(41 days)
Not Found
No
The device description and performance studies focus on the chemical and biological properties of the culture medium for detecting MRSA based on color change, with no mention of AI or ML.
No
The device is a diagnostic tool used to detect MRSA colonization, not to treat MRSA infections. Its intended use explicitly states it is "not intended to diagnose MRSA infection nor to guide or monitor treatment for infections."
Yes
This device is a diagnostic device because it is used for the qualitative direct detection of nasal colonization by methicillin resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections. It tests for the presence of MRSA, which is a diagnostic purpose.
No
The device description clearly states it is a "medium" (BBL CHROMagar MRSA medium) which is a physical substance used for growing microorganisms, indicating it is a hardware component, 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 human specimen (anterior nares swab) to provide information about a patient's health status (presence of MRSA colonization).
- Device Description: The description details a medium used to grow and identify bacteria from a specimen. This is a classic example of an in vitro diagnostic test.
- Specimen Type: It uses "anterior nares swab specimens from patients and healthcare workers." These are human specimens.
- Performance Studies: The document includes detailed analytical and clinical studies evaluating the performance of the device in detecting MRSA from human specimens. This is a requirement for IVDs.
- Predicate Device: The mention of a predicate device (K863821; BBL™ Oxacillin Screen Agar) further indicates that this device is being compared to another legally marketed IVD.
All of these factors align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or inborn abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
BBL™ CHROMagar™ MRSA is a selective and differential 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 and healthcare workers to screen for MRSA colonization. BBL™ CHROMagar™ MRSA is not intended to diagnose MRSA infection nor to guide or monitor treatment for infections.
Product codes
JSO
Device Description
The BBL CHROMagar MRSA medium permits the direct detection and identification of MRSA through the incorporation of specific chromogenic substrates and cefoxitin. The cephalosporin (Cefoxitin) is incorporated to select for methicillin resistant strains of Staphylococcus aureus. MRSA strains will grow in the presence of cefoxitin and produce mauve-colored colonies resulting from hydrolysis of the chromogenic substrate. Additional selective agents are incorporated for the suppression of gram-negative organisms, yeast and some gram-positive cocci. Bacteria other than MRSA may utilize other chromogenic substrates in the medium resulting in blue to blue/green colored colonies or if none of the chromogenic substrates are utilized, appear as white or colorless. The incorporation of chromogens and cephalosporin permits the differentiation of MRSA from other organisms.
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
ANALYTICAL STUDIES:
Interfering Substances
Study Type: Interfering Substances.
Summary: To determine the effect of potential interfering substances on the recovery and color production of MRSA, a variety of substances expected to be associated with the target specimen were tested with the BBL CHROMagar MRSA (CMRSA). Identification was not adversely affected by commonly used medications, bacterial transport devices, and human blood. A concentration of 10% Phenylephrine Hydrochloride (nasal spray) did show an inhibitory affect on organism growth on both the nonselective blood agar plate (TSA II w/5% sheep blood) and CMRSA.
Reproducibility
Study Type: Reproducibility.
Sample Size: 17 test strains.
Summary: Reproducibility testing of the CMRSA was evaluated using 17 test strains. Three different lots of CMRSA were tested to determine that CMRSA reliably detects MRSA within lots, and across lots at different time intervals. Acceptance reproducibility rate of ≥95% for both inter-lot and overall testing intervals was achieved.
Expression of Resistance
Study Type: Expression of Resistance.
Sample Size: 17 strains (11 heterogeneous, 5 homogenous and one negative).
Summary: To assess the ability of CMRSA to detect MRSA strains with varying levels of resistance expression, a total of 17 strains (11 heterogeneous, 5 homogenous and one negative) were tested. CMRSA was compared to nonselective TSA II w/5% sheep blood medium. Testing demonstrated that CMRSA medium can adequately detect both heterogeneous as well as homogeneous MRSA.
Performance
Study Type: Performance (sensitivity and specificity).
Key Results: The sensitivity and specificity criteria of ≥90% was met for CMRSA as compared to Oxacillin MIC testing and Oxacillin Screen Agar testing however 48 hour incubation is necessary.
CLINICAL STUDIES:
Reproducibility Testing
Study Type: Reproducibility testing.
Clinical Sites: Four geographically diverse clinical sites, composed of regional hospitals and university-based laboratories.
Sample Size: 10 methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) S. aureus strains.
