(101 days)
The Roche Diagnostics Corporation OnTrak TesTcard 9 is an in vitro diagnostic test intended for use by health care professionals only for the qualitative detection of drug or drug metabolites in urine. OnTrak TesTcard 9 simultaneously tests for the presence of multiple drugs or drug metabolites. The OnTrak TesTcard 9 profile (cutoff) consists of amphetamines (1000 ng/ml), barbiturates (200 ng/ml), benzodiazepines (100 ng/ml), cocaine metabolite (300 ng/ml), methamphetamine (500 ng/ml), morphine (300 ng/ml), tricyclic antidepressants (TCA-1000 ng/ml) and THC (50 ng/ml).
OnTrak TesTcard 9 provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmation method. Clinical consideration and professional judgment should be applied to any drug abuse test result, particularly when preliminary positive results are used.
The OnTrak TesTcard 9 is an in vitro test intended for use by health care professionals only for the qualitative detection of drug or drug metabolites in urine. The OnTrak TesTcard 9 profile (cutoff) consists of amphetamines (1000 ng/ml), barbiturates (200 ng/ml), benzodiazepines (100 ng/ml), cocaine metabolite (300 ng/ml), methamphetamine (500 ng/ml), morphine (300 ng/ml), PCP (25 ng/ml), tricyclic antidepressants (1000 ng/ml) and THC (50 ng/ml).
The TesTcard 9 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.
When the TesTcard 9 contacts the urine sample, the sample is absorbed into the TesTcard 9 sample pad. The absorbed sample travels through the reagent strips 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 conjugates and blue bands are formed in the result areas.
When drugs are present in the specimen, they bind to the respective antibodycoated microparticles. If sufficient drug is present, the microparticles are inhibited from binding the appropriate drug conjugate and no blue band is formed in the result area below the drug name. A positive sample causes the membrane to remain white.
An additional antibody/antigen reaction occurs at the "TEST VALID" area. The "TEST VALID" blue band forms when antibodies, 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 in the "TEST VALID" area are valid, and the results are ready to interpret.
1. Acceptance Criteria and Device Performance
The acceptance criteria for the OnTrak TesTcard 9 are based on achieving substantial equivalence to its predicate devices (Biosite Diagnostics Triage® Panel Plus TCA and OnTrak TesTstik™ Methamphetamines) in terms of qualitative detection of specific drug or drug metabolites in urine at defined cutoff concentrations.
The provided document does not explicitly state a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy percentages) that the device must meet for clearance. Instead, the clearance document (K012396) focuses on demonstrating substantial equivalence by comparing the device's technical characteristics, methodology, and cutoffs to the predicate devices. The "reported device performance" is implicitly demonstrated through this comparison, indicating that the OnTrak TesTcard 9 performs similarly to the already cleared predicate devices.
However, we can infer the performance by listing the assays the device performs and their respective cutoffs, which are central to its function and comparison with predicate devices.
| Drug / Drug Metabolite | Cutoff (ng/ml) | Predicate Device Cutoff (ng/ml) (Triage® Panel for most) |
|---|---|---|
| Amphetamines | 1000 | 1000 |
| Barbiturates | 200 | 300 |
| Benzodiazepines | 100 | 300 |
| Cocaine metabolite | 300 | 300 |
| Methamphetamine | 500 | 500 (OnTrak TesTstik™ Methamphetamines) |
| Morphine | 300 | 300 |
| PCP | 25 | 25 |
| Tricyclic Antidepressants (TCA) | 1000 | 1000 |
| Cannabinoid (THC) | 50 | 50 |
2. Sample Size and Data Provenance for Test Set
The provided 510(k) summary (K012396) does not contain specific details regarding the sample size used for a test set or the data provenance (e.g., country of origin, retrospective/prospective). This type of detail is typically included in the full study report, which is usually referenced in the 510(k) but not fully reproduced in the summary. The summary focuses on the comparison of the device's characteristics to predicate devices rather than presenting detailed clinical study results with specific sample sizes.
