(52 days)
- The ONTRAK TESTSTIK for Amphetamines is an in vitro diagnostic test intended for professional use for the qualitative detection of amphetamines in urine at or above a cutoff concentration of 1000 ng/mL.
- The ONTRAK TESTSTIK for Cocaine is an in vitro diagnostic test intended for professional use for the qualitative detection of cocaine metabolite in urine at or above a cutoff concentration of 300 ng/mL.
- The ONTRAK TESTSTIK for Morphine is an in vitro diagnostic test intended for professional use for the qualitative detection of morphine in urine at or above a cutoff concentration of 300 ng/mL
- The ONTRAK TESTSTIK for PCP is an in vitro diagnostic test intended for professional use for the qualitative detection of phencyclidine in urine at or above a cutoff concentration of 25 ng/mL.
- The ONTRAK TESTSTIK for THC is an in vitro diagnostic test intended for professional use for the qualitative detection of cannabinoids in urine at or above a cutoff concentration of 50 ng/mL.
The 5 ONTRAK TESTSTIK Assays contained in this submission are in vitro diagnostic tests intended for professional use for the qualitative detection of drug or drug metabolite in urine. They are the ONTRAK TESTSTIK for Amphetamines (1000 ng/mL cutoff), the ONTRAK TESTSTIK for Cocaine (300 ng/mL cutoff), the ONTRAK TESTSTIK for THC (50 ng/mL cutoff), the ONTRAK TESTSTIK for Morphine (300 ng/mL cutoff) and the ONTRAK TESTSTIK for PCP (25 ng/mL cutoff).
The ONTRAK TESTSTIK Assays are based on the principle of microparticle capture inhibition. These tests rely on the competition between the specific drug, which may be present in the urine being tested, and drug conjugate immobilized on a membrane test chamber.
When an ONTRAK 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 particles, the microparticles are inhibited from binding the drug conjugate and no blue band is formed at the result window. Therefore, a positive sample causes 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 embedded in the reagent membrane, bind to the antigen on the blue microparticles.
This document describes the acceptance criteria and supporting study for the ONTRAK TESTSTIK Assays for various drugs of abuse (Amphetamines, Cocaine, Morphine, PCP, THC).
The study aims to demonstrate substantial equivalence to previously marketed predicate devices. The acceptance criteria essentially mirror the performance characteristics of the predicate devices and focus on precision and accuracy against a reference method.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as a single set of predefined metrics that the new device must meet. Instead, it presents performance characteristics for both the new ONTRAK TESTSTIK assays and their predicate devices. The implicit acceptance criterion is that the ONTRAK TESTSTIK assays show comparable performance to the predicate devices. The tables below synthesize the reported performance, which effectively acts as the demonstrated acceptance of the device's capabilities.
