← Product Code [JSO](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JSO) · K122187 # VRESELECT CULTURE MEDIUM (K122187) _Bio-Rad · JSO · Nov 6, 2012 · Microbiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JSO/K122187 ## Device Facts - **Applicant:** Bio-Rad - **Product Code:** [JSO](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JSO.md) - **Decision Date:** Nov 6, 2012 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.1700 - **Device Class:** Class 2 - **Review Panel:** Microbiology ## Intended Use VRESelect™ is a selective and differential chromogenic medium, containing 8 µg/mL of vancomycin, for the qualitative detection of gastrointestinal colonization of vancomycin-resistant Enterococcus faecium (VREfm) and vancomycin-resistant Enterococcus faecalis (VREfs) and to aid in the prevention and control of vancomycin-resistant Enterococcus (VRE) in healthcare settings. The test is performed on rectal swabs, or fecal specimens from patients to be screened for VRE colonization. VRESelect™ is not intended to diagnose VRE infection nor to guide or monitor treatment of infection. Results can be interpreted after 24 to 28 hours incubation. Subculture to non-selective media (e.g., trypticase soy agar with 5% sheep blood) is needed for further identification, susceptibility testing and epidemiological typing. ## Device Story VRESelect™ is a selective/differential chromogenic culture medium containing 8 µg/mL vancomycin; used in healthcare settings for VRE screening. Input: rectal swabs or fecal specimens. Principle: antifungal/antibiotic mixture inhibits non-VRE organisms; chromogenic substrates cleaved by specific enzymes produce color-coded colonies (pink for VREfm, blue for VREfs). Output: visual colony identification after 24-28 hours incubation. Interpretation: manual/visual by laboratory personnel. Blue colonies require confirmation via catalase test and antimicrobial susceptibility testing. Subculture to non-selective media required for further identification/typing. Benefits: aids in VRE prevention and control programs. ## Clinical Evidence Performance evaluated at three sites using 946 fecal samples. Compared against Bile Esculin Azide Agar (BEAV) plus conventional identification (Gram stain, catalase, PYR, VITEK 2, E-Test). At 28 hours, positive agreement was 98% (186/189) and negative agreement was 95% (721/757) vs BEAV. VREfm positive agreement vs Vitek 2 was 97% at 28 hours; VREfs positive agreement was 94%. Analytical sensitivity (LOD) is 10³ CFU/mL. No cross-reactivity observed with 119 strains. ## Technological Characteristics Selective/differential chromogenic culture medium. Contains 8µg/mL vancomycin and antifungal/antibiotic mixture. Principle: enzymatic cleavage of chromogenic substrates. Form factor: plated medium. Incubation: 24-28 hours at 35-37°C. No software or electronic components. ## Regulatory 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 - Spectra VRE Chromogenic Media ([K092819](/device/K092819.md)) - Bile Esculin Azide Agar with 6ug/mL vancomycin ([K972359](/device/K972359.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ # KIZZI87 #### 510(k) SUMMARY NOV 6 2012 Date of Summary November 6, 2012 Product Name Sponsor VRESelect TM Media 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 VRESelect ™ is substantially equivalent to the Thermo Fisher Scientific (formerly Remel) Spectra VRE Chromogenic Media (reference 510(k) K092819) and the Thermo Fisher Bile Esculin Azide Agar with 6ug/mL vancomycin (reference 510(k) K972359). The predicate device Package Inserts are included for reference (see Appendix II). Thermo Fisher Scientific (formerly Remel) Manufacturer: Products: Spectra VRE Chromogenic Media Bile Esculin Azide Agar with 6ug/mL vancomycin {1}------------------------------------------------ | Product Attribute | Intended use | Methodology | Inoculation | Sample Type | Substantial Equivalent | |-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|--------------------|---------------------------------|------------------------| | Bio-Rad VRESelect ™ | VRE Select ™ is a selective and differential chromogenic medium, containing 8µg/mL of Vancomycin, for the qualitative