(120 days)
OnTrak TesTstik 3 for Cocaine/Morphine/THC is an in vitro diagnostic test intended for professional use for the qualitative detection of cocaine metabolite, morphine, and cannabinoids in uripe. The OnTrak TesTstik 3 for Cocaine/Morphine/THC cutoff levels (300 ng/ml for cocaine and morphine and 50 ng/ml for THC) are based on the Federal Mandatory Guidelines. OnTrak TesTstik 3 for Cocaine/Morphine/THC is not intended for over-the-counter sale.
OnTrak TesTstik 3 for Cocaine/Morphine/THC provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytices I rosult. Tras chromatography/mass spectrometry (GC/MS) is the preferred confirmation method.) Cluireal consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The OnTrak TesTstik 3 for Cocaine/Morphine/THC is an in vitro diagnostic test intended for professional use in the qualitative detection of cocainc metabolite, morphine and cannabinoids in urine at or above a cutoff of 300 ng/ml (cocaine and morphine) and 50 ng/ml (THC).
Like the predicate TesTstik devices, the OnTrak TesTstik 3 is also based on the principles of microparticle capture inhibition. The test relies on the competition between drugs, which may be present in the urine being tested, and drug conjugates immobilized on the membrane.
Here's an analysis of the provided text, outlining the acceptance criteria and the study details for the OnTrak TesTstik 3 for Cocaine/Morphine/THC device:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance (OnTrak TesTstik 3) |
|---|---|
| Precision: >95% confidence at 150% cutoff | >95% confidence at 150% cutoff (Same as predicate) |
| Cocaine Accuracy: Clinical correlation between device and GC/MS / automated immunoassay | 94% agreement for all positive (including near cutoff) and negative specimens |
| Morphine Accuracy: Clinical correlation between device and GC/MS / automated immunoassay | 94% agreement for all positive (including near cutoff) and negative specimens |
| THC Accuracy: Clinical correlation between device and GC/MS / automated immunoassay | 95% agreement for all positive (including near cutoff) and negative specimens |
Study Details
-
Sample size used for the test set and the data provenance:
- Cocaine:
- 70 specimens (positive, including near cutoff)
- 100 urine specimens (negative)
- Data Provenance: Clinical laboratory, likely retrospective as specimens were "obtained." Country of origin is not specified but is general clinical laboratory practice.
- Morphine:
- 70 specimens (positive, including near cutoff)
- 100 urine specimens (negative)
- Data Provenance: Clinical laboratory, likely retrospective. Country of origin is not specified.
- THC:
- 70 specimens (positive, including near cutoff)
- 100 urine specimens (negative)
- Data Provenance: Clinical laboratory, likely retrospective. Country of origin is not specified.
- Cocaine:
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number of experts or their qualifications. The ground truth was established by automated immunoassays and confirmed by GC/MS (Gas Chromatography/Mass Spectrometry), which are laboratory methods rather than direct human expert assessment. This implies that the 'experts' in this context are the laboratory personnel performing and interpreting these analytical tests, but their specific qualifications are not detailed.
-
Adjudication method for the test set:
- Not applicable in the traditional sense of human review. The ground truth was established by a two-step laboratory process: initial screening by automated immunoassay, followed by confirmation with GC/MS. This acts as the "adjudication" against which the device performance is measured, but it's not a panel of human experts.
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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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is an in vitro diagnostic test, and its performance is evaluated directly against laboratory reference methods, not in comparison to human reader improvement with or without AI assistance.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, performance evaluation was done in a standalone manner. The device, OnTrak TesTstik 3, is a qualitative diagnostic test that provides a visual "color" endpoint read. Its accuracy was tested against established laboratory methods (automated immunoassay and GC/MS) without direct human intervention as part of its reading mechanism; the human interprets the color change produced by the device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth used was laboratory confirmation: initial screening by automated immunoassay and definitive confirmation by Gas Chromatography/Mass Spectrometry (GC/MS). For negative specimens, a portion (15%) were also confirmed negative by GC/MS.
-
The sample size for the training set:
- The document describes performance evaluation using clinical specimens. It does not explicitly state details about a separate "training set" or its size, common in machine learning contexts. This suggests the study is a performance validation utilizing a test set, without detailing an explicit training phase in the context of an AI/ML algorithm. For traditional IVDs, the development process might involve internal validation, but this summary focuses on the final performance study.
-
How the ground truth for the training set was established:
- As a distinct training set is not explicitly mentioned or detailed in the provided summary, the method for establishing its ground truth is also not provided. For the performance evaluation (test set), the ground truth was established via automated immunoassay and GC/MS confirmation as described in point 6.
