ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING

K040560 · Ab Biodisk · NGZ · Jul 27, 2004 · Microbiology

Device Facts

• Record ID: K040560
• Device Name: ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING
• Applicant: Ab Biodisk
• Product Code: NGZ · Microbiology
• Decision Date: Jul 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

Etest® is an agar-based gradient technique for quantitative antifungal susceptibility testing of Candida species. It uses a predefined concentration gradient of the specific antifungal agent to determine the Minimum Inhibitory Concentration (MIC) in ug/mL inhibiting the growth of the test organism under defined conditions. This 510k submission is for an application for in wire diagnostic use of Etest for MIC determination of fluconazole, itraconazole and flucytosine with Candida species.

Device Story

Etest® is an agar-based diagnostic tool for determining antifungal susceptibility of Candida species. The device consists of a 5mm x 60mm inert plastic strip containing a predefined, exponential gradient of a dried antifungal agent. In a clinical laboratory setting, a technician inoculates an agar plate with isolated Candida colonies and applies the strip. The antifungal agent diffuses into the agar, creating a concentration gradient. Following 24-48 hours of incubation at 35°C, a symmetrical inhibition ellipse forms around the strip. The intersection of the inhibition zone edge with the strip indicates the Minimum Inhibitory Concentration (MIC) in ug/mL. Results are read manually by laboratory personnel. The MIC value informs clinicians regarding the susceptibility of the fungal isolate to specific antifungal agents, aiding in the selection of appropriate therapeutic interventions.

Clinical Evidence

Performance evaluated via multi-site clinical laboratory studies comparing Etest® to the NCCLS M27-A2 broth microdilution reference method. Testing included 591-722 samples per agent. Primary endpoints were Essential Agreement (EA) within ±2 dilutions and Category Agreement (CA). Results: Fluconazole (97.1% EA, 87.6% CA at 48h), Itraconazole (94.7% EA, 84.2% CA at 48h), Flucytosine (98.3% EA, 96.2% CA at 48h). 24-hour readings were found to be less reliable, particularly for Itraconazole (high very major error rate), necessitating 48-hour confirmation.

Technological Characteristics

Inert, non-porous plastic strip (5mm x 60mm) with a predefined, exponential gradient of dried antifungal agent. Operates via diffusion of the agent into inoculated agar. Manual reading of inhibition ellipse. Requires incubation at 35°C. Medium: RPMI 1640 with 2% glucose and 1.5% Bacto agar per NCCLS M27-A2.

Indications for Use

Indicated for quantitative antifungal susceptibility testing (MIC determination) of Candida species using fluconazole, itraconazole, or flucytosine. For in vitro diagnostic use by prescription.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Anne Bolmström President & CEO AB Biodisk Dalvägen 10 S-169 56 Solna Sweden

JUL 2 7 2004

Re: k040560 Trade/Device Name: Etest® for 1. Fluconazole 0.016-256 ug/ml 2. Itraconazole 0.002 - 32 ug/ml 3. Flucytosine 0.002 - 32 ug/ml Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: NGZ Dated: July 16, 2004 Received: July 19, 2004

Dear Ms. Bolmström:

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, 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 (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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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). You may obtain other general information on your responsibilities under the Act 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.

Salartys

Sally A. Hoivat. M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

### 510(k) Number: K040560

Device Name: Etest® for:

1. Fluconazole 0.016 - 256 µg/mL

2. Itraconazole 0.002 -32 µg/mL

3. Flucytosine 0.002 - 32 µg/mL

#### Indications For Use:

Etest® is an agar-based gradient technique for quantitative antifungal susceptibility testing of Candida species. It uses a predefined concentration gradient of the specific antifungal agent to determine the Minimum Inhibitory Concentration (MIC) in ug/mL inhibiting the growth of the test organism under defined conditions.

This 510k submission is for an application for in wire diagnostic use of Etest for MIC determination of fluconazole, itraconazole and flucytosine with Candida species.

Prescription Use _X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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