Key Results: Overall reproducibility was 100% across all three sites.
Challenge Strain Testing
Study Type: Challenge Strain testing.
Clinical Sites: Three clinical sites.
Sample Size: 20 challenge strains, composed of methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) S. aureus strains.
Key Results: CMRSA was able to reliably detect both at 100%, both at each individual site and across all three sites.
Reference Oxacillin MIC Testing
Study Type: Clinical Performance, comparison to Reference Oxacillin MIC.
Sample Size: 1,974 compliant nares surveillance specimens.
Key Results: CMRSA overall recovery of MRSA from 1,974 compliant nares surveillance specimens was at 95% (126/132) when compared to isolation on TSA II of 89% (117/132). As an overall MRSA screening test, % negative agreement was at 99% (1829/1842),when colony color alone was used to report MRSA at 24 hours, and with a confirmatory coagulase test at 48 hours. Specificity was improved by confirming mauve colonies from CMRSA with morphology determination and coagulase testing, particularly at the 48 hour reading, when there was significant breakthrough of mauve-colored coagulase negative staphylococci and gram positive rods. In direct comparison of susceptibility results to Oxacillin MIC, the combined final CMRSA % agreement of MRSA was at 95% (111/117) and % agreement of MSSA was 97% (201/208). Overall category agreement of the CMRSA test with Oxacillin MIC was 96% (312/325).
Reference Oxacillin Screen Agar Testing
Study Type: Clinical Performance, comparison to Reference Oxacillin Screen Agar.
Sample Size: 1,974 nares surveillance specimens.
Key Results: CMRSA overall recovery of MRSA from 1,974 nares surveillance specimens was at 95% (125/131) when compared to isolation on TSA of 89% (116/131). As an overall MRSA-screening test, % negative agreement was at 99% (1830/1843), when colony color alone was used to report MRSA at 24 hours, and with a confirmatory coagulase test at 48 hours. Specificity was improved by confirming mauve colonies from CMRSA with morphology determination and coagnlase testing, particularly at the 48 hour reading. In direct comparison of susceptibility results to Oxacillin Screen Agar, the combined final CMRSA % agreement of MRSA was acceptable at 95% (110/116), and % agreement of MSSA was 97% (202/209). Overall category agreement of the CMRSA test with Oxacillin Screen Agar was 96% (312/325).
Performance Compared to PBP2' Latex Agglutination, Cefoxitin Disk Diffusion and PCR detection of the mecA gene
Study Type: Clinical Performance, comparison to PBP2' Latex Agglutination, Cefoxitin Disk Diffusion and PCR detection of the mecA gene.
Key Results:
CMRSA vs. Cefoxitin Disk Diffusion: % Agreement of MRSA: 94.9% (112/118) (95% CI: 89.3%, 98.1%), % Agreement of MSSA: 98% (200/204) (95% CI: 95.1%, 99.5%).
CMRSA vs. PBP2' Latex Agglutination: % Agreement of MRSA: 93.5% (115/123) (95% CI: 87.6%, 97.2%), % Agreement of MSSA: 98.5% (198/201) (95% CI: 95.7%, 99.7%).
CMRSA vs. PCR (mecA): % Agreement of MRSA: 95.7% (111/116) (95% CI: 90.2%, 98.6%), % Agreement of MSSA: 97% (196/202) (95% CI: 93.6%, 98.9%).
Key Metrics
Sensitivity and specificity criteria of ≥90% was met for CMRSA as compared to Oxacillin MIC testing and Oxacillin Screen Agar testing.
CMRSA overall recovery of MRSA from 1,974 compliant nares surveillance specimens was at 95% (126/132) when compared to isolation on TSA II of 89% (117/132).
As an overall MRSA screening test, % negative agreement was at 99% (1829/1842).
In direct comparison of susceptibility results to Oxacillin MIC, the combined final CMRSA % agreement of MRSA was at 95% (111/117) and % agreement of MSSA was 97% (201/208). Overall category agreement of the CMRSA test with Oxacillin MIC was 96% (312/325).
CMRSA overall recovery of MRSA from 1,974 nares surveillance specimens was at 95% (125/131) when compared to isolation on TSA of 89% (116/131).
As an overall MRSA-screening test, % negative agreement was at 99% (1830/1843).