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510(k) Summary
| 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 | ||
| Contact Person: Jennifer Tribbett | Date Prepared: March 6, 2000 |
- Device Name The device name, including both the trade/proprietary name and classification name is provided below.
| Product Name | ClassificationName | ProductCode | CFRClassificationName | PredicateDevice Name | DatePredicateCleared | Predicate510(k)Number |
|---|---|---|---|---|---|---|
| OnTrak TesTstik3 for Cocaine/Morphine/THC | Cocaine TestSystem | 91DIO | 862.3250 | OnTrakTesTstik forCocaine | 10/9/97 | K973075 |
| OnTrak TesTstik3 for Cocaine/Morphine/THC | Morphine TestSystem | 91DJJ | 862.3640 | OnTrakTesTstik forMorphine | 10/9/97 | K973075 |
| OnTrak TesTstik3 for Cocaine/Morphine/THC | CannabinoidTest System | 91LDJ | 862.3870 | OnTrakTesTstik forTHC | 10/9/97 | K973075 |
-
Predicate We claim substantial equivalence to the currently marketed Roche device Diagnostics OnTrak TesTstik for Cocaine (K973075), OnTrak TesTstik for Morphine (K973075) and OnTrak TesTstik for THC (K973075).
-
Device The OnTrak TesTstik 3 for Cocaine/Morphine/THC is an in vitro diagnostic Description test intended for professional use in the qualitative detection of cocainc metabolite, morphine and cannabinoids in urine at or above a cutoff of 300 ng/ml (cocaine and morphine) and 50 ng/ml (THC).
Like the predicate TesTstik devices, the OnTrak TesTstik 3 is also based on the principles of microparticle capture inhibition. The test relies on the competition between drugs, which may be present in the urine being tested, and drug conjugates immobilized on the membrane.
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| 5. TechnologyCharacteristics | Tables 1, 2, 3 and 4 outline the technological characteristics (methodologies) of the OnTrak TesTstik 3 for Cocaine/Morphine/THC in comparison to the predicate devices. | ||
|---|---|---|---|
| 6. SubstantialEquivalence | Tables 1, 2, 3 and 4 also provide the significant characteristics relied upon for a determination of substantial equivalence. This information concludes that the performance of the TesTstik 3 for Cocaine/Morphine/THC is substantially equivalent to the currently marketed OnTrak TesTstik Cocaine, OnTrak TesTstik Morphine and OnTrak TesTstik THC. |
TABLE 1
| Item | OnTrak TesTstik 3 forCocaine/Morphine/THCNew Device | OnTrak TesTstikfor CocainePredicate | OnTrak TesTstikfor MorphinePredicate | OnTrak TesTstikfor THCPredicate |
|---|---|---|---|---|
| Methodology | Competitive microparticlecapture inhibition | Same | Same | Same |
| Measurement | Qualitative | Same | Same | Same |
| Sample Type | Urine | Same | Same | Same |
| Endpoint read | Color | Same | Same | Same |
| Cutoff | 300 ng/ml (cocaine)300ng/ml (morphine)50 ng/ml (THC) | Same300 ng/ml (cocaine) | Same300 ng/ml (morphine) | Same50 ng/ml (THC) |
| Reagent(activeingredients) | • Blue dyed microparticlescoated with mousemonoclonal anti-benzoylecgonine antibody,anti-morphine antibody andanti-cannabinoid antibody. | • Blue dyedmicroparticles coatedwith mousemonoclonal anti-benzoylecgonineantibody. | • Blue dyedmicroparticles coatedwith mousemonoclonal anti-morphine antibody. | • Blue dyedmicroparticles coatedwith mousemonoclonal anti-cannabinoidantibody. |
| • Drug conjugatesimmobilized on a membrane | • Drug conjugatesimmobilized on amembrane | • Drug conjugatesimmobilized on amembrane | • Drug conjugatesimmobilized on amembrane | |
| • Mouse monoclonal anti-BSA antibody immobilizedon membrane | • Mouse monoclonalanti-BSA antibodyimmobilized on amembrane | • Mouse monoclonalanti-BSA antibodyimmobilized on amembrane | • Mouse monoclonalanti-BSA antibodyimmobilized on amembrane | |
| Performance:Precision | >95% confidence at 150%cutoff | Same | Same | Same |
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510K Summary -Continued-
Table 2
| Item | OnTrak TesTstik 3 forCocaine/Morphine/THC | OnTrak TesTstik for CocainePredicate |
|---|---|---|
| CocainePerformance:Accuracy | OnTrak TesTstik 3 forCocaine/Morphine/THC wasevaluated using clinicalspecimens screened by anautomated immunoassay andconfirmed positive by GC/MS.Seventy (70) specimens,including near cutoff specimens,positive for cocaine wereevaluated on OnTrak TesTstik 3.One hundred urine specimenswere obtained from a clinicallaboratory and screened negativeby automated immunoassaysrelative to a 300 ng/ml cutoff forcocaine. A portion (15%) of thenegative specimens were alsoconfirmed negative for cocaineby GC/MS. Clinical correlationfor all positive (including nearcutoff samples) and negativespecimens was demonstrated as94% agreement. | OnTrak TesTstik for Cocainewas evaluated using specimensscreened by an automatedimmunoassay and confirmedpositive by GC/MS at a 150ng/ml cutoff. Fifty (50) samplespositive for cocaine were positiveby OnTrak TesTstik (100%).One hundred six (106) urinesamples, obtained from a clinicallaboratory and screened negativeby an automated immunoassayrelative to a 300 ng/ml cutoff forcocaine were evaluated andfound negative using OnTrakTesTstik.All positive and negative sampleswere also assayed by, andcompared to, Abuscreen OnTrakfor Cocaine. All samplesdemonstrated 100% agreementbetween the two assays. |
