K Number

Device Name

VRESELECT CULTURE MEDIUM

Manufacturer

BIO-RAD

Date Cleared

2011-10-21

(308 days)

Product Code

JSO

Regulation Number

866.1700

Intended Use

VRESelect ™ is a selective and differential chromogenic medium, containing 8 µg/mL of vancomycin, for the qualitative detection of gastrointestion 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 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 need for susceptibility testing and epidemiological typing.

Device Description

VRESelect ™ is a selective medium for the detection of vancomyoin-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 facium which produces pink colonies and Enterococcus faecalis which produces blue colonies. Enterococcus gallinarum and Enterocccus casseliflavus are intrinsically resistant to vancomycin and may grow on the VRESelect™ medium as colories 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 VRESm. Blue colonies should be confirmed by a catalase test and susceptibility testing (refer to limitation 8 in package insert).

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K092819, K972359

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a chromogenic culture medium that relies on chemical reactions and visual interpretation of colony color for detection. There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI/ML.

Therapeutic

No
The device is a diagnostic tool used for the detection of vancomycin-resistant Enterococcus (VRE) colonization, not for treating or preventing disease in patients.

Diagnostic

Yes

Explanation: The device is used for the qualitative detection of vancomycin-resistant Enterococcus faecium (VREfm) and vancomycin-resistant Enterococcus faecalis (VREfs) from rectal swabs to aid in the prevention and control of vancomycin-resistant Enterococcus (VRE). This is a diagnostic function, even though it explicitly states it is "not intended to diagnose VRE infection" but rather for detection of colonization to aid in prevention.

SaMD (Software as a Medical Device)

The device is a selective and differential chromogenic medium, which is a physical substance used in laboratory testing, not a software program.

IVD (In Vitro Diagnostic)

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 gastrointestion of vancomycin-resistant Enterococcus faecium (VREfm) and vancomycin-resistant Enterococcus faecalis (VREfs)" from "rectal swabs from patients". This involves testing a sample taken from the human body to provide information about a patient's health status (specifically, colonization with VRE).
Device Description: It describes a "selective and differential chromogenic medium" used to identify specific microorganisms based on their growth and metabolic activity. This is a common type of in vitro diagnostic test.
Performance Studies: The document details various performance studies (Interfering Substances, Cross Reactivity, Recovery, Reproducibility, Challenge Panel, Method Comparison) which are typical evaluations required for IVD devices to demonstrate their analytical and clinical performance.
Key Metrics: The inclusion of metrics like % Positive Agreement and % Negative Agreement from method comparison studies further indicates that this is a diagnostic test being evaluated against reference methods.
Predicate Devices: The mention of predicate devices (K092819 and K972359) which are also IVD media for VRE detection strongly suggests that this device falls under the same regulatory category.

While it's not intended to diagnose infection or guide treatment, its purpose is to detect the presence of specific microorganisms in a human sample to aid in prevention and control efforts in healthcare settings. This aligns with the definition of an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

JSO

Device Description

Detection is based on the cleavage of chromogenic substrates by specific enzymes of Enterococcus facium which produces pink colonies and Enterococcus faecalis which produces blue colonies.

Enterococcus gallinarum and Enterocccus casseliflavus are intrinsically resistant to vancomycin and may grow on the VRESelect™ medium as colories 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 VRESm. Blue colonies should be confirmed by a catalase test and susceptibility testing (refer to limitation 8 in package insert).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

gastrointestinal, rectal swabs

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)