3. Number and Qualifications of Experts for Ground Truth
The provided 510(k) summary does not mention the use of experts to establish ground truth for a test set, nor does it specify their number or qualifications. This type of information would be relevant for studies involving subjective interpretation (e.g., image analysis) or where expert consensus is needed to define a reference standard. For an in vitro diagnostic device like the OnTrak TesTcard 9, the ground truth is typically established through analytical methods in a laboratory setting.
4. Adjudication Method for Test Set
The document does not describe any adjudication method. This is expected given that the device performs a biochemical assay, where the outcome is objectively determined by chemical reactions rather than subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not conducted or reported in this 510(k) summary. MRMC studies are typically used for devices that involve human interpretation of results, such as imaging devices, to assess the impact of the device on reader performance. The OnTrak TesTcard 9 is an in vitro diagnostic test that provides a direct qualitative result, not requiring human interpretation of complex data in the same manner.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
Yes, the performance described for the OnTrak TesTcard 9 is inherently standalone. The device is an in vitro diagnostic test that provides a qualitative detection of drug or drug metabolites in urine directly. Its performance is evaluated based on its ability to accurately detect these substances at specified cutoff levels, independent of human intervention in the interpretation of the primary result. The summary states it provides "a preliminary analytical test result," and a "more specific alternate chemical method must be used in order to obtain a confirmed analytical result" (e.g., GC/MS), which further emphasizes its standalone nature as an initial screening tool.
7. Type of Ground Truth Used
The ground truth for evaluating the OnTrak TesTcard 9's performance would be established through analytical methods, specifically by comparing its results to a gold standard laboratory confirmation method, such as Gas Chromatography/Mass Spectrometry (GC/MS). The document explicitly states: "A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmation method." This indicates that the ground truth for positive or negative drug presence at specific concentrations would be determined by highly accurate and precise analytical techniques.
8. Sample Size for the Training Set
The provided 510(k) summary does not mention a training set or its sample size. This is because the OnTrak TesTcard 9 is a chemical immunoassay device, not a machine learning or AI-based algorithm that requires a separate training set. Its design and performance are based on chemical principles and validation against known concentrations of analytes, not on learning from data.
9. How Ground Truth for Training Set Was Established
Since there is no training set mentioned or implied for this device (as it's an immunoassay, not an AI/ML device), the concept of establishing ground truth for a training set is not applicable here. The device's performance is validated through analytical studies using controlled samples with known concentrations of drugs/metabolites, with the ground truth established by reference analytical methods like GC/MS.
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NOV 0 5 2001
510(k) Summary
According to the requirements of 21 CFR 807.92, the following information Introduction Provides sufficient detail to understand the basis for a determination of substantial equivalence.
Roche Diagnostics Corporation 1) Submitter 9115 Hague Rd. name, address, Indianapolis, IN 46250 contact (317) 845-2000
Contact Person: Jennifer Tribbett
Date Prepared: October 2, 2001
The device name, including both the trade/proprietary name and classification 2) Device Name name is provided below.
