(62 days)
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.
The OnTrak TesTstik PCP assay contained in this submission is an in vitro 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.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Item (Implicit) | Reported Device Performance |
|---|---|
| PCP Cutoff Concentration (for detection) | 25 ng/mL (same as predicate) |
| Precision (at 150% cutoff) | >95% confidence |
| Accuracy (Positive Samples) | 100% positive for PCP (50 samples tested) |
| Accuracy (Negative Samples) | 100% negative for PCP (106 samples tested) |
| Agreement with Comparative Assay (Abuscreen) | 100% agreement between the two assays (OnTrak TesTstik and Abuscreen OnLine for PCP) |
2. Sample Size Used for the Test Set and Data Provenance
- Positive Test Set: 50 samples
- Negative Test Set: 106 samples
- Data Provenance: The text states, "One hundred six (106) urine samples, obtained from a clinical laboratory". This indicates the data is retrospective clinical samples. The country of origin is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The study does not use human experts to establish ground truth in the traditional sense of medical image interpretation or clinical diagnosis. Instead, the ground truth for the test set was established by analytical methods:
- Experts: Not applicable in the context of interpretation.
- Ground Truth Establishment: Samples were "screened by an automated immunoassay and confirmed positive by GC/MS at the 25 ng/mL cutoff." For negative samples, they were "screened negative by an automated immunoassay relative to a 25 ng/mL cutoff for PCP." This indicates a laboratory-based, objective method for establishing ground truth, not reliant on human expert interpretation of the test device itself.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by laboratory instrumentation (GC/MS and automated immunoassay), not by human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is an in vitro diagnostic device for analyte detection. MRMC studies are typically performed for devices that involve human interpretation of medical images or diagnostic outputs, assessing the impact of AI on reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this study is a standalone performance assessment. The OnTrak TesTstik for PCP is a qualitative diagnostic test that provides a result (positive/negative) based on a chemical reaction. Its performance is evaluated intrinsically against confirmed samples, not as part of a human-in-the-loop system. The text specifies "professional use," implying a human will perform the test and interpret the visual result, but the "performance" described is the device's ability to accurately detect PCP in the samples.
7. The Type of Ground Truth Used
The ground truth used was analytical confirmation by Gas Chromatography/Mass Spectrometry (GC/MS) for positive samples, and automated immunoassay for negative samples, both relative to a 25 ng/mL cutoff. This is a highly objective and quantitative method for determining the presence or absence of a substance.
8. The Sample Size for the Training Set
The provided text does not mention a training set or any machine learning/AI component. This device is a chemical immunoassay, not an AI-powered diagnostic. Therefore, the concept of a "training set" as it relates to AI models is not applicable here. The device's design and manufacturing likely involved internal development and validation, but not in the context of training a predictive algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of immunoassay device.
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JAN 27 2000
、
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) Submittername, address,contact | Roche Diagnostics Corporation |
|---|---|
| 9115 Hague Rd. | |
| Indianapolis, IN 46250 |
Contact Person: Jennifer Tribbett
Date Prepared: November 24, 1999
-
- Device Name The device name, including both the trade/proprietary name and classification name is provided below.
| ProductName | ClassificationName | ProductCode | CFRClassificationName | PredicateDeviceName | DatePredicateCleared | Predicate510(k)Number |
|---|---|---|---|---|---|---|
| OnTrakTesTstikfor PCP | EnzymeImmunoassayPhencyclidine | 91LCM | Unassigned | OnTrakTesTstik forPCP | 10/9/97 | K973075 |
- Predicate We claim substantial equivalence to the currently marketed Roche device Diagnostics OnTrak TesTstik for PCP (K973075).
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- 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.
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510K Summary -Continued-
- 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 PCPNew PCP Monoclonal Antibody | OnTrak TesTstik for PCPPredicate |
|---|---|---|
| Methodology | Competitive microparticle captureinhibition | Same |
| Measurement | Qualitative | Same |
| Sample Type | Urine | Same |
| Endpoint read | Color | Same |
| PCP Cutoff | 25 ng/mL | Same |
| Reagent(activeingredients) | •Blue dyed microparticles coatedwith mouse monoclonalantiphencyclidine.•Drug conjugates immobilized on amembrane•Mouse monoclonal anti-BSAantibody immobilized on membrane | •Blue dyed microparticlescoated with rabbit polyclonalantiphencyclidine.•Drug conjugates immobilizedon a membrane•Mouse monoclonal anti-BSAantibody immobilized on amembrane |
| Controls | OnTrak TesTcup Positive andNegative Controls | Same |
| Performance:Precision | >95% confidence at 150% cutoff | Same |
TABLE 1
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510K Summary --Continued-
| Item | OnTrak TesTstik for PCPNew PCP MonoclonalAntibody | OnTrak TesTstik for PCPPredicate |
|---|---|---|
| PCPPerformance:Accuracy | OnTrak TesTstik for PCP wasevaluated using specimensscreened by an automatedimmunoassay and confirmedpositive by GC/MS at the 25ng/mL cutoff. Fifty (50) samplespositive for PCP were positive byOnTrak TesTstik (100%).One hundred six (106) urinesamples, obtained from a clinicallaboratory and screened negativeby an automated immunoassayrelative to a 25 ng/mL cutoff forPCP were evaluated and foundnegative using OnTrak TesTstikfor PCP. | OnTrak TesTstik for PCP wasevaluated using specimensscreened by an automatedimmunoassay and confirmedpositive by GC/MS at the 25ng/mL cutoff. Fifty (50) samplespositive for PCP were positive byOnTrak TesTstik (100%).One hundred six (106) urinesamples, obtained from a clinicallaboratory and screened negativeby an automated immunoassayrelative to a 25 ng/mL cutoff forPCP were evaluated and foundnegative using OnTrak TesTstik. |
| All positive and negative sampleswere also assayed by, andcompared to, Abuscreen OnLinefor PCP. All samplesdemonstrated 100% agreementbetween the two assays. | All positive and negative sampleswere also assayed by, andcompared to, Abuscreen OnTrakfor PCP. All samplesdemonstrated 100% agreementbetween the two assays. |
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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.
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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
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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
N/A