 i 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) Additionally, for questions on the promotion and 594-4588. 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Sutman
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
3
INDICATIONS FOR USE
Applicant: Phamatech
510(k) Number (if known): _ K972577
Device Name: QuickScreen IM One Step AmphetamineTest
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 amphetamine, a central nervous system stimulating drug, in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of amphetamine use and overdose.
PLEASE DO NOT WRITE BELOW THIS LINE
| Concurrence of CDRH Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K972577 |
| Division Sign-Off | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number: | |
| Prescription Use: | ✓ |
| OR Over the Counter | |
| Per 21 CFR 801.109 |