(25 days)
Immunoassay for the qualitative detection of amphetamine, THC metabolites, methamphetamine, opiates, and phencyclidine in human urine to assist in screening of drugs of abuse samples. The detecting cut-off concentrations are as follows:
| AMP | Amphetamine | 1000 ng/mL |
|---|---|---|
| THC | 11-nor-A9-9-carboxylic acid | 50 ng/mL |
| COC | Benzoylecgonine | 300 ng/mL |
| MET | D-Methamphetamine | 1000 ng/mL |
| OPI | Morphine | 300 ng/mL |
| PCP | Phencyclidine | 25 ng/mL |
Not Found
The provided FDA document (K991751) is a 510(k) clearance letter for the Status Cup™ drug testing device. It does not contain a detailed study report with acceptance criteria and performance data in the format requested. The document primarily confirms that the device is substantially equivalent to legally marketed predicate devices for the qualitative detection of multiple drugs in human urine.
However, based on the Indications For Use section (page 3), we can infer the implied acceptance criteria and the claimed device performance with respect to the detecting cut-off concentrations.
Here's an attempt to structure the information based on the prompt, drawing directly from the provided text and acknowledging the limitations:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states the "detecting cut-off concentrations" for each substance. While not explicitly termed "acceptance criteria" in a typical study report, these are the thresholds the device is designed to meet for qualitative detection. The "reported device performance" is the claim that the device does detect at these concentrations.
| Drug Abbreviation | Drug Name | Acceptance Criteria (Cut-off Concentration) | Reported Device Performance (Detection at Cut-off) |
|---|---|---|---|
| AMP | Amphetamine | 1000 ng/mL | Qualitatively detects at 1000 ng/mL |
| THC | 11-nor-Δ9-9-carboxylic acid | 50 ng/mL | Qualitatively detects at 50 ng/mL |
| COC | Benzoylecgonine | 300 ng/mL | Qualitatively detects at 300 ng/mL |
| MET | D-Methamphetamine | 1000 ng/mL | Qualitatively detects at 1000 ng/mL |
| OPI | Morphine | 300 ng/mL | Qualitatively detects at 300 ng/mL |
| PCP | Phencyclidine | 25 ng/mL | Qualitatively detects at 25 ng/mL |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not specified in the provided document.
- Data provenance: Not specified in the provided document (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not specified.
- Qualifications of experts: Not specified.
4. Adjudication method for the test set:
- Not specified.
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:
- MRMC study: Not applicable. This device is an in-vitro diagnostic (IVD) immunoassay, not an AI-assisted diagnostic tool requiring human reader interpretation in the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This device is an immunoassay cup. Its performance is inherently "standalone" in that it produces a result directly from a biochemical reaction. There is no separate "algorithm" performance beyond the cup's chemical reactivity.
7. The type of ground truth used:
- While not explicitly stated, for IVD drug screens, the ground truth for performance studies is typically established using confirmatory analytical methods (e.g., Gas Chromatography-Mass Spectrometry (GC-MS) or Liquid Chromatography-Mass Spectrometry (LC-MS)) on urine samples spiked with known concentrations of the target analytes or using clinically characterized urine samples.
8. The sample size for the training set:
- Training set size: Not applicable/not specified. For an immunoassay, there isn't typically a "training set" in the machine learning sense. Performance is based on chemical design and validation studies.
9. How the ground truth for the training set was established:
- Ground truth establishment for training set: Not applicable, as there's no "training set" in the machine learning sense for this type of device.
Summary of Limitations:
The provided document is a 510(k) clearance letter, which confirms substantial equivalence. It does not include the detailed study reports or performance data that would typically contain the requested information about sample sizes, ground truth establishment, expert qualifications, or specific study methodologies. These details would be found within the premarket notification (510(k) submission) itself, which is not publicly available in this format.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 18 1999
Jemo Kang, Ph.D., M.B.A. Director Princeton BioMeditech Corporation 4242 U.S. Route 1 Monmouth Junction, New Jersey 08852-1905
Re: K991751
Trade Name: Status Cup™ - AMP/THC/COC/MET/OPI/PCP Regulatory Class: II Product Code: DKE, DIO, LAG, DJG, LCM, DKZ Dated: May 15, 1999 Received: May 24, 1999
Dear Dr. Kang:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 predicate 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 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, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Butman
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
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Page_of_of_of_________________________________________________________________________________________________________________________________________________________________
2(k) Number (if known): _ 1 9 1 75
Device Name:__Status Cup
Indications For Use:
Immunoassay for the qualitative detection of amphetamine, THC metabolites, methamphetamine, opiates, and phencyclidine in human urine to assist in screening of drugs of abuse samples. The detecting cut-off concentrations are as follows:
| AMP | Amphetamine | 1000 ng/mL |
|---|---|---|
| THC | 11-nor-A9-9-carboxylic acid | 50 ng/mL |
| COC | Benzoylecgonine | 300 ng/mL |
| MET | D-Methamphetamine | 1000 ng/mL |
| OPI | Morphine | 300 ng/mL |
| PCP | Phencyclidine | 25 ng/mL |
JeanCooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K991751
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Professional Use:_X Prescription Use:_X 'Per 21 CFR 801.109)
OR
(Optional Format 1-2-96)
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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).