← Product Code [JWY](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JWY) · K971951

# PASCO MIC AND MIC/ID PANELS (K971951)

_Pasco Laboratories, Inc. · JWY · Aug 15, 1997 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JWY/K971951

## Device Facts

- **Applicant:** Pasco Laboratories, Inc.
- **Product Code:** [JWY](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JWY.md)
- **Decision Date:** Aug 15, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.1640
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## 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. This 510(k) notification is for the addition of Levofloxacin to Pasco panels at concentrations of 0.03 to 16 mcg/ml for determining the susceptibility of bacterial pathogens with the exception of Haemophilus and S. Pneumoniae.

## 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 identify organisms. The device consists of panels containing various concentrations of antimicrobial agents (specifically Levofloxacin at 0.03 to 16 mcg/ml). Laboratory technicians inoculate the panels with bacterial samples; the panels are then incubated. The device measures bacterial growth inhibition to provide quantitative MIC (Minimum Inhibitory Concentration) results or qualitative category results. Healthcare providers use these results to guide antibiotic therapy selection for patients with bacterial infections.

## Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing of antimicrobial susceptibility performance.

## Technological Characteristics

In vitro diagnostic microdilution panels. Contains dehydrated antimicrobial agents (Levofloxacin) at specific concentrations (0.03-16 mcg/ml). Designed for use with rapidly growing aerobic and facultative anaerobic bacteria. Manual or automated inoculation and reading systems.

## Regulatory 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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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Linda K. Dillon Technical Manager Pasco Laboratories, Inc. AUG 1 5 1997 1-2750 West Forty-Second Avenue ………………… Wheat Ridge, Colorado 80033

Re: K971951 Trade Name: Pasco MIC and MIC/ID Panels/Levofloxacin Regulatory Class: II Product Code: JWY Dated: August 5, 1997 Received: August 7, 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 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 (770)488-7655.

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 (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" (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 (800) 638-2041 or at (301) 443-6597 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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Device Name:

PASCO MIC and MIC/ID Panels; Inclusion of LEVOFLOXACIN

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 Levofloxacin to Pasco panels at concentrations of 0.03 to 16 mcg/ml for determining the susceptibility of bacterial pathogens with the exception of Haemophilus and S. Pneumoniae.

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

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)

Oee Pini

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

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