Predicate Devices

BBL™ CHROMagar™ MRSA

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 color change to detect MRSA. There is no mention of computational analysis, algorithms, or learning processes.

Therapeutic

No
The device is described as a selective and differential chromogenic medium for the qualitative detection of MRSA, specifically stating it is "not intended to diagnose MRSA infection nor to guide or monitor treatment for infections." This indicates it's a diagnostic tool, not a therapeutic one.

Diagnostic

No
The "Intended Use / Indications for Use" states that the device is "not intended to diagnose MRSA infection".

SaMD (Software as a Medical Device)

No

The device is a chromogenic culture medium, which is a physical product used in laboratory testing, not a software application.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states it's for the "qualitative detection of nasal colonization by methicillin-resistant S. aureus (MRSA)". This involves testing a biological sample (anterior nares swab specimens) to provide information about a patient's health status (presence of MRSA colonization).
Device Description: The description details a "selective and differential chromogenic medium" used to grow and identify bacteria from a biological sample. This is a typical characteristic of an IVD used in microbiology.
Performance Studies and Key Metrics: The document includes information about clinical studies and performance metrics like sensitivity and specificity, which are standard for demonstrating the analytical and clinical performance of an IVD.
Predicate Device: The mention of a predicate device (BBL™ CHROMagar™ MRSA) further indicates that this device falls within the regulatory framework for IVDs, as predicate devices are used for comparison in the regulatory submission process for new IVDs.

The device is designed to be used in vitro (outside the body) to examine a biological specimen and provide diagnostic information.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

chromID™ MRSA agar is a selective and differential chromogenic medium for the qualitative detection of nasal colonization by methicillin-resistant S. aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings. The test is performed on anterior nares swab specimens from patients and healthcare workers to screen for MRSA colonization. chromID™ MRSA agar is not intended to diagnose MRSA infection nor to guide or monitor treatment for infections.

Product codes

JSO

Device Description

chromID™ MRSA agar is a selective and differential chromogenic medium for the qualitative detection of MRSA from anterior nares swab specimens.

chromID™ MRSA agar consists of a rich nutritive base combining different peptones. It also contains a chromogenic substrate of a-glucosidase and a combination of several antibiotics, which favor the growth of MRSA including hetero-resistant strains. The antibiotics include: cefoxitin (4 mg/l), aztreonam (64 mg/l), and amphotericin B (3 mg/l). The selective mixture of antibiotics inhibits most bacteria not belonging to the genus Staphylococcus, as well as yeasts. The MRSA strains are identified by the presence of green colonies that result from the chromogen incorporated in the medium. The chromogen targets the a-qlucosidase activity of S. aureus. The a-ducosidase produced by S. aureus cleaves the chromogenic substrate, which gives a green color to the S. aureus colonies growing on the medium. This chromogen is identified as "Green a-glucoside" (5-Bromo-4-chloro-3-indoxyl-N-methyl-α-D-glucoside) (patent registered).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Anterior nares

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

Clinical studies were performed and demonstrate acceptable performance of chromID™ MRSA. The overall agreement for detection of MRSA and non-MRSA by chromiD™ MRSA compared to conventional methods including the identification and susceptibility testing was 98.6% (12421259) at 24 h.

Key Metrics

Methods	MRSA	Non-MRSA
cMRSA	94.7% (304/321) 95% CI = 91.7 – 96.9%	100.0% (938/938) 95% CI = 99.6 – 100%
TSAB	91.6% (294/321) 95% CI = 88.0 – 94.4%	100.0% (938/938) 95% CI = 99.6 – 100%
cMRSA vs. Latex Agglutination	96.3% (309/321) 95% CI = 93.6 – 98.1%	98.4% (923/938) 95% CI = 97.4 – 99.1%
cMRSA vs. Cefoxitin Screen	96.3% (309/321) 95% CI = 93.6 – 98.1%	98.4% (923/938) 95% CI = 97.4 – 99.1%
cMRSA vs. mecA PCR	100.0% (321/321) 95% CI = 98.9 – 100%	97.9% (918/938) 95% CI = 96.7 – 98.7%

Predicate Device(s)

BBL™ CHROMagar™ MRSA

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

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Image /page/0/Picture/0 description: The image shows a handwritten string of characters, "K091024". The characters are written in black ink on a white background. The handwriting is somewhat stylized, with the characters having a slightly elongated appearance.

