(251 days)
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Not Found
No
The device description clearly outlines a competitive binding immunoassay, which is a chemical reaction-based test, not an AI/ML technology. There is no mention of AI, ML, or any computational analysis of data.
No.
The device is a diagnostic test used to screen for the presence of Phencyclidine (PCP) in urine, not to treat or prevent a disease or condition.
Yes
The device is intended for "determination of Phencyclidine (PCP) in urine," providing "preliminary data" and screening for the "presence of Phencyclidine (PCP) and its metabolites." These functions fall under the definition of diagnosing or detecting a condition.
No
The device description clearly describes a physical test strip that utilizes a chromatographic absorbent device and chemical reactions to detect the presence of PCP in urine. This is a hardware-based diagnostic device, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "determination of Phencyclidine (PCP) in urine." Urine is a biological specimen, and the test is performed in vitro (outside the body).
- Device Description: The description details a "chromatographic absorbent device" that analyzes a "test sample" (urine) to detect the presence of a substance (PCP). This is a typical description of an IVD test.
- Performance Studies: The document describes performance studies conducted on urine samples, comparing the device's results to other screening methods and GC/MS, which are standard practices for evaluating IVD performance.
- Key Metrics: The document provides key metrics like accuracy, sensitivity, and specificity, which are standard performance indicators for IVD devices.
- Intended User/Care Setting: The intended users are "professional laboratories (medical & forensic)," which are common settings for performing IVD tests.
The entire description aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
LCM
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
accuracy: 100%
relative sensitivity: 100%
relative specificity: 100%
false positives (compared to GC/MS): 2 (for both Emit® II and One Step strip)
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).
Not Found
N/A
0
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.
1
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
3
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)