(55 days)
The UCP Multiple Drug Screen Test Cups are rapid, qualitative, competitive binding immunoassays for the detection of Amphetamine, Barbiturates, Bezodiazepines, Cocaine, Marijuana, Methadone, Methamphetamine, MDMA, Morphine, Opiate 2000, Oxycodone, Phencyclidine, Tricyclic Antidepressants, Propoxyphene and their metabolites in human urine at the following cutoff levels:
| Test | Calibrator | Cut-off |
|---|---|---|
| Amphetamine | D-Amphetamine | 1000 ng/mL |
| Barbiturates | Secobarbital | 300 ng/mL |
| Benzodiazepines | Oxazepam | 300 ng/mL |
| Cocaine | Benzoylecgonine | 300 ng/mL |
| Marijuana | Delta-9-THC-COOH | 50 ng/mL |
| Methadone | Methadone | 300 ng/mL |
| Methamphetamine | D-Methamphetamine | 1000 ng/mL |
| MDMA | MDMA | 500 ng/mL |
| Morphine | Morphine | 300 ng/mL |
| Opiate 2000 | Morphine | 2000 ng/mL |
| Oxycodone | Oxycodone | 100 ng/mL |
| Phencyclidine | Phencylidine | 25 ng/mL |
| Tricyclic Antidepressant | Nortriptyline | 1000 ng/mL |
| Propoxyphene | Propoxyphene | 300 ng/mL |
The tests provide only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). The test configuration comes with any combination of multiple drug screen tests. Clinical considerations and professional judgment should be applied to any drug of abuse test results, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels.
Prescription Use (21 CFR Part 801 Subpart D) And/Or Over the Counter Use (21 CFR Part 801 Subpart C)
The UCP Multiple Drug Screen Test Cups are rapid, qualitative, competitive binding immunoassays for the detection of Amphetamine, Barbiturates, Bezodiazepines, Cocaine, Marijuana, Methadone, Methamphetamine, MDMA, Morphine, Opiate 2000, Oxycodone, Phencyclidine, Tricyclic Antidepressants, Propoxyphene and their metabolites in human urine.
The provided text describes a 510(k) premarket notification for the "UCP Multiple Drug Screen Test Cups," which is an in vitro diagnostic device. The document issues a substantial equivalence determination for this device, meaning it is considered equivalent to legally marketed predicate devices.
However, the provided text does not contain detailed information about the specific acceptance criteria, a standalone study to prove the device meets these criteria, sample sizes for test or training sets, ground truth establishment methods, or the qualifications of experts. The document is an FDA clearance letter and an "Indication for Use" statement, not a scientific study report.
The "Indication for Use" section lists the drugs detected and their respective cutoff levels (calibrator and cutoff concentration), which could be interpreted as part of the performance specification. However, it does not explicitly state "acceptance criteria" and "reported device performance" in the format of a typical scientific or validation study. It describes what the device is designed to do.
Therefore, I cannot fulfill most of your request using the provided text.
Here's what I can extract or infer:
1. A table of acceptance criteria and the reported device performance:
The document describes the intended performance specifications (detection of specific drugs at specific cutoff levels). It does not provide a table of acceptance criteria (e.g., sensitivity, specificity thresholds) alongside reported device performance (actual experimental results against those thresholds).
The table below shows the inherent performance specification from the "Indication for Use" section:
| Test | Calibrator | Cut-off (ng/mL) |
|---|---|---|
| Amphetamine | D-Amphetamine | 1000 |
| Barbiturates | Secobarbital | 300 |
| Benzodiazepines | Oxazepam | 300 |
| Cocaine | Benzoylecgonine | 300 |
| Marijuana | Delta-9-THC-COOH | 50 |
| Methadone | Methadone | 300 |
| Methamphetamine | D-Methamphetamine | 1000 |
| MDMA | MDMA | 500 |
| Morphine | Morphine | 300 |
| Opiate 2000 | Morphine | 2000 |
| Oxycodone | Oxycodone | 100 |
| Phencyclidine | Phencylidine | 25 |
| Tricyclic Antidepressant | Nortriptyline | 1000 |
| Propoxyphene | Propoxyphene | 300 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Information Not Found. The document does not provide details of specific studies, including sample size or data 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):
- Information Not Found. The document does not describe the establishment of ground truth or the involvement of experts for validation studies. The ground truth for drug tests like these is typically established through analytical chemistry methods, not expert consensus in the same way as medical imaging.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Information Not Found. This concept is generally not applicable to a chemical immunoassay, which provides a direct quantitative or qualitative result based on chemical reaction, not human interpretation requiring adjudication.
