(251 days)
TCPI's One Step™ Urine Drug of Abuse: Phencyclidine (PCP) Test 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. TCPI's One Step™ Urine Drug of Abuse: Phencyclidine (PCP) Test is not intended to monitor drug levels, but only to screen urines for the presence of Phencyclidine (PCP) and its metabolites.
TCPI's One Step Urine Drug of Abuse Phencyclidine™ (PCP) Test Strip is a rapid, qualitative, competitive binding immunoassay for the determination of Phencyclidine (PCP) in urine. The One Step Urine Drug of Abuse Phencyclidine™ (PCP) Test Strip is 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 a limited number of antibody binding sites. As a test sample flows up through the absorbent device, labeled antibody-dye conjugate binds to free drug in the specimen, forming an antibody-antigen complex. This complex with immobilized antigen conjugate in the Test Zone of the strip, and will not produce a magenta color band when the drug concentration in the specimen is above the detection level of 25 ng/ml. Unbound dye conjugate birds to the reagent in the Control Zone of the strip, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A negative specimen produces two distinct color bands, one in the Test Zone and one in the Control Zone A positive specimen produces only one color band in the Control Zone.
This submission describes the "One Step Urine Drug of Abuse: Phencyclidine™ (PCP) Test" by Technical Chemicals and Products, Inc. (TCPI).
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the comparison to the Emit® II assay, which is a legally marketed predicate device, and the subsequent confirmation by GC/MS. The goal is 100% agreement with Emit® II.
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Overall Accuracy (vs. Emit® II) | 100% | 513/513 (100%) |
| Sensitivity (Agreement with positive Emit® II) | 100% | 223/223 (100%) |
| Specificity (Agreement with negative Emit® II) | 100% | 290/290 (100%) |
| False Positives (vs. GC/MS) | As low as reasonably achievable, comparable to predicate | 2 (out of 513 total samples) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 286 individual urine samples for the clinical trial, in addition to 227 in-house tested samples, for a total of 513 samples.
- Data Provenance: The 286 clinical trial samples were submitted to a "NDA certified laboratory," implying external, potentially real-world, clinical samples. The country of origin is not explicitly stated but can be inferred as the US based on the FDA submission. The study is retrospective in the sense that the samples were already collected and tested by the NDA certified laboratory using Emit® II before being re-tested with the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Experts: Not explicitly stated as "experts" in the traditional sense of clinicians establishing a diagnosis. The ground truth for the preliminary comparison was the Emit® II Phencyclidine (PCP) assay.
- Qualifications: The Emit® II assay was performed by an "NDA certified laboratory." The personnel performing these tests would be qualified laboratory technicians or clinical scientists.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable in the traditional sense for diagnostic test evaluation against a gold standard or predicate.
- The initial comparison was directly against the Emit® II assay as the predicate.
- For samples that tested positive by either the Emit® II or the new device (223 samples), all were confirmed by GC/MS. This acts as a confirmatory "adjudication" against the true (analytical) ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This is an in vitro diagnostic device, not an imaging or interpretation device that would typically involve multiple human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
- Yes, this study represents a standalone performance evaluation of the immunoassay device itself. The interpretation of the color bands (positive/negative) is inherent to the device's design, and while a human observes the result, the "performance" is based on the chemical reaction within the device.
7. The Type of Ground Truth Used
- Primary Ground Truth for Comparison: Emit® II Phencyclidine (PCP) assay results (predicate device).
- Confirmatory Ground Truth: Gas Chromatography/Mass Spectrometry (GC/MS). This is considered the analytical gold standard for confirming drug presence and concentration.
8. The Sample Size for the Training Set
- The document does not explicitly mention a separate "training set" in the context of machine learning or AI. This is an immunoassay device, which typically does not involve a training phase in the same way an AI algorithm would. The 227 "in-house" tested samples could be considered an internal validation/development set, but not a training set for an algorithm.
9. How the Ground Truth for the Training Set was Established
- As there is no explicit "training set" for an AI algorithm mentioned, this question is not directly applicable. For the in-house testing, the ground truth would have been established through controlled spiking of samples or comparison to established methods like Emit® II or GC/MS, similar to the test set. The document states "In both studies, the laboratories used Emit® II Phencyclidine (PCP) as their screening procedure, with a cutoff of 25 ng/ml."
