MRSASELECT

K070361 · Bio-Rad · JSO · Sep 13, 2007 · Microbiology

Device Facts

• Record ID: K070361
• Device Name: MRSASELECT
• Applicant: Bio-Rad
• Product Code: JSO · Microbiology
• Decision Date: Sep 13, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1700
• Device Class: Class 2

Intended Use

MRSASelect is a selective and differential chromogenic medium for the qualitative detection of nasal colonization of methicillin resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings. The test can be performed on anterior nares specimens from patients and healthcare workers to screen for MRSA colonization. MRSASelect is not intended to diagnose MRSA infection nor to guide or monitor treatment of infection.

Device Story

MRSASelect is a selective/differential chromogenic culture medium; used for qualitative detection of MRSA nasal colonization. Input: anterior nares specimens (direct or indirect inoculation). Principle: medium contains antibiotic/antifungal mixture and organized salts to inhibit yeast, Gram-negative, and Gram-positive bacteria (except MRSA); chromogenic substrate cleaved by S. aureus enzymatic activity produces pink colonies. Output: visual identification of pink colonies after 18-24 hours incubation at 35-37°C. Used in clinical settings; operated by laboratory personnel. Results aid infection control/prevention; not for diagnosing active infection or guiding treatment.

Clinical Evidence

Prospective clinical evaluation at three hospitals using 3,013 anterior nares surveillance samples. Compared MRSASelect (24-hour incubation) against routine culture (Trypticase Soy Agar with 5% blood, confirmed by coagulase/oxacillin susceptibility) and BD BBL CHROMagar MRSA. Against routine culture: 96% sensitivity, 98% specificity, 87% PPV, 99% NPV. Against CHROMagar: 94% sensitivity, 99% specificity, 92% PPV, 99% NPV. No interference noted with common medicinal substances or transport devices.

Technological Characteristics

Selective/differential chromogenic culture medium. Contains antibiotic/antifungal mixture and organized salts for selective inhibition. Manual visual inspection of colony color (pink = MRSA). Incubation: 18-24 hours at 35-37°C. No electronic components or software.

Indications for Use

Indicated for the detection and direct identification of MRSA from anterior nares specimens in patients and healthcare workers to screen for colonization.

Regulatory Classification

Identification

A culture medium for antimicrobial susceptibility tests is a device intended for medical purposes that consists of any medium capable of supporting the growth of many of the bacterial pathogens that are subject to antimicrobial susceptibility tests. The medium should be free of components known to be antagonistic to the common agents for which susceptibility tests are performed in the treatment of disease.

Predicate Devices

• BBL CHROMagar MRSA (k042812)

Submission Summary (Full Text)

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Bio-Rad MRSASelect Culture Media 510(k) Submission -- K070361 Request for Additional Information

SEP 1 3 2007

# 510(k) SUMMARY

| Date of Summary | September 4, 2007 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Bio-Rad MRSASelect<br>A selective medium for the detection and direct identification<br>of methicillin-resistant Staphylococcus aureus. |
| Sponsor | Bio-Rad<br>3 Boulevard Raymond Poincaré<br>92430 Marnes-la-Coquette<br>France |
| Correspondent | MDC Associates, LLC<br>Fran White, Regulatory Consultant<br>163 Cabot Street<br>Beverly, MA 01915 |

# Substantially Equivalent Device

MRSASelect is substantially equivalent to BBL CHROMagar MRSA (510(k) number: K042812)

| Product Attribute | Bio-Rad MRSASelect™ | BBL CHROMagar MRSA | Substantially<br>Equivalent? |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Intended use | MRSASelect is a selective<br>and differential<br>chromogenic medium for<br>the qualitative detection of<br>nasal colonization of<br>methicillin-resistant<br><i>Staphylococcus aureus</i><br>(MRSA) to aid in the<br>prevention and control of<br>MRSA infections in<br>healthcare settings. | CHROMagar is a selective<br>and differential<br>chromogenic medium for<br>the qualitative detection of<br>nasal or colonization of<br>methicillin-resistant<br><i>Staphylococcus aureus</i><br>(MRSA) to aid in the<br>prevention and control of<br>MRSA infections in<br>healthcare settings. | √ |
| Sample | Nasal swabs | Nasal swabs | √ |
| Test<br>methodology | Selective Media | Selective Media | √ |

Manufacturer: Becton Dickinson & Company Product: BBL CHROMagar MRSA

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Bio-Rad MRSASelect Culture Media 510(k) Submission - K070361 Request for Additional Information

## PRODUCT DESCRIPTION:

Methicillin-resistant Staphylococcus aureus is a major cause of nosocomial and life threatening infections which have been associated with significantly higher rates of mortality and morbidity. The Bio-Rad MRSASelect is a selective and differential chromogenic culture medium for the qualitative detection of MRSA from anterior nares specimens.

