(50 days)
Syntron's QuikStrip One Step Phencyclidine (PCP) assay is a rapid, qualitative, competitive binding immunoassay for the determination of Phencyclidine (PCP) in urine at the cutoff level of 25 ng/ml. The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated6. Syntron's QuikStrip One Step Phencyclidine (PCP) Test is not intended to monitor drug levels, but only to screen urines for the presence of Phencyclidine (PCP) and its metabolites.
Syntron's QuikStrip One Step Phencyclidine (PCP) 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 25 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.
This question is about a medical device called the "QuikStrip One Step Phencyclidine (PCP) Test" and the study that demonstrates it meets its acceptance criteria.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Relative Sensitivity (Agreement within positive samples) | High (ideally 100%) | 100% (against Syva EMIT® II, confirmed by GC/MS) |
| Relative Specificity (Agreement within negative samples) | High (ideally 100%) | 100% (against Syva EMIT® II, confirmed by GC/MS) |
| Accuracy | High (ideally 100%) | 100% (against Syva EMIT® II, confirmed by GC/MS) |
| False Positives | Low (ideally 0) | 2 false positives (due to PCP levels between 20-25 ng/ml by GC/MS) |
| False Negatives | Low (ideally 0) | 0 false negatives |
Note on Acceptance Criteria: The document mentions "The combined data yielded a relative sensitivity of 100%, a relative specificity of 100% with an accuracy of 100% when compared to Emit II® run at 25 ng/ml." While explicit "acceptance criteria" are not listed in a separate section, these reported performance values (100% for sensitivity, specificity, and accuracy) strongly imply that these were indeed the target acceptance criteria. The discussion of false positives and negatives further supports these implied criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 286 samples (for the clinical trial).
- Data Provenance: Not explicitly stated regarding country of origin. The study is described as a "clinical trial" which typically implies prospective data collection, but it's not explicitly stated as prospective versus retrospective. It was conducted by a "Clinical Trial site."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The reference methods, Syva EMIT® II and GC/MS, are laboratory tests, implying trained personnel would have performed and interpreted them, but their specific expert qualifications are not detailed.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly described. The primary reference standard for confirmation was GC/MS (Gas Chromatography/Mass Spectrometry) at a 25 ng/ml cutoff. For the initial screening, the device was compared to Syva EMIT® II. Any positive samples by either screening method were confirmed by GC/MS. This suggests GC/MS served as the definitive "ground truth" and likely adjudicated discrepancies, but a formal adjudication process (e.g., 2+1) is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This device is a rapid, qualitative immunoassay for PCP. Its output is a presence/absence (positive/negative) result, not highly subjective imaging or diagnostic interpretation that would typically involve multiple human readers. The comparison was between the device's performance and a predicate device (EMIT II) and a confirmatory method (GC/MS).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, a standalone performance study was done. The described testing of "Syntron's QuikStrip One Step Phencyclidine (PCP) Test" involves the device itself generating a result (a magenta color band or absence thereof) which is then interpreted as positive or negative. The performance metrics (sensitivity, specificity, accuracy) are reported for the device's output compared to established reference methods, without explicitly mentioning a human reader's interpretation enhancing or altering the device's direct output. The device itself is designed to provide qualitative results.
7. The Type of Ground Truth Used
- Type of Ground Truth: The primary and definitive ground truth used for confirmation was GC/MS (Gas Chromatography/Mass Spectrometry), specifically at a cutoff of 25 ng/ml. This is an objective analytical chemistry method for identifying and quantifying substances. For initial comparison, Syva EMIT® II was also used as a reference.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not explicitly stated. The document describes "In-house testing" and "A clinical trial consisting of 286 samples." It's common for devices to undergo internal development and testing (which could constitute a training or development set), but the specific size and nature of such a set are not provided. The 286 samples are clearly described as part of the clinical trial for performance evaluation.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not explicitly stated. If there was a distinct training set, the document doesn't detail how its ground truth was established. However, given that GC/MS was used for the clinical trial and "in-house testing," it is highly probable that GC/MS would have been used to establish ground truth for any internal development or training samples as well.
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510k Submission for QuikStrip One Step Phencyclidine (PCP) Test
Syntron Bioresearch, Inc.
Revision A 2/24/98 Printed on 3/11/98
Page 83 of 83
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 Phencyclidine (PCP) and its metabolites in a screening format.
The trade name of the device is QuikStrip One Step Phencyclidine (PCP) Test having a designated common name of Phencyclidine (PCP) Test System and a classification as a Class II device per FDA. This device is intended for the medical/forensic screening of urine.
Syntron's QuikStrip One Step Phencyclidine (PCP) 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 25 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 Phencyclidine (PCP) Test vielded a relative sensitivity or agreement within positive samples of 1.000 and relative specificity or agreement within negative samples of 1.000 and an accuracy of 100% when tested against Syva EMIT® (25) II on samples documented to be positive by GC/MS. A clinical trial consisting of 286 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® run at 25 ng/ml. By non parametric testing the results are not significantly different from one another. Both Emit II and QuikStrip vielded 2 false positives due to the presence of Phencyclidine (PCP) at levels below 25 ng/ml, but above 20 ng/ml as determined by GC/MS.
All positive samples by either screening method were confirmed by GC/MS (25 ng/m) . The testing performed by the Clinical Trial site did find 2 false positives and no false negatives in the samples tested. The False Positives were due to the presence phencyclidine (PCP) between 20 and 25 ng/ml by GC/MS.
Additional information on this submission mav be obtained by contacting Dr. Cleve W. Laird. President, Drial Consultants, Inc. at 805-522-6223(Ca) or by fax at 805-522-1526.
MAY
7 1998
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
7 1998 MAY
Syntron Bioresearch, Inc. C/O Drial Consultants, Inc. Cleve W. Laird, Ph.D. 1420 Los Angeles Avenue, Suite 201 Simi Valley, California 93065
K981019 Re : QuickStrip One Step Phencyclidine (PCP) Test Regulatory Class: II Product Code: LCM, EIA Dated: March 17, 1998 March 18, 1998 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 vour 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. ਧੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (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 requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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 .
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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 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
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510(k) Number (if Known): To Be Assigned
Device Name: QuikStrip One Step Phencyclidine (PCP) Test
Indications For Use:
INTENDED USE
Syntron's QuikStrip One Step Phencyclidine (PCP) assay is a rapid, qualitative, competitive binding immunoassay for the determination of Phencyclidine (PCP) in urine at the cutoff level of 25 ng/ml. The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated6. Syntron's QuikStrip One Step Phencyclidine (PCP) Test is not intended to monitor drug levels, but only to screen urines for the presence of Phencyclidine (PCP) and its metabolites.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANDOTHER PAGE IF NEEDED)
Concurance of CDRH, Office of Device Evaluation (ODE)
Or
Caryl Benson Alfred Montgomery
(Division Sign-Off)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K981019
Perscription Use: /
(Per 21 CFR 801.109
Over The Counter Use: (Optional Format 1-2-96)
N/A