(71 days)
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No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators of AI/ML technology. The intended use describes a qualitative visual test, which typically does not involve AI/ML.
No
The intended use describes this device as a qualitative visual test for the presence of Methamphetamine and its metabolites in a sample. This indicates a diagnostic or analytical purpose, not a therapeutic function which would involve treating a disease or condition.
Yes
The intended use states "Qualitative visual test for the presence of Methamphetamine and its metabolites in Urine sample," which describes a process of identifying a substance in a biological sample, a key function of a diagnostic device.
Unknown
The provided text is a very incomplete 510(k) summary. It lacks a device description, which is crucial for determining if the device is software-only or includes hardware components. The intended use describes a qualitative visual test for a substance in a urine sample, which could potentially involve a physical test strip or other hardware, but this is not confirmed without a device description.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "Qualitative visual test for the presence of Methliam phetamine and its metabolites in Uside sample". This indicates the device is designed to perform a test on a biological sample (likely urine, given the context of drug testing) outside of the body to provide diagnostic information (presence of a substance).
This aligns directly with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnostic, monitoring, or screening purposes.
N/A
Intended Use / Indications for Use
Qualitative visual teit for the presence of Methliam phetamine and its metabolites in Uside sample
Product codes
DKZ
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
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Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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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 features a stylized eagle with its wings outstretched, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is presented in black and white.
AUG 1 2 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ming Sun, Ph.D. Sun Biomedical Labs., Inc. 2040 Fairfax Avenue Cherry Hill, NJ 08003
Re : K972032/S1 Visualine® II Methamphetamine Requlatory Class: II Product Code: DKZ Dated: July 18, 1997 Received: July 23, 1997
Dear Dr. Sun:
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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 Requlations.
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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 requlation (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 Litman
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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Sera Products Co. 6097510681 P.02
FRI 12:52 FAX 301 5945940 FDA DCLD 002
Page 2 of 2
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K97032 |
| Device Name: | Visualine II Methamphetamine |
| Indications For Use: | Qualitative visual teit for the presence of Methliam phetamine and its metabolites in Uside sample |
(Division Sign-Off)
Division of Clinical, Laboratory Devices
| Labels | Values |
|---|---|
| 510(k) Number | K972032 |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Labels | Values |
|---|---|
| Prescription Use (Per 21 CFR 801.109) | / |
| OR | Over-The-Counter Use (Optional Format 1-2-96) |