(65 days)
Not Found
No
The device description details a lateral flow immunoassay based on microparticle capture inhibition, which is a purely chemical and physical process. There is no mention of computational analysis, algorithms, or learning processes.
No
Explanation: This device is an in vitro diagnostic test for detecting morphine in urine, providing a preliminary analytical test result. It is not designed to treat, cure, or prevent any condition, which are characteristics of a therapeutic device.
Yes
The device is an "in vitro test intended for professional use in the qualitative detection of morphine in urine", which is a diagnostic purpose.
No
The device description clearly outlines a physical in vitro diagnostic test kit that uses chemical reactions and capillary action on a reagent strip to detect substances 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/Indications for Use: The document explicitly states "OnTrak TesTstik for Morphine 2000 (M2K) is an in vitro test intended for professional use in the qualitative detection of morphine in urine..." and "OnTrak TesTcup® M2K is an in vitro test intended for professional use for the qualitative detection of drug or drug metabolite in urine." The term "in vitro" directly indicates that the test is performed outside of the living body.
- Device Description: The description details a test that analyzes a biological sample (urine) using chemical reactions (microparticle capture inhibition) to detect the presence of a substance (morphine). This is characteristic of an in vitro diagnostic test.
- Performance Studies: The document describes studies evaluating the device's performance using urine samples, which is standard practice for validating IVDs.
Therefore, based on the provided information, the OnTrak TesTstik and TesTcup M2K devices are clearly intended and described as in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The OnTrak TesTstik Morphine 2000 assay contained in this submission is an in vitro test intended for professional use in the qualitative detection of morphine in urine at or above a cutoff concentration of 2000 ng/mL.
OnTrak TesTcup® M2K is an in vitro test intended for professional use for the qualitative detection of drug or drug metabolite in urine. OnTrak TesTcup M2K simultaneously tests for the presence of multiple drugs or drug metabolites. The OnTrak TesTcup M2K cutoff levels are based on the Federal Mandatory Guidelines. The OnTrak TesTcup M2K profile (cutoff) consists of d,l-amphetamines (1000 ng/mL), cocaine metabolite (300 ng/mL), THC (50 ng/mL) and morphine (2000 ng/mL). OnTrak TesTcup M2K provides only a preliminary analytical test result. A more specific. alternate chemical method must be used in order to obtain a configures and presult.
Product codes (comma separated list FDA assigned to the subject device)
DKZ, DIO, DJJ, LDJ
Device Description
The OnTrak TesTstik Morphine 2000 assay contained in this submission is an in vitro test intended for professional use in the qualitative detection of morphine in urine at or above a cutoff concentration of 2000 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 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance: Precision: >95% confidence at 150% cutoff When one hundred (100) replicates of urine standards containing different concentrations of drug were tested with OnTrak TesTstik, the following results were found: Standard (ng/mL) Morphine 2000 Assay: 0 (100+0), 500 (100+0), 1000 (76+24), 1500 (11+89), 2500 (0+100), 3000 (0+100).
Performance: Accuracy: OnTrak TesTstik for Morphine 2000 (M2K) was evaluated using specimens screened by an automated immunoassay and confirmed positive by GC/MS at the 2000 ng/mL cutoff. Fifty (50) samples positive for morphine were positive by OnTrak TesTstik 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 TesTstik M2K. One hundred (100) were negative for morphine by OnTrak TesTstik for Morphine 2000 (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 TesTstik M2K and Abuscreen OnLine II for Opiates 2000, demonstrated 100% agreement.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: 100% for 50 positive samples and 100% for 100 negative samples. 100% agreement between OnTrak TesTstik M2K and Abuscreen OnLine II for Opiates 2000 for 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
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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
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510(k) Summary
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.
- Submitter Roche Diagnostics Corporation name, address, 9115 Hague Rd. contact Indianapolis, IN 46250 (317) 845-2000
control control consideration in
Contact Person: Jennifer Tribbett
Date Prepared: March 22, 1999
-
- Device Name The device name, including both the trade/proprietary name and classification name is provided below.
| Product
Name | Classification
Name | Class | CFR
Classification
Name | Predicate
Device Name | Date
Predicate
Cleared | Predicate
510(k)
Number |
|--------------------------------------------------|-------------------------|-------|-------------------------------|---------------------------------------------------|------------------------------|-------------------------------|
| OnTrak
TesTstik for
Morphine
2000 (M2K) | Morphine
test system | II | 862.3640 | Abuscreen
Online II for
Opiates
300/2000 | 04/24/98 | K974840 |
and the same of the comments of the comments of the comments of
and the comments of the comments of the country of
i
- Predicate We claim substantial equivalence to the currently marketed Roche device Diagnostics Abuscreen OnLine II for Opiates 300/2000 (K974840).
. . . .
