(187 days)
Not Found
Not Found
No
The description details a standard immunochromatographic test, which relies on chemical reactions and visual interpretation, not AI/ML algorithms. There are no mentions of AI, ML, image processing, or data analysis methods typically associated with AI/ML.
No.
This device is an in-vitro diagnostic test used to detect drug substances in urine, providing a preliminary analytical result, not a treatment or therapy.
Yes
The "Intended Use / Indications for Use" section states that the device is "intended for the qualitative determination of up to nine different drug substances in human urine," which classifies it as a diagnostic test.
No
The device description explicitly states it is an "immunochromatographic one-step in-vitro test," which is a physical test kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The MICROMEDIC® Drugs of Abuse Panel Test is an immunochromatographic one-step in-vitro test intended for the qualitative determination of up to nine different drug substances in human urine..."
The "Device Description" section also states: "The MICROMEDIC® Drugs of Abuse Panel Test is an immunochromatographic one-step in-vitro test intended for the qualitative determination of up to nine different drug substances in human urine."
The term "in-vitro" means "in glass" or "in the lab," referring to tests performed outside of a living organism. This is the defining characteristic of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MICROMEDIC® Drugs of Abuse Panel Test is an immunochromatographic one-step in-vitro test intended for the qualitative determination of up to nine different drug substances in human urine at the following cut-off levels (amphetamine, 1000 ng/ml; barbiturate [secobarbital], 300 ng/ml; benzodiazepine [oxazepam], 300 ng/ml; cocaine, 300 ng/ml; methadone, 300 ng/ml; methamphetamine, 1000 ng/ml; opiates, 2000 ng/ml; phencyclidine, 25 ng/ml; and cannabinoid, 50 ng/ml).
The MICROMEDIC® Drugs of Abuse Panel Test is intended for use in a point-ofcare (POC) setting to include emergency hospitals and medical care facilities (i.e., emergency rooms, ambulances, etc.), as well as the workplace, criminal justice and transportation arenas, and walk-in, or mobile drug testing facilities. The MICROMEDIC® Drugs of Abuse Panel Test will provide a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMHSA). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. It is the responsibility of those organizations required to follow Department of Transportation (DOT) or the Substance Abuse and Mental Health Administration (SAMHSA) Workplace Drug Testing Guidelines to determine that use of this product satisfics the criteria for workplace testing established under DOT and SAMHSA.
Product codes
DKZ, DIS, JXM, LDJ, DIO, DJR, DJC, DJG, and LCM
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
point-of-care (POC) setting to include emergency hospitals and medical care facilities (i.e., emergency rooms, ambulances, etc.), as well as the workplace, criminal justice and transportation arenas, and walk-in, or mobile drug testing facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or other bird-like figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 7 2004
Ms. Robin J. Helen, MS Rapid Diagnostics, Inc. c/o Hellen Professional Services 9418 Lasaine Avenue Northridge, CA 91325
Re: K033566
Trade/Device Name: MICROMEDIC® Drugs of Abuse Panel Test Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ, DIS, JXM, LDJ, DIO, DJR, DJC,DJG, and LCM Dated: March 19, 2004 Received: March 24, 2004
Dear Ms. Hellen:
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).
1
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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its 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,
Jean M. Cooper, US, DVM.
Yean M. Cooper, MS, 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
2
STATEMENT FOR INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
MICROMEDIC® Drugs of Abuse Panel Test
The MICROMEDIC® Drugs of Abuse Panel Test is an immunochromatographic one-step in-vitro test intended for the qualitative determination of up to nine different drug substances in human urine at the following cut-off levels (amphetamine, 1000 ng/ml; barbiturate [secobarbital], 300 ng/ml; benzodiazepine [oxazepam], 300 ng/ml; cocaine, 300 ng/ml; methadone, 300 ng/ml; methamphetamine, 1000 ng/ml; opiates, 2000 ng/ml; phencyclidine, 25 ng/ml; and cannabinoid, 50 ng/ml).
The MICROMEDIC® Drugs of Abuse Panel Test is intended for use in a point-ofcare (POC) setting to include emergency hospitals and medical care facilities (i.e., emergency rooms, ambulances, etc.), as well as the workplace, criminal justice and transportation arenas, and walk-in, or mobile drug testing facilities. The MICROMEDIC® Drugs of Abuse Panel Test will provide a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMHSA). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. It is the responsibility of those organizations required to follow Department of Transportation (DOT) or the Substance Abuse and Mental Health Administration (SAMHSA) Workplace Drug Testing Guidelines to determine that use of this product satisfics the criteria for workplace testing established under DOT and SAMHSA.
Concurrence of the CDRH, Office of Device Evaluation (ODE)
Alberto Lu
Division Sign-Off
Division Sign-off
| Prescription Use: | X |
|---|---|
| ------------------- | ----------------------------------------- |
Office of In Vitro Diagnostics Counter Use: Device Evaluation and Safety
510(k) K033566