(345 days)
Not Found
No
The device is a chromogenic culture medium that relies on chemical reactions for detection, not computational analysis. The summary explicitly states "Not Found" for mentions of AI, DNN, or ML.
No.
The device is a diagnostic tool used to detect nasal colonization by MRSA to aid in the prevention and control of MRSA infections; it is explicitly stated that it is "not intended to diagnose, guide or monitor treatment for MRSA infections."
Yes
The device is described as "a selective and differential chromogenic medium for the qualitative direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA)." It screens for MRSA colonization to aid in the prevention and control of MRSA infections, which falls under the definition of a diagnostic device. While it states it is "not intended to diagnose, guide or monitor treatment for MRSA infections," its role in detecting colonization for prevention purposes is a diagnostic function.
No
The device is a selective and differential chromogenic medium (agar plate) for detecting MRSA, which is a physical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings." This involves testing a specimen (anterior nares swab) from a patient to obtain information about their health status (MRSA colonization).
- Device Description: The description details how the medium interacts with the specimen (growth of MRSA and color change) to provide a result.
- Performance Studies: The document includes detailed descriptions of analytical and clinical studies conducted to evaluate the performance of the device in detecting MRSA from patient specimens.
- Key Metrics: Performance metrics like Positive Percent Agreement and Negative Percent Agreement are provided, which are standard for evaluating the accuracy of diagnostic tests.
- Predicate Device(s): The mention of predicate devices (K042812 BBL TM CHROMagar TM MRSA and K863821 BBL TM Oxacillin Screen Agar) further indicates that this device is being compared to other legally marketed IVDs.
All of these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
BBL™ CHROMagar™ MRSA II is a selective and differential chromogenic medium for the qualitative direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings. The test is performed on anterior nares swab specimens from patients to screen for MRSA colonization.
BBL CHROMagar MRSA II is not intended to diagnose, guide or monitor treatment for MRSA infections. A negative result does not preclude MRSA nasal colonization. Concomitant cultures are necessary for organism identification, susceptibility testing or epidemiological typing.
Product codes
JSO
Device Description
BBL™ CHROMagar™ MRSA II (CMRSA II) permits the direct detection and identification of MRSA through the incorporation of specific chromogenic substrates and cefoxitin. MRSA strains will grow in the presence of cefoxitin' and produce mauvecolored colonies resulting from hydrolysis of the chromogenic substrate. Selective agents are incorporated for the suppression of gram-negative organisms, yeast and enterococci and some other gram-positive cocci. Bacteria other than MRSA may utilize other chromogenic substrates in the medium resulting in the growth of colonies that are not mauve.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Studies:
- Interfering Substances: Evaluated common transport devices, nasal spray, and whole blood. Nasal sprays containing fluticasone propionate, azelastine hydrochloride, and oxymetazoline hydrochloride, as well as OTC throat drops containing menthol, showed antibacterial activity. No other substances or transport devices interfered.
- Reproducibility: Tested 20 strains using three different lots of CMRSA II. Acceptance criteria for reproducibility of >95% for both inter-lot and overall testing intervals was met.
- Recovery Rate (Limit of Detection): Evaluated 7 test strains (5 heterogeneous, 2 homogeneous MRSA). Non-selective Columbia Agar with 5% Sheep Blood plates were used to determine CFU. Analytical studies used an MRSA suspension of 1x10^5 CFU/mL.
Clinical Studies:
- Reproducibility Testing: Testing of ten (10) masked strains of S. aureus (7 MRSA, 3 MSSA) was conducted at three clinical sites. Individual and combined site reproducibility agreements were 100% across three successive days.
- Challenge Strain Testing: Testing of twenty (20) challenge strains of S. aureus (14 MRSA, 6 MSSA) was conducted at three clinical sites. Individual sites and combined site agreements were 100%.
- Clinical Accuracy: Performance evaluated at three clinical laboratories in the U.S. A total of 1187 compliant remnant, prospective, nares specimens were enrolled. Specimens were compared to traditional culture media. S. aureus recovered on traditional culture media was tested by cefoxitin disk diffusion test method. BBL™ CHROMagar™ MRSA II was interpreted as positive for MRSA at 20-26 hours based on detection of mauve colonies.
