(65 days)
Not Found
No
The device description details a lateral flow immunoassay based on chemical reactions and visual interpretation of color bands, with no mention of computational analysis or algorithms.
No
This device is an in vitro diagnostic test used for the qualitative detection of morphine in urine. It provides preliminary analytical results, which is a diagnostic function, not a therapeutic one. It does not treat or prevent any disease or condition.
Yes
The device is described as an "in vitro test intended for professional use for the qualitative detection of morphine in urine," and its purpose is to provide a "preliminary analytical test result" for the presence of a substance. This indicates its use in identifying a condition or state (the presence of morphine), which aligns with the definition of a diagnostic device.
No
The device description clearly outlines a physical in vitro diagnostic test that uses chemical reactions and a membrane to detect substances in urine. It is not software-only.
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 test intended for professional use for the qualitative detection of morphine in urine". The term "in vitro" means "in glass" or "in the lab," referring to tests performed outside of a living organism.
- Device Description: The description details how the test works by analyzing a biological sample (urine) using chemical reactions on a membrane. This is characteristic of an in vitro diagnostic device.
- Performance Studies: The document describes performance studies conducted on urine samples to evaluate the device's accuracy and precision in detecting morphine. This is standard practice for validating IVD devices.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K962411) indicates that this device is being compared to a previously cleared medical device, which is a common process for IVD submissions to regulatory bodies like the FDA. The predicate device itself is also named "Roche Diagnostics OnTrak TesTcup," further confirming the nature of the device.
Therefore, based on the provided text, the OnTrak TesTstik™ for Morphine 2000 (M2K) is clearly an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Roche Diagnostics Corporation OnTrak TesTstik™ for Morphine 2000 (M2K) is an in vitro t st intended for professional use for the qualitative detection of morphine in urine at or above a cutoff concentration of 2000 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 (comma separated list FDA assigned to the subject device)
DJJ, DMY
Device Description
The OnTrak TesTcup M2K is an in vitro test intended for professional use in the qualitative detection of d,l-amphetamines (1000ng/mL), cocaine metabolite (300 ng/mL), THC (50 ng/mL) and morphine (2000 ng/mL). The TesTcup 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 in the test chamber. Urine is collected directly in the OnTrak TesTcup M2K. After closing the cap and moving it to the "TEST" position, the sample reservoir is filled by tilting the cup. Urine then flows through a membrane by capillary action and reacts with antibody-coated microparticles and drug conjugate present on the membrane. In the absence of drug, the antibody is free to interact with the drug conjugate, causing the formation of a blue band ("negative" sign). When drug is present in the specimen, it binds to the antibody-coated microparticles. If sufficient drug is present, the microparticles are inhibited from binding the drug conjugate, and no blue band is formed. A positive sample causes the membrane to remain white ("positive" sign). An additional antibody/antigen reaction occurs at the "TEST VALID" area for all assays. The "TEST VALID" blue band forms when antibodies, which are imbedded in the membrane, interact with, and bind to, the antigen on the blue-dyed microparticles.
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
Fifty (50) samples positive for morphine, confirmed by GC/MS at 2000 ng/mL cutoff, were evaluated using OnTrak TesTcup M2K. One hundred (100) urine samples, obtained from a clinical laboratory and screened negative by an automated immunoassay relative to a 2000 ng/mL cutoff for morphine, were evaluated using OnTrak TesTcup M2K. All positive and negative samples were also assayed by, and compared to, Abuscreen OnLine II for Opiates 2000.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance: Precision
95% confidence at 150% cutoff. One hundred (100) replicates of urine standards containing different concentrations of drug were tested with OnTrak TesTcup.
Results:
- 0 ng/mL: 100 negative, 0 positive
- 500 ng/mL: 100 negative, 0 positive
- 1000 ng/mL: 98 negative, 2 positive
- 1500 ng/mL: 60 negative, 40 positive
- 2500 ng/mL: 0 negative, 100 positive
- 3000 ng/mL: 0 negative, 100 positive
Morphine Performance: Accuracy
OnTrak TesTcup M2K was evaluated using specimens screened by an automated immunoassay and confirmed positive by GC/MS at 2000 ng/mL cutoff. All fifty (50) samples positive for morphine were positive by OnTrak TesTcup M2K (100%).
