MRSASELECT - EXTENDED INCUBATION

K081212 · Bio-Rad · JSO · Jun 13, 2008 · Microbiology

Device Facts

• Record ID: K081212
• Device Name: MRSASELECT - EXTENDED INCUBATION
• Applicant: Bio-Rad
• Product Code: JSO · Microbiology
• Decision Date: Jun 13, 2008
• 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. Results can be interpreted after 18 - 28 hours incubation.

Device Story

MRSASelect is a selective and differential chromogenic culture medium used in healthcare settings to screen for nasal MRSA colonization. It utilizes an antibiotic/antifungal mixture and optimized salt concentrations to inhibit non-MRSA organisms; a chromogenic substrate is cleaved by specific S. aureus enzymatic activity to produce pink colonies. The device is inoculated with anterior nares swabs; results are interpreted visually by laboratory personnel after 18-28 hours of incubation. The output (presence of pink colonies) aids infection control programs by identifying colonized individuals. It does not diagnose active infection or guide therapy.

Clinical Evidence

Clinical performance was evaluated at two sites using 200 fresh nasal swabs compared to routine culture (Blood Agar, Coagulase, E-Test). Results were consistent across 18, 20, 24, and 28-hour incubation periods. Sensitivity was 100% and specificity was 98% at all time points. Discordant samples were confirmed positive via PCR. Data supports the extended incubation window.

Technological Characteristics

Selective/differential chromogenic culture medium. Contains antibiotic/antifungal mixture and optimized salt concentration for selective growth. Employs chromogenic substrate for enzymatic identification of S. aureus. Form factor: culture plate. Incubation: 35-37°C, ambient conditions. No software or electronic components.

Indications for Use

Indicated for qualitative detection of nasal MRSA colonization in patients and healthcare workers to aid in infection control. Not for diagnosing active MRSA infection or guiding/monitoring treatment.

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

• MRSASelect (K070361)

Submission Summary (Full Text)

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Bio-Rad MRSASelect Culture Media 510(k) Submission

Page 19 of 73

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K081212

JUN 1 3 2008

# 510(k) SUMMARY

| Date of Summary | April 28, 2008 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Bio-Rad MRSASelect<br>A selective medium for the detection and direct<br>identification of methicillin-resistant Staphylococcus<br>aureus. Results can be interpreted after 18 - 28 hours<br>incubation. |
| 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 |

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# Substantially Equivalent Device

MRSASelect with extended incubation times is substantially equivalent to MRSASelect (reference 510(k) K070361).

Manufacturer: Bio-Rad Product: MRSASelect

| Product Attribute | Bio-Rad MRSASelect™<br>(18 - 28 hours incubation) | Bio-Rad MRSASelect™<br>(24 hours incubation) | 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. The<br>test can be performed on<br>anterior nares specimens<br>from patients and<br>healthcare workers to<br>screen for MRSA<br>colonization. MRSASelect<br>is not intended to diagnose<br>MRSA infection nor to<br>guide or monitor treatment<br>of infection. Results can<br>be interpreted after 18 - 28<br>hours incubation. | 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. The<br>test can be performed on<br>anterior nares specimens<br>from patients and<br>healthcare workers to<br>screen for MRSA<br>colonization. MRSASelect<br>is not intended to diagnose<br>MRSA infection nor to<br>guide or monitor treatment<br>of infection. | √ |
| Sample | Nasal swabs | Nasal swabs | √ |
| Test<br>methodology | Chromogenic Media | Chromogenic Media | √ |

### 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. Results can be interpreted after 18 - 28 hours incubation.

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Bio-Rad MRSASelect Culture Media 510(k) Submission

### 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. Results can be interpreted after 18 - 28 hours incubation.

# 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.

Within 18 - 28 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 Extended Incubation was evaluated at two geographically diverse hospitals with fresh anterior nares surveillance specimens. A total of 200 surveillance samples were evaluated. MRSA on routine culture was defined as isolation of Staphylococci on Trypticase Soy Agar with 5% blood, with identification confirmed by coagulase and Oxacillin susceptibility using E-Test. MRSASelect plates were incubated at 35 - 37ºC at ambient conditions. Plates were read after 18, 20, 24, 28 hours incubation. No difference in performance was noted at the defined incubation times.

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#### Summary Performance Data

A total of 200 samples were tested at two sites against routine culture (blood agar plate, coagulase and susceptibility), and MRSASelect. MRSASelect plates were read and results read at 18, 20, 24 and 28 hours incubation.

#### Comparison with Routine Culture

| | Routine Culture | | | | | |
|-------------------------|-----------------|-----|-----|-------|------|------|
| | | pos | neg | total | | |
| | | | | | sen | 100% |
| | Pos | 18 | 3 | 21 | spec | 98% |
| MRSA Select<br>18 hours | Neg | 0 | 179 | 179 | ppv | 86% |
| | | 18 | 182 | 200 | npv | 100% |
| | | | | | | |
| | Routine Culture | | | | | |
| | | pos | neg | total | | |
| | | | | | sen | 100% |
| | Pos | 18 | 3 | 21 | spec | 98% |
| MRSA Select<br>20 hours | Neg | 0 | 179 | 179 | ppv | 86% |
| | | 18 | 182 | 200 | npv | 100% |
| | | | | | | |
| | Routine Culture | | | | | |
| | | pos | neg | total | | |
| | | | | | sen | 100% |
| | Pos | 18 | 3 | 21 | spec | 98% |
| MRSA Select<br>24 hours | Neg | 0 | 179 | 179 | ppv | 86% |
| | | 18 | 182 | 200 | npv | 100% |
| | | | | | | |
| | Routine Culture | | | | | |
| | | pos | neg | total | | |
| | | | | | sen | 100% |
| MRSA Select<br>28 hours | Pos | 18 | 3 | 21 | spec | 98% |
| | Neg | 0 | 179 | 179 | ppv | 86% |
| | | 18 | 182 | 200 | npv | 100% |

#### STATEMENT OF SAFETY AND EFFICACY:

200 nasal swabs (surveillance samples) were tested on MRSASelect and routine culture (Trypticase Soy Agar w/5% blood, coagulase and susceptibility). Performance of MRSASelect was noted after 18, 20, 24 and 28 hours incubation, comparing results to culture

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results. MRSASelect Sensitivity was 100%, with Specificity at 98% at all incubation time intervals noted. 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/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings represented by a series of curved lines.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 1 8 2008

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

> k081212 Trade/Device Name: Bio- Rad MRSASelect Regulation Number: 21 CFR § 866.1700 Regulation Name: Culture medium for antimicrobial susceptibility test Regulatory Class: Class II Product Code: JSO Dated: April 28th, 2008 Received: April 29th, 2008

Dear Ms. White:

Re:

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 udications for use stated in the enclosure) to legally marketed predicate devices marketed in intention 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 Federallions, Or us 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, ilsting of devices, good manufacturing practice, labeling, and prohibitions against misburaniing 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 mourfacturing pratis e 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 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 yours,

Sally attym

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

#### Indications for Use

510(k) Number (if known):

Device Name:

MRSASelect

R081812

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. Results are interpreted after 18 - 28 hours incubation.

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 In Vitro Diagnostic Device Evaluation and Safety (OVD)

Ferdinand Pode

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)

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