(101 days)
dBest Amphetamines Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of amphetamines in urine with cutoff of 1000 ng/ml. The dBest Amphetamines Test Kits are for professional and laboratory use only.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the "dBest AMP Test Kit" and related documents. It does not contain the detailed information necessary to answer all the questions about acceptance criteria or a specific study proving the device meets them. This type of regulatory document typically confirms equivalence to a predicate device based on submitted data, rather than detailing the full study methodology and results.
However, based on the limited information present in the document, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or a detailed performance table. The "Indications For Use" section provides a key performance characteristic:
| Characteristic | Acceptance Criterion (Implicit) | Reported Performance (Implicit) |
|---|---|---|
| Amphetamines detection cutoff in urine | N/A (Not explicitly stated as a criterion) | 1000 ng/ml |
2. Sample size used for the test set and the data provenance
This information is not available in the provided text. The document is a clearance letter, not the study report itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not available in the provided text.
4. Adjudication method for the test set
This information is not available in the provided text.
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
This device is an "immunochromatographic assay" – a rapid test kit for detecting amphetamines. It is not an AI-powered diagnostic device, nor does it involve "human readers" in the sense of interpreting complex images. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to AI algorithm performance. As established above, this is not an AI device. The device itself is standalone in that it provides a direct result (qualitative detection of amphetamines).
7. The type of ground truth used
While not explicitly stated for the testing proving the device performance, for a diagnostic test like this, the ground truth would typically be established by a reference method, such as:
- Mass Spectrometry (e.g., GC-MS or LC-MS): This is the gold standard for confirming drug presence and concentration in urine samples.
8. The sample size for the training set
This information is not available in the provided text, as it doesn't describe the study details. Furthermore, for a simple immunochromatographic assay, the concept of a "training set" (as typically used in machine learning) might not directly apply in the same way. Development would involve extensive analytical validation, but not necessarily machine learning training.
9. How the ground truth for the training set was established
This information is not available in the provided text. (See point 8 regarding "training set.")
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
6 1398 AUG
K.C. Yee, Ph.D. President & CEO AmeriTek, Inc. 7030 35th Avenue, N.E. Seattle, Washington 98115
Re : K981504 dBest AMP Test Kit Requlatory Class: II Product Code: DKZ Dated: June 21, 1998 Received: June 29, 1998
Dear Dr. Yee:
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 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, Druq, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗೆ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set wire 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 In addition, FDA may publish further announcements action. 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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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/dsmamain.html".
Sincerely yours,
Steven Gutman
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
510 (K) Number (if known): 981504
Device Name: dBest Amphetamines Test Kits
Indications For Use:
dBest Amphetamines Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of amphetamines in urine with cutoff of 1000 ng/ml. The dBest Amphetamines Test Kits are for professional and laboratory use only.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 1981504
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PATE IF NEEDEN)
Prescription Use
OR
Over-The -Counter Use (Optional Format 1-2-96)
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).