One hundred (100) urine samples, obtained from a clinical laboratory and screened negative by an automated immunoassay relative to a 2000 ng/mL cutoff for morphine were evaluated using OnTrak TesTcup M2K. All one hundred were negative for morphine by OnTrak TesTcup M2K (100%).
All positive and negative samples were also assayed by, and compared to, Abuscreen OnLine II for Opiates 2000. One hundred fifty (150) samples tested by both OnTrak TesTcup M2K and Abuscreen OnLine II for Opiates 2000 demonstrated 99.3% agreement.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision: >95% confidence at 150% cutoff.
Accuracy:
- 100% agreement for 50 positive morphine samples.
- 100% agreement for 100 negative morphine samples.
- 99.3% agreement with Abuscreen OnLine II for Opiates 2000 across 150 samples.
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.
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
§ 862.3640 Morphine test system.
(a)
Identification. A morphine test system is a device intended to measure morphine, an addictive narcotic pain-relieving drug, and its analogs in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of morphine use or overdose and in monitoring levels of morphine and its analogs to ensure appropriate therapy.(b)
Classification. Class II (special controls). A morphine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
0
510(k) Summary
100 - 100
| Introduction | According to the requirements of 21 CFR 807.92, the following information
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
(317) 845-2000 | | |
| | Contact Person: Jennifer Tribbett | | |
| | Date Prepared: March 22,1999 | | |
2) Device name
ー】
| Product Name | Classification Name | Class | CFR
Classification |
|------------------------|----------------------|-------|-----------------------|
| OnTrak TesTcup®
M2K | Morphine test system | II | 862.3640 |
! ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------
:
and the comments of the comments of
:
We claim substantial equivalence to the currently marketed Roche 3) Predicate device Diagnostics OnTrak TesTcup (K962411).
. . . . i
.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
510(k) Summary, Continued
| 4) Device
Description | The OnTrak TesTcup M2K is an in vitro test intended for professional use in
the qualitative detection of d,l-amphetamines (1000ng/mL), cocaine
metabolite (300 ng/mL), THC (50 ng/mL) and morphine (2000 ng/mL). |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The TesTcup 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 in the test chamber. |
| | Urine is collected directly in the OnTrak TesTcup M2K. After closing the
cap and moving it to the "TEST" position, the sample reservoir is filled by
tilting the cup. Urine then flows through a membrane by capillary action and
reacts with antibody-coated microparticles and drug conjugate present on the
membrane. In the absence of drug, the antibody is free to interact with the
drug conjugate, causing the formation of a blue band ("negative" sign). |
| | When drug is present in the specimen, it binds to the antibody-coated
microparticles. If sufficient drug is present, the microparticles are inhibited
from binding the drug conjugate, and no blue band is formed. A positive
sample causes the membrane to remain white ("positive" sign). |
| | An additional antibody/antigen reaction occurs at the "TEST VALID" area
for all assays. The "TEST VALID" blue band forms when antibodies, which
are imbedded in the membrane, interact with, and bind to, the antigen on the
blue-dyed microparticles. |
| 5. Technology
Characteristics | Table 1 shown on the next pages outlines the technological characteristics
(methodologies) of the OnTrak TesTcup M2K in comparison to the predicate
device, OnTrak TesTcup. |
| 6. Substantial
Equivalence | Table 1 also provides the results of clinical and non-clinical studies
performed using the OnTrak TesTcup M2K. The significant performance
characteristics relied upon for a determination of substantial equivalence is
summarized in this chart. This information concludes that the performance of
the OnTrak TesTcup M2K device is substantially equivalent to the predicate
device. |
.
