PASCO MIC AND MIC/ID PANELS

K974362 · Pasco Laboratories, Inc. · JWY · Feb 12, 1998 · Microbiology

Device Facts

• Record ID: K974362
• Device Name: PASCO MIC AND MIC/ID PANELS
• Applicant: Pasco Laboratories, Inc.
• Product Code: JWY · Microbiology
• Decision Date: Feb 12, 1998
• 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 or category results) the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the blochemical identification of those organisms.

Device Story

Pasco MIC and MIC/ID panels consist of frozen microtiter plates containing twofold dilutions of antimicrobial agents. Clinical laboratory personnel inoculate panels with bacterial isolates; incubate for 16-24 hours. Device detects minimum inhibitory concentration (MIC) via visual observation of growth or color changes; biochemical identification is determined by metabolic byproduct production. Results assist clinicians in selecting appropriate antimicrobial therapy for bacterial infections. System is intended for professional use in clinical laboratory settings.

Clinical Evidence

Bench and clinical performance testing compared Pasco panels to reference panels using CDC challenge strains and clinical isolates. Gram-negative isolates: 98.2% initial Essential Agreement (EA), 99.4% after retest; 97.3% Category Agreement (CA). Gram-positive isolates: 100% EA; 88.1% CA. Reproducibility testing demonstrated 98.8% agreement within +/- 1 dilution. QC endpoints remained within NCCLS ranges.

Technological Characteristics

Microtiter panel format containing twofold dilutions of antimicrobial agents. Frozen storage; requires thawing prior to inoculation. Principle of operation: broth microdilution for MIC determination and biochemical substrate analysis for organism identification. Manual or visual interpretation of growth/color change.

Indications for Use

Indicated for quantitative susceptibility testing of rapidly growing aerobic and facultative anaerobic bacterial pathogens to antimicrobial agents, including Cefepime (0.03-64 mcg/ml), and biochemical identification. Target organisms include Enterobacter spp., E. coli, K. pneumoniae, P. mirabilis, P. aeruginosa, and methicillin-susceptible S. aureus. Not indicated for 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.

Predicate Devices

• Pasco MIC and MIC/ID panels (K972567)
• Pasco MIC and MIC/ID panels (K971951)
• Pasco MIC and MIC/ID panels (K946126)

Submission Summary (Full Text)

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PASCO LABORATORIES, 12750 WEST FORTY-SECOND AVEN

WHEAT RIDGE, COLORADO 8003

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FEB | 2 |998

510(k) SUMMARY (page 1 of 2)

| DATE: | November 13, 1997 |
|-----------------------|----------------------------------------------------------------------|
| CONTACT PERSON: | Linda K. Dillon |
| TRADE NAME OF DEVICE: | Pasco MIC and MIC/ID Panels |
| COMMON NAME: | Antimicrobial Susceptibility Test |
| CLASSIFICATION NAME: | Class II Antimicrobial Susceptibility<br>Test Microbiology Panel #83 |

## SUBSTANTIAL EQUIVALENCE:

In review of previous 510(k) notifications for the Pasco MIC and MIC/ID panels (most recently K972567, August 20,1997 RE: Sparfloxacin; K971951, August 15, 1997 RE: Levofloxacin; and K946126, January 17, 1995 RE: Detection of Resistant pneumococci), the FDA has determined the Pasco panels to be substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments.

The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence as found in the Federal Food, Drug, and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.

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510(k) SUMMARY

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(page 2 of 2)

DESCRIPTION OF THE DEVICE:

Varying concentrations of antimicrobial agents (usually in twofold dilutions) are dispensed into the Pasco panels and the panels are then frozen. Panels are thawed prior to use, inoculated with the test organisms, incubated the traditional 16-24 hours and then observed for visible growth or color changes as described in the package insert.

The lowest concentration of each antimicrobial agent with no apparent visible growth of the test organism is recorded as the minimum inhibitory concentration (MIC). Changes in pH and production of specific metabolites from growth in biochemical substrates are interpreted as described in the package insert for conventional tubed media.

INTENDED USE FOR THE PASCO MIC AND MIC/ID PANELS: PASCO MIC AND MIC/ID PANELS are used for quantitatively measuring (with the exception of the Breakpoint/ID panel which provides qualitative measurement or category results) the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the blochemical identification of those organisms.

SUMMARY/CONCLUSION OF SUBSTANTIAL EQUIVALENCE TESTING: Test panels containing Cefepime at concentrations ranging from 64 to 0.03 mcq/ml were prepared in-house at Pasco using routine manufacturing procedures. Comparative testing of the Pasco test panel to a reference panel was performed at two sites using CDC challenge strains and clinical isolates.

Test results of the gram-negative isolates demonstrated acceptable Essential Agreement (EA) of 98.2% on initial testing and 99.4 % after retesting. One Very Major (VM) error was observed on initial testing of Klebsiella pneumoniae, however this was resolved upon retest. Category Agreement (CA) was 97.3% with nine random minor errors noted.

Test results of the gram-positive isolates demonstrated acceptable Essential Agreement (EA) of 100% on initial testing. No Major or Very Major errors were observed. Category Agreement (CA) was 88.1% with twenty nine random errors noted.

QC endpoints from both the reference and Pasco panels throughout testing were within the recommended acceptable ranges listed in the product information and NCCLS. Reproducibility testing at each site demonstrated 98.8% within the acceptable plus or minus 1 dilution.

The results of the clinical testing, reproducibility testing and QC performance testing supports Substantial Equivalence as outlined in the FDA draft document "Review Criteria For Assessment Of Antimicrobial Susceptibility Devices" (May 1991).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged around the circumference of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FFB 1 2 1998

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

Re: K974362 Trade Name: Pasco MIC and MIC/ID Panels Regulatory Class: II Product Code: JWY Dated: November 13, 1997 Received: November 19, 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 (EDA) 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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## Page 2

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 vours.

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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Device Name:

PASCO MIC and MIC/ID Panels; Inclusion of Cefepime

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 Cefepime to Pasco panels at concentrations of 0.03 to 64 mcg/ml for use in determining the susceptibility of Enterobacter spp., E. col, K. pneumoniae, P. mirabilis, P. aeruginosa and methicillin susceptible strains of S. aureus. Clinical testing of S. pneumoniae has not been performed with the Pasco system.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON AMOTHER PAGE IF NEEDED )

Concurrence of CDRH, Office of Device Evaluation (ODE)

V Prescription Use (Per 21 CFR 801.109)

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

Flo Hain 2/10/98

Division Sign-OH) Division of Clinical Laboratory Devices

OR

510(k) Number .