(241 days)
The MIDI Sherlock® Mycobacteria Identification System is intended to aid in the identification of M. tuberculosis and differentiation from other mycobacteria species through the analysis of mycolic acids derived from cultured bacterial samples, using high performance liquid chromatography (HPLC) performed on the Agilent model 1100 HPLC, along with Sherlock® pattern recognition software.
The system is used, along with other identification methods, to identify mycobacteria that have been isolated from clinical specimens by traditional culturing techniques. Following observation of growth on the solid medium, identification of the mycobacterial isolate is done with the MIDI Sherlock® Mycobacteria Identification System device. Results should be interpreted in conjunction with other laboratory observations and procedures.
The MIDI Sherlock® Mycobacteria Identification System is intended to aid in the identification of M. tuberculosis and differentiation from other mycobacteria species through the analysis of mycolic acids derived from cultured bacterial samples, using high performance liquid chromatography (HPLC) performed on the Agilent model 1100 HPLC, along with Sherlock® pattern recognition software.
I am sorry, but the provided text does not contain information about acceptance criteria and a study proving a device meets them. The text is a 510(k) clearance letter for the MIDI Sherlock® Mycobacteria Identification System, which details the FDA's decision regarding its substantial equivalence to a predicate device and its intended use. It does not include details about device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications.
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OCT 31 2002
Food and Drug Administration 098 Gaither Road Rockville MD 20850
Mr. William Stimson Quality Assurance/Compliance Manager MIDI, Inc. 125 Sandy Drive Newark, DE 19713
Re: K020689
Trade/Device Name: MIDI Sherlock® Mycobacteria Identification System Regulation Number: 21 CFR 866.3370 Regulation Name: Mycobacterium Tuberculosis Immunofluorescent Reagents Regulatory Class: Class I Product Code: NJO Dated: August 19, 2002 Received: August 19, 2002
Dear Mr. Stimson:
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 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 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 Butman
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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510(k) Number (if known): K020689
Device Name: MIDI Sherlock® Mycobacteria Identification System
Indications For Use
The MIDI Sherlock® Mycobacteria Identification System is intended to aid in the identification of M. tuberculosis and differentiation from other mycobacteria species through the analysis of mycolic acids derived from cultured bacterial samples, using high performance liquid chromatography (HPLC) performed on the Agilent model 1100 HPLC, along with Sherlock® pattern recognition software.
The system is used, along with other identification methods, to identify mycobacteria that have been isolated from clinical specimens by traditional culturing techniques. Following observation of growth on the solid medium, identification of the mycobacterial isolate is done with the MIDI Sherlock® Mycobacteria Identification System device. Results should be interpreted in conjunction with other laboratory observations and procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Eyaluation (ODE)
Freddie m. 100/4
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K020689
Prescription Use ✓
§ 866.3370
Mycobacterium tuberculosis immunofluorescent reagents.(a)
Identification. Mycobacterium tuberculosis immunofluorescent reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyMycobacterium tuberculosis directly from clinical specimens. The identification aids in the diagnosis of tuberculosis and provides epidemiological information on this disease.Mycobacterium tuberculosis is the common causative organism in human tuberculosis, a chronic infectious disease characterized by formation of tubercles (small rounded nodules) and tissue necrosis (destruction), usually occurring in the lung.(b)
Classification. Class I (general controls).