In direct comparison of susceptibility results to Oxacillin Screen Agar, the combined final CMRSA % agreement of MRSA was acceptable at 95% (110/116), and % agreement of MSSA was 97% (202/209). Overall category agreement of the CMRSA test with Oxacillin Screen Agar was 96% (312/325).
CMRSA vs. Cefoxitin Disk Diffusion: % Agreement of MRSA: 94.9%, % Agreement of MSSA: 98%.
CMRSA vs. PBP2' Latex Agglutination: % Agreement of MRSA: 93.5%, % Agreement of MSSA: 98.5%.
CMRSA vs. PCR (mecA): % Agreement of MRSA: 95.7%, % Agreement of MSSA: 97%.
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).
0
NOV 2 2 2004
510(k) SUMMARY
| SUBMITTED BY: | BECTON, DICKINSON AND COMPANY
7 LOVETON CIRCLE
SPARKS, MD 21152
Phone: 410-316-4619
Fax: 410-316-4499 |
|------------------------|-------------------------------------------------------------------------------------------------------------------|
| CONTACT NAME: | Dennis Mertz, Sr. Manager Regulatory Affairs |
| DATE PREPARED: | October 8, 2004 |
| DEVICE TRADE NAME: | CHROMagar TM MRSA |
| DEVICE COMMON NAME: | Culture Medium |
| DEVICE CLASSIFICATION: | 21 CFR§866.1700, Class II |
| PREDICATE DEVICES: | BBL TM Oxacillin Screen Agar
(K863821) |
INTENDED USE:
BBL™ CHROMagar™ MRSA is a selective and differential 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 and healthcare workers to screen for MRSA colonization. BBL™ CHROMagar™ MRSA is not intended to diagnose MRSA infection nor to guide or monitor treatment for infections.
DEVICE DESCRIPTION:
The BBL CHROMagar MRSA medium permits the direct detection and identification of MRSA through the incorporation of specific chromogenic substrates and cefoxitin. The cephalosporin (Cefoxitin) is incorporated to select for methicillin resistant strains of Staphylococcus aureus. MRSA strains will grow in the presence of cefoxitin and produce mauve-colored colonies resulting from hydrolysis of the chromogenic substrate. Additional selective agents are incorporated for the suppression of gram-negative organisms, yeast and some gram-positive cocci. Bacteria other than MRSA may utilize other chromogenic substrates in the medium resulting in blue to blue/green colored colonies or if none of the chromogenic substrates are utilized, appear as white or colorless.
1
The incorporation of chromogens and cephalosporin permits the differentiation of MRSA from other organisms.
DEVICE COMPARISON:
The BBL CHROMagar MRSA was compared to BBL Oxacillin Screen Agar (K863821), a legally marketed device to determine resistance of Staphylococcus aureus to oxacillin, methicillin and nafcillin. Since BBL CHROMagar MRSA is designed as a primary plating medium, the most notable differences are the added selectivity, use of cefoxitin as an indicator of methicillin resistance and the inclusion of chromogenic substrates.
The BBL CHROMagar MRSA medium differs from the BBL Oxacillin Screen Aqar method in that:
- The BBL CHROMagar MRSA medium is an antimicrobial susceptibility . test medium that is selective and differential while the BBL. Oxacillin Screen Agar is an antimicrobial susceptibility test medium that requires a pure culture prior to inoculation
- The BBL CHROMagar MRSA provides detection and identification of . methicillin resistant Staphylococcus aureus (MRSA) at 24 hours and up to 48 hours if necessary. The BBL Oxacillin Screen Agar provides identification at 24 hours.
- The BBL CHROMagar MRSA utilizes a specimen swab directly inoculate u to the plate for streaking. BBL Oxacillin Screen Agar requires sample preparation of a pure culture to a 0.5 McFarland standard in TSB prior to plating and streaking.
- The BBL CHROMagar MRSA utilizes chromogenic substrates to facilitate . the differentation of Staphylococcus aureus from other bacteria by producing mauve colored colonies. Bacteria other than MRSA appear as blue to blue/green colored colonies. BBL Oxacillin Screen Agar does not differentiate growth on the plate since only pure cultures are used.
- The BBL CHROMagar MRSA utilizes cefoxitin as its selective agent. The . BBL™ Oxacillin Screen Agar utilizes oxacillin as its selective agent.
- The BBL CHROMagar MRSA uses an incubation temperature of 35 피 37ºC. The BBL Oxacillin Screen Agar utilizes an incubation temperature of 30 - 35℃.