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K981363: One Step Urine Drug of Abuse: Phencyclidine™ (PCP) Test
Technical Chemicals and Products, Inc. (TCPD)
Page 82 of 82
Revision B - 12/14/98
Summary of Safety and Effectiveness
The Sponsor, TCPI, Inc. (3341 S.W. 15th Street, Pompano Beach, FL 33069), 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 One Step Urine Drug of Abuse Phencyclidine™ (PCP) Test, having a designated common name of Phencyclidine (PCP) Test System and a classification as a Class II device per FDA ..
TCPI's One Step Urine Drug of Abuse Phencyclidine™ (PCP) Test Strip is a rapid, qualitative, competitive binding immunoassay for the determination of Phencyclidine (PCP) in urine. The One Step Urine Drug of Abuse Phencyclidine™ (PCP) Test Strip is intended to be used in professional laboratories (medical & forensic) where preliminary screening is essential. The test provides only preliminary data which should be confirmed by other methods in particular, preliminary positive results must be substantiated with an approved confirmatory method, such as gas chromatography/mass spectrometry (GC/MS) Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are positive. This test is not intended to be used for monitoring drug levels, but only to screen urines for the presence of Phencyclidine (PCP)
TCPI's One Step Urine Drug of Abuse Phencyclidine™ (PCP) Test Strip is 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 a limited number of antibody binding sites. As a test sample flows up through the absorbent device, labeled antibody-dye conjugate binds to free drug in the specimen, forming an antibody-antigen complex. This complex with immobilized antigen conjugate in the Test Zone of the strip, and will not produce a magenta color band when the drug concentration in the specimen is above the detection level of 25 ng/ml. Unbound dye conjugate birds to the reagent in the Control Zone of the strip, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A negative specimen produces two distinct color bands, one in the Test Zone and one in the Control Zone A positive specimen produces only one color band in the Control Zone.
TCPI's One Step Urine Drug of Abuse Phencyclidine™ (PCP) Test Strip was tested in-house on 227 individual urine samples, and was subsequently tested in a clinical trial on 286 individual urine samples which were submitted to a NDA certified laboratory. In both studies, the laboratories used Emit® II Phencyclidine (PCP) as their screening procedure, with a cutoff of 25 ng/ml. The accuracy of the One Step Urine Drug of Abuse Phencyclidine™ (PCP) Test Strip was 513/513 or 100%, when compared to Emit® II. Compared to Emit® II, the relative sensitivity or agreement between positive samples was 223/223 or 100%, and the relative specificity or agreement between negative samples was 290/290 or 100%. All 223 samples which tested positive by either screening method (Emit® II or One Step Urine Drug of Abuse Phencyclidine™ (PCP) Test Strip) were confirmed by GC/MS. When compared to GC/MS, the Emit® II screening method reported two (2) false positives and the One Step strip reported two (2) false positives GC/MS results for these samples indicated that they contained phencyclidine levels of 21 and 23 ng/ml.
Additional information on this submission may be obtained by contacting Dr. Jeffrey Bolts, Technical Chemicals and Products, Inc., at 954-979-0400 (FL) or by fax at 954-979-0009.
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Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the logo.
DEC 22 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. Jeffrey Bolts Director of Quality Assurance Technical Chemicals & Products, Inc. P.O. Box 8726 Ft. Lauderdale, FL 33310
Re: K981363 Trade Name: One Step Urine Drug of Abuse: Phencyclidine (PCP) Test Regulatory Class: II Product Code: LCM Dated: November 20, 1998 Received: November 27, 1998
Dear Dr. Bolts:
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 legally marketed predicate 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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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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 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
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510(k) Number (if Known): Not Yet Issued
Device Name: One Step™ Urine Drug of Abuse: Phencyclidine (PCP) Test
Indications For Use:
INTENDED USE
TCPI's One Step™ Urine Drug of Abuse: Phencyclidine (PCP) Test 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. TCPI's One Step™ Urine Drug of Abuse: 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
or
Ston L. Leach
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K981363
Prescription Use:
(Per 21 CFR 801.109
Over The Counter Use: (Optional Format 1-2-96)
N/A