PASCO MIC AND MIC/ID PANELS, CEFOTAXIME

K992568 · Pasco Laboratories, Inc. · JTN · Oct 14, 1999 · Microbiology

Device Facts

• Record ID: K992568
• Device Name: PASCO MIC AND MIC/ID PANELS, CEFOTAXIME
• Applicant: Pasco Laboratories, Inc.
• Product Code: JTN · Microbiology
• Decision Date: Oct 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1620
• 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 biochemical identification of those organisms.

Device Story

Pasco MIC and MIC/ID panels consist of frozen microtiter plates containing two-fold dilutions of antimicrobial agents. Panels are thawed, inoculated with bacterial samples, and incubated for 16-24 hours. Device measures minimum inhibitory concentration (MIC) by identifying the lowest concentration of antimicrobial agent preventing visible growth. Biochemical identification is performed via observation of pH changes and metabolite production in substrates. Used in clinical laboratories by trained personnel. Results assist clinicians in selecting appropriate antibiotic therapy for bacterial infections. Benefits include standardized, quantitative susceptibility testing to guide patient treatment.

Clinical Evidence

Bench testing performed comparing Pasco panels to reference panels using 101 S. pneumoniae strains and 130 non-pneumococcal strains. Results for S. pneumoniae showed 99.4% Essential Agreement (EA) and 99.4% Category Agreement (CA). Results for non-pneumococcal strains showed 100% EA and 100% CA. Reproducibility testing across 12 organisms demonstrated 100% agreement within +/- 1 dilution. QC performance using S. pneumoniae ATCC 49619 remained within NCCLS acceptable ranges.

Technological Characteristics

Frozen microtiter panels containing antimicrobial agents in two-fold dilutions. Principle of operation: broth microdilution for MIC determination and biochemical substrate analysis for organism identification. Incubation period: 16-24 hours. Manual or visual interpretation of growth/color change.

Indications for Use

Indicated for determining antimicrobial susceptibility and biochemical identification of rapidly growing aerobic and facultative anaerobic bacterial pathogens, specifically S. pneumoniae and non-pneumococcal streptococci, using Cefotaxime concentrations of 4-0.03 mcg/ml.

Regulatory Classification

Identification

An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure by a disc-agar diffusion technique or a disc-broth elution technique the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents. In the disc-agar diffusion technique, bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface. The disc-broth elution technique is associated with an automated rapid susceptibility test system and employs a fluid medium in which susceptibility is ascertained by photometrically measuring changes in bacterial growth resulting when antimicrobial material is eluted from the disc into the fluid medium. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

Predicate Devices

• Minocycline (K982235)
• Cefdinir (K982156)
• Trovafloxacin (K980955)
• Cefepime (K974362)
• Cefpodoxime (K973317)
• Meropenem (K973695)
• Sparfloxacin (K972567)
• Levofloxacin (K971951)
• Detection of resistant pneumococci (K946126)

Submission Summary (Full Text)

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1999 OCT 1:44

K992568

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# 510(k) SUMMARY (page 1 of 2)

| DATE: | July 29, 1999 |
|-----------------------|----------------------------------------------------------------------|
| CONTACT PERSON: | Linda K. Dillon<br>Chuck Lakel |
| TRADE NAME OF DEVICE: | Pasco MIC and MIC/ID Panels |
| COMMON NAME: | Antimicrobial Susceptibility Test |
| CLASSIFICATION NAME: | Class II Antimicrobial Susceptibility Test Microbiology Panel<br>#83 |

# SUBSTANTIAL EQUIVALENCE:

In review of previous 510(k) notifications for the Pasco MIC and MIC/ID panels (most recently: K982235, July 30, 1998 RE: Minocvcline; K982156, July 29, 1998 RE: Cefdinir; K980955 May 18, 1998 RE: Trovafloxacin; K974362, February 12, 1998 RE: Cefepime; K973317, November 14, 1997 RE: Cefpodoxime: K973695, November 5, 1997 RE: Meropenem; 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.

#### DESCRIPTION OF THE DEVICE:

Varying concentrations of antimicrobial agents (usually in two-fold 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 panels are then observed for visible growth or color changes as described in the package insert.

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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 biochemical identification of those organisms.

## SUMMARY/CONCLUSION OF SUBSTANTIAL EQUIVALENCE TESTING:

Test panels containing Cefotaxime at concentrations ranging from 4-0.03 mcg/ml were prepared inhouse 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 101 S. pneumoniae strains demonstrated acceptable Essential Agreement (EA) of 99.4% on initial testing and an EA of 99.4% on retesting. One minor error was observed upon initial testing. Although retest results were acceptable, this error was not considered resolved since the reference method MIC results did not change. Category agreement (CA) was 99.4% with 16 random minor errors noted. Test results of the 130 non-pneumococcal strains demonstrated acceptable Essential Agreement (EA) of 100%. No major (M), very major (VM) or minor errors were observed. Category Agreement (CA) was 100% with no random minor errors noted.

QC endpoints for the QC organism S. pneumoniae ATCC 49619 from both the reference and Pasco panels throughout testing were within the recommended NCCLS acceptable range.

Reproducibility testing of 12 organisms at each site provided 9 organisms with on-scale endpoints. Overall reproducibility data demonstrated 100% 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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 1 4 1999

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

Re: K992568 Trade Name: PASCO MIC and MIC/ID Panels (Cefotaxime) Regulatory Class: II Product Code: JTN Dated: July 29, 1999 Received: August 2, 1999

#### 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 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). 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 requirements, 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 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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Device Name:

PASCO MIC and MIC/ID Panels; Inclusion of Cefotaxime

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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 Cefotaxime to Pasco panels at concentrations of 4-0.03 mcg/ml for use in determining the susceptibility of S. pneumoniae and non-pneumococcal streptococci.

Woody Dubois

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K992568

Prescription Use (Per 21 CFR 801.109) OR

Over-The Counter Use

(Optional Format 1-2-96)