(62 days)
Not Found
No
The device description details a chemical immunoassay based on microparticle capture inhibition, which is a traditional diagnostic technology and does not involve AI or ML. The performance studies describe standard analytical and clinical evaluations of this type of assay. There is no mention of AI, ML, or related concepts in the document.
No.
This device is an in vitro diagnostic test for the qualitative detection of PCP in urine. It provides analytical test results, not therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states "The Roche Diagnostics Corporation OnTrak TesTstik™ for PCP is an in vitro diagnostic test".
No
The device description clearly outlines a physical in vitro diagnostic test kit that utilizes chemical reactions and capillary action on a reagent strip to detect PCP in urine. This involves hardware components (the TesTstik itself) and is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is an "in vitro diagnostic test."
- Device Description: The "Device Description" section also reiterates that it is an "in vitro diagnostic test."
- Mechanism: The description of how the test works involves analyzing a biological sample (urine) outside of the body to detect a substance (PCP). This is the core function of an in vitro diagnostic device.
- Professional Use: While it's for professional use, this doesn't preclude it from being an IVD. Many IVDs are intended for use by trained healthcare professionals.
N/A
Intended Use / 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.
Product codes
91LCM
Device Description
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 microparticles. The microparticle-urine suspension continues to migrate through the reagent strip and comes in contact with the immobilized drug conjugate. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
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.
Key Metrics
Accuracy: OnTrak TesTstik for PCP detected 50 out of 50 (100%) positive samples and 106 out of 106 negative samples.
Precision: >95% confidence at 150% cutoff.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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) Submitter
name, 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.
| 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 |
- Predicate We claim substantial equivalence to the currently marketed Roche device Diagnostics OnTrak TesTstik for PCP (K973075).
1
- 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-
- 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