## INTENDED USE:

MRSASelect is a selective and differential chromogenic medium for the qualitative detection of nasal colonization of methicillin resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings. The test can be performed on anterior nares specimens from patients and healthcare workers to screen for MRSA colonization. MRSASelect is not intended to diagnose MRSA infection nor to guide or monitor treatment of infection.

## SUMMARY OF TECHNOLOGY:

MRSASelect is a selective medium for the detection and direct identification of MRSA. The selectivity of this medium is based on the presence of an antibiotic/antifungal mixture and an optimized salt concentration and that inhibits the growth of yeast and the majority of Gram negative and Gram positive bacteria with the exception of methicillin-resistant staphylococci. Identification is based on the cleavage of a chromogenic substrate by a specific enzymatic activity of Staphylococcus aureus leading to a strong pink coloration of the Staphylococcus aureus colonies.

At 24 hours incubation time methicillin-resistant Staphylococcus aureus produce small pink colonies on MRSASelect. Coagulase negative methicillin-resistant staphylococci that do not metabolize the chromogenic substrate appear as colorless or white colonies (possibly light pink). Methicillin sensitive staphylococci (MSS) are inhibited.

# PERFORMANCE DATA:

Performance of MRSASelect was evaluated at three geographically diverse hospitals with fresh surveillance specimens of the anterior nares samples. A total of 3013 nares samples were evaluated. MRSASelect was compared to routine culture which was defined as isolation on Staphylococci on Trypticase Soy Agar with 5% blood, with identification confirmed by Coagulase and Oxacillin susceptibility and BD BBL™ CHROMagar™ MRSA. Culture results and MRSASelect results were reported at 24 hours, BD ChromAgar was read at 48 hours in accordance with manufacturers instructions. Product performance is summarized below:

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#### Comparison with Routine Culture

| | | | Routine Culture | | | | | |
|-------------------------|-----|-----|-----------------|------|-------|------|-----|-----|
| | | | pos | neg | total | | | |
| MRSA Select<br>24 hours | pos | 227 | 33 | 260 | | sen | 96% | |
| | neg | 10 | 1502 | 1512 | | spec | 98% | |
| | | | 237 | 1535 | 1772 | | ppv | 87% |
| | | | | | | | npv | 99% |

## Comparison with CHROMagar

| | | | CHROMagar | | | | |
|-------------------------|-----|-----|-----------|------|-------|-----|--|
| | | | pos | neg | total | | |
| MRSA Select<br>24 hours | pos | 297 | 24 | 321 | sen | 94% | |
| | neg | 18 | 2674 | 2692 | spec | 99% | |
| | | 315 | 2698 | 3013 | ppv | 92% | |
| | | | | | npv | 99% | |

# Interference Study

Commonly used medicinal substances and commonly used transport devices were evaluated for potential interference of the chromogenic reaction of the MRSASelect medium. No interference was noted. Commonly used nasal sprays at concentrations may inhibit growth that is unrelated to medium performance.

# STATEMENT OF SAFETY AND EFFICACY:

MRSASelect was tested and compared to routine culture, identification and susceptibility methods, and BD CHROMagar. MRSASelect, when testing 3013 surveillance samples, demonstrated, at 24 incubation, 98% agreement to routine culture, identification and susceptibility and 99% as compared to CHROMagar.

Bio-Rad confirms that any/all data provided in this submission may be released upon request.

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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 eagle with three stripes representing the three branches of government. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

SEP 1 3 2007

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Public Health Service

Bio-Rad c/o Ms. Fran White Regulatory Consultant MDC Associates, LLC 163 Cabot Street Beverly, MA 01915

Re: k070361

Trade/Device Name: MRSASelect Regulation Number: 21 CFR 866.1700 Regulation Name: Culture Medium for Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: JSO Dated: September 5, 2007 Received: September 6, 2007

Dear Ms. White:

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 af 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). This letter will allow your o begin marketing your device as described in your Section 510(k) premarket notification. The

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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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely vours.

Sally attaym

Sally A. Hojvat, 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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Bio-Rad MRSASelect Culture Media 510(k) Submission - K070361 Request for Additional Information

#### Indications for Use

510(k) Number (if known): K070361

Device Name: MRSASelect

Indications for Use:

MRSASelect is a selective and differential chromogenic medium for the qualitative detection of nasal colonization of methicillin resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings. The test can be performed on anterior nares specimens from patients and healthcare workers to screen for MRSA colonization. MRSASelect is not intended to diagnose MRSA infection nor to guide or monitor treatment of infection.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K07036/