detection of gastrointestinal colonization of vancomycin-resistant Enterococcus faecium (VRE fm ) and vancomycin-resistant Enterococcus faecalis (VRE fs ) and to aid in the prevention and control of vancomycin-resistant Enterococcus (VRE) in healthcare settings. The test is performed on rectal swabs or fecal specimens from patients to be screened for VRE colonization. VRE Select ™ is not intended to diagnose VRE infection nor to guide or monitor treatment of infection. Results can be interpreted after 24 to 28 hours incubation. Subculture to non-selective media (e.g., trypticase soy agar with 5% sheep blood) is needed for susceptibility testing and epidemiological typing. | Enzymatic | Direct or indirect | Rectal swabs or fecal specimens | | | Spectra VRE | Chromogenic media
Remel Spectra VRE is a selective and differential chromogenic medium, containing 6µg/mL of Vancomycin, intended for use in the qualitative detection of gastrointestinal colonization with vancomycin-resistant Enterococcus faecium and Enterococcus faecalis (VRE) to aid in the prevention and control of VRE in healthcare settings. The test is performed with a rectal swab and fecal specimens from patients to screen for VRE colonization. Spectra VRE is not intended to diagnose VRE infection or to guide or monitor treatment for infections. Subculture to non-selective media (e.g. Tryptic Soy Agar with 5% sheep blood) is needed for further identification, susceptibility testing, and epidemiological typing. | Enzymatic | Direct specimen | Rectal swabs or fecal specimens | ✓ | | Bile Esculin Azide Agar | Remel's Bile Esculin Azide Agar w/ 6µg/mL vancomycin is a plated medium recommended for use in qualitative procedures as a selective and differential medium for the primary isolation of vancomycin-resistant enterococci from surveillance cultures. This product is not intended for use as [a] method of antimicrobial susceptibility testing. Confirmation of resistance by an approved method is recommended as some organisms on initial isolation may overcome the inhibitory effects of the medium. | Enzymatic | Direct specimen | Fecal or urine specimens | ✓ | {2}------------------------------------------------ # Product Description VRESelect ™ is a selective medium for the detection of vancomycin-resistant Enterococcus (VRE). The selectivity of this medium is based on the presence of an antifungal/antibiotic mixture that inhibits the growth of most yeast, Gram negative and Gram positive bacteria, with the exception of vancomycin-resistant Enterococci (VRE). Detection is based on the cleavage of chromogenic substrates by specific enzymes of Enterococcus faecium which produces pink colonies and Enterococcus faecalis which produces blue colonies. Enterococcus gallinarum and Enterococcus casseliflavus are intrinsically resistant to vancomycin and may grow on the VRESelect™ medium as colorless or white colonies because they do not metabolize the chromogenic substrates. Vancomycin susceptible enterococci are inhibited. After 24 to 28 hours incubation pink colonies can be reported as VREfm. Blue colonies should be confirmed by a catalase test and susceptibility (refer to limitation 9 in package insert). # Intended Use VRESelect ™ is a selective and differential chromogenic medium, containing 8μg/mL of vancomycin, for the qualitative detection of gastrointestinal colonization of vancomycin-resistant Enterococcus faecium (VREfm) and vancomycin-resistant Enterococcus faecalis (VREfs) and to aid in the prevention and control of VRE in healthcare settings. The test is performed on rectal swabs or fecal specimens from patients to be screened for VRE colonization. VRESelect ™ is not intended to diagnose VRE infection nor to guide or monitor treatment of infection. Results can be interpreted after 24 to 28 hours incubation. Subculture to non-selective media (e.g., trypticase soy agar with 5% sheep blood) is needed for susceptibility testing and epidemiological typing. #### Performance Data #### Interfering Substances The following potential interfering substances were tested to confirm that they did not interfere with the performance of the VRESelect TM media: - Dulcolax®, Adult Glycerin