MODIFICATION OF EST CULTURE SYSTEM II - MYCO

K972756 · Accumed Intl., Inc. · MDB · Aug 1, 1997 · Microbiology

Device Facts

• Record ID: K972756
• Device Name: MODIFICATION OF EST CULTURE SYSTEM II - MYCO
• Applicant: Accumed Intl., Inc.
• Product Code: MDB · Microbiology
• Decision Date: Aug 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2560
• Device Class: Class 1

Intended Use

The ESP Culture System II - Myco is an automated system for the growth and detection of mycobacteria from human specimens, including the use of nucleic acid probes for the direct confirmation of positive ESP - myco bottles.

Device Story

ESP Culture System II - Myco is an automated laboratory instrument for culturing and detecting mycobacteria in human clinical specimens. System utilizes specialized culture bottles to support mycobacterial growth. Detection mechanism monitors for metabolic activity or growth indicators within bottles. System supports integration with nucleic acid probe testing for direct confirmation of positive samples. Operated by laboratory technicians in clinical laboratory environments. Provides automated monitoring to alert clinicians to positive cultures, facilitating timely identification of mycobacterial infections and informing clinical treatment decisions.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on 510(k) notification review.

Technological Characteristics

Automated culture and detection system for mycobacteria. Includes specialized culture bottles and integration capability for nucleic acid probe assays. Operates as a laboratory diagnostic instrument.

Indications for Use

Indicated for the growth and detection of mycobacteria from human clinical specimens. Intended for use by trained laboratory personnel in clinical settings.

Regulatory Classification

Identification

A microbial growth monitor is a device intended for medical purposes that measures the concentration of bacteria suspended in a liquid medium by measuring changes in light scattering properties, optical density, electrical impedance, or by making direct bacterial counts. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

Submission Summary (Full Text)

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1997

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Marianne R. Plaunt, Ph.D. Research Manager AUG - I AccuMed International, Inc. - 29299 Clemens Road, Suite 1-K Westlake, Ohio 44145

Re: K972756 Trade Name: ESP™ Culture System II - Myco/modification Regulatory Class: I Product Code: MDB Dated: May 16, 1997 Received: May 30, 1997

Dear Dr. Plaunt:

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 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, Drug, 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 Regulations, Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Sutman

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): Device Name: ESP Culture System II - Myco

Indications For Use:

The ESP Culture System II - Myco is an automated system for the growth and detection of -mycobacteria from human specimens, including the use of nucleic acid probes for the direct confirmation of positive ESP - myco bottles.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)

Khatme Alverly for Cickon Pontes
(Division Sign-Off)

Division of Clinical Laboratory Devices 510(k) Number ..