(65 days)
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.
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.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Stated performance in summary) | Reported Device Performance (OnTrak TesTcup M2K for Morphine 2000) |
|---|---|
| Precision: >95% confidence at 150% cutoff | Precision: |
| When 100 replicates of urine standards were tested: | |
| * 0 ng/mL standard: 100% Negative (0% Positive) | |
| * 500 ng/mL standard: 100% Negative (0% Positive) | |
| * 1000 ng/mL standard: 98% Negative (2% Positive) | |
| * 1500 ng/mL standard: 60% Negative (40% Positive) | |
| * 2500 ng/mL standard: 0% Negative (100% Positive) | |
| * 3000 ng/mL standard: 0% Negative (100% Positive) | |
| (Note: The summary for M2K simply presents these results, implying they meet the ">95% confidence at 150% cutoff" criterion without explicitly stating that each concentration level individually satisfies it. However, at the 150% cutoff (3000 ng/mL), 100% positive is achieved, and well below the cutoff (0, 500 ng/mL), 100% negative is achieved, consistent with the criterion. The intermediate percentages demonstrate appropriate sensitivity around the cutoff.) | |
| Accuracy: 100% agreement with GC/MS for positive samples at 2000 ng/mL cutoff | Accuracy (Positive Samples): All fifty (50) samples positive for morphine (confirmed by GC/MS at 2000 ng/mL cutoff) were positive by OnTrak TesTcup M2K (100%). |
| Accuracy: 100% agreement with automated immunoassay for negative samples at 2000 ng/mL cutoff | Accuracy (Negative Samples): All one hundred (100) urine samples (screened negative by an automated immunoassay relative to a 2000 ng/mL cutoff for morphine) were negative for morphine by OnTrak TesTcup M2K (100%). |
| Overall Agreement: High agreement with predicate automated immunoassay for both positive and negative samples (specific percentage not explicitly stated as a target, but demonstrated by predicate) | Overall Agreement: 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. |
Study Details
2. Sample Size Used for the Test Set and Data Provenance:
- Precision Test Set: 100 replicates for each urine standard concentration (0, 500, 1000, 1500, 2500, 3000 ng/mL). The provenance of these standards (e.g., synthetic urine, spiked human urine) and their origin (country) is not specified.
- Accuracy Test Set:
- 50 positive samples: Confirmed by GC/MS at 2000 ng/mL cutoff. Provenance details (e.g., country of origin, retrospective/prospective collection) are not specified beyond being "specimens screened by an automated immunoassay."
- 100 negative samples: Obtained from a clinical laboratory and screened negative by an automated immunoassay relative to a 2000 ng/mL cutoff. Provenance details are not specified.
- 150 samples for overall agreement: Tested by both OnTrak TesTcup M2K and Abuscreen OnLine II for Opiates 2000. These likely overlap with the positive and negative accuracy samples, but the exact breakdown and provenance are not detailed.
All samples appear to be retrospective as they were collected and then tested.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not explicitly state the number of experts or their qualifications for establishing ground truth.
- For positive samples, ground truth was established by GC/MS (Gas Chromatography/Mass Spectrometry) at a 2000 ng/mL cutoff. GC/MS is a laboratory analytical method, not typically performed by a "human expert" in the context of adjudication.
- For negative samples, ground truth was established by an automated immunoassay. This is also a laboratory analytical method.
4. Adjudication Method for the Test Set:
Not applicable. The ground truth was established by objective laboratory analytical methods (GC/MS and automated immunoassay), not by human expert review requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. This device is a diagnostic test kit for in-vitro use, not a medical imaging device or a software that assists human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, a standalone performance study was conducted. The OnTrak TesTcup M2K is an in-vitro diagnostic device that provides a result independently. Its performance (precision, accuracy, and agreement) was assessed directly against established laboratory methods (GC/MS, automated immunoassay, and a predicate immunoassay) without human interpretation affecting the device's output. The device itself produces the "positive" or "negative" result based on color change.
7. The Type of Ground Truth Used:
- GC/MS (Gas Chromatography/Mass Spectrometry): Used to confirm positive samples for morphine. This is considered a gold standard analytical method for drug confirmation.
- Automated Immunoassay: Used to screen negative samples. This is a common and accepted laboratory method for initial drug screening.
- Comparison to a Predicate Device (Abuscreen OnLine II for Opiates 2000): Used for overall agreement, implying the predicate device's performance serves as an additional reference point for evaluating the new device's concordance.
