(83 days)
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No
The summary describes a qualitative urine test strip, which is a chemical assay and does not typically involve AI/ML. There are no mentions of AI, ML, image processing, or data analysis that would suggest the use of such technology.
No
The device is intended to qualitatively detect metabolites of drugs in urine, which is a diagnostic purpose, not a therapeutic one. It identifies a condition (presence of opiate metabolites) rather than treating or preventing it.
Yes
The device is intended to qualitatively detect metabolites of drugs in urine, which is a diagnostic purpose.
No
The 510(k) summary describes a "Micro-Strip for Opiate Metabolites," which strongly suggests a physical test strip, a hardware component, is involved in the detection of metabolites. The lack of a device description prevents definitive confirmation, but the name points away from a software-only device.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed to "qualitatively detect the metabolites of Opiate and Opiate-like drugs in urine."
- Sample Type: The device analyzes a biological sample (urine) taken from the human body.
- Purpose: The purpose is to provide information about a person's health status (presence of drug metabolites) by testing this sample in vitro (outside the body).
These are the key characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Microdiagnostics, Inc. Micro-Strip for Opiate Metabolites is intended to qualitatively detect the metabolites of Opiate and Opiate-like drugs in urine.
Product codes (comma separated list FDA assigned to the subject device)
DJG
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 4 1997
Roy Chung · President Microdiagnostics, Inc. 28062 Forbes Road, Suite B Laguna Niquel, California 92677
Re : K973761 Micro-Strip for Opiate Metabolites Requlatory Class: II Product Code: DJG Dated: November 17, 1997 Received: November 21, 1997
Dear Mr. Chung:
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 regulations 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 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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 Sitman
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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CRODIAGNOSTICS
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510(k) Number (if known):
Device Name: Micro-Strip for Opiate Metabolites
Indications For Use:
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The Microdiagnostics, Inc. Micro-Strip for Opiate Metabolites is intended to qualitatively detect the metabolites of Opiate and Opiate-like drugs in urine.
/// M. Mbraild for rw/Mmmymny
(Division Sign-On)
Division of Clinical Laboratory Devices
510(k) Number. 4973761
LEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF EDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
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Over-The-Counter Use
(Optional Format 1-2-96)