(241 days)
Not Found
No
The device is a chromogenic culture medium, which is a chemical-based diagnostic method, not a software or hardware device that would typically incorporate AI/ML. The summary explicitly states "Not Found" for mentions of AI, DNN, or ML, and describes a traditional laboratory testing process.
No
The device is a diagnostic tool used to detect MRSA, not to treat or cure a disease. Its intended use explicitly states it is "not intended to guide, or monitor treatment for MRSA infection."
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA".
No
The device description clearly states it is a "selective and differential chromogenic culture medium," which is a physical laboratory 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 detection of methicillin resistant Staphylococcus aureus (MRSA) from skin and soft-tissue wound specimens" and is "indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections." This clearly describes a test performed in vitro (outside the body) on a biological specimen to provide information for diagnosis.
- Device Description: The description confirms it's a "selective and differential chromogenic culture medium," which is a common type of IVD used in microbiology laboratories.
- Performance Studies: The document details performance studies conducted on clinical samples, which is a requirement for demonstrating the effectiveness of an IVD.
- Key Metrics: The inclusion of metrics like sensitivity and specificity are standard for evaluating the performance of diagnostic tests.
- Intended User/Care Setting: The mention of "laboratory tests and clinical data" implies use in a laboratory setting, which is where IVDs are typically used.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MRSASelect™ is a selective and differential chromogenic medium for the qualitative detection of methicillin resistant Staphylococcus aureus (MRSA) from skin and soft-tissue wound specimens. The MRSASelect™ is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections. Concomitant cultures and susceptibility testing are necessary for all skin and soft-tissue wound specimens. MRSASelect™ is not intended to guide, or monitor treatment for MRSA infection, or provides results of susceptibility to methicillin. Results can be interpreted after 18 to 28 hours incubation.
Product codes
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 skin or soft-tissue wound specimens. Results can be interpreted after 18 - 28 hours incubation.
MRSASelect is a selective and differential chromogenic medium for the qualitative detection of methicillin resistant Staphylocccus aureus (MRSA) from skin and soft-tissue wound specimens. The selectivity of this medium is based on the presence of an antibiotic/antifungal mixture and an optimized salt concentration 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin and soft-tissue wound specimens
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Performance Data:
Interfering Substances: In order to evaluate the possible interference of common topical agents used in wound care samples of these agents were inoculated with MRSA and plated on MRSASelect media. Use of the following compounds has an inhibitory effect on MRSA growth that is unrelated to medium performance: Bactine (Benzalkonium chloride 0.13%. Lidocaine hydrochloride 2.5%); Betadine (liquid) (Povidoneiodine 10%), Iodine Tincture (liquid) (Iodine 2%), Biseptine (liquid) (Chlorhexidine Gluconate 0.25%, Benzalkonium chloride 0.025%), Sodium hypochlorite (liquid), StaphAseptic (ointment) (Benzethonium Chloride 0.2%, Lidocaine HCl 2.5%), and silver chloride.
Cross Reactivity Testing (Analytical Specificity): 35 bacterial and fungal strains found in wound or skin samples were cultured and inoculated onto MRSASelect™ plates at a concentration of ≥10 CFU/mL. No cross-reactivity was observed on any strains tested. Most strains showed no growth on MRSASelect™ with the exception of Corynebacterium jeikeium and Candida tropicalis. With both of these organisms pinpoint white colonies were observed: these are not representative of MRSA colonies, and therefore these are not cross-reactants. No variation was seen between 24 and 28 hour incubation time.
Analytical Sensitivity: 102 strains of MRSA, including USA100, 200, 300, 500, 600, and 1000 were inoculated onto MRSASelect™ plates at concentrations of 10 to 10 CFU/mL. USA300-0114 was also tested. 97% (99/102) sensitivity was observed after 24 hours incubation.
Reproducibility: A panel of 6 organisms, including MRSA, MSSA and S. epidermidis, was evaluated on MRSASelect™. It was performed at concentrations of 108 CFU/mL for MRSA, and 108 CFU/mL for non-MRSA. The panel was tested in triplicate each day for three clinical sites. Overall reproducibility was 100% after 24 hours incubation when testing this panel.
Method Comparison: 943 skin and soft-tissue wound samples were collected and tested at four clinical laboratories in the United States. Each sample was tested on MRSASelect™, Trypticase Soy Agar (TSA) with 5% Sheep's Blood, and Tryptic Soy Broth (TSB) with 6.5% NaCl. Samples that were positive on TSA or TSB were confirmed with Gram stain, Pastorex™ Staph Plus, and mecA mediated oxacillin resistance using 30 ug/mL Cefoxitin disk (R: ≤21 mm, S: ≥ 22 mm).