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510K Summary -Continued-
| Table 3 | ||
|---|---|---|
| Item | OnTrak TesTstik 3 forCocaine/Morphine/THC | OnTrak TesTstik for MorphinePredicate |
| MorphinePerformance:Accuracy | OnTrak TesTstik 3 forCocaine/Morphine/THC wasevaluated using clinicalspecimens screened by anautomated immunoassay andconfirmed positive by GC/MS.Seventy (70) specimens,including near cutoff specimens,positive for morphine wereevaluated on OnTrak TesTstik 3. | OnTrak TesTstik for Morphinewas evaluated using specimensscreened by an automatedimmunoassay and confirmedpositive by GC/MS at a 300ng/ml cutoff. Forty nine (49)samples positive for morphinewere positive by OnTrakTesTstik (>99%). |
| One hundred urine specimenswere obtained from a clinicallaboratory and screened negativeby automated immunoassaysrelative to a 300 ng/ml cutoff formorphine. A portion (15%) ofthe negative specimens were alsoconfirmed negative for opiates(morphine and codeine) byGC/MS. Clinical correlation forall positive (including near cutoffsamples) and negative specimenswas demonstrated as 94%agreement. | One hundred six (106) urinesamples, obtained from a clinicallaboratory and screened negativeby an automated immunoassayrelative to a 300 ng/ml cutoff formorphine were evaluated usingOnTrak TesTstik. One hundredfive (105) were and negative formorphine using OnTrakTesTstik.All positive and negative sampleswere also assayed by, andcompared to, Abuscreen OnTrakfor Morphine. One hundred fiftysix (156) samples tested by bothOnTrak TesTstik and AbuscreenOnTrak for Morphinedemonstrated 99.3% agreement. |
. Table 3
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510K Summary -Continued-
Table 4
| Item | OnTrak TesTstik 3 forCocaine/Morphine/THC | OnTrak TesTstik for THCPredicate |
|---|---|---|
| THCPerformance:Accuracy | ||
| OnTrak TesTstik 3 forCocaine/Morphine/THC wasevaluated using clinicalspecimens screened by anautomated immunoassay andconfirmed positive by GC/MS.Seventy (70) specimens,including near cutoff specimens,positive for THC were evaluatedon OnTrak TesTstik 3. | OnTrak TesTstik for THC wasevaluated using specimensscreened by an automatedimmunoassay and confirmedpositive by GC/MS at a 15 ng/mlcutoff. Forty five (45) samplespositive for THC were positive byOnTrak TesTstik (100%). | |
| One hundred urine specimenswere obtained from a clinicallaboratory and screened negativeby automated immunoassaysrelative to a 50 ng/ml cutoff forTHC. A portion (15%) of thenegative specimens were alsoconfirmed negative for THC byGC/MS. Clinical correlation for | One hundred six (105) urinesamples, obtained from a clinicallaboratory and screened negativeby an automated immunoassayrelative to a 50 ng/ml cutoff forTHC were evaluated and foundnegative using OnTrak TesTstik. | |
| all positive (including near cutoffsamples) and negative specimenswas demonstrated as 95%agreement. | All positive and negative sampleswere also assayed by, andcompared to, Abuscreen On Trakfor THC. All samplesdemonstrated 100% agreementbetween the two assays. |
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 7 2000
Ms. Jennifer Tribbett Regulatory Affairs Specialist Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457
Re: K994165 Trade Name: Ontrak TesTstik™ 3 Regulatory Class: II Product Code: DIO, DJJ, LDJ Dated: March 6, 2000 Received: March 7, 2000
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
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 gencral 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
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510(k) Number (if known): Device Name: Roche Diagnostics Corporation, OnTrak TesTstik™ 3 for Cocaine/Morphine/THC
Indications for Use:
OnTrak TesTstik 3 for Cocaine/Morphine/THC is an in vitro diagnostic test intended for professional use for the qualitative detection of cocaine metabolite, morphine, and cannabinoids in uripe. The OnTrak TesTstik 3 for Cocaine/Morphine/THC cutoff levels (300 ng/ml for cocaine and morphine and 50 ng/ml for THC) are based on the Federal Mandatory Guidelines. OnTrak TesTstik 3 for Cocaine/Morphine/THC is not intended for over-the-counter sale.
OnTrak TesTstik 3 for Cocaine/Morphine/THC provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytices I rosult. Tras chromatography/mass spectrometry (GC/MS) is the preferred confirmation method.) Cluireal consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory evices
510(k) Number 4994165
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
CONFIDENTIAL
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).