chromID™ VRE agar is a selective and differential chromogenic medium containing 8 µg/mL of vancomycin, for the qualitative detection of Enterococcus faecium and E. faecalis showing acquired vancomycin resistance (VRE) in stool specimens. chromID™ VRE agar can be used as an aid to identify, prevent and control VRE colonization in healthcare settings. chromID™ VRE agar is not intended to diagnose VRE infection nor to guide or monitor treatment for infections. 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 Description

chromID™ VRE agar is a selective chromogenic medium for the detection of E. faecalis showing acquired vancomycin resistance (VRE), in at risk patients. The detection of this resistance is particularly important for the prevention and epidemiological surveillance of these infections and also to prevent the emergence of vancomycin-resistant Staphylococus aureus (VRSA), by t context, the use of chromID™ VRE agar contributes to the active surveillance for VRE agar is a selective and differential chromogenic medium for the qualitative detection of E. faecalis showing acquired vancomycin resistance (VRE), from stool specimens.

chromID™ VRE agar consists of a rich nutritive base including a variety of peptones. It also contains two chromogenic substrates and a mixture of antibiotics including vancomycin (8 ug/mL) which enable the specific and selective growth of VRE. After 24-48 hours incubation vancomycin-resistant E. faecium colonies are a violet color for ß-galactosidase-producing strains. Vancomycin-resistant E. faecalis colonies are a blue-to-green color for a-ducosidase-producing strains. The selective components in the medium inhibit enterpooccal strains that do not express acquired vancomycin resistance, enterococcal strains that express natural intinsic vancomycin resistance (vanC phenotype: E. gallinarum and E. casselflavus), as well as most Gram-negative and Gram-positive bacteria.

AI/ML Overview

Below is an analysis of the provided text regarding the chromID™ VRE Agar, outlining acceptance criteria and supporting study details.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria (e.g., "The device must achieve at least X% sensitivity and Y% specificity"). However, it does present performance metrics against which an implicit acceptance was made for 510(k) clearance.

Performance Metric (Device: chromID™ VRE Agar)	Reported Device Performance (24h incubation)	Reported Device Performance (48h incubation)	Comments/Context
Positive % Agreement (vs. Conventional Methods)	97.1% (334/344) (95% CI = 94.7%, 98.6%)	96.9% (344/355) (95% CI = 94.5%, 98.4%)	Compared to a combination of Gram stain, catalase, VITEK® 2 GP, 16S-500 sequencing, and vancomycin resistance confirmed by agar dilution.
Negative % Agreement (vs. Conventional Methods)	99.7% (952/955) (95% CI = 99.1%, 99.9%)	99.7% (941/944) (95% CI = 99.1%, 99.3%)	Compared to a combination of Gram stain, catalase, VITEK® 2 GP, 16S-500 sequencing, and vancomycin resistance confirmed by agar dilution.
Positive % Agreement (vs. VITEK® 2 ID: E. faecium)	94.3% (316/335) (95% CI = 91.3%, 96.6%)	96.7% (324/335) (95% CI = 94.2%, 98.4%)	Specific identification of E. faecium.
Negative % Agreement (vs. VITEK® 2 ID: E. faecium)	11.1% (1/9) (95% CI = 0.3%, 42.3%)	0.0% (0/9) (95% CI = 0.0%, 33.6%)	Low negative agreement for E. faecium vs. VITEK 2, indicating false positives by chromID™ VRE.
Positive % Agreement (vs. VITEK® 2 ID: E. faecalis)	87.1% (27/31) (95% CI = 70.2%, 96.4%)	96.8% (30/31) (95% CI = 83.3%, 99.9%)	Specific identification of E. faecalis.
Negative % Agreement (vs. VITEK® 2 ID: E. faecalis)	0/0*	0/0*	No negative cases for E. faecalis in this comparison.
Positive % Agreement (vs. Vancomycin MIC: E. faecium)	94.4% (321/340) (95% CI = 91.4%, 96.6%)	97.1% (330/340) (95% CI = 94.7%, 98.6%)	Agreement on vancomycin resistance for E. faecium.
Negative % Agreement (vs. Vancomycin MIC: E. faecium)	25.0% (1/4) (95% CI = 0.6%, 80.6%)	25.0% (1/4) (95% CI = 0.6%, 80.6%)	Low negative agreement for E. faecium vs. Vancomycin MIC, indicating false positives by chromID™ VRE.
Positive % Agreement (vs. Vancomycin MIC: E. faecalis)	86.7% (26/30) (95% CI = 69.3%, 96.3%)	96.7% (29/30) (95% CI = 82.8%, 99.9%)	Agreement on vancomycin resistance for E. faecalis.
Negative % Agreement (vs. Vancomycin MIC: E. faecalis)	0.0% (0/1) (95% CI = 0.0%, 97.5%)	0.0% (0/1) (95% CI = 0.0%, 97.5%)	Low negative agreement for E. faecalis vs. Vancomycin MIC, indicating a false positive by chromID™ VRE.
Reproducibility (24h incubation)	80%	-	For a set of 10 challenge organisms.
Reproducibility (48h incubation)	-	100%	For a set of 10 challenge organisms.
Lowest CFU detection	Equivalent to 100 CFU per mL of sample	Equivalent to 100 CFU per mL of sample	Confirmed by recovery study.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: A total of 1299 stool samples were evaluated in the primary performance study.
Data Provenance: The study was conducted at four geographically diverse laboratories, implying multi-site data collection, which is generally considered robust. The document does not specify the country of origin, but given the submitter's address (Missouri, USA) and the FDA submission, it implicitly refers to data collected in the US or internationally for a US submission. It is a prospective study as specimens were "inoculated" on the media for evaluation, indicating a forward-looking collection and analysis.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number or qualifications of experts involved in establishing the ground truth. It details the methods used for ground truth confirmation rather than the human assessors:

Gram stain
Catalase
VITEK® 2 GP
16S-500 sequencing
Vancomycin resistance confirmed by agar dilution

These methods represent a "conventional reference method" rather than a consensus established by a panel of human experts.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method in the context of human expert disagreement. The ground truth was established by a combination of laboratory tests. For the performance comparisons, the device's results were directly compared against the outcomes of these established laboratory methods.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No MRMC comparative effectiveness study was done. This device is a culture medium, not an AI or imaging diagnostic tool that would typically involve human readers interpreting AI-assisted outputs. The performance is based on direct observation of colony color and growth on the agar.

6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance study was done. The chromID™ VRE agar's performance in detecting VRE was evaluated directly by observing the growth and colony characteristics after incubation. This is an "algorithm only" type of assessment in the sense that the medium itself acts as the diagnostic "algorithm" that produces a visible result without mandatory human interpretation of complex data (beyond simple color/growth observation). The study compared the chromID™ VRE agar's outputs against conventional microbiological methods.

7. The Type of Ground Truth Used

The ground truth used was a combination of conventional microbiological identification and antimicrobial susceptibility testing methods:

Gram stain
Catalase
VITEK® 2 GP (for species identification)
16S-500 sequencing (for species identification)
Vancomycin resistance confirmed by agar dilution (the gold standard for vancomycin resistance).

This represents a robust, multi-faceted approach to establishing ground truth for microbial identification and resistance.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of an AI/machine learning model. For traditional diagnostic assays like culture media, there isn't typically a distinct training set in the AI sense. However, the development of the chromID™ VRE agar would have involved extensive laboratory work and testing of various formulations and indicators before it reached the validation stage described in the performance section.

Challenge Testing: 75 well-characterized challenge strains were used to evaluate expected results.
Low-level resistance testing: 49 enterococci strains with intermediate or low vancomycin resistance were evaluated.
Cross-reactivity study: 99 organisms were included.

These studies, while not explicitly "training sets," serve a similar purpose in device development and characterization prior to clinical validation.