Interfering Substances: The following potential interfering substances were tested to confirm that they did not interfere with the performance of the VRESelect ™ 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), K Y 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™ plates. Exceptions: Tuck's Medicated Cooling Pads (coloration delayed after 24 hours with VREfm (ATCC 700221)) and Miconazole cream. Blood and mucins caused a delayed growth of one VREfs (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 nineteen (119) 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.
Recovery Study: The minimum concentration of VRE reliably detected by VRESelect ™ is 10^3 CFU/mL. A panel of eighteen vancomycin-resistant enterococci - 8 VREfm and 10 VREfs - were tested at varying dilutions. 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. The plates were incubated at 35-37°C 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 ™ is 10^3 CFU/mL.
Reproducibility: A blinded panel of 6 ATCC reference strains (2 VREfs, 3 VREfm, and 1 vancomyvin-susceptible Enterococcus) were tested at three sites. At each site three technicians tested the panel on three lots of VRESelect™ each day. 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: 757 specimens 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)).
Biochemical identification (Vitek) vs. VRESelect™ 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.
Vancomycin MIC vs. VRESelect™ results: VRESelect ™ (pink or blue colonies observed between 24 and 28 hours incubation) compared to Vancomycin minimal inhibitory concentration (MIC).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

BEAV +Confirmation vs. VRESelect™ results:

24 hrs: % Positive Agreement 98% (118/120, [0.94, 1.00]), % Negative Agreement 97% (615/637, [0.95, 0.98])
28 hrs: % Positive Agreement 99% (119/120, [0.95, 1.00]), % Negative Agreement 96% (610/637, [0.94, 0.97])*

Biochemical identification (Vitek) vs. VRESelect™ results:
VREfm:

VRESelectTM @ 24 hours: % Positive Agreement 97% (94/97, [0.91, 0.99]), % Negative Agreement 97% (639/660, [0.95, 0.98])
VRESelectTM @ 28 hours: % Positive Agreement 98% (95/97, [0.92, 0.99]), % Negative Agreement 97% (639/660, [0.95, 0.98])*
VREfs:
VRESelectTM @ 24 hours: % Positive Agreement 79% (30/38, [0.63, 0.89]) **, % Negative Agreement 97% (696/719, [0.95, 0.98])†
VRESelectTM @ 28 hours: % Positive Agreement 82% (31/38, [0.66, 0.91]), % Negative Agreement 97% (701/719, [0.96, 0.98])

Vancomycin MIC vs. VRESelect™ results:
VREfm:

VRESelectTM @ 24 hours: % Positive Agreement 99% (93/94, [0.94, 0.99]), % Negative Agreement 98% (626/637, 0.97, 0.99])
VRESelectTM @ 28 hours: % Positive Agreement 100% (94/94, [0.95, 1.00]), % Negative Agreement 98% (626/637, 0.97, 0.99])*
VREfs:
VRESelectTM @ 24 hours: % Positive Agreement 96% (27/28, [0.81, 0.99]), % Negative Agreement 98% (622/637, [0.96, 0.99])
VRESelectTM @ 28 hours: % Positive Agreement 96% (27/28, [0.81, 0.99]), % Negative Agreement 97% (617/637, [0.95, 0.98])**

Predicate Device(s)

K092819, K972359

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

510(k) Submission K103684 Request for Additional Information VRESelect™ Culture Media Page 12 of 19

OCT 2 1 2011

510(k) SUMMARY

Date of Summary

October 19, 2011

Product Name

Sponsor

VRESelect ™ 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

510(k) Submission K 103684
Request for Additional Information
VRESelect™ Culture Media
Page 13 of 19

	Spectra VRE	Bile Esculin Agar	Substantial Equivalent
TM	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.	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.
and
medium,
vancomycin,
of
of
Enterococcus
vancomycin-
faecalis
prevention
resistant
healthcare
on
to
infection.
to guide
after 24 to
subculture to
(trypticase
blood) is
and			✓
✓
	Enzymatic	Enzymatic
	Direct specimen	Direct specimen

510(k) Submission K103684
Request for Additional Information
VRESSelec/™ Culture Media
Page 14 of 19

| | The Matther Mand Company Company Collection Company Collection Comparis Comparent Collection Compress of Children Comparis of Children Comparis of Children Comparis of Childr
Rectal swabs | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
ectal swabs or fecal specimer
The state of the state of the state of the status and the states of the states of the states of | Comments of the Comments of Children of Children Comments of Children
Fecal or urine specime | COCITION CONTINUE |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| The Children Children and Children
.erpreta*
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | =
lanual
MITS Children Card Children Children Children Children Children Children Children Children Children Children Children Children Children Children A | CARANDAL CALL COLOR CLASS CALL CONSULT COLLEGION CONSULTION CONSULTION CONSULTION COLLEGION
TTTATTATTATTATTATATACTAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
ISUS
Aanual | All All And All Annual Almond Almond
Manual. | Comments of Children a Children and Children Company of Children
Comments of Children And Californial Collection |