Suppositories, Vaseline®, Preparation H®, Original . Boudreaux's Butt Paste®, Tuck's Medicated Cooling Pads®, Pepto-Bismol®, Miconazole cream, Nonoxynol-9 (spermicide), KY® Jelly, and Pepcid AC Max strength®. - Blood and Mucins . - Three commonly used transport media Amies without charcoal, Cary Blair. and LQ . Stuart The interfering substances tested caused no significant differences between the number of colonies observed on the Control plates and the number of colonies observed on the VRESelect TM plates. The only exceptions were Tuck's Medicated Cooling Pads® (coloration delayed after {3}------------------------------------------------ 24 hours with VREfm (ATCC 700221)) and Miconazole cream. The blood and mucins caused a delayed growth of one VREfs strain (ATCC 51299). #### Cross Reactivity Testing (Analytical Specificity) A cross-reactivity study was performed to determine if strains other than vancomycin-resistant enterococci could grow on VRESelect ™. One hundred thirty one (131) microorganisms representing Gram-negative rods, Gram-positive cocci, and yeasts were evaluated with the VRESelect ™. No cross-reactivity was observed with any strain tested. No variation was seen between 24 and 28 hour incubation time. #### Limit of Detection Study The minimum concentration of VRE reliably detected by VRESelect ™ is 103 CFU/mL. To determine the percent recovery for the VRESelect ™ media a panel of eighteen vancomycinresistant enterococci - 8 VREfm and 10 VREfs - were tested at varying dilutions. For each strain to be tested a 0.5 McFarland suspension of the strain was prepared. A series of 10-fold serial dilutions in saline were carried out and inoculated onto three lots of VRESelect ™ plates and one lot of Blood Agar plates were incubated at 35-37℃ ambient air and read at 24 and 28 hours. The color and number of colonies were recorded. The Blood Agar plates were used to confirm the inoculum concentration at each dilution. Data confirmed that the minimum concentration of VRE reliably detected by VRESelect TM is 10 CFU/mL. #### Reproducibility In order to confirm the reproducibility of the VRESelect™ medium a blinded panel of 6 ATCC reference strains (2 VREfs, 3 VREfm, and 1 vancomycin-susceptible Enterococcus) were tested at three sites. At each site three technicians tested the panel on three lots of VRESelect™ each day for three days. The strains produced the expected results with VRESelect™ 100% of the time at 24 and 28 hours. #### Challenge Panel VRESelect ™ was evaluated with fifty-six (56) well-characterized strains including vancomycin-resistant and vancomycin-susceptible E. faecalis and E. faecium, as well as microorganisms commonly isolated from stool. All strains showed expected results. #### Method Comparison 946 stool samples were tested on VRESelect ™ media (pink or blue colonies between 24 and 28 hours incubation) and BEAV (colonies with dark halos between 24 and 48 hours incubation) plus confirmatory testing (Gram stain, catalase, PYR, Vitek 2 identification and vancomycin (MIC E-Test) showed the following results. {4}------------------------------------------------ # Table 1 BEAV +Confirmation vs. VRESelect™ results | | | BEAV plus Confirmation | | |------------|----------|-----------------------------|------------------------------| | | | % Positive Agreement | % Negative Agreement | | VRESelect™ | 24 hours | 96% (182/189, [0.92, 0.98]) | 96% (727/757, [0.94, 0.97]) | | | 28 hours | 98% (186/189, [0.95, 0.99]) | 95% (721/757, [0.93, 0.96])* | * Thirty-three (33) of the 36 specimens that were BEAV plus Confirmation negative and that grew pink and/or blue colonies on VRESelect™ media, after subculture to blood agar plates (BAPs), were confirmed to be vancomycin resistant E. faecium and/or E. faecalis by biochemical identification and vancomycin E-Test. Three (3) specimens that were BEAV plus Confirmation negative and that grew pink and/or blue colonies on VRESelect™ media, after subculture to blood agar plates (BAPs), were not confirmed biochemical identification and vancomycin E-Test to be E. faecium and/or E. faecalis and represent false positive results. VRESelect ™ (pink or blue colonies between 24 and 28 