The following results were obtained: specificity 99.4% (95% CI: [98.5, 99.8]) and sensitivity 91.7% (95% CI: [87.3, 94.7]). The overall prevalence of MRSA in the study was 24.2% (95% CI: [21.5, 27.0]).
Summary Table: MRSASelect™ vs. Routine Culture and TSB
MRSASelect™ Pos: Routine Culture & TSB Pos 209, Routine Culture & TSB neg 4, total 213
MRSASelect™ Neg: Routine Culture & TSB Pos 19*, Routine Culture & TSB neg 711, total 730
Total: Routine Culture & TSB Pos 228, Routine Culture & TSB neg 715, total 943
- For 12/19 samples - MRSA were isolated only from TSB with 6.5% NaCl and were not isolated on initial direct culture.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 91.7% (95% CI: [87.3, 94.7])
Specificity: 99.4% (95% CI: [98.5, 99.8])
Overall % agreement: 97.6% [96.3, 98.4]
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).
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October 21, 2010 Page 39 of 42
510(k) SUMMARY
OCT 2 9 2010
| Date of Summary | October 21, 2010 |
|---|---|
| Product Name | Bio-Rad MRSASelect -- Wound Specimens |
| A selective and differential chromogenic medium for the | |
| qualitative detection of methicillin-resistant Staphylococcus aureus | |
| from skin and soft-tissue wound specimens. Results can be | |
| interpreted after 18 - 28 hours incubation. | |
| Sponsor | Bio-Rad |
| 3 Boulevard Raymond Poincaré | |
| 92430 Marnes-la-Coquette | |
| France | |
| Correspondent | MDC Associates, LLC |
| Fran White, Regulatory Consultant | |
| 180 Cabot Street | |
| Beverly, MA 01915 |
Substantially Equivalent Device
MRSASelect for skin and soft-tissue wounds is substantially equivalent to Bio-Rad MRSASelect extended incubation (reference 510(k) K081212). Products are thromogenic media used for the detection of MRSA direct from a specimen swab.
Manufacturer: Bio-Rad MRSASelect -- extended incubation Product:
| Product Attribute | Bio-Rad MRSASelect™
Extended Incubation | Bio-Rad MRSASelect™
Wound Specimen |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | MRSASelect is a selective and
differential chromogenic medium
for the qualitative detection of
MRSA direct from a nasal swab
for the detection of methicillin
resistant Staphylococcus aureus
(MRSA). | MRSASelect is a selective and differential
chromogenic medium for the
qualitative detection of methicillin resistant
Staphylococcus aureus (MRSA) from skin
and soft-tissue wound specimens. |
| Product format | Chromogenic agar | Chromogenic Agar |
| Read time | After 18-24 hour incubation | After 18-24 hours incubation |
| Quality Control | Daily with recommended | Daily - same recommended organisms |
Similarities
1
0
| organisms | ||
|---|---|---|
| Differences | ||
| Product Attribute | Bio-Rad MRSASelect™ Extended Incubation | Bio-Rad MRSASelect™ Wound Specimen |
| Intended use | MRSASelect is a screen for the detection of colonization of methicillin resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings. | MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections. Concomitant cultures and susceptibility testing are necessary for all skin and soft-tissue wound specimens. MRSASelect™ is not intended to guide, or monitor treatment for MRSA infection, or provides results of susceptibility to methicillin. |
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 skin or soft-tissue wound specimens. Results can be interpreted after 18 - 28 hours incubation.
Intended Use
MIRSASelect™ is a selective and differential chromogenic medium for the qualitative detection of methicillin resistant Staphylococcus aureus (MRSA) from skin and soft-tissue wound specimens. The MRSASelect™ is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections. Concomitant cultures and susceptibility testing are necessary for all skin and soft-tissue wound specimens. MRSASelect™ is not intended to guide, or monitor treatment for MRSA infection, or provides results of susceptibility to methicillin. Results can be interpreted after 18 to 28 hours incubation.
Summary of Technology
MRSASelect is a selective and differential chromogenic medium for the qualitative detection of methicillin resistant Staphylocccus aureus (MRSA) from skin and soft-tissue wound specimens. The selectivity of this medium is based on the presence of an antibiotic/antifungal mixture and an optimized salt concentration 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
2
October 21, 2010 Page 41 of 42
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
Interfering Substances
In order to evaluate the possible interference of common topical agents used in wound care samples of these agents were inoculated with MRSA and plated on MRSASelect media. Use of the following compounds has an inhibitory effect on MRSA growth that is unrelated to medium performance:
Bactine (Benzalkonium chloride 0.13%. Lidocaine hydrochloride 2.5%); Betadine (liquid) (Povidoneiodine 10%), Iodine Tincture (liquid) (Iodine 2%), Biseptine (liquid) (Chlorhexidine Gluconate 0.25%, Benzalkonium chloride 0.025%), Sodium hypochlorite (liquid), StaphAseptic (ointment) (Benzethonium Chloride 0.2%, Lidocaine HCl 2.5%), and silver chloride.