—

→

510(k) Submission K103684 Request for Additional Information VRESelect™ Culture Media Page 15 of 19

Product Description

Detection is based on the cleavage of chromogenic substrates by specific enzymes of Enterococcus facium which produces pink colonies and Enterococcus faecalis which produces blue colonies.

After 24 to 28 hours incubation pink colonies can be reported as VRESm. Blue colonies should be confirmed by a catalase test and susceptibility testing (refer to limitation 8 in package insert).

Intended Use

VRESelect ™ is a selective and differential chromogenic medium, containing 8ug/mL of vancomycin, for the qualitative detection of gastrointestinal of vancomycin-resistant Enterococcus faccium (VREfm) and vancomycin-resistant Enterococcus faccalis (VREfs) and to aid in the prevention and control of VRE in healthcare settings. The test is performed on rectal swabs from patients to screen 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 need 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 ™ 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), K Y 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™ plates. The only exceptions were Tuck's Medicated Cooling Pads (coloration delayed after 24 hours with VREfm (ATCC 700221)) and Miconazole cream. The blood and mucins caused a delayed growth of one VREfs (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 nineteen (119) microorganisms representing Gram-negative rods, Grampositive 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.

510(k) Submission K 103684 Request for Additional Information VRESelect™ Culture Media Page 16 of 19

Recovery 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 vancomycin-resistant 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°C 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 ™ is 103 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 vancomvcin-susceptible Enterococcus) were tested at three sites. At each site three technicians tested the panel on three lots of VRESelect™ each 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

757 specimens 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.

Table 1

BEAV +Confirmation vs. VRESelect™ results

		BEAV +Confirmation
		% Positive Agreement	% Negative Agreement
VRESelect™	24 hrs	98% (118/120, [0.94, 1.00])	97% (615/637, [0.95, 0.98])
	28 hrs	99% (119/120, [0.95, 1.00])	96% (610/637, [0.94, 0.97])*

Ten of the 27 specimens that were BEAV plus confirmation negative and grew pink and/or blue colonies on VRESelect™ media, after subculture from VRESelect™ to Blood Agar Plates (BAPs), were confirmed as vancomycin-resistant E. faecium and/or E. faecalis by Vitek 2 biochemical identification and vancomycin E-Test. Seventeen specimens grew pink and/or blue colonies on VRESelect™ that were not confirmed by Viek 2 biochemical identification and vancomycin E-Test to be either vancomycin-resistant 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.

510(k) Submission K103684 Request for Additional Information VRESelect™ Culture Media Page 17 of 19

Table 2

Biochemical identification (Vitek) vs. VRESelect™ results

	Vitek 2 Biochemical Identification
	% Positive Agreement	% Negative Agreement
VREfm
VRESelectTM @ 24 hours	97% (94/97, [0.91, 0.99])	97% (639/660, [0.95, 0.98])
VRESelectTM @ 28 hours	98% (95/97, [0.92, 0.99])	97% (639/660, [0.95, 0.98])*
VREfs
VRESelectTM @ 24 hours	79% (30/38, [0.63, 0.89]) **	97% (696/719, [0.95, 0.98])†
VRESelectTM @ 28 hours	82% (31/38, [0.66, 0.91])	97% (701/719, [0.96, 0.98])

ギ Twenty-one (21) specimens not identified as E. faecium on the study grew pink colonies on VRESelect™ media. 20 of those specimens, after subculture from VRESelect™ to BAPs, were confirmed as vancomycin-resistant E. faecium or E. faecium/E. faecalis by Vitek 2 biochemical identification and vancomycin E-Test. One specimen was determined to be false positive.