2
510(k) Summary, Continued
Table 1
| Item | OnTrak TesTcup M2K for Morphine 2000 | OnTrak TesTcup |
|---|---|---|
| Methodology | Competitive microparticle capture inhibition | Same |
| Measurement | Qualitative | Same |
| Sample Type | Urine | Same |
| Endpoint read | Color | Same |
| Morphine Cutoff | 2000 ng/mL | 300 ng/mL |
| Reagent (active ingredients) | • Azo-blue dyed microparticles coated with mouse monoclonal anti-morphine antibody | |
| • Drug conjugates immobilized on a membrane | ||
| • Mouse monoclonal anti-BSA antibody immobilized on membrane | Same | |
| Controls | OnTrak TesTcup Positive and Negative Controls | Same |
| Performance: Precision | >95% confidence at 150% cutoff | |
| When one hundred (100) replicates of urine standards containing different concentrations of drug were tested with OnTrak TesTcup, the following results were found: | >95% confidence at 150% cutoff | |
| Standard (ng/mL) | Morphine 2000 Assay | |
| = + | ||
| 0 | 100 0 | |
| 500 | 100 0 | |
| 1000 | 98 2 | |
| 1500 | 60 40 | |
| 2500 | 0 100 | |
| 3000 | 0 100 | |
| Item | OnTrak TesTcup M2K for | |
| Morphine 2000 | OnTrak TesTcup | |
| Morphine | ||
| Performance: | ||
| Accuracy | OnTrak TesTcup M2K was | |
| evaluated using specimens screened | ||
| by an automated immunoassay and | ||
| confirmed positive by GC/MS at | ||
| 2000 ng/mL cutoff. All fifty (50) | ||
| samples positive for morphine were | ||
| positive by OnTrak TesTcup M2K | ||
| (100%). | OnTrak TesTcup was evaluated | |
| using specimens screened by | ||
| an automated immunoassay | ||
| and confirmed positive by | ||
| GC/MS at the 300 ng/mL | ||
| cutoff. All ninety (90) samples | ||
| positive for morphine were | ||
| positive by OnTrak TesTcup | ||
| (100%). | ||
| One hundred (100) urine samples, | ||
| obtained from a clinical laboratory | ||
| and screened negative by an | ||
| automated immunoassay relative to | ||
| a 2000 ng/mL cutoff for morphine | ||
| were evaluated using OnTrak | ||
| TesTcup M2K. All one hundred | ||
| were negative for morphine by | ||
| OnTrak TesTcup M2K (100%). | Three hundred seven (307) | |
| urine samples, obtained from a | ||
| clinical laboratory and screened | ||
| negative by an automated | ||
| immunoassay relative to a 300 | ||
| ng/mL cutoff for morphine | ||
| were evaluated using OnTrak | ||
| TesTcup. Three hundred five | ||
| were negative for morphine by | ||
| OnTrak TesTcup (>99%). | ||
| All positive and negative samples | ||
| were also assayed by, and compared | ||
| to, Abuscreen OnLine II for Opiates |
- One hundred fifty (150)
samples tested by both OnTrak
TesTcup M2K and Abuscreen
OnLine II for Opiates 2000
demonstrated 99.3% agreement. | All positive and negative
samples were also assayed by,
and compared to, Abuscreen
OnTrak for Morphine. Three
hundred ninety seven (397)
samples tested by both OnTrak
TesTcup and Abuscreen
OnTrak for Morphine
demonstrated 99.8%
agreement. |
: ・
. .
3
510(k) Summary, Continued
TABLE 1 -Continued-
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 5 1999
Jennifer L. Tribbett Regulatory Affairs Specialist Roche Diagnostics Corporation 9115 Hague Road Indianapolis, IN 46250-0457
K990409 Re: Trade Name: OnTrak TesTstik M2K Regulatory Class: II Product Code: DJJ, DMY Dated: January 25, 1999 Received: February 9, 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 (OS) 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
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 Autman
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 Morphine 2000 (M2K)
Indications for Use:
The Roche Diagnostics Corporation OnTrak TesTstik™ for Morphine 2000 (M2K) is an in vitro t st intended for professional use for the qualitative detection of morphine in urine at or above a cutoff concentration of 2000 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.
Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K990469
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)