Cross Reactivity Testing (Analytical Specificity)
To evaluate the analytical specificity of the MRSASelect™ media 35 bacterial and fungal strains found in wound or skin samples were cultured and inoculated onto MRSASelect™ plates at a concentration of ≥10° CFU/mL.
No cross-reactivity was observed on any strains tested. Most strains showed no growth on MRSASelect™ with the exception of Corynebacterium jeikeium and Candida tropicalis. With both of these organisms pinpoint white colonies were observed: these are not representative of MRSA colonies, and therefore these are not cross-reactants. No variation was seen between 24 and 28 hour incubation time.
Analytical Sensitivity To evaluate the analytical sensitivity of the MRSASElect™, 102 strains of MRSA, including USA100, 200, 300, 500, 600, and 1000 were inoculated onto MRSASelect™ plates at concentrations of 10 to 10 CFU/mL. USA300-0114 was also tested. 97% (99/102) sensitivity was observed after 24 hours incubation.
Reproducibility
A panel of 6 organisms, including MRSA, MSSA and S. epidermidis, was evaluated on MRSASelect™. It was performed at concentrations of 108 CFU/mL for MRSA, and 108 CFU/mL for non-MRSA. The panel was tested in triplicate each day for three clinical sites. Overall reproducibility was 100% after 24 hours incubation when testing this panel.
3
Method Comparison
943 skin and soft-tissue wound samples were collected and tested at four clinical laboratories in the United States. Each sample was tested on MRSASelect™, Trypticase Soy Agar (TSA) with 5% Sheep's Blood, and Tryptic Soy Broth (TSB) with 6.5% NaCl. Samples that were positive on TSA or TSB were confirmed with Gram stain, Pastorex™ Staph Plus, and mecA mediated oxacillin resistance using 30 ug/mL Cefoxitin disk (R: ≤21 mm, S: ≥ 22 mm)
The following results were obtained: specificity 99.4% (95% CI: [98.5, 99.8]) and sensitivity 91.7% (95% CI: [87.3, 94.7}). The overall prevalence of MRSA in the study was 24.2% (95% CI: [21.5, 27.0]). MRSASelect™ vs. Routine Culture and TSB
| | | Routine Culture
&TSB | | |
|---------|-------|-------------------------|-----|-------|
| | | Pos | neg | total |
| MRSA | pos | 209 | 4 | 213 |
| Select™ | neg | 19* | 711 | 730 |
| | total | 228 | 715 | 943 |
- For 12/19 samples - MRSA were isolated only from TSB with 6.5% NaCl and were not isolated on initial direct culture.
99.4% [98.5, 99.8] Overall % agreement 97.6% [96.3, 98.4] Specificity Sensitivity 91.7% [87.3, 94.7]
Statement of Safety and Efficacy
The data presented demonstrates the safety and efficacy of the Bio-Rad MRSASelect™ as compared to routine culture and identification when results are interpreted after 18 to 28 hours incubation in ambient air.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
BIO-RAD c/o MDC Associates, LLC 180 Cabot Street Beverly, Massachusetts 01915 Attn: Fran White
OCT 2 9 2010
Re: K100589
| Trade/Device Name: MRSASelect |
|---|
| Regulation Number: 21 CFR §866.1700 |
| Regulation Name: Culture medium for antimicrobial susceptibility tests |
| Regulatory Class: Class II |
| Product Code: JSO |
| Dated: October 21, 2010 |
| Received: October 25, 2010 |
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. Ilsting 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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
Page 2 - Ms. Fran White
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Ledale hi-Poole, Ms
day
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
6
October 21, 2010 Page 37 of 42
OCT 2 9 2010
Indications for Use
510(k) Number (if known): K100589
Device Name: MRSASelect
Indications for Use:
MRSASelect™ is a selective and differential chromogenic medium for the qualitative detection of methicillin resistant Staphylococcus aureus (MRSA) from skin and soft-tissue wound specimens. The MRSASelect™ is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections. Concomitant cultures and susceptibility testing are necessary for all skin and soft-tissue wound specimens. MRSASelect™ is not intended to guide, or monitor treatment for MRSA infection, or provides results of susceptibility to methicillin. Results can be interpreted after 18 to 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)
Leedole. Podo, M.S.
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
KI66585 510(k)
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