(49 days)
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.
Not Found
This document is a 510(k) premarket notification from the FDA, approving a drug test cup. It does not contain information about a study with acceptance criteria and device performance in the way typically associated with AI-powered diagnostic devices or other medical imaging/diagnostic tools that require extensive clinical validation studies.
The device described, "Scooper™ Drug/Adulteration Test Cup," is an in vitro diagnostic (IVD) device for rapid detection of specific drugs and adulterants in human urine. The approval is based on "substantial equivalence" to legally marketed predicate devices, not on a new clinical study comparing its performance against a gold standard in a detailed manner as requested in the prompt.
Therefore, most of the requested information cannot be extracted from this document because the described approval process does not involve such a study with the specified acceptance criteria format.
However, I can provide the limited relevant information:
1. A table of acceptance criteria and the reported device performance:
The document lists "cutoff concentrations" for various drugs. These act as intrinsic performance specifications for the test cups. The approval indicates that the device meets these cutoffs effectively for its intended use as an in vitro screen test.
| Drug / Metabolite | Cutoff Concentration (ng/mL) |
|---|---|
| Morphine (OPI) | 2000 |
| Amphetamines (AMP) | 1000 |
| 11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic acid (THC) | 50 |
| Benzoylecgonine (COC) | 300 |
| Phencyclidine (PCP) | 25 |
Note: This document does not provide a table of "reported device performance" against these cutoffs in terms of sensitivity, specificity, or accuracy based on a clinical study where the device results were compared to a gold standard. The approval is based on substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. The document does not describe a clinical study with a test set of this nature. The approval is based on substantial equivalence to predicate devices, implying that the device was tested to perform as expected against its stated cutoffs, but not through a large-scale clinical trial with specified sample sizes and provenance.
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):
Not applicable. The approval process for this type of IVD device typically relies on analytical validation against known concentrations and comparison to predicate devices, rather than expert-established ground truth on a test set in a clinical setting.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No such clinical test set or adjudication method is described.
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:
Not applicable. This is not an AI-powered device, nor is it a device that requires human "readers" in the context of interpretation that would necessitate an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a point-of-care, visually read test cup, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For this type of device, the "ground truth" during its development and validation would primarily be the known concentrations of target analytes (drugs/metabolites) in synthetic or spiked urine samples, and comparison to established methods or predicate devices. It would not typically involve expert consensus, pathology, or outcomes data in the sense of a clinical trial for a diagnostic image analysis algorithm.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device.
{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.
{1}------------------------------------------------
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) |
§ 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).