PASCO MIC AND MIC/ID PANELS

K973695 · Pasco Laboratories, Inc. · JWY · Nov 5, 1997 · Microbiology

Device Facts

• Record ID: K973695
• Device Name: PASCO MIC AND MIC/ID PANELS
• Applicant: Pasco Laboratories, Inc.
• Product Code: JWY · Microbiology
• Decision Date: Nov 5, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Indications for Use

Pasco MIC and MIC/ID panels are used for quantitatively measuring (with the exception of the Breakpoint/ID panel which provides qualitative measurement of category results) the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms.

Device Story

Pasco MIC and MIC/ID panels are in vitro diagnostic devices used in clinical laboratories to determine bacterial susceptibility to antimicrobial agents and perform biochemical identification. This submission adds Meropenem to the existing panel line. The device utilizes standardized concentrations of antimicrobial agents to measure bacterial growth inhibition. Laboratory technicians inoculate the panels with patient-derived bacterial isolates; panels are then incubated and analyzed to determine the Minimum Inhibitory Concentration (MIC). Results assist clinicians in selecting appropriate antibiotic therapy for patients with bacterial infections. The device is intended for prescription use only.

Clinical Evidence

No clinical data provided. The submission relies on the established performance of the Pasco MIC/ID panel system for antimicrobial susceptibility testing.

Technological Characteristics

In vitro diagnostic panel for antimicrobial susceptibility testing and biochemical identification. Employs standardized antimicrobial concentrations (0.03 to 32 mcg/ml for Meropenem).

Indications for Use

Indicated for determining susceptibility of K. pneumoniae, E. coli, and P. aeruginosa to Meropenem (0.03 to 32 mcg/ml). Not indicated for Haemophilus sp., Viridans group streptococci, or S. pneumoniae.

Regulatory Classification

Identification

An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV - 5 1997

Linda K. Dillon Technical Manager Pasco Laboratories, Inc. 12750 West Forty-Second Avenue Wheat Ridge, Colorado 80033

K973695 Re:

Trade Name: Pasco MIC and MIC/ID Panels/meropenem Regulatory Class: II Product Code: JWY Dated: September 23, 1997 Received: September 26, 1997

Dear Ms. Dillon:

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, 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 current Good Manufacturing Practice requirement, 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 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 Autman

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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Device Name:

## PASCO MIC and MIC/ID Panels; Inclusion of MEROPENEM

Indication For Use:

Pasco MIC and MIC/ID panels are used for quantitatively measuring (with the exception of the Breakpoint/ID panel which provides qualitative measurement of category results) the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms.

This 510(k) notification is for the addition of Meropenem to Pasco panels at concentrations of 0.03 to 32 mcg/ml for use in determining the susceptibility of K. pneumoniae, E. coli and P. aeruginosa. Clinical testing with Haemophilus sp., Viridans group streptococci and S. pneumoniae with Meropenem has not been performed with the Pasco system.

Ken Cooper
(Division Sign-Off)

Division of Clinical Laboratory Devices 510(k) Number 17 7

Prescription Use √ (Per 21 CFR 801.109) OR

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)