1
| 4) Device
Description | The OnTrak TesTstik Morphine 2000 assay contained in this submission is an
in vitro test intended for professional use in the qualitative detection of
morphine in urine at or above a cutoff concentration of 2000 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
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 pages outlines the technological characteristics
(methodologies) of the OnTrak TesTstik for Morphine 2000 (M2K) in
comparison to the Abuscreen OnLine II for Opiates 300/2000. |
| 6. Substantial
Equivalence | Table 1 provides the significant performance characteristics relied upon for a
determination of substantial equivalence. This information concludes that the
performance of the TesTstik Morphine 2000 device is substantially equivalent
to the currently marketed Abuscreen OnLine II for Opiates 300/2000
(K974840). |
| | |
a marka mana mana mana mana mana marka masa marka masa marka mara mara mara mara mara mara mara mara mara mara mara mara mara mara mara mara mara mara mara mara mara mara ma
4 0 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -
2
510K Summary -Continued-
| Item | OnTrak TesTstik for Morphine 2000 (M2K) | Abuscreen Online for Opiates 2000 |
|---|---|---|
| Methodology | Competitive microparticle capture inhibition | Kinetic interaction of microparticles |
| Measurement | Qualitative | Qualitative and Semi-Quantitative |
| Sample Type | Urine | Urine |
| Endpoint read | Color | Absorbance change |
| Cutoff | 2000 ng/mL | 2000 ng/mL |
| Reagent (active ingredients) | •Azo-blue dyed microparticles coated with mouse monoclonal anti-morphine antibody in a buffered solution with BSA and sodium azide. | |
| •Drug conjugates immobilized on a membrane | ||
| •Mouse monoclonal anti-BSA antibody immobilized on membrane | •Microparticles coated with mouse monoclonal morphine antibody . | |
| •Morphine conjugated derivative in a buffer with BSA and sodium azide. | ||
| Controls | OnTrak TesTcup Positive and Negative Controls | Abuscreen OnLine Positive and Negative Controls |
| Performance: Precision | >95% confidence at 150% cutoff | |
| When one hundred (100) replicates of urine standards containing different concentrations of drug were tested with OnTrak TesTstik, the following results were found: | >95% confidence at 1.2 x (2400ng/mL) cutoff | |
| Standard (ng/mL) $Morphine 2000 Assay$ | ||
| = + | ||
| 0 100 0 | ||
| 500 100 0 | ||
| 1000 76 24 | ||
| 1500 11 89 | ||
| 2500 0 100 | ||
| 3000 0 100 | ||
| Performance: | ||
| Accuracy | ||
| OnTrak TesTstik for Morphine 2000 | ||
| (M2K) was evaluated using | ||
| specimens screened by an automated | ||
| immunoassay and confirmed | ||
| positive by GC/MS at the 2000 | ||
| ng/mL cutoff. Fifty (50) samples | ||
| positive for morphine were positive | ||
| by OnTrak TesTstik 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
TesTstik M2K. One hundred (100)
were negative for morphine by
OnTrak TesTstik for Morphine 2000
(100%). | Forty-two (42) samples shown
to contain morphine and/or
codeine by GC/MS above 2000
ng/mL were also positive in the
Abuscreen OnLine II relative to
the 2000 ng/mL cutoff (100%
agreement)
One hundred (100) urine
samples, obtained from a
clinical laboratory where they
screened negative in a drug test
panel, were evaluated with the
Abuscreen OnLine II for
Opiates 300/2000. All 100
samples were negative at both
the 300 ng/mL and 2000 ng/mL
cutoffs (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
TesTstik M2K and Abuscreen
OnLine II for Opiates 2000,
demonstrated 100% agreement. | | |
TABLE 1
4 1
3
Table 1 -continued-
j
4
Image /page/4/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing right, arranged in a way that they resemble a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
APR 15 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Jennifer L. Tribbett Regulatory Affairs Specialist Roche Diagnostics Corporation 9115 Hague Road Indianapolis, IN 46250-0457
K990399 Re: Trade Name: OnTrak TesTcup M2K Regulatory Class: II Product Code: DKZ, DIO, DJJ, LDJ Dated: February 5, 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 (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
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
6
510(k) Number (if known): Device Name: Roche Diagnostics Corporation, OnTrak TesTcup® M2K for Morphine 2000
Indications for Use:
……
OnTrak TesTcup® M2K is an in vitro test intended for professional use for the qualitative detection of drug or drug metabolite in urine. OnTrak TesTcup M2K simultaneously tests for the presence of multiple drugs or drug metabolites. The OnTrak TesTcup M2K cutoff levels are based on the Federal Mandatory Guidelines.
The OnTrak TesTcup M2K profile (cutoff) consists of d,l-amphetamines (1000 ng/mL), cocaine metabolite (300 ng/mL), THC (50 ng/mL) and morphine (2000 ng/mL).
OnTrak TesTcup M2K provides only a preliminary analytical test result. A more specific. alternate chemical method must be used in order to obtain a configures and presult. Division of Clinical Laboratory Devices
510(k) Number_ x 990 399
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)