8. The Sample Size for the Training Set:
The document does not provide any information regarding a training set. This is typical for simple in-vitro diagnostic devices where performance is assessed through analytical and clinical validation, rather than machine learning models requiring training data.
9. How the Ground Truth for the Training Set Was Established:
As no training set is mentioned or applicable given the device type, this information is not provided.
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510(k) Summary
100 - 100
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. | ||
|---|---|---|---|
| 1) Submittername, address,contact | Roche Diagnostics Corporation9115 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 | CFRClassification |
|---|---|---|---|
| OnTrak TesTcup®M2K | Morphine test system | II | 862.3640 |
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:
and the comments of the comments of
:
We claim substantial equivalence to the currently marketed Roche 3) Predicate device Diagnostics OnTrak TesTcup (K962411).
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510(k) Summary, Continued
| 4) DeviceDescription | The OnTrak TesTcup M2K is an in vitro test intended for professional use inthe qualitative detection of d,l-amphetamines (1000ng/mL), cocainemetabolite (300 ng/mL), THC (50 ng/mL) and morphine (2000 ng/mL). |
|---|---|
| The TesTcup 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 in the test chamber. | |
| Urine is collected directly in the OnTrak TesTcup M2K. After closing thecap and moving it to the "TEST" position, the sample reservoir is filled bytilting the cup. Urine then flows through a membrane by capillary action andreacts with antibody-coated microparticles and drug conjugate present on themembrane. In the absence of drug, the antibody is free to interact with thedrug conjugate, causing the formation of a blue band ("negative" sign). | |
| When drug is present in the specimen, it binds to the antibody-coatedmicroparticles. If sufficient drug is present, the microparticles are inhibitedfrom binding the drug conjugate, and no blue band is formed. A positivesample causes the membrane to remain white ("positive" sign). | |
| An additional antibody/antigen reaction occurs at the "TEST VALID" areafor all assays. The "TEST VALID" blue band forms when antibodies, whichare imbedded in the membrane, interact with, and bind to, the antigen on theblue-dyed microparticles. | |
| 5. TechnologyCharacteristics | Table 1 shown on the next pages outlines the technological characteristics(methodologies) of the OnTrak TesTcup M2K in comparison to the predicatedevice, OnTrak TesTcup. |
| 6. SubstantialEquivalence | Table 1 also provides the results of clinical and non-clinical studiesperformed using the OnTrak TesTcup M2K. The significant performancecharacteristics relied upon for a determination of substantial equivalence issummarized in this chart. This information concludes that the performance ofthe OnTrak TesTcup M2K device is substantially equivalent to the predicatedevice. |
.
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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% cutoffWhen 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 forMorphine 2000 | OnTrak TesTcup |
| MorphinePerformance:Accuracy | OnTrak TesTcup M2K wasevaluated using specimens screenedby an automated immunoassay andconfirmed positive by GC/MS at2000 ng/mL cutoff. All fifty (50)samples positive for morphine werepositive by OnTrak TesTcup M2K(100%). | OnTrak TesTcup was evaluatedusing specimens screened byan automated immunoassayand confirmed positive byGC/MS at the 300 ng/mLcutoff. All ninety (90) samplespositive for morphine werepositive by OnTrak TesTcup(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 OnTrakTesTcup M2K. All one hundredwere negative for morphine byOnTrak TesTcup M2K (100%). | Three hundred seven (307)urine samples, obtained from aclinical laboratory and screenednegative by an automatedimmunoassay relative to a 300ng/mL cutoff for morphinewere evaluated using OnTrakTesTcup. Three hundred fivewere negative for morphine byOnTrak TesTcup (>99%). | |
| All positive and negative sampleswere also assayed by, and comparedto, Abuscreen OnLine II for Opiates2000. One hundred fifty (150)samples tested by both OnTrakTesTcup M2K and AbuscreenOnLine II for Opiates 2000demonstrated 99.3% agreement. | All positive and negativesamples were also assayed by,and compared to, AbuscreenOnTrak for Morphine. Threehundred ninety seven (397)samples tested by both OnTrakTesTcup and AbuscreenOnTrak for Morphinedemonstrated 99.8%agreement. |
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510(k) Summary, Continued
TABLE 1 -Continued-
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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 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.
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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 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
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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)
§ 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).