hours incubation) compared to samples identified as VREfm or VREfs using commercially available biochemical identification system demonstrated the following results. # Table 2 Biochemical identification (Vitek) vs. VRESelect™ results | | | % Positive Agreement | % Negative Agreement | |-----------------------|--|-----------------------------|-----------------------------| | VREfm | | | | | VRESelect™ @ 24 hours | | 94% (171/181, [0.90, 0.97]) | 97% (740/765, [0.95, 0.98]) | | VRESelect™ @ 28 hours | | 97% (175/181, [0.93, 0.99]) | 96% (734/765, [0.94, 0.97]) | | VREfs | | | | | VRESelect™ @ 24 hours | | 94% (15/16, [0.70, 0.99]) | 98% (910/930, [0.97, 0.99]) | | VRESelect™ @ 28 hours | | 94% (15/16, [0.70, 0.99]) | 98% (909/930, [0.97, 0.99]) | VRESelect ™ (pink or blue colonies observed between 24 and 28 hours incubation) compared to Vancomycin minimal inhibitory concentration (MIC) demonstrated the following results. {5}------------------------------------------------ # · Table 3 Vancomycin Resistance vs. VRESelect™ results | | Vancomycin Resistance (E-Test) | | |-----------------------|--------------------------------|-----------------------------| | | % Positive Agreement | % Negative Agreement | | VREfm | | | | VRESelect™ @ 24 hours | 96% (171/178, [0.92, 0.98]) | 97% (743/768, 0.95, 0.98]) | | VRESelect™ @ 28 hours | 98% (175/178, [0.95, 0.99]) | 96% (737/768, 0.94, 0.97]) | | VREfs | | | | VRESelect™ @ 24 hours | 100% (12/12, [0.82, 1.00]) | 98% (911/934, [0.96, 0.99]) | | VRESelect™ @ 28 hours | 100% (12/12, [0.82, 1.00]) | 97% (910/934, [0.96, 0.98]) | #### Conclusion The VRESelect ™ showed high diagnostic sensitivity and accuracy in this study. # Statement of Safety and Efficacy The data presented clearly demonstrates the safety and efficacy of the Bio-Rad VRESelect ™ for testing stool samples as compared to routine culture and identification when results are interpreted after 24 to 28 hours incubation. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the logo is a stylized image of an eagle. # DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002 Bio-Rad C/O Fran White, Regulatory Consultant MDC Associates, LLC 180 Cabot Street Beverly, MA 01915 6 2012 NOV Re: K122187 Trade/Device Name: VRESelect™ Culture Medium Regulation Number: 21 CFR 866.1700 Regulation Name: Culture Medium for Antimicrobial Susceptibility Tests Regulatory Class: Class II Product Code: JSO Dated: October 10, 2012 Received: October 11, 2012 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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {7}------------------------------------------------ Page 2 - Fran White 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. If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industrv/support/index.html. Sincerely yours, # Sally A. Hojvat Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ #### Indications for Use 412218 510(k) Number (if known): Device Name: VRESelect TM Indications for Use: VRESelect ™ is a selective and differential chromogenic medium, containing 8 µg/mL of vancomycin, for the qualitative detection of gastrointestinal colonization of vancomycin-resistant Enterococcus faecium (VREfm) and vancomycin-resistant Enterococcus faecalis (VREfs) and to aid in the prevention and control of vancomycin-resistant Enterococcus (VRE) in healthcare settings. The test is performed on rectal swabs or fecal specimens from patients to be screened for VRE colonization. VRESelect ™ is not intended to diagnose VRE infection nor to guide or monitor treatment of infection. Results can be interpreted after 24 to 28 hours incubation. Subculture to non-selective media (e.g., trypticase soy agar with 5% sheep blood) is needed for susceptibility testing and epidemiological typing. 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 Diagnostics and Radiological Health (OIR) Nagaat Division Sign Off Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety K122187 510(k) --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JSO/K122187](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JSO/K122187) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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