** Of the eight (8) specimens that were identified as E. faecalis by Vitek 2 biochemical identification and did not grow blue colonies on VRESelect™ media, six were shown to be vancomycin susceptible by the reference arm of the study. One specimen grew blue colonies on VRESelect™ after 28 hours and one specimen was determined to be false negative

ート Twenty-three (23) specimens not identified as E. faecalis on the reference arm of the study grew blue colonies on VRESelect™ media. Thirteen (13) of those specimens, after subculture from VRESelect to BAPs, were confirmed as vancomycin-resistant E. faecalis /E. faecium by Vitek 2 biochemical identification and vancomycin E-Test. Ten (10) specimens were found to be false positive (including 6 staphylococci catalase positive).

VRESelect ™ (pink or blue colonies observed between 24 and 28 hours incubation) compared to Vancomycin minimal inhibitory concentration (MIC) demonstrated the following results.

510(k) Submission K103684 Request for Additional Information VRESelect™ Culture Media Page 18 of 19

Table 3

Vancomycin MIC vs. VRESelect™ results

	Vancomycin Resistance (E-Test)
	% Positive Agreement	% Negative Agreement
VREfm
VRESelectTM @ 24 hours	99% (93/94, [0.94, 0.99])	98% (626/637, 0.97, 0.99])
VRESelectTM @ 28 hours	100% (94/94, [0.95, 1.00])	98% (626/637, 0.97, 0.99])*
VREfs
VRESelectTM @ 24 hours	96% (27/28, [0.81, 0.99])	98% (622/637, [0.96, 0.99])
VRESelectTM @ 28 hours	96% (27/28, [0.81, 0.99])	97% (617/637, [0.95, 0.98])**

Note: Specimens that were identified in the reference arm of the study as vancomycin-resistant and identified as E. faecium or E. faecalis by Vitek 2 AND grew pink or blue colonies on VRESelect™ were considered in positive agreement.

Eleven (11) specimens not identified as vancomycin-resistant on the reference arm of the study grew pink colonies on VRESelect™, the colonies which grew from 10 of those specimens, after subculture to a BAP, were confirmed to be vancomycin-resistant E. faecium by Vitek 2 biochemical identification and vancomycin E-Test. One specimen was determined to be false positive.

** Twenty (20) specimens not identified as vancomycin-resistant on the reference arm of the study grew blue colonies on VRESelect™. When colonies from those specimens were subcultured to BAPs five were identified as vancomycin-resistant E. faecium and 15 were not confirmed to be vancomycin-resistant E. faecalis / E. faecium, or were vancomycin-susceptible (including 8 staphylococci catalase positive).

Conclusion

The VRESelect ™ showed high diagnostic sensitivity and specificity and accuracy in this study.

Statement of Safety and Efficacy

The data presented clearly demonstrates the safety and efficacy of the Bio-Rad VRESelect ™ as compared to routine culture and identification when results are interpreted after 24 to 28 hours incubation.

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles a human figure in profile, with three wavy lines emanating from the head, representing health and well-being.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

OCT 2 1 2011

Bio-Rad C/o Fran White, Regulatory Consultant MDC Associates, LLC 180 Cabot Street Beverly, MA 01915

Re: K103684

Trade/Device Name: VRESelect ™ Culture Medium Regulation Number: 21 CFR 866.1700 Regulation Name: Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar Regulatory Class: Class II Product Code: JSO Dated: October 19, 2011 Received: October 20, 2011

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 class II (Special Controls), 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

Page 2 - Ms. White

CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety 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/industry/support/index.html,

Sincerely vours.

Yreddie Lu. Poole, ms

Sally 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

510(k) Submission K103684 Request for Additional Information VRESelect™ Culture Media Page 19 of 19

Indications for Use

510(k) Number (if known): K103684

Device Name:

VRESelect ™ Culture Media

Indications for Use: J '

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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 (OIVD)

Freddie h. Poole

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K103684

Page 1 of 1