- Versus Cefoxitin Disk: 162 specimens were MRSA positive. Positive Percent Agreement: 92% (149/162). Negative Percent Agreement: 99.9% (1024/1025).
- Versus Traditional Culture (Two Clinical Trial Sites Combined): Positive Percent Agreement: 92% (92/100). Negative Percent Agreement: 98.8% (760/769).
- Versus Traditional Culture (Third Clinical Trial Site): Positive Percent Agreement: 90.2% (46/51). Negative Percent Agreement: 98.9% (264/267).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Positive Percent Agreement:
- 92% (86.7%, 95.7%) against Cefoxitin Disk
- 92% (84.8%, 96.5%) against Traditional Culture (Combined Two Sites)
- 90.2% (78.6%, 96.7%) against Traditional Culture (Third Site)
- Negative Percent Agreement:
- 99.9% (99.5%, 100%) against Cefoxitin Disk
- 98.8% (97.8%, 99.5%) against Traditional Culture (Combined Two Sites)
- 98.9% (96.8%, 99.8%) against Traditional Culture (Third Site)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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CONFIDENTIAL AND PROPRIETARY
| 510(k) SUMMARY | ||
|---|---|---|
| SUBMITTED BY: | BECTON, DICKINSON AND COMPANY | |
| 7 LOVETON CIRCLE | ||
| SPARKS, MD 21152 | ||
| Phone: 410-316-4905 | ||
| Fax: 410-316-4499 | AUG 20 2010 | |
| CONTACT NAME: | Paul Swift, Regulatory Affairs Specialist | |
| DATE PREPARED: | August 12, 2010 | |
| DEVICE TRADE NAME: | BBL TM CHROMagar TM MRSA II | |
| DEVICE COMMON NAME: | Culture Medium | |
| DEVICE CLASSIFICATION: | 21 CFR§866.1700, Class II | |
| PREDICATE DEVICES: | BBL TM CHROMagar TM MRSA (K042812) | |
| BBL TM Oxacillin Screen Agar (K863821) |
INTENDED USE:
BBL™ CHROMagar™ MRSA II is a selective and differential chromogenic medium for the qualitative direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings. The test is performed on anterior nares swab specimens from patients to screen for MRSA colonization.
BBL CHROMagar MRSA II is not intended to diagnose, guide or monitor treatment for MRSA infections. A negative result does not preclude MRSA nasal colonization. Concomitant cultures are necessary for organism identification, susceptibility testing or epidemiological typing.
DEVICE DESCRIPTION:
BBL™ CHROMagar™ MRSA II (CMRSA II) permits the direct detection and identification of MRSA through the incorporation of specific chromogenic substrates and cefoxitin. MRSA strains will grow in the presence of cefoxitin' and produce mauvecolored colonies resulting from hydrolysis of the chromogenic substrate. Selective agents are incorporated for the suppression of gram-negative organisms, yeast and enterococci and some other gram-positive cocci. Bacteria other than MRSA may utilize other
- BD Diagnostic Systems Becton, Dickinson and Company
l
4 Clinical and Laboratory Standards Institute. 2009. Performance Standards for Antimicrobial Susceptibility Testing; Nineteenth Informational Supplement, M100-S19. Clinical and Laboratory Standards Institute, Wayne, PA.
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chromogenic substrates in the medium resulting in the growth of colonies that are not mauve.
DEVICE COMPARISON:
The BBLTM CHROMagar™ MRSA II (CMRSA II) differs from the BBL CHROMagar MRSA (CMRSA) (K042812) in the following ways:
- CMRSA II detects and identifies MRSA within 20-26 hours; whereas, CMRSA . detects and identifies MRSA at 24 ± 4 hours to 48 ± 4 hours.
