(326 days)
Not Found
No
The device is a chromogenic culture medium that relies on chemical reactions and visual interpretation of color changes for detection, not AI/ML.
No
The device is a laboratory culture medium used for qualitative detection of VRE for colonization surveillance, not for treating or preventing disease in a patient.
Yes
The device, chromID™ VRE agar, is used for the qualitative detection of vancomycin-resistant Enterococcus (VRE) in stool specimens, which aids in identifying, preventing, and controlling VRE colonization in healthcare settings. While it explicitly states it is "not intended to diagnose VRE infection," its function is to detect a specific biological marker (VRE) for clinical decision-making regarding colonization, surveillance, and prevention, which falls under the broad definition of a diagnostic device.
No
The device is a chromogenic agar medium, which is a physical substance used in laboratory testing, not a software program.
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 Enterococcus faecium and E. faecalis showing acquired vancomycin resistance (VRE) in stool specimens." This is a diagnostic purpose, even though it's for colonization and not infection diagnosis.
- Device Description: The description details a laboratory reagent (agar medium) used to analyze a biological sample (stool).
- Performance Studies: The document includes performance data comparing the device to a reference method (BEAV agar) and other identification methods, which is typical for IVD submissions.
- Predicate Device: A predicate device (Remel Bile Esculin Azide Agar w/6ug/ml Vancomycin) is listed, which is a common practice for demonstrating substantial equivalence for IVD devices.
- Anatomical Site: It specifies the use of "Stool specimens," which are biological samples.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
JSO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
chromID™ VRE agar @ 24h incubation: Positive % Agreement 97.1% (334/344) (95% CI = 94.7%, 98.6%), Negative % Agreement 99.7% (952/955) (95% CI = 99.1%, 99.9%)
chromID™ VRE agar @ 48h incubation: Positive % Agreement 96.9% (344/355) (95% CI = 94.5%, 98.4%), Negative % Agreement 99.7% (941/944) (95% CI = 99.1%, 99.3%)
BEAV agar @ 24h incubation: Positive % Agreement 87.2% (300/344) (95% CI = 83.2%, 90.6%), Negative % Agreement 100.0% (955/955). (95% CI = 99.6%, 100.0%)
BEAV agar @ 48h incubation: Positive % Agreement 91.8% (326/355) (95% CI = 88.5%, 94.5%), Negative % Agreement 100.0% (944/944) (95% CI = 99.6%, 100.0%)
E. faeclum vs VITEK 2 ID:
chromID™ VRE agar @ 24h incubation: Positive % Agreement 94.3% (316/335) (95% CI = 91.3%, 96.6%), Negative % Agreement 11.1% (1/9)* (95% CI = 0.3%, 42.3%)
chromID™ VRE agar @ 48h incubation: Positive % Agreement 96.7% (324/335) (95% CI = 94.2%, 98.4%), Negative % Agreement 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.
E. faecalis vs VITEK 2 ID:
chromID™ VRE agar @ 24h incubation: Positive % Agreement 87.1% (27/31) (95% CI = 70.2%, 96.4%), Negative % Agreement 0/0*
chromID™ VRE agar @ 48h incubation: Positive % Agreement 96.8% (30/31) (95% CI = 83.3%, 99.9%), Negative % Agreement 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.
E. faecium vs Vancomycin MIC:
chromID™ VRE agar @ 24h incubation: Positive % Agreement 94.4% (321/340) (95% CI = 91.4%, 96.6%), Negative % Agreement 25.0% (1/4)* (95% CI = 0.6%, 80.6%)
chromID™ VRE agar @ 48h incubation: Positive % Agreement 97.1% (330/340) (95% CI = 94.7%, 98.6%), Negative % Agreement 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 vs Vancomycin MIC:
chromID™ VRE agar @ 24h incubation: Positive % Agreement 86.7% (26/30) (95% CI = 69.3%, 96.3%), Negative % Agreement 0.0% (0/1)* (95% CI = 0.0%, 97.5%)
chromID™ VRE agar @ 48h incubation: Positive % Agreement 96.7% (29/30) (95% CI = 82.8%, 99.9%), Negative % Agreement 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.
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.
Remel Bile Esculin Azide Agar w/6ug/ml Vancomycin, K972359
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).
0
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
1
:
:
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 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. | REMEL Bile Esculin Azide Agar w/ 6 | |
| µg/ml Vancomycin is a solid medium | ||
| recommended for use in qualitative | ||
| procedures as a screening method for | ||
| primary isolation and presumptive | ||
| identification of vancomycin resistant | ||
| enterococci (VRE) from surveillance | ||
| cultures. | ||
| Test method | Manual | Manual |
| Inoculum | Direct Specimen | Direct Specimen |
| Specimen | Stool samples | Urine, stool |
| Differences | ||
| Detection method | Two chromogenic substrates provide | |
| for the direct detection of E. faecium | ||
| and E. faecalis through characteristic | ||
| colony color. |
- E. faecium : violet color for β-
galactosidase-producing strains, - E. faecalis : blue-to-green color for α-
glucosidase-producing strains. | Organisms positive for esculin
hydrolysis hydrolyze the glycoside
esculin to esculetin and dextrose. The
esculetin reacts with the ferric citrate to
form a dark brown or black complex,
esculetin, which reacts with the ferric
ammonium citrate to produce a black-
brown complex in the medium. |
| Incubation Conditions | 35-37°C in aerobic conditions, in the
dark | 33-37°C in aerobic conditions or in 5-
10% CO2 |
2
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 @ 24h
incubation | 87.2% (300/344 )
(95% CI = 83.2%, 90.6%) | 100.0% (955/955).
(95% CI = 99.6%, 100.0%) |
| BEAV agar @ 48h
incubation | 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.
3
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
4
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.
5
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
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