(46 days)
OnTrak TesTcup and OnTrak TesTstik products, as listed below, are in vitro diagnostics tests On Flax Tes I cup and On Frak Test realitative detection of drugs in urine at or above the stated cutoff concentrations.
OnTrak TesTcup and OnTrak TesTstik products provide only a preliminary analytical test result. On Frax Test cap and On Flair For roler por roler to obtain a confirmed analytical result.
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This looks like a 510(k) clearance letter for the OnTrak Test Tcup and OnTrak Test Tstik, which are in vitro diagnostics for the qualitative detection of drugs in urine.
Unfortunately, the provided document does not contain the detailed study information required to answer your request in full. The letter itself is a notice of substantial equivalence being granted by the FDA, and it typically refers to a submission that would contain such studies.
Here's what I can infer and what is missing based on the provided text:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: The "Cutoff Concentrations" table (Amphetamines 1000 ng/mL, Morphine 300 ng/mL, etc.) represents the critical threshold for qualitative detection, which implicitly serves as the acceptance criterion for a positive or negative result. A device is expected to correctly identify samples above the cutoff as positive and below as negative (within a certain margin of error and considering cross-reactivity).
- Reported Device Performance: This information is not present in the provided document. A 510(k) submission would typically include sensitivity, specificity, accuracy, and potentially cross-reactivity data against these cutoffs.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not present in the provided document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not present in the provided document. For drug tests, the "ground truth" is typically established by a reference method (e.g., GC/MS or LC/MS) not by human expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not present in the provided document. Adjudication methods are more relevant for subjective interpretations (like medical imaging). For a drug test, the ground truth is analytically determined.
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:
- No. This is an in vitro diagnostic device (a test kit for drugs in urine), not an AI-powered diagnostic imaging tool. MRMC studies are not applicable here. The "reader" is typically a lab technician or user interpreting test lines, not a "human reader" in the AI sense.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is an in vitro diagnostic device. Its performance is inherent to the chemical reactions and readout mechanism. It doesn't have an "algorithm" in the AI sense. The device is the standalone test. The performance would be "algorithm only" in the sense that the test itself performs the detection.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for such drug tests is typically established using a confirmatory analytical method, such as Gas Chromatography-Mass Spectrometry (GC/MS) or Liquid Chromatography-Mass Spectrometry (LC/MS). The document explicitly states: "OnTrak TesTcup and OnTrak TesTstik products provide only a preliminary analytical test result. For a confirmed analytical result, secondary confirmatory method such as GC/MS must be used." This strongly implies that a confirmatory method like GC/MS was used to establish the ground truth in their studies.
8. The sample size for the training set:
- This information is not present in the provided document. As this is not an AI/machine learning device, the concept of a "training set" in that context does not apply. The device's formulation and design would be optimized through R&D, not trained on data.
9. How the ground truth for the training set was established:
- Not applicable as there is no "training set" in the context of AI/ML. The ground truth for the performance evaluation (test set) is established by a confirmatory analytical method (likely GC/MS or LC/MS) as mentioned in point 7.
In summary, the provided document is a regulatory clearance letter and not the scientific study report itself. Therefore, most of the detailed questions about study design, sample sizes, and expert involvement cannot be answered from this text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN - 6 2004
Ms. Lorna Gamboa Regulatory Affairs Manager Varian, Inc. Consumable Products 25200 Commercentre Drive Lake Forest, CA 92630
K033659 Re:
Trade/Device Name: OnTrak Test Tcup® and OnTrak Test Tstik® Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine Test System Regulatory Class: Class II Product Code: DKZ, DIO, DJG, LDJ, LCM, LDJ, JXM, DIS Dated: November 19, 2003 Received: November 21, 2003
Dear Ms. Gamboa:
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 misb: anding 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. 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 Division of Small Manufacturers, 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 Butman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number: K03 3659 ______________________________________________________________________________________________________________________________________________________
Device Name: OnTrak TesTcup and OnTrak TesTstik_____
Indications for Use:
OnTrak TesTcup and OnTrak TesTstik products, as listed below, are in vitro diagnostics tests On Flax Tes I cup and On Frak Test realitative detection of drugs in urine at or above the stated cutoff concentrations.
| OnTrak TesTcup Products: | OnTrak TesTstik Products: |
|---|---|
| OnTrak TesTcup 4 | OnTrak TesTstik AMP |
| OnTrak TesTcup 5 | OnTrak TesTstik BAR |
| OnTrak TesTcup 5 M2K | OnTrak TesTstik BNZ |
| OnTrak TesTcup 501 | OnTrak TesTstik COC |
| OnTrak TesTcup PRO-5 | OnTrak TesTstik MET |
| OnTrak TesTstik MOR | |
| OnTrak TesTstik PCP | |
| OnTrak TesTstik THC |
Cutoff Concentrations:
| Amphetamines | 1000 ng/mL | Morphine | 300 ng/mL |
|---|---|---|---|
| Barbiturates | 200 ng/mL | Morphine (M2K) | 2000 ng/mL |
| Benzodiazepines | 100 ng/mL | Phencyclidine (PCP) | 25 ng/mL |
| Cocaine metabolite | 300 ng/mL | Tetrahydrocannabinols (THC) | 50 ng/mL |
| Methamphetamine | 500 ng/mL |
OnTrak TesTstik 2 COC/THC
OnTrak TesTstik 3 COC/MOR/THC
OnTrak TesTcup and OnTrak TesTstik products provide only a preliminary analytical test result. On Frax Test cap and On Flair For roler por roler to obtain a confirmed analytical result.
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Division Sign-Off | |
| Office of In Vitro Diagnostic Device Evaluation and Safety | |
| 510(k) | Ko 33659 |
| Prescription Use (Per 21 CFR 801.109) | ✓ OR Over-the Counter Use ______ |
| (Optional Format 1-2-96) | CONFIDENTIAL |
137
§ 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).