(143 days)
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No
The device description details a competitive binding immunoassay based on chemical reactions and colorimetric detection, with no mention of computational analysis, algorithms, or learning processes.
No.
The device is an immunoassay for detecting methamphetamine in urine; it screens for the presence of the substance rather than treating a condition.
Yes
The device is described as a "rapid, qualitative, competitive binding immunoassay for the determination of methamphetamine in urine," providing "preliminary data" that screens "urines for the presence of methamphetamine and its metabolites." This indicates it is used to identify a condition (presence of methamphetamine), which is a key characteristic of a diagnostic device.
No
The device description clearly describes a physical chromatographic absorbent device, which is a hardware component, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "determination of methamphetamine in urine." This involves testing a biological sample (urine) in vitro (outside the body) to gain information about a person's health status (presence of a drug).
- Device Description: The description details a "chromatographic absorbent device" that uses an immunoassay to detect the presence of a substance (methamphetamine or its metabolites) in a sample. This is a common method used in IVD tests.
- Sample Type: The test is performed on "urine," which is a biological specimen.
- Purpose: The purpose is to "screen urines for the presence of methamphetamine and its metabolites," which is a diagnostic activity.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Syntron's QuikStrip One Step Methamphetamine assay is a rapid, qualitative, competitive binding immunoassay for the determination of methamphetamine in urine. The test provides only preliminary data which should be confirmed by other methods such as gas chromatography-mass spectrophotometry (GCMS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. Syntron's Quikstrip One Step Methamphetamine Test is not intended to monitor drug levels, but only screen urines for the presence of methamphetamine and its metabolites.
Product codes (comma separated list FDA assigned to the subject device)
DKZ, LAF
Device Description
The trade name of the device is QuikStrip One Step Methamphetamine Test having a designated common name of Methamphetamine Test System and a classification as a class II device per 21 CFR 9 862.3610. This device is intended for the medical/forensic screening of urine.
Syntron's QuikStrip One Step Methamphetamine Test consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody:antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the detection level of 500 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
medical/forensic screening
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In-house testing of Syntron's QuikStrip One Step Methamphetamine Test yielded a relative sensitivity or agreement within positives and relative specificity or agreement within negatives of 1.00 and an accuracy of 100% when tested against Syva EMIT® II on samples documented to be positive by GC/MS. A clinical trial consisting of 305 samples was run and the combined data yielded a relative sensitivity or agreement within positives of 100%, a relative specificity or agreement within negatives of 97.7% with an accuracy of 98.68%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
In-house testing: relative sensitivity or agreement within positives of 1.00, relative specificity or agreement within negatives of 1.00, accuracy of 100%.
Clinical trial: relative sensitivity or agreement within positives of 100%, relative specificity or agreement within negatives of 97.7%, accuracy of 98.68%.
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.
Not Found
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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§ 862.3100 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
JUN 26 1997
510k Submission for
QuikStrip One Step Methamphetamine Test K970395
Syntron Bioresearch, Inc.
Page 24 of 57
Revision C 5/06/97 Printed on 5/15/97
8. Summary of Safety and Effectiveness
The sponsor, Syntron Bioresearch, Inc. (2774 Loker Ave. West, Carlsbad, California, 92008), has developed, manufactured and tested under GMP/GLP guidelines a device for the qualitative testing of urine for the presence of methamphetamine and its metabolites in a screening format.
The trade name of the device is QuikStrip One Step Methamphetamine Test having a designated common name of Methamphetamine Test System and a classification as a class II device per 21 CFR 9 862.3610. This device is intended for the medical/forensic screening of urine.
Syntron's QuikStrip One Step Methamphetamine Test consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody:antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the detection level of 500 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly.
In-house testing of Syntron's QuikStrip One Step Methamphetamine Test yielded a relative sensitivity or agreement within positives and relative specificity or agreement within negatives of 1.00 and an accuracy of 100% when tested against Syva EMIT® II on samples documented to be positive by GC/MS. A clinical trial consisting of 305 samples was run and the combined data yielded a relative sensitivity or agreement within positives of 100%, a relative specificity or agreement within negatives of 97.7% with an accuracy of 98.68%.
All positive samples by either screening method were confirmed by GC/MS. Four of the 6 samples were negative for methamphetamine, but positive for Amphetamine by GC/MS. The other two were negative for methamphetamine but positive for Pseudoephedrine and Phenyl Propanolamine (PPA) respectively.
Additional information on this submission may be obtained by contacting Dr. Cleve W. Laird, President, Drial Consultants, Inc. at 805-522-6223(Ca) or by fax at 805-522-1526.
Proprietary Information Confidential
Do Not Copy
Proprietary Information Confidential
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three stripes forming its wing and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
JUN 26 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. Cleve W. Laird President and CEO Drial Consultants, Inc. 1420 Los Angeles Avenue, Suite 201 Simi Valley, California 93065
Re : K970395 QuikStrip One Step Methamphetamine Test Requlatory Class: II Product Code: DKZ, LAF Dated: May 13, 1997 Received: May 16, 1997
Dear Dr. Laird:
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 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 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 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.
2
Paqe 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 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 qeneral 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
3
510(k) Number (if Known): Not yet Assigned
Device Name: QuikStrip One Step Methamphetamine Test Indications For Use:
INTENDED USE
Syntron's QuikStrip One Step Methamphetamine assay is a rapid, is a rapid, i quality attorn Quikstrip Une Step Methamphetamine assay is a rapid
qualitative, competitive binding immunoassay for the determination of methods, confective binding immunoassay for the determination of the drepla,
methamphetamine in urine. The test provides only preliminaty data which should be confirmed by other methods such as gas chromation of
should be confirmed by other methods such as gas chromaiographymass spection commined by other methods such as gas chromator and proved winten
spectophotometry (GCMS). Clinical considerations and provessional judgment should be applied to any drug of abuse test result, particularly and professional
professions of any drug of abuse test result, particularly when preliminary positive results are indicated. Syntron's Quilstrip When
Methamphetamine Test is not indicated. Syntron's Quilstrip One Step and and by pointe Test is are indicated. Syntron's Quiks in included to mon
screen urines for the presence of methambatemines artis see a spiroadinne Test is not intended to monitor drug levels, but only of the stude
screen urines for the presence of methamphetamine and its metabolites.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANDOTHER PAGE IF NEEDED!
Concurance of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off)
Division of Clinical Laboratory Devices
$10(k) Number. W970395
Perscription Use:
(Per 21 CFR 801.109
or
Over The Counter Use:
(Optional Format 1-2-96)