(58 days)
Syntron's QuikStrip One Step Amphetamine assay is a rapid, gualitative, competitive binding immunoassay for the determination of qualitative, components ble test provides only preliminary data which Amplietamine firmed by other methods such as gas should be commy/mass spectrophotometry (GC/MS). Clinical chroilatograppyrinass opesional judgment should be applied to any considerations and professarioularly when preliminary positive drug of abuse teated. Syntron's QuikStrip One Step Amphetamine Test is not intended to monitor drug levels, but only to screen urines for the presence of amphetamine and its metabolites.
Syntron's QuikStrip One Step Amphetamine 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.
Here's a breakdown of the acceptance criteria and study details for the QuikStrip One Step Amphetamine Test, based on the provided 510(k) submission:
Acceptance Criteria and Device Performance
| Metric | Acceptance Criteria | Reported Device Performance (Clinical Trial) |
|---|---|---|
| Relative Sensitivity (Agreement within positive samples) | Not explicitly stated as a numerical AC, but implied to be high for a screening device. | 100% |
| Relative Specificity (Agreement within negative samples) | Not explicitly stated as a numerical AC, but implied to be high for a screening device. | 100% |
| Accuracy | Not explicitly stated as a numerical AC, but implied to be high for a screening device. | 100% |
Note: The document phrasing "yielded a relative sensitivity or agreement within positive samples and relative specificity or agreement within negative samples of 1.00 and an accuracy of 100%" for in-house testing, and "a relative sensitivity of 100%, a relative specificity of 100% with an accuracy of 100%" for the clinical trial, strongly suggests these high percentages were the de facto acceptance criteria.
Study Details
2. Sample Size and Data Provenance
- Test Set Sample Size:
- In-house testing: Not explicitly stated, but performed against samples "documented to be positive by GC/MS."
- Clinical Trial: 308 samples.
- Data Provenance: Not explicitly stated (e.g., country of origin). The submission is from Syntron Bioresearch, Inc. in Carlsbad, California, implying the study was likely conducted in the USA.
- Retrospective or Prospective: Not explicitly stated. Given the context of a 510(k) submission for an existing product type and comparison to a predicate device, it's possible it was retrospective, using archived samples or newly collected samples for the purpose of the submission.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Number of Experts: Not applicable/not specified. The ground truth was established by laboratory methods (GC/MS and EMIT II®), not by human experts interpreting results.
- Qualifications of Experts: N/A.
4. Adjudication Method (Test Set)
- Adjudication Method: Not applicable. Results were compared against a reference method (EMIT II®) and a confirmatory method (GC/MS). Discrepancies were resolved by GC/MS.
5. 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 read directly from the test strip (presence/absence of a color band). Human reader variability is not a primary concern for its performance evaluation in this context. The study focuses on comparing the device's output to other analytical methods.
6. Standalone Performance Study
- Was a standalone study done? Yes. The entire study describes the standalone performance of the QuikStrip One Step Amphetamine Test by comparing its results directly to established reference methods (EMIT II® and GC/MS) without human readers interpreting its output in combination with other information.
7. Type of Ground Truth Used
- Type of Ground Truth:
- Primary Comparison: Syva EMIT® II (Enzyme Multiplied Immunoassay Technique), which is itself a screening assay.
- Confirmatory Ground Truth: Gas Chromatography/Mass Spectrometry (GC/MS). All positive samples by either screening method (QuikStrip or EMIT II®) that were used to determine the true positive/negative status were confirmed by GC/MS. This is considered a gold standard for drug detection.
8. Sample Size for the Training Set
- Training Set Sample Size: Not specified. As a lateral flow immunoassay, the device itself is not a machine learning algorithm that requires a "training set" in the computational sense. The "training" of the device is inherent in its chemical and biological formulation and manufacturing process, which would have been refined during development. The provided document only details the validation (test set) performance.
9. How Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there isn't a "training set" in the context of a machine learning algorithm. For traditional IVDs, the "ground truth" during development involves iterative testing and refinement against known positive and negative samples, often using methods like GC/MS to characterize those samples. However, the specific details for the "training set" are not provided in this 510(k) summary.
{0}------------------------------------------------
510k Submission for MAY 30 1997
QuikStrip One Step Amphetamine Test K971218
Syntron Bioresearch, Inc.
Page 58 of 56
Revision B 4/21/97 Printed on 5/8/97
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 Amphetamine and its metabolites in a screening format.
The trade name of the device is QuikStrip One Step Amphetamine Test having a designated common name of Amphetamine Test System and a classification as a class II device per 21 CFR ¶ 862.3610. This device is intended for the medical/forensic screening of urine.
Syntron's QuikStrip One Step Amphetamine 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 Amphetamine Test vielded a relative sensitivity or agreement within positive samples and relative specificity or agreement within negative samples 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 308 samples was run and the combined data yielded a relative sensitivity of 100%, a relative specificity of 100% with an accuracy of 100% when compared to Emit II®.
All positive samples by either screening method were confirmed by GC/MS. The results on the 13 discrepant samples clearly demonstrated the same errors by both methods. Thirteen Samples were positive by both Emit II® and QuikStrip, but negative for amphetamine by GC/MS. Of these thirteen (13) samples, twelve (12) were positive for ephedrine by GC/MS. The other one (1) was negative for Amphetamine but positive for Phenvl Propanolamine (PPA).
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.
{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 caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular pattern around the left side of the logo.
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
MAY 30 1097
Re : K971218 QuikStrip One Step Amphetamine Test Requlatory Class: II Product Code: DKZ March 24, 1997 Dated: April 2, 1997 Received:
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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 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}------------------------------------------------
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 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
{3}------------------------------------------------
510(k) Number (if Known): K971218
Device Name: QuikStrip One Step Amphetamine Test
Indications For Use: .
Syntron's QuikStrip One Step Amphetamine assay is a rapid, gualitative, competitive binding immunoassay for the determination of qualitative, components ble test provides only preliminary data which Amplietamine firmed by other methods such as gas should be commy/mass spectrophotometry (GC/MS). Clinical chroilatograppyrinass opesional judgment should be applied to any considerations and professarioularly when preliminary positive drug of abuse teated. Syntron's QuikStrip One Step Amphetamine Test is not intended to monitor drug levels, but only to screen urines for the presence of amphetamine and its metabolites.
Concurance of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number: | |
|---|---|
| -- | ------------------------------------------------------------------------------------------------------------- |
| Perscription Use: (Per 21 CFR 801.109 | |
|---|---|
| --------------------------------------- | -- |
or
| Over The Counter Use: (Optional Format 1-2-96) | |
|---|---|
| -- | ------------------------------------------------ |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANDOTHER PAGE IF NEEDED)
§ 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).