(143 days)
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.
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.
Acceptance Criteria and Study Details for QuikStrip One Step Methamphetamine Test
The QuikStrip One Step Methamphetamine Test is a qualitative, competitive binding immunoassay for the determination of methamphetamine in urine. Its intended use is for medical/forensic screening.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device appear to be implicitly set by the performance observed in the in-house testing and clinical trial, demonstrating high agreement with a reference method (Syva EMIT® II and GC/MS confirmation).
| Metric | Acceptance Criteria (Implied) | Reported Device Performance (In-house) | Reported Device Performance (Clinical Trial) |
|---|---|---|---|
| Relative Sensitivity (Agreement within positives) | High (e.g., ≥95%) | 1.00 (100%) | 100% |
| Relative Specificity (Agreement within negatives) | High (e.g., ≥95%) | 1.00 (100%) | 97.7% |
| Accuracy | High (e.g., ≥95%) | 100% | 98.68% |
Note: The document does not explicitly state numerical acceptance criteria prior to presenting the results. The 100% and near 100% performance suggests that these high levels of agreement were deemed acceptable for the device's intended use as a screening tool.
2. Sample Size and Data Provenance
- Test Set (Clinical Trial): 305 samples.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, the description of "clinical trial" suggests prospective data collection in a clinical setting. The reference to "in-house testing" implies internal data for initial validation.
3. Number, Qualifications, and Adjudication Method of Experts for Ground Truth
The ground truth was established by comparison to reference methods, not directly by human expert interpretation of the device's results.
- Number of Experts: Not applicable in the context of human interpretation of the device.
- Qualifications of Experts: Not applicable.
- Adjudication Method: Not applicable.
4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. This device is an in-vitro diagnostic (IVD) test where the result is determined by the test strip itself (presence or absence of a color band), not by human interpretation or reading that would vary between individuals needing such a study.
- Effect size of AI vs. without AI assistance: Not applicable. The device is a standalone chemical/immunological test, not an AI-assisted diagnostic tool.
5. Standalone Performance Study
- Was a standalone study done? Yes. Both the "in-house testing" and the "clinical trial" represent standalone performance evaluations of the QuikStrip One Step Methamphetamine Test. The results presented in the table above reflect this standalone performance against reference methods.
6. Type of Ground Truth Used
- Type of Ground Truth:
- Syva EMIT® II: This is a widely accepted immunoassay for drug screening, serving as an initial comparative method.
- GC/MS (Gas Chromatography/Mass Spectrophotometry): This is the gold standard for confirmatory drug testing, offering highly accurate and specific identification and quantification of substances. All positive samples by either screening method (QuikStrip or EMIT) were confirmed by GC/MS. This indicates GC/MS was the ultimate ground truth for positive samples.
7. Sample Size for the Training Set
- The document does not explicitly mention a separate "training set" in the context of an algorithm or machine learning device. For an immunoassay, the "training" usually refers to the development and optimization of the reagents and assay parameters through iterative laboratory testing. The sample sizes mentioned (in-house and clinical trial) are for validation and performance assessment.
8. How the Ground Truth for the Training Set Was Established
- As above, the concept of a "training set" ground truth for an immunoassay is not directly applicable in the same way as for an AI/ML algorithm. The assay's performance characteristics (e.g., cutoff concentration, cross-reactivity) are established during development and verified against known samples (either spiked samples or characterized clinical specimens) using reference methods like GC/MS.
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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
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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.
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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
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510(k) Number (if Known): Not yet Assigned
Device Name: QuikStrip One Step Methamphetamine Test Indications For Use:
INTENDED USE
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spectophotometry (GCMS). Clinical considerations and provessional judgment should be applied to any drug of abuse test result, particularly and professional
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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)
§ 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).