The BBL™ CHROMagar™ MRSA II differs from the BBL™ Oxacillin Screen Agar (OSA) (K863821) in the following ways:
- CMRSA II is selective and differential culture medium for antimicrobial . susceptibility testing of MRSA, whereas, OSA is a selective culture medium for antimicrobial susceptibility testing of MRSA.
- CMRSA II is intended to identify MRSA from nares specimens; whereas, OSA is . cleared for the identification of MRSA from pure clinical isolates that were identified as Staphylococcus aureus.
- CMRSA II utilizes direct inoculation from specimen collection devices. OSA . utilizes indirect inoculation from a broth suspension of pure S. aureus colonies isolated from18-24 hour culture.
- . CMRSA II utilizes cefoxitin as a selective agent to differentiate MRSA from methicillin-susceptible S. aureus and other organisms; whereas, OSA utilizes oxacillin as a selective agent to identify MRSA from a pure S. aureus culture.
- CMRSA II utilizes chromogenic substances to facilitate the differentiation of . MRSA from MSSA and other organisms; whereas, OSA does not contain chromogenic substances to differentiate growth on the plate.
- CMRSA II produces mauve colonies as an indicator of MRSA; whereas, any . colony growth seen on OSA is an indicator of MRSA.
- CMRSA II detects and identifies MRSA in 20-26 hours; whereas, OSA identifies . MRSA in 24 hours.
- CMRSA II utilizes incubation conditions at a temperature of 35-37℃; whereas, . OSA utilizes incubation conditions at temperature of 30-35°C.
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SUMMARY OF PERFORMANCE DATA:
Analytical Studies:
Interfering Substances
Commonly used transport devices, nasal spray and whole blood were evaluated for potential interference and inhibition of MRSA on CMRSA II.
Nasal sprays containing fluticasone propionate, azelastine hydrochloride and oxymetazoline hydrochloride as well as OTC throat drops containing menthol demonstrated antibacterial activity. No other substances or transport devices interfered with recovery of MRSA on CMRSA II.
Reproducibilitv
Reproducibility testing of the CMRSA II was evaluated using 20 test strains. Three different lots of CMRSA II were tested to determine that CMRSA II reliably detects MRSA within lots and across lots. Acceptance criteria for reproducibility of >95% for both inter-lot and overall testing intervals was met.
Recovery Rate (Limit of Detection)
BBL CROMagar MRSA II was evaluated to determine the recovery rate (limit of detection (LOD)) for recovery of methicillin-resistant S. aureus. Seven test strains, representing five heterogeneous and two homogeneous MRSA were evaluated for recovery on BBL CHROMagar MRSA II. Non-selective Columbia Agar with 5% Sheep Blood plates were used to determine the organism concentration expressed in colony forming units (CFU) for each dilution. Analytical studies, including incubation time, analytical reactivity or sensitivity, interfering substances and reproducibility were all performed using an MRSA suspension of 1x105 CFU/mL. Ten ul of this suspension was then inoculated on to BBL CHROMagar MRSA II.
Clinical Studies
Reproducibility Testing
Testing of ten (10) masked strains of S. aureus was conducted at three clinical sites. The panel included seven (7) MRSA and three (3) methicillin sensitive S. aureus (MSSA). Individual and combined site reproducibility agreements were 100% across three successive days.
Challenge Strain Testing
Testing of twenty (20) challenge strains of S. aureus was conducted at three clinical sites. The panel included 14 MRSA and 6 MSSA. Individual sites and combined site agreements were 100%.
Clinical Accuracy
The performance of BBL™ CHROMagar™ MRSA II was evaluated at three diverse clinical laboratories in the U.S. A total of 1187 compliant remnant, prospective, nares
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specimens were enrolled. Specimens were evaluated by comparing the recovery of MRSA on traditional culture media and BBLTM CHROMagar™ MRSA II plates. S. aureus recovered on the traditional culture media was tested by the cefoxitin disk diffusion test method. BBL™ CHROMagar™ MRSA II was interpreted as positive for MRSA at 20-26 hours based on detection of mauve colonies.