2
| Screen Agar: | ||
|---|---|---|
| BBL CHROMagar MRSA | BBL Oxacillin Screen Agar | |
| Intended Use | BBLTM CHROMagarTM MRSA is a selective and | |
| differential 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 | ||
| and healthcare workers to screen for MRSA colonization. | ||
| BBLTM CHROMagarTM MRSA is not intended to | ||
| diagnose MRSA infection nor to guide or monitor | ||
| treatment for infections. | Oxacillin Screen Agar is a antimicrobial susceptibility test medium to | |
| determine resistance of Staphylococcus aureus to oxacillin, | ||
| methicillin and naficillin. | ||
| Specimen type | Anterior nares | Pure culture isolate |
| Inoculation | Direct from specimen collection device. | Dilution of pure culture from TSA. |
| Incubation Temperature | Incubation at 35 - 37°C. | Incubation at 30 - 35°C. |
| Incubation Length | 24 hours, if negative re-incubate additional 24 hours. | 24 hours. |
| Selective agent | Cefoxitin 6.0 mg | Oxacillin 6.0 mg |
| Testing Method | Manual | Manual |
| Growth Detection | Identification at 24 hours or 48 hours. | Identification at 24 hours. |
| Organism Differentiation | Chromogenic substrates facilitate differentiation of S. aureus from other organisms. | None |
| Shelf Life | 10 weeks | 12 weeks |
.
The following is a table showing the comparison of device characteristics of BBL CHROMagar MRSA to BBL Oxacilling
Screen Agar:
3
| CHROMagar MRSA | G/L | Oxacillin Screen Agar | G/L |
|---|---|---|---|
| Chromopeptone | 40.0 | Beef Extract | 2.0 |
| Agar | 14.0 | Agar | 17.0 |
| Chromogen Mix | 0.5 | Starch | 1.5 |
| Inhibitory agents | 0.07 | Acid Hydrolysate of | |
| Casein | 9.0 | ||
| Sodium Chloride | 25.0 | Sodium Chloride | 40.0 |
| Cefoxitin | 0.006 | Oxacillin | 0.006 |
Ingredients Approximate formula Per liter
SUMMARY OF PERFORMANCE DATA:
ANALYTICAL STUDIES:
Interfering Substances
To determine the effect of potential interfering substances on the recovery and color production of MRSA, a variety of substances expected to be associated with the target specimen were tested with the BBL CHROMagar MRSA (CMRSA). Identification was not adversely affected by commonly used medications, bacterial transport devices, and human blood. A concentration of 10% Phenylephrine Hydrochloride (nasal spray) did show an inhibitory affect on organism growth on both the nonselective blood agar plate (TSA II w/5% sheep blood) and CMRSA.
Reproducibility
Reproducibility testing of the CMRSA was evaluated using 17 test strains. Three different lots of CMRSA were tested to determine that CMRSA reliably detects MRSA within lots, and across lots at different time intervals. Acceptance reproducibility rate of ≥95% for both inter-lot and overall testing intervals was achieved.
Expression of Resistance
To assess the ability of CMRSA to detect MRSA strains with varying levels of resistance expression, a total of 17 strains (11 heterogeneous, 5 homogenous and one negative) were tested. CMRSA was compared to nonselective TSA II w/5% sheep blood medium. Testing demonstrated that CMRSA medium can adequately detect both heterogeneous as well as homogeneous MRSA.
Performance
Determine the performance (sensitivity and specificity) of CMRSA medium, BBL Oxacillin Screen Agar oxacillin MIC and oxacillin and cefoxitin disk diffusion and PBP2 for detection of methicillin resistant S. aureus. The sensitivity and specificity criteria of ≥90% was met for CMRSA as compared to Oxacillin MIC testing and Oxacillin Screen Agar testing however 48 hour incubation is necessary.
4
CLINICAL STUDIES:
The CMRSA medium was evaluated at four geographically diverse clinical sites, composed of regional hospitals and university-based laboratories.
Reproducibility Testing
The reproducibility of the CMRSA was evaluated at three clinical sites using a total of 10 methcillin-susceptible (MSSA) and methicillin-resistant (MRSA) S. aureus strains. Observed results were compared to expected results. Overall reproducibility was 100% across all three sites.
