Who is the manufacturer of ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2?

Roche Diagnostics Corp. filed the 510(k) submission for ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2 (K994020).

What is the FDA product code for ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2?

LCM. as a Class U device in the TX panel.

What is the regulatory pathway for ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2

K994020 · Roche Diagnostics Corp. · LCM · Jan 27, 2000 · TX

Device Facts

Record ID	K994020
Device Name	ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2
Applicant	Roche Diagnostics Corp.
Product Code	LCM · TX
Decision Date	Jan 27, 2000
Decision	SESE
Submission Type	Traditional
Device Class	Class U

Intended Use

The Roche Diagnostics Corporation OnTrak TesTstik™ for PCP is an in vitro diagnostic test intended for professional use for the qualitative detection of PCP in urine at or above a cutoff concentration of 25 ng/mL. OnTrak TesTstik provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result.

Device Story

OnTrak TesTstik for PCP is a lateral flow, competitive microparticle capture inhibition immunoassay for qualitative detection of PCP in urine. Device consists of a reagent strip with antibody-coated blue microparticles and immobilized drug conjugate. Operation: device immersed in urine; sample migrates via capillary action; rehydrates microparticles. In absence of PCP, microparticles bind to immobilized drug conjugate, forming a blue band (negative result). In presence of PCP, drug binds microparticles, inhibiting conjugate binding, preventing blue band formation (positive result). Includes internal 'TEST VALID' control band. Used in clinical settings by professionals. Provides preliminary screening results; requires confirmatory testing (e.g., GC/MS) for clinical decision-making. Benefits include rapid, point-of-care preliminary assessment of drug presence.

Clinical Evidence

Bench testing only. Accuracy evaluated using 50 PCP-positive and 106 PCP-negative urine samples (confirmed by GC/MS). Results showed 100% agreement with GC/MS and 100% agreement with the predicate device (Abuscreen OnLine for PCP). Precision demonstrated >95% confidence at 150% of the cutoff concentration.

Technological Characteristics

Competitive microparticle capture inhibition immunoassay. Components: blue dyed microparticles coated with mouse monoclonal anti-phencyclidine, drug conjugates immobilized on a membrane, and mouse monoclonal anti-BSA antibody immobilized on a membrane. Form factor: reagent strip/test stick. Qualitative colorimetric endpoint. Standalone device; no energy source required.

Indications for Use

Indicated for professional use for the qualitative detection of phencyclidine (PCP) in human urine at or above a 25 ng/mL cutoff concentration. Provides preliminary analytical results; requires confirmation by alternate chemical methods.

Predicate Devices

OnTrak TesTstik for PCP (K973075)

Reference Devices

Abuscreen OnLine for PCP

Related Devices

K012107 — LIVESURE PHENECYCLINE (PCP) SCREEN TESTS · Pan Probe Biotech, Inc. · Jul 20, 2001
K973075 — ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK TESTSTIK FOR MORPHINE, ONTRAK TESTSTIK FOR PCP, ON · Roche Diagnostic Systems, Inc. · Oct 9, 1997
K981019 — QUIKSTRIP ONE STEP PHENCYCLIDINE (PCP) TEST · Syntron Bioresearch, Inc. · May 7, 1998
K981363 — ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST · Tcpi, Inc. · Dec 22, 1998

Submission Summary (Full Text)

