(49 days)
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No
The description indicates a visual, qualitative in vitro screen test, which is a traditional immunoassay and does not mention any AI/ML components or image processing.
No
The device is described as an "in vitro screen test for the rapid detection" of substances in human urine, which indicates it is a diagnostic tool, not a therapeutic one. It provides "visual, qualitative results" and does not treat or alleviate any condition.
No
The device is described as an "in vitro screen test for the rapid detection" of substances in human urine, providing "visual, qualitative results." This indicates it's a screening tool, not a device used to definitively diagnose a disease or condition. While it detects substances that might be relevant to a diagnosis (e.g., drug use), it doesn't itself perform the diagnostic function.
No
The device is described as a "Test Cup" which is a physical object used for in vitro testing of urine, indicating it is a hardware device, not software-only.
Yes, based on the provided information, the Scooper™ Drug/Adulterant Test Cup is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that it is an "in vitro screen test for the rapid detection" of specific substances in "human urine."
- In Vitro: "In vitro" means "in glass" or "outside of the body." Testing substances in a sample like urine, which is collected from the body and tested externally, falls under the definition of in vitro diagnostics.
- Diagnostic: While it's a "screen test" and provides "visual, qualitative results," it is used to detect the presence of substances that can indicate drug use or adulteration, which is a form of diagnostic information.
The fact that it's intended for "over-the-counter sale to lay persons" and provides "visual, qualitative results" further supports its classification as an IVD, specifically a type of IVD often referred to as a point-of-care or home-use diagnostic.
N/A
Intended Use / Indications for Use
The Scooper™ Drug/Adulterant Test Cup is an in vitro screen test for the rapid detection. The test The Scooper -- Drug/Adulterail: Test Sup Sup son and phencyclidine in human urine. The cutoff concentrations are as follows:
| OPI | Morphine | 2000 ng/m |
|---|---|---|
| AMP | Amphetamines | 1000 ng/m |
| THC | 11-nor-A9-Tetrahydrocannabinol-9-carboxylic acid | 50 ng/m |
| COC | Benzoylecgonine | 300 ng/m |
| PCP | Phencyclidine | 25 ng/m |
The Scooper™ Drug/Adulteration Test Cup is used to obtain visual, qualitative results The Scooper - Drug/Additeration 2001 Super-the-counter sale to lay persons.
Product codes
DJJ, DKZ, LDJ, DIO
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
Not Found
Intended User / Care Setting
lay persons
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
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
§ 862.3640 Morphine test system.
(a)
Identification. A morphine test system is a device intended to measure morphine, an addictive narcotic pain-relieving drug, and its analogs in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of morphine use or overdose and in monitoring levels of morphine and its analogs to ensure appropriate therapy.(b)
Classification. Class II (special controls). A morphine 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 eagle with three horizontal lines representing its wings. The eagle is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Re:
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Raphael Wong President Branan Medical Corporation 10015 Muirlands Road - Suite E Irvine, CA 92618
NOV 0 7 2001
K013124 Trade/Device Name: Scooper TM Drug/Adulteration Test Cup-MOR/AMP/THC/COC/PCP Drug Screen Tests with Adulteration Pads for Creatinine, Nitrite, pH and Oxidizing Agents Regulation Number: 21 CFR 862.3650; 21 CFR 862.3100; 21 CFR 862.3870; 21 CFR 862.3250 Regulation Name: Opiate test system; Amphetamine test system; Cannabinoid test system; Cocaine and cocaine metabolite test system Regulatory Class: Class II; Class II; Class II, Class II Product Code: DJJ; DKZ; LDJ; DIO Dated: October 18, 2001 Received: October 22, 2001
Dear Mr. Wong:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for the building 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 11 your de roo is exactional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed noaticate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, (Jory Sy Hot the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
NOV 0 7 2001
1 Page ← of
510(k) Number (if known): /K013124
Scooper™ Drug/Adulteration Test Cup -Device Name: MOR/AMP/THC/COC/PCP Drug Screen Tests with MONAMI / HEPCOCH OF Creatinine, Nitrite, pH and Oxidizing Agents
Indications For Use:
The Scooper™ Drug/Adulterant Test Cup is an in vitro screen test for the rapid detection. The west The Scooper -- Drug/Adulterail: Test Sup Sup son and phencyclidine in human urine. The cutoff concentrations are as follows:
| OPI | Morphine | 2000 ng/m |
|---|---|---|
| AMP | Amphetamines | 1000 ng/m |
| THC | 11-nor-A9-Tetrahydrocannabinol-9-carboxylic acid | 50 ng/m |
| COC | Benzoylecgonine | 300 ng/m |
| PCP | Phencyclidine | 25 ng/m |
The Scooper™ Drug/Adulteration Test Cup is used to obtain visual, qualitative results The Scooper - Drug/Additeration 2001 Super-the-counter sale to lay persons.
Alan Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K013124
(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) |