9. How the Ground Truth for the Training Set Was Established

Given that there isn't a "training set" in the AI sense, the ground truth for the various developmental and characterization studies (challenge testing, low-level resistance, cross-reactivity) would have been established through well-defined, standard phenotypic and genotypic microbiological methods, similar to or more extensive than those used for the main performance study (e.g., standard culture, biochemical tests, molecular methods for identification, and MIC determination for resistance). For example, the challenge strains are described as "well-characterized," implying their identity and resistance profiles were already known through such reference methods.

Summary

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K091025

Image /page/0/Picture/1 description: The image shows the logo for bioMerieux. The logo consists of the word "BIOMERIEUX" in a stylized font, with a graphic above it. The graphic is a circle bisected by a curved line, with one half of the circle filled with vertical lines.

510(k) SUMMARY

A 510(k) Submission Information:

MAR - 222010

bioMérieux, Inc. Submitter's Name: Address: 595 Anglum Road Hazelwood, MO 63042 Contact Person: Nancy Weaver Associate Director, Regulatory Affairs Phone Number: 314-731-8695 Fax Number: 314-731-8689 Date of Preparation: April 8, 2009 B. Device Name: chromID™ VRE Agar Formal/Trade Name: Classification Name: Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar. 21 CFR 866.1700

Common Name:

C. Predicate Device:

Excluding Mueller Hints

Culture media

Remel Bile Esculin Azide Agar w/6ug/ml Vancomycin, K972359

D. 510(k) Summary:

Intended Use:

chromID™ VRE agar is a selective and differential chromogenic medium containing 8 ug/mL of vancomycin, for the qualitative detection of Enterococcus faecium and E. faecalis showing acquired vancomycin resistance (VRE) in stool specimens, chromID™ VRE agar can be used as an aid to identify, prevent and control VRE colonization in healthcare settings. chromID™ VRE agar is not intended to diagnose VRE infection nor to guide or monitor treatment for infections. 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 Description:

chromID™ VRE agar is a selective chromogenic medium for the detection of E. faecalis showing acquired vancomycin resistance (VRE), in at risk patients11). The detection of this resistance is particularly important for the prevention and epidemiological surveillance of these infections and also to prevent the
emergence of vancomycin-resistant Staphylococus aureus (VRSA), by t context, the use of chromID™ VRE agar contributes to the active surveillance for VRE agar is a selective and differential chromogenic medium for the qualitative detection of E. faecalis showing acquired vancomycin resistance (VRE), from stool specimens.

chromID™ VRE agar consists of a rich nutritive base including a variety of peptones. It also contains two chromogenic substrates and a mixture of antibiotics including vancomycin (8 ug/mL) which enable the specific and selective growth of VRE. After 24-48 hours incubation vancomycin-resistant E. faecium colonies are a violet color for ß-galactosidase-producing strains. Vancomycin-resistant E. faecalis colonies are a blue-togreen color for a-ducosidase-producing strains. The selective components in the medium inhibit enterpooccal strains that do not express acquired vancomycin resistance, enterococcal strains that express natural intinsic vancomycin resistance (vanC phenotype: E. gallinarum and E. casselflavus), as well as most Gram-negative and Gram-positive bacteria.

bioMérieux, Inc.

595 Anglum Road, Hazelwood, Missouri 63042-2320, USA Phone: 314/731-8500 800/638-4835 Fax: 314/731-8700 http://www.biomerieux-usa.com

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Substantial Equivalence

chromID™ VRE agar is substantially equivalent to Remel Bile Esculin Azide Agar w/ 6 μg/ml
Vancomycin (K972359) .

