(65 days)
OnTrak TesTstik for Morphine 2000 (M2K) 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.
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.
Here's a breakdown of the acceptance criteria and study information for the OnTrak TesTstik for Morphine 2000 (M2K), based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance (OnTrak TesTstik M2K) |
|---|---|
| Precision | >95% confidence at 150% cutoff, as detailed below: |
| - 500 ng/mL: 100% Negative (0% Positive) | |
| - 1000 ng/mL: 76% Negative (24% Positive) | |
| - 1500 ng/mL: 11% Negative (89% Positive) | |
| - 2500 ng/mL: 0% Negative (100% Positive) | |
| - 3000 ng/mL: 0% Negative (100% Positive) | |
| Accuracy | - Positive Samples: 100% positive (50/50) |
| - Negative Samples: 100% negative (100/100) | |
| - Overall Agreement with Predicate Device: 100% agreement (150/150) with Abuscreen OnLine II for Opiates 2000 |
Study Details
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Sample size used for the test set and the data provenance:
- Precision: 100 replicates of urine standards for each concentration (0, 500, 1000, 1500, 2500, 3000 ng/mL). The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin specified.
- Accuracy:
- 50 samples confirmed positive for morphine by GC/MS.
- 100 urine samples, screened negative by an automated immunoassay, obtained from a clinical laboratory.
- An additional 150 samples were tested for comparison between the OnTrak TesTstik M2K and the predicate device.
- The data provenance for accuracy studies is not explicitly stated as retrospective or prospective, nor is the country of origin specified beyond "obtained from a clinical laboratory."
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of human experts to establish ground truth for the test set. Instead, objective laboratory methods were used:
- For positive samples, ground truth was established by GC/MS (Gas Chromatography/Mass Spectrometry).
- For negative samples, ground truth was established by screening with an automated immunoassay relative to the 2000 ng/mL cutoff for morphine.
- The document does not mention the use of human experts to establish ground truth for the test set. Instead, objective laboratory methods were used:
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- No adjudication method involving multiple readers is mentioned. The ground truth was established by objective laboratory methods (GC/MS and automated immunoassay).
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study involving human readers or AI assistance was conducted. This device is an in-vitro diagnostic test for qualitative detection of morphine in urine, not an imaging or interpretive AI device that would involve human readers for diagnostic improvement.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the performance study is entirely standalone. The device (OnTrak TesTstik for Morphine 2000) is an in-vitro diagnostic test that provides a visual result (blue band for negative, white for positive), and its performance was evaluated against laboratory-established ground truth without human interpretive input for the test results themselves. The "reading" is an objective visual assessment of band presence/absence.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth used was objective laboratory testing:
- GC/MS (Gas Chromatography/Mass Spectrometry) for confirmed positive samples.
- Automated immunoassay for confirmed negative samples.
- The concentrations of drug in the standards for precision studies served as their own ground truth.
- The ground truth used was objective laboratory testing:
-
The sample size for the training set:
- The document describes performance studies, but it does not provide information about a training set size. This is typical for a device using capture inhibition technology (a chemical assay) rather than a machine learning or AI-based device that would require training data.
-
How the ground truth for the training set was established:
- Since no training set is mentioned (as the device is a chemical assay, not an AI/ML model), there is no information on how the ground truth for a training set was established.
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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.
| ProductName | ClassificationName | Class | CFRClassificationName | PredicateDevice Name | DatePredicateCleared | Predicate510(k)Number |
|---|---|---|---|---|---|---|
| OnTrakTesTstik forMorphine2000 (M2K) | Morphinetest system | II | 862.3640 | AbuscreenOnline II forOpiates300/2000 | 04/24/98 | K974840 |
and the same of the comments of the comments of the comments of
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- Predicate We claim substantial equivalence to the currently marketed Roche device Diagnostics Abuscreen OnLine II for Opiates 300/2000 (K974840).
. . . .
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| 4) DeviceDescription | The OnTrak TesTstik Morphine 2000 assay contained in this submission is anin vitro test intended for professional use in the qualitative detection ofmorphine in urine at or above a cutoff concentration of 2000 ng/mL. |
|---|---|
| The TesTstik assays are based on the principle of microparticle captureinhibition. The test relies on the competition between drug, which may bepresent in the urine being tested, and drug conjugate immobilized on amembrane. | |
| When the TesTstik is immersed in the urine sample, some of the sample isabsorbed into the TesTstik sample pad. The absorbed sample travels througha reagent strip contained in the device by capillary action. In the reagentstrip, the sample rehydrates and mobilizes antibody-coated bluemicroparticles. The microparticle-urine suspension continues to migratethrough the reagent strip and comes in contact with the immobilized drugconjugate. In the absence of drug in the urine, the antibody-coatedmicroparticles bind to the drug conjugate and a blue band is formed at theresult window ("negative" sign). | |
| When drug is present in the specimen, it binds to the antibody-coatedmicroparticles. If sufficient drug is present, the micro-particles are inhibitedfrom binding the drug conjugate and no blue band is formed at the resultwindow. 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 imbeddedin the reagent membrane, bind to the antigen on the blue microparticles. Thepresence of the "TEST VALID" band indicates that the test has completed,the reagents are viable, and the results are ready to interpret. | |
| 5. TechnologyCharacteristics | Table 1 on the next pages outlines the technological characteristics(methodologies) of the OnTrak TesTstik for Morphine 2000 (M2K) incomparison to the Abuscreen OnLine II for Opiates 300/2000. |
| 6. SubstantialEquivalence | Table 1 provides the significant performance characteristics relied upon for adetermination of substantial equivalence. This information concludes that theperformance of the TesTstik Morphine 2000 device is substantially equivalentto the currently marketed Abuscreen OnLine II for Opiates 300/2000(K974840). |
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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% cutoffWhen 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 usingspecimens screened by an automatedimmunoassay and confirmedpositive by GC/MS at the 2000ng/mL cutoff. Fifty (50) samplespositive for morphine were positiveby OnTrak TesTstik M2K (100%).One hundred (100) urine samples,obtained from a clinical laboratoryand screened negative by anautomated immunoassay relative toa 2000 ng/mL cutoff for morphinewere evaluated using OnTrakTesTstik M2K. One hundred (100)were negative for morphine byOnTrak TesTstik for Morphine 2000(100%). | Forty-two (42) samples shownto contain morphine and/orcodeine by GC/MS above 2000ng/mL were also positive in theAbuscreen OnLine II relative tothe 2000 ng/mL cutoff (100%agreement)One hundred (100) urinesamples, obtained from aclinical laboratory where theyscreened negative in a drug testpanel, were evaluated with theAbuscreen OnLine II forOpiates 300/2000. All 100samples were negative at boththe 300 ng/mL and 2000 ng/mLcutoffs (100%) | |
| All positive and negative sampleswere also assayed by, and comparedto, Abuscreen OnLine II for Opiates2000. One hundred fifty (150)samples, tested by both OnTrakTesTstik M2K and AbuscreenOnLine II for Opiates 2000,demonstrated 100% agreement. |
TABLE 1
4 1
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Table 1 -continued-
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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.
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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
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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)
§ 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).