JUL 1 7 2009

Image /page/0/Picture/2 description: The image shows the logo for the company BIOMÉRIEUX. The logo consists of the company name in a stylized font, with a vertical line running through the middle of the letters. Above the company name, there is a black circle. The logo is simple and modern, and it is likely used to represent the company's brand identity.

chromID ™ MRSA Agar Traditional 510(k) Submission

SECTION 2: EXECUTIVE SUMMARY

Intended Use:

chromID™ MRSA agar is a selective and differential chromogenic medium for the qualitative detection of nasal colonization by methicillin-resistant S. aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings. The test is performed on anterior nares swab specimens from patients and healthcare workers to screen for MRSA colonization. chromID™ MRSA agar is not intended to diagnose MRSA infection nor to guide or monitor treatment for infections.

Device Description:

chromID™ MRSA agar is a selective and differential chromogenic medium for the qualitative detection of MRSA from anterior nares swab specimens.

chromID™ MRSA agar consists of a rich nutritive base combining different peptones. It also contains a chromogenic substrate of a-glucosidase and a combination of several antibiotics, which favor the growth of MRSA including hetero-resistant strains. The antibiotics include: cefoxitin (4 mg/l), aztreonam (64 mg/l), and amphotericin B (3 mg/l). The selective mixture of antibiotics inhibits most bacteria not belonging to the genus Staphylococcus, as well as yeasts. The MRSA strains are identified by the presence of green colonies that result from the chromogen incorporated in the medium. The chromogen targets the a-qlucosidase activity of S. aureus. The a-ducosidase produced by S. aureus cleaves the chromogenic substrate, which gives a green color to the S. aureus colonies growing on the medium. This chromogen is identified as "Green a-glucoside" (5-Bromo-4-chloro-3-indoxyl-N-methyl-α-D-glucoside) (patent registered).

Device Comparison Table:

| Item | Device
chromIDTM MRSA Agar | Predicate
BBLTM CHROMagarTM MRSA |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | chromIDTM MRSA agar is a
selective and differential
chromogenic medium for the
qualitative detection of nasal
colonization by methicillin-
resistant S. aureus (MRSA) to aid
in the prevention and control of
MRSA infections in healthcare
settings. The test is performed on
anterior nares swab specimens
from patients and healthcare
workers to screen for MRSA
colonization. chromIDTM MRSA
agar is not intended to diagnose
MRSA infection nor to guide or
monitor treatment for infections. | BBLTM CHROMagarTM MRSA is a selective
and differential medium for the qualitative
direct detection of nasal colonization by
methicillin resistant Staphylococcus aureus
(MRSA) to aid in the prevention and control
of MRSA infections in healthcare settings.
The test is performed on anterior nares
swab specimens from patients and
healthcare workers to screen for MRSA
colonization. BBLTM CHROMagarTM MRSA
is not intended to diagnose MRSA infection
nor to guide or monitor treatment for
infections. |
| Test method | Manual | Manual |
| Inoculum | Direct Specimen | Direct Specimen |
| Specimen | Anterior nares specimens | Anterior nares specimens |

The similarities and differences of ChromID™ MRSA agar when compared to the predicate device are described in the following table.