| Product Name | ClassificationName | ProductCode | RegulationNumber | Predicate DeviceName | Date PredicateCleared | Predicate510(k) |
|---|---|---|---|---|---|---|
| OnTrak TesTcard 9 | Amphetamines testsystem | 91DKZ | 862.3100 | Triage® Panel | 12/03/97 | K973784 |
| OnTrak TesTcard 9 | Barbiturates testsystem | 91DIS | 862.3150 | Triage® Panel | 12/03/97 | K973784 |
| OnTrak TesTcard 9 | Benzodiazepinestest systems | 91JXM | 862.3170 | Triage® Panel | 12/03/97 | K973784 |
| OnTrak TesTcard 9 | Cocaine testsystems | 91DIO | 862.3250 | Triage® Panel | 12/03/97 | K973784 |
| OnTrak TesTcard 9 | Methamphetaminestest system | 91LAF | 862.3610 | OnTrak TesTstik™Methamphetamines | 04/26/00 | K000096 |
| OnTrak TesTcard 9 | Morphine testsystems | 91DJJ | 862.3640 | Triage® Panel | 12/03/97 | K973784 |
| OnTrak TesTcard 9 | PCP test systems | 91LCM | NotAssigned | Triage® Panel | 12/03/97 | K973784 |
| OnTrak TesTcard 9 | Tricyclicantidepressants testsystems | 91LFG | 862.3910 | Triage® Panel | 12/03/97 | K973784 |
| OnTrak TesTcard 9 | Cannabinoid testsystems | 91LDJ | 862.3870 | Triage® Panel | 12/03/97 | K973784 |
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We claim substantial equivalence to the currently marketed Biosite 3) Predicate Diagnostics Triage® Panel Plus TCA (K973784) and the Roche Diagnostics device Corporation, OnTrak TesTstikTM Methamphetamines (K000096).
The OnTrak TesTcard 9 is an in vitro test intended for use by health care 4) Device professionals only for the qualitative detection of drug or drug metabolites in Description urine. The OnTrak TesTcard 9 profile (cutoff) consists of amphetamines (1000 ng/ml), barbiturates (200 ng/ml), benzodiazepines (100 ng/ml), cocaine metabolite (300 ng/ml), methamphetamine (500 ng/ml), morphine (300 ng/ml), PCP (25 ng/ml), tricyclic antidepressants (1000 ng/ml) and THC (50 ng/ml).
The TesTcard 9 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.
When the TesTcard 9 contacts the urine sample, the sample is absorbed into the TesTcard 9 sample pad. The absorbed sample travels through the reagent strips 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 conjugates and blue bands are formed in the result areas.
When drugs are present in the specimen, they bind to the respective antibodycoated microparticles. If sufficient drug is present, the microparticles are inhibited from binding the appropriate drug conjugate and no blue band is formed in the result area below the drug name. A positive sample causes the membrane to remain white.
An additional antibody/antigen reaction occurs at the "TEST VALID" area. The "TEST VALID" blue band forms when antibodies, 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 in the "TEST VALID" area are valid, and the results are ready to interpret.
The TesTcard 9 assays are based on the principle of microparticle capture 5. Technology Characteristics 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.
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OnTrak TesTcard 9 is substantially equivalent to the currently marketed 6. Substantial Equivalence Biosite Diagnostics Triage® Panel Plus TCA (K973784) and the Roche Diagnostics Corporation, OnTrak TesTstik™ Methamphetamines (K000096). The following table describes the similarities and differences between the devices.
| Item | OnTrak TesTcard 9 | Triage® Panel | OnTrak TesTstikMethamphetamine |
|---|---|---|---|
| Methodology | Competitive microparticlecapture inhibition | Competitive binding immunoassay | Same as TesTcard 9 |
| Measurement | Qualitative | Same as TesTcard 9 | Same as TesTcard 9 |
| Sample Type | Urine | Same as TesTcard 9 | Same as TesTcard 9 |
| Cutoff | Amphetamines: 1000 ng/mlBarbiturates: 200 ng/mlBenzodiazepines: 100 ng/mlCocaine metabolite: 300 ng/mlMethamphetamine: 500 ng/mlMorphine: 300 ng/mlPCP: 25 ng/mlTCA: 1000 ng/mlTHC: 50 ng/ml | Amphetamines: 1000 ng/mlBarbiturates: 300 ng/mlBenzodiazepines: 300 ng/mlCocaine: 300 ng/mlOpiates (Morphine): 300 ng/mlPCP: 25 ng/mlTCA: 1000 ng/mlTHC: 50 ng/ml | Methamphetamine: 500 ng/ml |
