MICROSCAN SYNERGIES PLUS

K023202 · Dade Microscan, Inc. · JWY · Oct 23, 2002 · Microbiology

Device Facts

• Record ID: K023202
• Device Name: MICROSCAN SYNERGIES PLUS
• Applicant: Dade Microscan, Inc.
• Product Code: JWY · Microbiology
• Decision Date: Oct 23, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

The MicroScan® Synergies plus™ Dried Gram-Negative MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility for Gram-Negative organisms and screening for suspected ESBL production in E. coli, K. oxytoca and K. pneumoniae. After inoculation, panels are incubated for a minimum of 16 hours at 35°C in a non-CO2 incubator, and read visually, according to the Package Insert. This particular submission is for the antimicrobials cefpodoxime (0.015-64 ug/ml) and ceftazidime (0.5-64 ug/ml). The Gram-Negative organisms which may be used for screening for suspected ESBL production in this panel are: Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae

Device Story

MicroScan® Synergies plus™ Dried Gram-Negative MIC/Combo Panels are in vitro diagnostic devices used in clinical microbiology laboratories. The device consists of dried antimicrobial panels inoculated with Gram-Negative bacterial isolates. Following a minimum 16-hour incubation at 35°C in a non-CO2 incubator, the panels are read visually by laboratory personnel. The device provides quantitative and/or qualitative antimicrobial susceptibility results and screens for extended-spectrum beta-lactamase (ESBL) production. These results assist healthcare providers in selecting appropriate antibiotic therapies for patients with Gram-Negative infections, potentially improving clinical outcomes by guiding targeted treatment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dried antimicrobial susceptibility panels containing cefpodoxime (0.015-64 ug/ml) and ceftazidime (0.5-64 ug/ml). Principle of operation is based on standard broth microdilution susceptibility testing methods. Designed for visual reading after 16-hour incubation at 35°C.

Indications for Use

Indicated for determining antimicrobial susceptibility and screening for suspected ESBL production in Gram-Negative organisms (E. coli, K. oxytoca, K. pneumoniae). For prescription use only.

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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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of an eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 1 4 2004

Mr. Robert Eusebio Manager Regulatory Affairs Dade MicroScan, Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691

Re: k023202

Trade/Device Name: MicroScan® Synergies plus™ Dried Gram-Negative MIC/Combo Panels with Cefpodoxime (0.015-64 ug/ml) and Ceftazidime (0.5-64 ug/ml) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: JWY Dated: July 30, 2004 Received: August 3, 2004

Dear Mr. Eusebio:

This letter corrects our substantially equivalent letter of October 23, 2002, regarding the trade name which was changed to MicroScan® Synergies Plus to better reflect the intended use of the device.

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 (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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally Part 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 devine, please contact the Office of Compliance at [phone]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number [phone] or at [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

freddie L. Koch

Sally I Hojvat, M.S. 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 Statement

## 510(k) Number (if known): K023202

Device Name: MicroScan® Synergies plus" Dried Gram-Negative MIC/Combo Panels with Cefpodoxime (0.015-64 ug/ml) and Ceftazidime (0.5-64 ug/ml)

## Indications For Use:

The MicroScan® Synergies plus™ Dried Gram-Negative MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility for Gram-Negative organisms and screening for suspected ESBL production in E. coli, K. oxytoca and K. pneumoniae. After inoculation, panels are incubated for a minimum of 16 hours at 35°C in a non-CO2 incubator, and read visually, according to the Package Insert.

This particular submission is for the antimicrobials cefpodoxime (0.015-64 ug/ml) and ceftazidime (0.5-64 ug/ml).

The Gram-Negative organisms which may be used for screening for suspected ESBL production in this panel are:

> Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

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

Fuddie. Pool.

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Office of In Vitro Diagnostic Device Evaluation and Safety

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