ONTRAK TESTSTIK for Amphetamines
| Performance Characteristic | Acceptance Criteria (from predicate) | Reported Device Performance (ONTRAK TESTSTIK) |
|---|---|---|
| Precision | > 99% confidence at 200% of cutoff | > 95% confidence at 150% cutoff |
| Accuracy (Positive Samples) | GC/MS: 45 positive, 1 negative | TESTSTIK: 50 positive, 0 negative |
ONTRAK TESTSTIK for Cocaine
| Performance Characteristic | Acceptance Criteria (from predicate) | Reported Device Performance (ONTRAK TESTSTIK) |
|---|---|---|
| Precision | > 99% confidence at 200% of cutoff | > 95% confidence at 150% cutoff |
| Accuracy (Positive Samples) | GC/MS: 49 positive, 0 negative | TESTSTIK: 50 positive, 0 negative |
ONTRAK TESTSTIK for Morphine
| Performance Characteristic | Acceptance Criteria (from predicate) | Reported Device Performance (ONTRAK TESTSTIK) |
|---|---|---|
| Precision | > 99% confidence at 200% of cutoff | > 95% confidence at 150% cutoff |
| Accuracy (Positive Samples) | GC/MS: 50 positive, 0 negative | TESTSTIK: 49 positive, 0 negative |
ONTRAK TESTSTIK for PCP
| Performance Characteristic | Acceptance Criteria (from predicate) | Reported Device Performance (ONTRAK TESTSTIK) |
|---|---|---|
| Precision | > 99% confidence at 200% of cutoff | > 95% confidence at 150% cutoff |
| Accuracy (Positive Samples) | GC/MS: 50 positive, 1 negative | TESTSTIK: 50 positive, 0 negative |
ONTRAK TESTSTIK for THC
| Performance Characteristic | Acceptance Criteria (from predicate) | Reported Device Performance (ONTRAK TESTSTIK) |
|---|---|---|
| Precision | > 99% confidence at 200% of cutoff | > 95% confidence at 150% cutoff |
| Accuracy (Positive Samples) | GC/MS: 45 positive, 0 negative | TESTSTIK: 45 positive, 0 negative |
Note on "Acceptance Criteria" interpretation: The document refers to "significant performance characteristics relied upon for a determination of substantial equivalence" (Page 3). The tables then show the performance of both the new device and the predicate. Thus, the predicate's performance serves as the benchmark or de facto acceptance criteria for the new device to demonstrate substantial equivalence.
2. Sample size used for the test set and the data provenance:
- Sample Size:
- Amphetamines: 50 positive samples, 0 negative samples for the ONTRAK TESTSTIK accuracy test. The GC/MS comparison implies 46 samples (45 positive, 1 negative).
- Cocaine: 50 positive samples, 0 negative samples for the ONTRAK TESTSTIK accuracy test. The GC/MS comparison implies 49 samples (49 positive, 0 negative).
- Morphine: 49 positive samples, 0 negative samples for the ONTRAK TESTSTIK accuracy test. The GC/MS comparison implies 50 samples (50 positive, 0 negative).
- PCP: 50 positive samples, 0 negative samples for the ONTRAK TESTSTIK accuracy test. The GC/MS comparison implies 51 samples (50 positive, 1 negative).
- THC: 45 positive samples, 0 negative samples for the ONTRAK TESTSTIK accuracy test. The GC/MS comparison implies 45 samples (45 positive, 0 negative).
- It is not explicitly stated how many negative samples were tested with the ONTRAK TESTSTIK for accuracy, only the positive sample count against the GC/MS reference.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The submission is from Roche Diagnostic Systems, Inc. in Somerville, New Jersey, USA, but this doesn't confirm the origin of the test samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The ground truth (reference method) is established using GC/MS (Gas Chromatography/Mass Spectrometry), which is an analytical laboratory technique, not human expert interpretation.
4. Adjudication method for the test set (e.g. 2+1, 3+1, none):
This information is not applicable/provided. The ground truth is established by an objective analytical method (GC/MS), not by human interpretation requiring adjudication.
5. 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:
This is not an AI/CAD device. The ONTRAK TESTSTIK Assays are in vitro diagnostic tests for qualitative detection of drugs in urine. Therefore, an MRMC study and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is a standalone chemical assay. Its performance is evaluated intrinsically through chemical reactions, not through an algorithm. The reported accuracy metrics relate to the device's ability to produce a correct result when compared to a reference standard. There isn't an "algorithm-only" performance as the device itself is the testing mechanism. The human interaction is limited to operating the device and visually interpreting the "color" endpoint (blue band for negative, no blue band for positive).
7. The type of ground truth used:
The ground truth for the accuracy studies was established by GC/MS (Gas Chromatography/Mass Spectrometry). This is considered a highly reliable and definitive analytical method for confirming the presence and concentration of drugs and metabolites in urine samples.
8. The sample size for the training set:
There is no mention of a training set as this is an in vitro diagnostic chemical assay, not an AI/machine learning device. The performance data presented are from validation studies.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
§ 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).