(218 days)
Not Found
No
The device description and performance studies focus on a chromogenic culture medium and its comparison to other culture methods, with no mention of AI or ML.
No.
The device is described as a diagnostic tool for detecting MRSA colonization, not for treating or preventing disease in a therapeutic manner. The "Intended Use" explicitly states it is "not intended to diagnose MRSA infection nor to guide or monitor treatment of infection."
No
The "Intended Use / Indications for Use" section explicitly states, "MRSASelect is not intended to diagnose MRSA infection nor to guide or monitor treatment of infection."
No
The device description clearly states it is a "selective and differential chromogenic culture medium," which is a physical product used in laboratory testing, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "qualitative detection of nasal colonization of methicillin resistant Staphylococcus aureus (MRSA)". This involves testing a biological sample (anterior nares specimens) in vitro (outside the body) to provide information about a patient's health status (MRSA colonization).
- Device Description: The description details a "selective and differential chromogenic culture medium" used for detecting MRSA from specimens. This is a classic description of an IVD used in microbiology.
- Performance Studies: The document describes performance studies comparing the device to other methods for detecting MRSA from patient samples, which is typical for demonstrating the effectiveness of an IVD.
- Predicate Device: The mention of a predicate device (K042812; BBL CHROMagar MRSA) further confirms its classification as an IVD, as predicate devices are used for comparison in the regulatory submission process for new IVDs.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JSO
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior nares
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare settings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance 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 and BD BBL™ CHROMagar™ MRSA.
Comparison with Routine Culture (1772 samples):
Sensitivity: 96%
Specificity: 98%
PPV: 87%
NPV: 99%
Comparison with CHROMagar (3013 samples):
Sensitivity: 94%
Specificity: 99%
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Against Routine Culture:
Sensitivity: 96%
Specificity: 98%
PPV: 87%
NPV: 99%
Against CHROMagar:
Sensitivity: 94%
Specificity: 99%
PPV: 92%
NPV: 99%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.1700 Culture medium for antimicrobial susceptibility tests.
(a)
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.(b)
Classification. Class II (performance standards).
0
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 |
| A selective medium for the detection and direct identification | |
| of methicillin-resistant Staphylococcus aureus. | |
| Sponsor | Bio-Rad |
| 3 Boulevard Raymond Poincaré | |
| 92430 Marnes-la-Coquette | |
| France | |
| Correspondent | MDC Associates, LLC |
| Fran White, Regulatory Consultant | |
| 163 Cabot Street | |
| 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
Equivalent? |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| 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. | CHROMagar is a selective
and differential
chromogenic medium for
the qualitative detection of
nasal or colonization of
methicillin-resistant
Staphylococcus aureus
(MRSA) to aid in the
prevention and control of
MRSA infections in
healthcare settings. | √ |
| Sample | Nasal swabs | Nasal swabs | √ |
| Test
methodology | Selective Media | Selective Media | √ |
Manufacturer: Becton Dickinson & Company Product: BBL CHROMagar MRSA
1
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:
2
Comparison with Routine Culture
| Routine Culture | ||||||||
|---|---|---|---|---|---|---|---|---|
| pos | neg | total | ||||||
| MRSA Select | ||||||||
| 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 | |||||||
| 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.
3
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 (800) 638-2041 or (240) 276-3150 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
5
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
l of 1
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K07036/