Device Comparison Table

	Device	Predicate
	chromID™ VRE Agar	Remel Bile Esculin Azide Agar w/6 µg/ml Vancomycin
Similarities
Intended Use	chromID™ VRE agar is a selective anddifferential chromogenic mediumcontaining 8 µg/mL of vancomycin, for thequalitative detection of Enterococcusfaecium and E. faecalis showing acquiredvancomycin resistance (VRE) in stoolspecimens. chromID™ VRE agar can beused as an aid to identify, prevent andcontrol VRE colonization in healthcaresettings. chromID™ VRE agar is notintended to diagnose VRE infection nor toguide or monitor treatment for infections.Subculture to non-selective media (e.g.trypticase soy agar with 5% sheep blood)is needed for further identification,susceptibility testing and epidemiologicaltyping.	REMEL Bile Esculin Azide Agar w/ 6µg/ml Vancomycin is a solid mediumrecommended for use in qualitativeprocedures as a screening method forprimary isolation and presumptiveidentification of vancomycin resistantenterococci (VRE) from surveillancecultures.
Test method	Manual	Manual
Inoculum	Direct Specimen	Direct Specimen
Specimen	Stool samples	Urine, stool
Differences
Detection method	Two chromogenic substrates providefor the direct detection of E. faeciumand E. faecalis through characteristiccolony color.- E. faecium : violet color for β-galactosidase-producing strains,- E. faecalis : blue-to-green color for α-glucosidase-producing strains.	Organisms positive for esculinhydrolysis hydrolyze the glycosideesculin to esculetin and dextrose. Theesculetin reacts with the ferric citrate toform a dark brown or black complex,esculetin, which reacts with the ferricammonium citrate to produce a black-brown complex in the medium.
Incubation Conditions	35-37°C in aerobic conditions, in thedark	33-37°C in aerobic conditions or in 5-10% CO2

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Performance

Performance of chrom!D™ VRE was evaluated at four geographically diverse laboratories. Stool specimens were inoculated on chromID™ VRE agar and bile esculin azide agar with 6 μ.g/ml vancomycin (BEAV). Both plates were observed for growth at 24 and 48 hours. Colonies with violet or blue-to-green pigment on chromID™ VRE agar and colonies on BEAV with brown to black pigment diffusing into the medium were identified with the following methods: Gram stain, catalase, VITEK® 2 GP and 16S-500 sequencing. Vancomycin resistance was confirmed by agar dilution.

A total of 1299 stool samples were evaluated with chromID™M VRE agar. Compared to the conventional reference methods described above chromID™ VRE identified 97.1% of the VRE positive samples and 99.7% of the VRE negative samples after 24 hours incubation. chromID™ VRE identified 96.9% of the VRE positive samples and 99.7% of the VRE negative samples after 48 hours incubation.

Performance vs. Conventional Methods

Table 1

	Positive% Agreement	Negative% Agreement
chromID™ VRE agar@24h incubation	97.1% (334/344)(95% CI = 94.7%, 98.6%)	99.7% (952/955)(95% CI = 99.1%, 99.9%)
chromID™ VRE agar@48h incubation	96.9% (344/355)(95% CI = 94.5%, 98.4%)	99.7% (941/944)(95% CI = 99.1%, 99.3%)

Table 2

	Positive% Agreement	Negative% Agreement
BEAV agar @ 24hincubation	87.2% (300/344 )(95% CI = 83.2%, 90.6%)	100.0% (955/955).(95% CI = 99.6%, 100.0%)
BEAV agar @ 48hincubation	91.8% (326/355)(95% CI = 88.5%, 94.5%)	100.0% (944/944)(95% CI = 99.6%, 100.0%)

Table 3 - Performance vs. VITEK 2 ID: E. faecium

E. faeclum	Positive% Agreement	Negative% Agreement
chromID™ VRE agar @24h incubation	94.3% (316/335)(95% CI = 91.3%, 96.6%)	11.1% (1/9)*(95% CI = 0.3%, 42.3%)
chromID™ VRE agar @48h incubation	96.7% (324/335)(95% CI = 94.2%, 98.4%)	0.0% (0/9)*(95% CI = 0.0%, 33.6%)

Of the nine isolates that were not identified as E. faecium by VITEK 2, one isolate was negative on the chromID™ VRE at 24 hours but was false positive after 48 hours. The other eight isolates were false positive on chromID™ VRE at 24 and 48 hours.