A total of 162 specimens were found to be MRSA positive. The positive percent agreement of BBLTM CHROMagar™ MRSA II to cefoxitin disk was 92% (149/162). The negative percent agreement of BBL CHROMagar MRSA II compared to cefoxitin disk 99.9% (1024/1025) (Table 1).
Table 1: BBL™ CHROMagar™ MRSA II Performance versus Cefoxitin Disk
| Cefoxitin Disk | |||
|---|---|---|---|
| CMRSA II Result | MRSA | Not MRSA | Total |
| MRSA | 149 | 1 | 150 |
| Not MRSA | 13 | 1024 | 1037 |
| 162 | 1025 | 1187 |
Reference Method: Cefoxitin Disk Positive Percent Agreement: 92% (86.7%, 95.7%) Negative Percent Agreement: 99.9% (99.5%, 100%)
With combined data from two clinical trial sites, the positive percent agreement of BBL™ CHROMagar™ MRSA II compared to Traditional Culture was 92% at 20-26h and the negative percent agreement was 98.8% (Table 2).
| Table 2: BBL™ CHROMagar™ MRSA II Performance vs. Traditional Culture at | |||
|---|---|---|---|
| Two Clinical Trial Sites |
| Traditional Culture | |||
|---|---|---|---|
| CMRSA II Result | MRSA | Not MRSA | Total |
| MRSA | 92 | 9* | 101 |
| Not MRSA | 8 | 760 | 768 |
| 100 | 769 | 869 |
Reference Method: Traditional Culture Positive Percent Agreement: 92% (84.8%, 96.5%) Negative Percent Agreement: 98.8% (97.8%, 99.5%)
- Nine samples that were positive on BBL™ CHROMagar™ MRSA II and negative by Traditional Culture were confirmed as MRSA by cefoxitin disk diffusion testing.
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At the third clinical trial site, the positive percent agreement of BBL™ CHROMagar™ MRSA II compared to Traditional Culture was 90.2% at 20-26h and the negative percent agreement was 98.9% (Table 3).
.
Table 3: BBL™ CHROMagar™ MRSA II Performance vs. Traditional Culture at Third Clinical Trial Site
| Traditional Culture | |||
|---|---|---|---|
| CMRSA II Result | MRSA | Not MRSA | Total |
| MRSA | 46 | 3* | 49 |
| Not MRSA | 5 | 264 | 269 |
| 51 | 267 | 318 |
Reference Method: Traditional Culture Positive Percent Agreement: 90.2% (78.6%, 96.7%) Negative Percent Agreement: 98.9% (96.8%, 99.8%)
- Two samples that were positive on BBL™ CHROMagar™ MRSA II and negative by Traditional Culture were confirmed as MRSA by cefoxitin disk diffusion testing.
BD Diagnostic Systems Becton, Dickinson and Company
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center-WO66-G609 Silver Spring, MD 20993-0002
Mr. Paul Swift Regulatory Affairs Specialist Becton Dickinson and Company 7 Loveton Circle Sparks, MD 21152
AUG 2 0 2010
Re: K092767
Trade/Device Name: BBL™ CHROMagar™ MRSA II Regulation Number: 21 CFR §866.1700 Regulation Name: Culture Medium for Antimicrobial Susceptibility Tests Regulatory Class: II Product Code: JSO Dated: August 18, 2010 Received: August 19, 2010
Dear Mr. Swift:
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. Iisting 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 (240) 276-0484. 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 to!!-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
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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Indication for Use
510(k) Number (if known): K092767
Device Name: BBLTM CHROMagar™ MRSA II
Indication For Use:
BBL™ CHROMagar™ MRSA II is a selective and differential chromogenic medium for the qualitative direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings. The test is performed on anterior nares swab specimens from patients to screen for MRSA colonization.
BBL CHROMagar MRSA II is not intended to diagnose, guide or monitor treatment for MRSA infections. A negative result does not preclude MRSA nasal colonization. Concomitant cultures are necessary for organism identification, susceptibility testing or epidemiological typing.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Luddi le Roo ly
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K692767
BD Diagnostic Systems Becton, Dickinson and Company