Challenge Strain Testing
The performance of the CMRSA was evaluated at three clinical sites using a panel of twenty (20) challenge strains, composed of methcillin-susceptible (MSSA) and methicillin-resistant (MRSA) S. aureus strains. CMRSA was able to reliably detect both at 100%, both at each individual site and across all three sites.
Reference Oxacillin MIC Testing
CMRSA overall recovery of MRSA from 1,974 compliant nares surveillance specimens was at 95% (126/132) when compared to isolation on TSA II of 89% (117/132). As an overall MRSA screening test, % negative agreement was at 99% (1829/1842),when colony color alone was used to report MRSA at 24 hours, and with a confirmatory coagulase test at 48 hours. Specificity was improved by confirming mauve colonies from CMRSA with morphology determination and coagulase testing, particularly at the 48 hour reading, when there was significant breakthrough of mauve-colored coagulase negative staphylococci and gram positive rods. In direct comparison of susceptibility results to Oxacillin MIC, the combined final CMRSA % agreement of MRSA was at 95% (111/117) and % agreement of MSSA was 97% (201/208). Overall category agreement of the CMRSA test with Oxacillin MIC was 96% (312/325).
Reference Oxacillin Screen Agar Testing
CMRSA overall recovery of MRSA from 1,974 nares surveillance specimens was at 95% (125/131) when compared to isolation on TSA of 89% (116/131). As an overall MRSA-screening test, % negative agreement was at 99% (1830/1843), when colony color alone was used to report MRSA at 24 hours, and with a confirmatory coagulase test at 48 hours. Specificity was improved by confirming mauve colonies from CMRSA with morphology determination and coagnlase testing, particularly at the 48 hour reading. In direct comparison of susceptibility results to Oxacillin Screen Agar, the combined final CMRSA % agreement of
5
MRSA was acceptable at 95% (110/116), and % agreement of MSSA was 97% (202/209). Overall category agreement of the CMRSA test with Oxacillin Screen Agar was 96% (312/325).
Performance Compared to PBP2' Latex Agglutination, Cefoxitin Disk Diffusion and PCR detection of the mecA gene
CMRSA was also compared to other test methods for identifying MRSA: the PBP2', a Cefoxitin (30µg) disk diffusion test, and PCR detection of the mecA gene. Sensitivity and specificity compared to these additional method is shown in the following table:
| CMRSA vs. Cefoxitin Disk Diffusion | CMRSA vs. PBP2' Latex Agglutination | CMRSA vs. PCR (mecA) | |||
|---|---|---|---|---|---|
| % Agreement of | |||||
| MRSA | |||||
| (95% CI) | % Agreement of | ||||
| MSSA | |||||
| (95% CI) | % Agreement of | ||||
| MRSA | |||||
| (95% CI) | % Agreement of | ||||
| MSSA | |||||
| (95% CI) | % Agreement | ||||
| of MRSA | |||||
| (95% CI) | % Agreement | ||||
| of MSSA | |||||
| (95% CI) | |||||
| 94.9% | |||||
| (112/118) | |||||
| (89.3%,98.1%) | 98% | ||||
| (200/204) | |||||
| (95.1%,99.5%) | 93.5% | ||||
| (115/123) | |||||
| (87.6%,97.2%) | 98.5% | ||||
| (198/201) | |||||
| (95.7%,99.7%) | 95.7% | ||||
| (111/116) | |||||
| (90.2%,98.6%) | 97% | ||||
| (196/202) | |||||
| (93.6%,98.9%) |
6
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 2 2 2004
Mr. Dennis Mertz Sr. Manager Regulatory Affairs BD Diagnostic Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152
Re: K042812
Trade/Device Name: BBLTM CHROMagar™ MRSA Regulation Number: 21 CFR 866.1700 Regulation Name: Culture Medium for Antimicrobial Susceptibility Tests Regulatory Class: Class II Product Code: JSO Dated: October 8, 2004 Received: October 12, 2004
Dear Mr. Mertz:
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 (OS) regulation (21 CFR Part 820).
7
Page 2
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 (301) 594-3084. 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 toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Sallarty
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
8
Page 1 of 1
510(k) Number: K042812
Device Name: BBLTM CHROMagar™ MRSA
Indications for Use:
BBL™ CHROMagar™ MRSA is a selective and differential 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 and healthcare workers to screen for MRSA colonization. BBLTM CHROMagar™ MRSA is not intended to diagnose MRSA infection nor to guide or monitor treatment for infections.
Prescription Use V (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 Lu, Rolo
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)