(126 days)
The Microdiagnostics, Inc. D&V The Microdiagnostics, Inc. Distincts the metabolit The Microdiagnostics, Inc. barge of detects the metabolites is an immunoassay that quartiallery oceates and Phencyclidine of Amphecamine, Gocaine, Massystems in human urine at the SAMHSA cutoff levels. This test is intended for professional use only.
Not Found
The provided text describes a 510(k) premarket notification for a "Multi-Test Strip" device for detecting drugs of abuse in human urine. However, it does not contain any information regarding acceptance criteria, study results, sample sizes (for test or training sets), expert qualifications, ground truth methods, or MRMC studies.
The document is a letter from the FDA to Microdiagnostics, Inc., confirming the substantial equivalence of their device to legally marketed predicate devices. It lists the device's indications for use and regulatory classifications but does not detail the internal validation studies performed by the manufacturer to establish performance.
Therefore, I cannot provide the requested information based on the input text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around the edge. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 25 2001
Ms. June Shozi Senior Scientist Microdiagnostics, Inc. 28062 Forbes Road - Suite B Laguna Niguel, CA 92677
K011952 Trade/Device Name: Multi-Test Strip Regulation Number: 21 CFR 862.3100; 21 CFR 862.3250; 21 CFR 862.3870; 21 CFR 862.3650 Regulation Name: Amphetamine test system; Cocaine and cocaine metabolite test system; Cannabinoid test system; Opiate test system Regulatory Class: Class II; Class II; Class II; Class II Product Code: DKZ; DIO; LDJ; DJG; LCM Dated: August 20, 2001 Received: August 23, 2001
Dear Ms. Shozi:
Re:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 needicate 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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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,
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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1011952/191 Page_1_of_1
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510(k) Number (if known): K011952
Device Name: Drugs of Abuse
Multi-Test strip
Indications For Usc:
The Microdiagnostics, Inc. D&V
The Microdiagnostics, Inc. Distincts the metabolit The Microdiagnostics, Inc. barge of detects the metabolites is an immunoassay that quartiallery oceates and Phencyclidine of Amphecamine, Gocaine, Massystems
in human urine at the SAMHSA cutoff levels.
This test is intended for professional use only.
Kan Cooper
(Division Sign-Off)
Division of Clinical Laboratory Device:
510(k) Number K011952
SK-43
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEBIED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
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).