| Reagent(activeingredients) | •Microparticles coated withmouse monoclonal anti-amphetamine and anti-barbiturate analogs,anti-benzoylecgonine,anti-methamphetamine,anti-morphine, anti-phencylidine, anti-TCA andanti-cannabinoid, sheeppolyclonal anti-benzodiazepineanalog and BSA in a bufferedsolution containingpreservative and dried on amembrane.•Drug or drug analogconjugates immobilized on amembrane•Mouse monoclonal anti-BSAimmobilized on membrane | • Mouse monoclonal antibodiesagainst phencyclidine,benzodiazepine metabolites,benzoylecgonine, amphetamines,THC, morphine, barbiturates andtricyclic antidepressantsimmobilized on a membrane• Mouse monoclonal antibodiesagainst phencyclidine,benzodiazepine metabolites,benzoylecgonine, amphetamines,THC, morphine, barbiturates andtricyclic antidepressants lyophilizedin a protein matrix containing<0.01% sodium azide• Drugs and drug derivativesconjugated to colloidal gold,lyophilized in a protein matrixcontaining <0.01% sodium azide• Lyophilized buffer | • Microparticles coated withmouse monoclonalanti-methamphetamineantibody, and BSA in abuffered solution containingpreservative and dried on amembrane.• Drug conjugatesimmobilized on a membrane.• Mouse monoclonal anti-BSA immobilized on amembrane. |
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 0 5 2001
Ms. Jennifer Tribbett Regulatory Affairs Specialist Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, In 46250-0457
Re: K012396
Trade/Device Name: Roche Diagnostics Corporation, OnTrak TesTcard 9 Regulation Number: 21 CFR 862.3100; 21 CFR 862.3150; 21 CFR 862.3170; 21 CFR 862.3250; 21 CFR 862.3610; 21 CFR 862.3640; Not Assigned; 21 CFR 862.3910; 21 CFR 862 3870 Regulation Name: Amphetamines test system; Barbiturates test system; Benzodiazepines test systems; Cocaine test systems; Methamphetamines test system; Morphine test systems; PCP test systems; Tricyclic antiepressants test Systems; Cannabinoid test systems Regulatory Class: Class II; Class II; Class II; Class II; Class II; Class II; Class II; Class II: Class II Product Code: DKZ; DIS; JXM; DIO; LAF; DJJ; LCM; LFG; LDJ Dated: October 3, 2001 Received: October 4, 2001
Dear Ms. Tribbett:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loast be advised that I Dr o lessantes over device complies with other requirements of the Act that I DA has made a active regulations administered by other Federal agencies. You must of any I cacal statutes and regerments, including, but not limited to: registration and listing (21 Comply with an the For 8 requirements) and manufacturing practice requirements as set CFN in the quality systems (DF CFR Part 820); and if applicable, the electronic form in the quality by stations (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will anow yourse organ finding of substantial equivalence of your device to a legally premated predicated 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 11 you desire specific ad 1809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 OF It F 4- - 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oiner general misters, International and Consumer 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 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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NOV 0 5 2001
510(k) Number (if known): Ko12396 Device Name: Roche Diagnostics Corporation, OnTrak TesTcard 9
Indications for Use:
The Roche Diagnostics Corporation OnTrak TesTcard 9 is an in vitro diagnostic test intended for use by health care professionals only for the qualitative detection of drug or drug metabolites in urine. OnTrak TesTcard 9 simultaneously tests for the presence of multiple drugs or drug metabolites. The OnTrak TesTcard 9 profile (cutoff) consists of amphetamines (1000 ng/ml), barbiturates (200 ng/ml), benzodiazepines (100 ng/ml), cocaine metabolite (300 ng/ml), methamphetamine (500 ng/ml), morphine (300 ng/ml), tricyclic antidepressants (TCA-1000 ng/ml) and THC (50 ng/ml).
OnTrak TesTcard 9 provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmation method. Clinical consideration and professional judgment should be applied to any drug abuse test result, particularly when preliminary positive results are used.
Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K012396
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)
CONFIDENTIAL
§ 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).