(46 days)
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No
The document describes an in vitro diagnostic test for drug detection in urine, which is a chemical analysis and does not typically involve AI/ML. There are no mentions of AI, ML, image processing, or data analysis methods that would suggest the use of these technologies.
No
The device is described as an "in vitro diagnostics test" for detecting drugs in urine, which means it is used for diagnostic purposes, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the products "are in vitro diagnostics tests."
No
The provided text describes in vitro diagnostic tests (OnTrak TesTcup and OnTrak TesTstik) which are physical devices used for drug detection in urine. There is no mention of software as the primary or sole component of the device.
Yes, based on the provided text, the device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"OnTrak TesTcup and OnTrak TesTstik products, as listed below, are in vitro diagnostics tests..."
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
DKZ, DIO, DJG, LDJ, LCM, LDJ, JXM, DIS
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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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 |
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