PASCO MIC AND MIC/ID PANELS

K031205 · Pasco Laboratories, Inc. · JWY · Jun 13, 2003 · Microbiology

Device Facts

• Record ID: K031205
• Device Name: PASCO MIC AND MIC/ID PANELS
• Applicant: Pasco Laboratories, Inc.
• Product Code: JWY · Microbiology
• Decision Date: Jun 13, 2003
• 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 biochemical identification of those organisms.

Device Story

Pasco MIC and MIC/ID Panels are microdilution plates containing two-fold dilutions of antimicrobial agents. Panels are frozen, thawed, and inoculated with bacterial pathogens. After 16-24 hours of incubation, the device is observed for visible growth or color changes. The lowest concentration of antimicrobial agent showing no visible growth is recorded as the Minimum Inhibitory Concentration (MIC). Biochemical identification is performed via interpretation of pH changes and metabolite production in substrates. Used in clinical laboratory settings by trained personnel. Results assist clinicians in selecting appropriate antimicrobial therapy for bacterial infections.

Clinical Evidence

Bench testing compared Pasco methodology to reference methodology using 413 Staphylococcus spp. and 365 Enterococcus spp. isolates. Essential Agreement (EA) was 99.9%; Category Agreement (CA) was 100% with no major or minor errors. Reproducibility testing (inter-site and intra-site) showed 100% agreement. Quality control using S. aureus ATCC 29213 and E. faecalis ATCC 29212 met acceptable endpoints.

Technological Characteristics

Microdilution panel containing two-fold dilutions of antimicrobial agents. Principle of operation: visual observation of bacterial growth inhibition and biochemical substrate colorimetric/pH change. Manual or automated interpretation of growth. No electronic sensing or software algorithms described.

Indications for Use

Indicated for susceptibility testing of rapidly growing aerobic and facultative anaerobic bacterial pathogens, specifically Enterococcus faecium (vancomycin-resistant), Staphylococcus aureus (including methicillin-resistant), Enterococcus faecalis (including vancomycin-resistant), Enterococcus faecium (vancomycin-susceptible), Staphylococcus epidermidis (including methicillin-resistant), and Staphylococcus haemolyticus.

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

• K011116
• K010508
• K020331
• K001953
• K001887
• K001721
• K001612
• K001516
• K992853
• K992726
• K992717
• K992646
• K992647
• K992593
• K992562
• K992568
• K992507
• K992546
• K992420
• K992296
• K992297
• K992143
• K992108
• K992076
• K992059
• K992077
• K991925
• K946126

Submission Summary (Full Text)

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K031205

②

# 510(k) SUMMARY

(page 1 of 3)

April 15, 2003

JUN 1 3 2003

Linda K. Dillon CONTACT PERSON: Chuck Lakel Pasco Laboratories 12750 West 42nd Avenue Wheat Ridge, Co 80033 303-423-9504 TRADE NAME OF DEVICE: Pasco MIC and MIC/ID Panels Antimicrobial Susceptibility Test COMMON NAME: Class II Antimicrobial Susceptibility Test CLASSIFICATION NAME: Microbiology Panel #83

# SUBSTANTIAL EQUIVALENCE:

DATE:

In review of previous 510(k) notifications for the Pasco MIC and MIC/ID panel: K011116. April 24, 2001 RE: ESBL Confirmatory Test; K010508, April 23, 2001 RE: ESBL Screen Test; K020331, March 20, 2002 RE: Ertapenem; K001953, August 10, 2000 RE: Amoxicillin; K001887, August 9, 2000 RE: Ampicillin; K001721, August 4, 2000 RE: Clarithromycin; K001612, July 18, 2000 RE: Linezolid; K001516, July 12, 2000 RE: Moxifloxacin: K992853, November 4, 1999 RE: Cefdinir; K992726, November 3, 1999 RE: Synercid (non-fastidious); K992717, November 2, 1999 RE: Synercid: K992646. October 19, 1999 RE: Penicillin: K992647, October 19, 1999 RE: Ervthromycin; K992593, October 14, 1999 RE: Chloramphenicol; K992562, October 13, 1999 RE: Ceftriaxone: K992568, October 14, 1999 RE: Cefotaxime: K992507, October 18, 1999 RE: Trovafloxacin; K992546, October 12, 1999 RE: Meropenem; K992420, September 27, 1999 RE: Sparfloxacin: K992296, September 21, 1999 RE: Vancomycin: K992297, September 3, 1999 RE: Levofloxacin; K992143, September 16, 1999 RE: Clindamycin; K992108, September 3, 1999 RE: Cefepime; K992076, August 30, 1999 RE: Cefuroxime: K992059, August 30, 1999 RE: Imipenem; K992077, September 3, 1999 RE: Ofloxacin; K991925, August 20, 1999 RE: Amoxicillin/Clavulanic Acid; 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

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#### 510(k) SUMMARY (page 2 of 3)

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:

Pasco Panels are used for quantitatively measuring 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. Varying concentrations of antimicrobial agents (usually in two-fold dilutions) are dispensed into the Pasco microdilution 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.

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: Challenge strains, fresh clinical isolates, stock clinical isolates and OC strains were tested concurrently using both Pasco methodology and reference methodology in panels contained Linezolid at concentrations ranging from 0.25 - 8 mcg/ml. Testing was conducted at three test sites.

Test results of 413 challenge and clinical Staphylococcus spp. and 365 challenge and clinical Enterococcus spp. demonstrated an Essential Agreement (EA) of 99.9%. Category agreement (CA) was 100% with no very major (VM), major (M) or minor errors observed.

QC endpoints for the NCCLS recommended OC organisms (S. aureus ATCC 29213 and E. faecalis ATCC 29212) from panels using both the reference and test methodology were acceptable.

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## 510(k) SUMMARY (page 3 of 3)

Reproducibility testing of 10 organisms at each site on three separate days in triplicate demonstrated inter-site reproducibility of MIC results of 100%. Intra-site reproducibility of MIC results was 100% for all sites as well.

The results of the clinical testing, reproducibility testing and QC performance testing supports Substantial Equivalence as outlined in the FDA document "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine and healing. The caduceus is depicted as a stylized design with three wavy lines. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 1 3 2003

Ms. Linda K. Dillon R&D Manager BD Diagnostics Systems Pasco Laboratories 12750 W. 42nd Avenue Wheat Ridge, CO 80033-2440

k031205 Re:

> Trade/Device Name: PASCO MIC and MIC/ID Panels Linezolid, 0.25-8 µg/ml Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: JWY Dated: April 15, 2003 Received: May 14, 2003

Dear Ms. Dillon:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K031205

Device Name: PASCO MIC and MIC/ID Panels

#### Indications For Use: Inclusion of Linezolid

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 the antimicrobial Linezolid at concentrations of 0.25 - 8 mcg/ml to Pasco Panels. Linezolid has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobic.

Active In Vitro and in Clinical Infectious Against:

#### Aerobic Gram-positive microorganisms

Enterococcus faecium (vancomycin-resistant strains only) Staphylococcus aureus (including methicillin-resistant strains)

Active In Vitro but their clinical significance is unknown

#### Aerobic Gram-positive microorganisms

Enterococcus faecalis (including vancomycin-resistant strains) Enterococcus faecium (vancomycin-susceptible strains) Staphylococcus epidermidis (including methicillin-resistant strains) Staphylococcus haemolyticus

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)_()3/205

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Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use
(Per 21 CRF 801.109) ✓

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