(50 days)
Not Found
Not Found
No
The device description and other sections do not mention AI, ML, or any related technologies. The device is described as a chromatographic immunoassay providing visual, qualitative results.
No
The device is an in vitro diagnostic test for detecting drugs in urine, not a device used for treating a disease or condition.
Yes
The device is described as an "in vitro screen test" and is explicitly stated to be "intended for professional in vitro diagnostic use only."
No
The device is described as an "in vitro screen test" and a "Drug Screen Cup," indicating it is a physical device for collecting and testing urine samples, not a software-only application.
Yes, based on the provided text, the ToxCup™ Drug Screen Cup is an IVD (In Vitro Diagnostic) device.
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The device is intended for professional in vitro diagnostic use only."
- Nature of the Test: The device performs a "chromatographic immunoassay" on "human urine" to detect specific substances (drugs). This is a classic example of an in vitro diagnostic test, as it analyzes a biological sample outside of the body to provide diagnostic information.
- Intended User: The device is intended for "professional in vitro diagnostic use only," further reinforcing its classification as an IVD.
Therefore, the text explicitly identifies the ToxCup™ Drug Screen Cup as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ToxCup™ Drug Screen Cup is an in vitro screen test that contains chromatographic immunoassays for the rapid detection of amphetamines, cocaine (benzoylecgonine), methamphetamines, opiates, phencyclidine and THC in human urine at the following cutoff concentrations:
| AMP | d-Amphetamine | 1000 ng/ml |
|---|---|---|
| COC | Benzoylecgonine | 300 ng/ml |
| MET500 | d-Methamphetamine | 500 ng/ml |
| OPI2000 | Morphine | 2000 ng/ml |
| OPI300* | Morphine | 300 ng/ml |
| PCP | Phencyclidine | 25 ng/ml |
| THC | 11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic acid | 50 ng/ml |
*The Opiates test is offered at the SAMHSA mandated cut-off concentration of 2000 ng/ml and the optional cu-off concentration indicated.
The ToxCup™ Drug Screen Cup provides visual, qualitative results for multiple drugs-ofabused in human urine. The device is intended for professional in vitro diagnostic use only. It is not intended for over-the-counter sale to lay persons.
Product codes
DIO, DJG, DJC, LDJ, DKZ, LCM
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
Professional in vitro diagnostic use only.
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)
Not Found
Reference Device(s)
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
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, with flowing lines above them. The profiles and lines are black. The graphic is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A.", also in black.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 2 1 2003
Ms. Chia Her Quality Manager Branan Medical Corporation 10015 Muirlands Road, Suite E Irvine, CA 92618
Re: K032057 Trade/Device Name: ToxCup™ Drug Screen Cup – AMP/COC/MET/OPI/PCP/THC Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: Class II Product Code: DIO; DJG; DJC; LDJ; DKZ; LCM Dated: August 14, 2003 Received: August 15, 2003
Dear Ms. Her:
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. Isting 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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
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
2
Page 1 of
.
K032057 510(k) Number (if known):
Device Name:
Indications For Use:
The ToxCup™ Drug Screen Cup is an in vitro screen test that contains chromatographic immunoassays for the rapid detection of amphetamines, cocaine (benzoylecgonine), methamphetamines, opiates, phencyclidine and THC in human urine at the following cutoff concentrations:
| AMP | d-Amphetamine | 1000 ng/ml |
|---|---|---|
| COC | Benzoylecgonine | 300 ng/ml |
| MET500 | d-Methamphetamine | 500 ng/ml |
| OPI2000 | Morphine | 2000 ng/ml |
| OPI300* | Morphine | 300 ng/ml |
| PCP | Phencyclidine | 25 ng/ml |
| THC | 11-nor- $\Delta^9$ -Tetrahydrocannabinol-9-carboxylic acid | 50 ng/ml |
*The Opiates test is offered at the SAMHSA mandated cut-off concentration of 2000 ng/ml and the optional cu-off concentration indicated.
The ToxCup™ Drug Screen Cup provides visual, qualitative results for multiple drugs-ofabused in human urine. The device is intended for professional in vitro diagnostic use only. It is not intended for over-the-counter sale to lay persons.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | |
|---|---|
| --------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------ |
OR
Over-The-Counter Use ______ (Optional Format 1-2-96)
Division Sign-Off
for Sean Cooper
Office of In Vitro Diagnostic Device Evaluation and Safety
| 510(k) | K032057 |
|---|---|
| -------- | --------- |