{0}------------------------------------------------ **JAN 27 2000** K994020 、 ## 510(k) Summary According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence. | 1) Submitter name, address, contact | Roche Diagnostics Corporation | |-------------------------------------------|-------------------------------| | | 9115 Hague Rd. | | | Indianapolis, IN 46250 | Contact Person: Jennifer Tribbett Date Prepared: November 24, 1999 - 2) Device Name The device name, including both the trade/proprietary name and classification name is provided below. | Product Name | Classification Name | Product Code | CFR Classification Name | Predicate Device Name | Date Predicate Cleared | Predicate 510(k) Number | |-------------------------------|----------------------------------------|-----------------|-------------------------------|-------------------------------|------------------------------|-------------------------------| | OnTrak TesTstik for PCP | Enzyme Immunoassay Phencyclidine | 91LCM | Unassigned | OnTrak TesTstik for PCP | 10/9/97 | K973075 | 3) Predicate We claim substantial equivalence to the currently marketed Roche device Diagnostics OnTrak TesTstik for PCP (K973075). {1}------------------------------------------------ 4) Device The OnTrak TesTstik PCP assay contained in this submission is an in vitro Description diagnostic test intended for professional use in the qualitative detection of PCP in urine at or above a cutoff concentration of 25 ng/mL. > The TesTstik assays are based on the principle of microparticle capture inhibition. The test relies on the competition between drug, which may be present in the urine being tested, and drug conjugate immobilized on a membrane. > When the TesTstik is immersed in the urine sample, some of the sample is absorbed into the TesTstik sample pad. The absorbed sample travels through a reagent strip contained in the device by capillary action. In the reagent strip, the sample rehydrates and mobilizes antibody-coated blue The microparticle-urine suspension continues to migrate microparticles. through the reagent strip and comes in contact with the immobilized drug In the absence of drug in the urine, the antibody-coated coniugate. microparticles bind to the drug conjugate and a blue band is formed at the result window ("negative" sign). > When drug is present in the specimen, it binds to the antibody-coated microparticles. If sufficient drug is present, the micro-particles are inhibited from binding the drug conjugate and no blue band is formed at the result window. A positive sample caused the membrane to remain white ("positive" sign). > An additional antibody/antigen reaction occurs at the "TEST VALID" area. The "TEST VALID" blue band forms when antibodies, which are imbedded in the reagent membrane, bind to the antigen on the blue microparticles. The presence of the "TEST VALID" band indicates that the test has completed, the reagents are viable, and the results are ready to interpret. #### 5. Technology Characteristics Table 1 on the next page outlines the technological characteristics (methodologies) of the OnTrak TesTstik for PCP in comparison to the predicate device. {2}------------------------------------------------ ## 510K Summary -Continued- 6. Substantial Table 1 provides the significant performance characteristics relied upon for a Equivalence determination of substantial equivalence. This information concludes that the performance of the modified TesTstik PCP device is substantially equivalent to the currently marketed OnTrak TesTstik PCP (K973075). | Item | OnTrak TesTstik for PCP New PCP Monoclonal Antibody | OnTrak TesTstik for PCP Predicate | |------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Methodology | Competitive microparticle capture inhibition | Same | | Measurement | Qualitative | Same | | Sample Type | Urine | Same | | Endpoint read | Color | Same | | PCP Cutoff | 25 ng/mL | Same | | Reagent (active ingredients) | •Blue dyed microparticles coated with mouse monoclonal antiphencyclidine. •Drug conjugates immobilized on a membrane •Mouse monoclonal anti-BSA antibody immobilized on membrane | •Blue dyed microparticles coated with rabbit polyclonal antiphencyclidine. •Drug conjugates immobilized on a membrane •Mouse monoclonal anti-BSA antibody immobilized on a membrane | | Controls | OnTrak TesTcup Positive and Negative Controls | Same | | Performance: Precision | >95% confidence at 150% cutoff | Same | ### TABLE 1 {3}------------------------------------------------ # 510K Summary --Continued- | Item | OnTrak TesTstik for PCP New PCP Monoclonal Antibody | OnTrak TesTstik for PCP Predicate | |---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | PCP Performance: Accuracy | OnTrak TesTstik for PCP was evaluated using specimens screened by an automated immunoassay and confirmed positive by GC/MS at the 25 ng/mL cutoff. Fifty (50) samples positive for PCP were positive by OnTrak TesTstik (100%). One hundred six (106) urine samples, obtained from a clinical laboratory and screened negative by an automated immunoassay relative to a 25 ng/mL cutoff for PCP were evaluated and found negative using OnTrak TesTstik for PCP. | OnTrak TesTstik for PCP was evaluated using specimens screened by an automated immunoassay and confirmed positive by GC/MS at the 25 ng/mL cutoff. Fifty (50) samples positive for PCP were positive by OnTrak TesTstik (100%). One hundred six (106) urine samples, obtained from a clinical laboratory and screened negative by an automated immunoassay relative to a 25 ng/mL cutoff for PCP were evaluated and found negative using OnTrak TesTstik. | | | All positive and negative samples were also assayed by, and compared to, Abuscreen OnLine for PCP. All samples demonstrated 100% agreement between the two assays. | All positive and negative samples were also assayed by, and compared to, Abuscreen OnTrak for PCP. All samples demonstrated 100% agreement between the two assays. | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human services. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 ## Jan 2 7 2000 Ms. Jennifer L. Tribbett Regulatory Affairs Specialist Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457 Re: K994020 Trade Name: OnTrak TesTstik™ for PCP Regulatory Class: II Product Code: LCM Dated: November 24 1999 Received: November 26, 1999 Dear Ms. Tribbett: 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 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. {5}------------------------------------------------ Page 2 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" (21CFR 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/dsma/dsmamain.html". Sincerely yours, Steven Butman 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 {6}------------------------------------------------ 510(k) Number (if known): Device Name: Roche Diagnostics Corporation, OnTrak TesTstik™ for PCP Indications for Use: The Roche Diagnostics Corporation OnTrak TesTstik™ for PCP is an in vitro diagnostic test intended for professional use for the qualitative detection of PCP in urine at or above a cutoff concentration of 25 ng/mL OnTrak TesTstik provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Hun Cooper ivision Sign-Off) Division of Clinical Laboratory Devices K 994020 510(k) Number. Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96) CONFIDENTIAL