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Table 4 - Performance vs. VITEK® 2 ID: E. faecalis

E. faecalis	Positive% Agreement	Negative% Agreement
chromID™ VRE agar @24h incubation	87.1% (27/31)(95% CI = 70.2%, 96.4%)	0/0*
chromID™ VRE agar @48h incubation	96.8% (30/31)(95% CI = 83.3%, 99.9%)	0/0*

All E. faecalls isolates were identified by VITEK 2 however four isolates did not produce the characteristic blue-to-green color at 24 hours. At 48h incubation, three of the four isolates developed the characteristic blue-to-green color.

Table 5 - Performance vs. Vancomycin MIC: E. faecium
------------------------------------------------------	--	--

E. faecium	Positive% Agreement	Negative% Agreement
chromID™ VRE agar @24h incubation	94.4% (321/340)(95% CI = 91.4%, 96.6%)	25.0% (1/4)*(95% CI = 0.6%, 80.6%)
chromID™ VRE agar @48h incubation	97.1% (330/340)(95% CI = 94.7%, 98.6%)	25.0% (1/4)*(95% CI = 0.6%, 80.6%)

Three of four isolates were false positive as they produced violet colonies on chromID™ VRE but were confirmed to be vancomycin susceptible E. faecium by MIC. The fourth isolate did not produce violet pigmented colonies.

E. faecalis	Positive% Agreement	Negative% Agreement
chromID™ VRE agar @24h incubation	86.7% (26/30)(95% CI = 69.3%, 96.3%)	0.0% (0/1)*(95% CI = 0.0%, 97.5%)
chromID™ VRE agar @48h incubation	96.7% (29/30)(95% CI = 82.8%, 99.9%)	0.0% (0/1)*(95% CI = 0.0%, 97.5%)

One sample produced blue to green colonies on chromID TM VRE and was vancomvoin susceptible by MIC.

Challenge Testing:

Seventy-five well-characterized challenge strains including vancomycin-resistant and vancomycinsusceptible E. faecalis and E. faecium, as well as Gram-positive microorganisms commonly isolated from stool, were evaluated on chromID™ VRE agar and produced the expected results. One challenge isolate, E. faecalis 13029 (vanB) produced blue-purple colonies after 48 hours incubation. This was due to a rare situation of activity of both enzymes («-glucosidase and ß-galactosidase) occurring in one strain. Both enzymes reacted with the chromogen in the chromID™ VRE agar and this mixture of activity produced the blue-purple color variation.

A second study was performed to evaluate the detection of enterococcal strains with low level vancomycin resistance. Forty-nine enterococci strains characterized by intermediate or low levels of resistance to vancomycin were evaluated. E. faecalis with a low level of vancomycin resistance, such as those carrying the vanB gene are detected on chromID™ VRE medium with their characteristic colony color if their vancomycin MIC is ≥ 4 ug/mL. For a majority of isolates, the characteristic colony coloration is observed after 48 h of incubation. E. casseliflavus strains are inhibited on chromID™ VRE. E. gallinarum

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strains are inhibited on chromID™ VRE unless they have an acquired vanA gene. In this case, characteristic violet color is observed after 48 h.

Interference Study

Commonly used medicinal substances, blood, Cary Blair Transport medium and physiological saline were evaluated for potential interference with the chromogenic reaction of the chromID™ VRE agar. None of the potentially interfering substances tested affected the performance of the chromogenic reaction of the chromID™ VRE medium but decreases in the quantity of growth were observed. Cary Blair Transport medium did not interfere with the chromogenic reaction of the chromID™ VRE agar or reduce the quantity of-growth on-the plate .- In-the-presence-of Preparation-H-Cream-or-Miconazole-7-the-detection-of-certainresistant E. faecalis or E. faecium isolates may be inhibited or delayed after 24 to 48 hours incubation on the chromID™ VRE medium. Other commonly used medicinal substances, blood and physiological saline may result in decreased growth.

