(68 days)
Not Found
Not Found
No
The device description and intended use indicate a simple in vitro diagnostic test strip, with no mention of AI/ML or related technologies.
No
The device is described as an "in vitro diagnostic test intended for use by health care professionals only for the qualitative detection of drug or drug metabolites in urine" and provides "only a preliminary analytical test result." It does not provide any treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the product is an "in vitro diagnostic test."
No
The device description clearly indicates it is an in vitro diagnostic test, which is a physical test card used to detect substances in urine. It is not a software-only device.
Yes, based on the provided information, the On Trak TesTcard 9 product is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The description explicitly states it 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." The term "in vitro diagnostic" is clearly used.
- Sample Type: It analyzes a biological sample (urine) outside of the body ("in vitro").
- Purpose: It is used to detect the presence of specific substances (drugs or drug metabolites) in that sample to provide information about a person's health status or condition (in this case, drug use).
The other sections like Device Description, Intended User, etc., further support its classification as an IVD by describing its function and intended use in a healthcare setting.
N/A
Intended Use / Indications for Use
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.
Product codes
DKZ, DIS, JXM, DIO, LAF, DJJ, LCM, LFG, LDJ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the emblem.
APR 1 8 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Lorna Gamboa Regulatory Affairs and Quality Affairs Manager Varian, Inc. 25200 Commercentre Drive Lake Forest, California 92630
Re: K050321
Trade/Device Name: Varian, Inc. On Trak TesTcard 9 Regulation Number: 21 CFR § 862.3100 Regulation Name: Amphetamine Test System Regulatory Class: II Product Code: DKZ, DIS, JXM, DIO, LAF, DJJ, LCM, LFG, LDJ Dated: February 3, 2005 Received: February 9, 2005
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 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 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).
1
Page 2 –
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 (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html
Sincerely yours,
Sean M. Cooper, MS, DUM
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number: K050321 On Trak TesTcard 9 Device Name: K050321 Indications For Use:
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 | Morphine | 300 ng/mL |
|---|---|---|---|
| Barbiturates | 200 ng/mL | Phencyclidine (PCP) | 25 ng/mL |
| Benzodiazepines | 100 ng/mL | Tricyclic Antidepressants (TCA) | 1000 ng/mL |
| Cocaine metabolite | 300 ng/mL | Tetrahydrocannabinols (THC) | 50 ng/mL |
| Methamphetamine | 500 ng/mL |
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol Benson
Division Sign Off
Page 1 of 2
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) kos0321
3
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.
·
Carol Benson
Division Sign-Off
Offic = Device I voluation and Safety
K05 6321
Page 2 of 2