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On Trak TesTcard 9 product, 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. On Trak TesTcard 9 simultaneously tests for the presence of multiple drugs or drug metabolites at or above the stated concentrations.
Cutoff Concentrations:
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
Phencyclidine (PCP) 25 ng/mL
Tricyclic Antidepressants (TCA) 1000 ng/mL
Tetrahydrocannabinols (THC) 50 ng/mL

On Trak TesTcard 9 product 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.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in the provided document beyond the qualitative nature of the test. However, the device is intended for the "qualitative detection of drug or drug metabolites in urine" at or above specific cutoff concentrations. Therefore, the device would be expected to accurately identify the presence or absence of these substances at the given thresholds. The reported performance is not detailed in terms of sensitivity, specificity, or accuracy compared to the gold standard, but the statement about "preliminary analytical test result" and the recommendation for "Gas chromatography/ mass spectrometry (GC/MS) as the preferred confirmation method" implies that the device serves as a screening tool.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide information on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

The document does not provide information on the number of experts used or their qualifications for establishing ground truth.

4. Adjudication Method

The document does not provide information on the adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or the effect size of human reader improvement with AI assistance. This type of study is generally not applicable to a qualitative diagnostic test like the On Trak TesTcard 9, which is designed for standalone analysis rather than human-AI collaboration.

6. Standalone Performance Study

The study described is inherently a standalone performance study. The device, On Trak TesTcard 9, is an "in vitro diagnostic test" intended for "qualitative detection," meaning it produces a result without human interpretation of complex outputs.

7. Type of Ground Truth Used

While not explicitly stated, the implication that "Gas chromatography/ mass spectrometry (GC/MS) is the preferred confirmation method" suggests that GC/MS is intended to be the gold standard or ground truth for confirming the results of the On Trak TesTcard 9.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for the training set was established. Given the nature of a rapid diagnostic test, the "training set" might refer to well-characterized samples with known concentrations of drug metabolites, likely confirmed by a highly accurate method like GC/MS.

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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.

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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