Reproducibility

Ten reproducibility organisms comprised of a subset of challenge isolates representing Vancomycin susceptible and resistant E. faecalis and E. faecium (both vanA & vanB), as well as quality control reference strains, were evaluated by chromlD™ VRE in triplicate each day for three days at each clinical trial site and produced the expected results. Preliminary results after 24 hours of incubation show 80% reproducibility for this set of organisms. After the chromID™ VRE plates were incubated for the full 48 hours, overall reproducibility was 100% for this set of organisms.

Cross Reactivity Study

A cross reactivity study was performed to determine if strains other than vancomycin-resistant enterococci could grow on chromID™ VRE agar and develop violet or blue-to-green colonies. Ninety-nine organisms were included in the cross-reactivity study. Five strains developed violet or blue-to-green pigmented colonies. These included one strain each of Candida albicans, C. tropicalis, Citrobacter freundii, Enterocccus raffinosus and two strains of Klebsiella pneumoniae. Several micro-organisms other than enterococci (including veasts and Gram-negative bacili), may grow and or develop pigmented colonies on chromID™ VRE. On rare occasions colonies may produce violet or blue-to-green pigment.

Recovery Study

A recovery study was performed to define the lowest number of colony forming units (CFU) of vancomycinresistant enterococci (VRE) that could grow on the chromID™ VRE medium. One strain each of Enterocccus faecalis (VRE) and E. faecium (VRE) were evaluated. A series of 10-fold serial dilutions were prepared in saline and then plated in duplicate onto chromID™ VRE medium. After 48 hours incubation, the number of CFU was counted on each plate. The number of CFU obtained on the two plates from each dilution was averaged. The lowest number of CFU that can be detected on chromID VRE is equivalent to a theoretical 100 CFU per mL of sample,

Swab Studv

The impact of swabs on the detection of E. faecalis (VRE) with chromID™ VRE medium was evaluated. Rayon swabs and nylon flocked swabs were tested dry and with Amies transport medium. The study evaluated detection of VRE based on contact times of 1, 4 and 18 hours for each swab type both at noom temperature and at 2-8°C. The organism test set included 16 strains of vanA or vanB positive Enterococus faccalis and E. faecium with various vancomycin MIC values. Results indicated that after 1 h and 4 h of contact. there was no significant difference in the sensitivity of detection between dry swabs and those in Amies transport medium. After 18 h of contact at room temperature, the nylon flocked swab with Amies media had the best results followed by the nylon flocked dry swab and rayon swab w/ Amies transport medium. After 18 h of contact at 2-8°C, the nylon flocked swabs with and without Amies media had the best results followed by the rayon swabs with and without Amies transport medium.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

HAR 0 2 2010

Nancy Weaver Associate Director, Regulatory Affairs bioMerieux. Inc. 595 Anglum Road Hazelwood, MO 63042

Re: K091025

Trade/Device Name: chromID™ VRE Agar Regulation Number: 21 CFR 866.1700 Regulation Name: Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar Regulatory Class: Class II Product Code(s): JSO Dated: April 8, 2009 Received: April 10, 2009

Dear Ms. Weaver:

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. ·

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Page 2 - Ms. Weaver

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); 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) 796-5680 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Feraldine M. Poole

ally A. Hoivat. Ph.D. Director, Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): K09 1025

Device Name: chromID™ VRE Agar

Indications For Use:

chromID™ VRE agar is a selective and differential chromogenic medium containing 8 µg/mL of vancomycin, for the qualitative detection of Enterococcus faecium and E. faecalis showing acquired vancomycin resistance (VRE) in stool specimens. chromID™ VRE agar can be used as an aid to identify, prevent and control VRE colonization in healthcare settings. ChromID™ VRE agar is not intended to diagnose VRE infection nor to guide or monitor treatment for infections. Subculture to non-selective media (e.g. trypticase soy agar with 5% sheep blood) is needed for further identification, susceptibility testing and epidemiological typing.

Prescription Use × (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)

Peraldi L. Pady
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K091025

Page 1 of 1

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).