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:
- Information Not Found. This device is an in vitro diagnostic test (immunoassay), not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Information Not Found (but implied by device type). The device itself is a standalone test that produces a result (positive/negative based on cutoff levels). Its performance is inherently "standalone" in this context. However, the document does not describe such a study or its results. It simply states the device's function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Inferred: For drug screen tests, the ground truth for validation is typically established by definitive analytical methods, most commonly Gas Chromatography/Mass Spectrometry (GC/MS). The document explicitly states: "The tests provide only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS)." This strongly implies GC/MS is the reference standard for confirmatory results and, therefore, the likely "ground truth" for validation studies.
8. The sample size for the training set:
- Information Not Found. The document refers to a commercial product, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
- Information Not Found. See point 8.
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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 stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and is smaller than the eagle symbol. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
UCP Biosciences, Inc. c/o Dr. Nancy Chen 1445 Koll Circle, Suite 111 San Jose, CA 95112
Re: K072062 Trade/Device Name: UCP Multiple Drug Screen Test Cups Regulation Number: 21 CFR 862.3910 Regulation Name: Tricyclic Antidepressant Drugs Test System. Regulatory Class: Class II Product Code: LFG, JXN, DKZ, DIS, JXM, LDJ, DIO, DJC, DJR, DJG, LCM Dated: August 23, 2007 Received: August 24, 2007
SEP 2 0 2007
Dear Dr. Chen:
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).
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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) 276-0490. Also, please nother the regulation entitled, "Misbranding by reference to premarket notification", (21CFR Part 80.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its than the (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean m. Cooper, M.S., D.V.M.
Yéan M. Cooper, M.S., 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
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Indication for Use
510(k) Number (if known): K072062 Device Name: UCP Multiple Drug Screen Test Cups Indication For Use:
The UCP Multiple Drug Screen Test Cups are rapid, qualitative, competitive binding immunoassays for the detection of Amphetamine, Barbiturates, Bezodiazepines, Cocaine, Marijuana, Methadone, Methamphetamine, MDMA, Morphine, Opiate 2000, Oxycodone, Phencyclidine, Tricyclic Antidepressants, Propoxyphene and their metabolites in human urine at the following cutoff levels:
| Test | Calibrator | Cut-off |
|---|---|---|
| Amphetamine | D-Amphetamine | 1000 ng/mL |
| Barbiturates | Secobarbital | 300 ng/mL |
| Benzodiazepines | Oxazepam | 300 ng/mL |
| Cocaine | Benzoylecgonine | 300 ng/mL |
| Marijuana | Delta-9-THC-COOH | 50 ng/mL |
| Methadone | Methadone | 300 ng/mL |
| Methamphetamine | D-Methamphetamine | 1000 ng/mL |
| MDMA | MDMA | 500 ng/mL |
| Morphine | Morphine | 300 ng/mL |
| Opiate 2000 | Morphine | 2000 ng/mL |
| Oxycodone | Oxycodone | 100 ng/mL |
| Phencyclidine | Phencylidine | 25 ng/mL |
| Tricyclic Antidepressant | Nortriptyline | 1000 ng/mL |
| Propoxyphene | Propoxyphene | 300 ng/mL |
The tests provide only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). The test configuration comes with any combination of multiple drug screen tests. Clinical considerations and professional judgment should be applied to any drug of abuse test results, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels.
Prescription Use (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K072062
Page 1 of 1
§ 862.3910 Tricyclic antidepressant drugs test system.
(a)
Identification. A tricyclic antidepressant drugs test system is a device intended to measure any of the tricyclic antidepressant drugs in serum. The tricyclic antidepressant drugs include imipramine, desipramine, amitriptyline, nortriptyline, protriptyline, and doxepin. Measurements obtained by this device are used in the diagnosis and treatment of chronic depression to ensure appropriate therapy.(b)
Classification. Class II (special controls). A tricyclic antidepressant drugs 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).