1

chromID ™ MRSA Agar

IFUX

Traditional 510(k) Submission

| Item | Device
chromID™ MRSA Agar | Predicate
BBL™ CHROMagar™ MRSA |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Differences | | |
| Detection method | chromID™ MRSA contains a
chromogenic substrate and a
combination of several
antibiotics including cefoxitin.
The chromogenic substrate
provides for the direct detection
of MRSA by revealing α-
glucosidase activity which
produces green colonies
(patent registered). | BBL™ CHROMagar™ MRSA contains
specific chromogenic substrates and
cefoxitin. MRSA strains growing in the
presence of these substrates will
produce mauve-colored colonies
resulting from hydrolysis of the
chromogenic substrate. |
| Incubation
Conditions | 24h at 35-37°C in aerobic
conditions | 24-48 h in 33-37°C in aerobic conditions |

Discussion:

Both devices have similar Intended Use statements. The technological characteristics are similar but not identical. Both devices, chromID™ MRSA agar and BBL™ CHROMagar™ MRSA, are chromogenic media incorporated with cefoxitin for the direct detection of methicillin resistant Staphylococcus aureus from anterior nares specimens. Both devices incorporate selective agents in the agar to most bacteria not belonging to the genus Staphylococcus, as well as yeasts. chromID™ MRSA agar contains chromogenic substrates that reveal a-glucosidase activity of MRSA strains and produce green colonies. BBL™ CHROMagar™ MRSA contains specific chromogenic substrates. MRSA strains growing in the presence of these substrates will produce mauve-colored colonies resulting from hydrolysis of the chromogenic substrate

The safety and effectiveness of the chromID™ MRSA agar is not impacted by the technology differences. The chromID™ MRSA agar utilizes nutrient agar medium that contains selective and differential agents and is very similar to the BBL™ CHROMagar™ MRSA agar. The significant technological difference between the two media is the type of chromogenic substrate incorporated in the media to indicate the presence of MRSA colonies.

Clinical studies were performed and demonstrate acceptable performance of chromID™ MRSA. The overall agreement for detection of MRSA and non-MRSA by chromiD™ MRSA compared to conventional methods including the identification and susceptibility testing was 98.6% (12421259) at 24 h. Performance comparisons to confirmed MRSA and non-MRSA strains can be found in the following table:

2

Image /page/2/Picture/0 description: The image shows the logo for BioMerieux. The logo consists of the company name in a blocky, sans-serif font. Above the name is a black circle with lines emanating from it, and a thin black line runs vertically through the circle and the name.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ﻜ --------------------------------------------------------------------------------------------------------------------------------------------------------------------------chromID ™ MRSA Agar

Traditional 510(k) Submission

Methods	MRSA	Non-MRSA
cMRSA	94.7% (304/321)
95% CI = 91.7 – 96.9%	100.0% (938/938)
95% CI = 99.6 – 100%
TSAB	91.6% (294/321)
95% CI = 88.0 – 94.4%	100.0% (938/938)
95% CI = 99.6 – 100%
cMRSA vs. Latex Agglutination	96.3% (309/321)
95% CI = 93.6 – 98.1%	98.4% (923/938)
95% CI = 97.4 – 99.1%
cMRSA vs. Cefoxitin Screen	96.3% (309/321)
95% CI = 93.6 – 98.1%	98.4% (923/938)
95% CI = 97.4 – 99.1%
cMRSA vs. mecA PCR	100.0% (321/321)
95% CI = 98.9 – 100%	97.9% (918/938)
95% CI = 96.7 – 98.7%

Clinical Performance Compared to Conventional Methods after 24 h Incubation:

Cl = Confidence Interval

Performance is based on the number of true positives detected from either medium during the trial (true positives = number of samples positive by TSAB + number of samples that are false negative by TSAB and positive by chromID™ MRSA).

Conclusion:

The analytical and clinical performance data presented in this submission support a substantial equivalence decision. Based on the Substantial Equivalence Decision Tree, the chromID™ MRSA agar is substantially equivalent to the BBL™ CHROMagar™ MRSA agar.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Biomerieux, Inc. c/o Nancy Weaver Director, Regulatory Affairs 595 Anglum Rd Hazelwood, Missouri 63042

Re: K091024

Trade/Device Name: chromID™M MRSA Agar Regulation Number: 21 CFR 866.1700 Regulation Name: Antimicrobial susceptibility test Regulatory Class: II Product Code: JSO Dated: July 8, 2009 Received: July 9, 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.

JUL 1 7 2009

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 807); labeling (21 CFR Parts 801 and 809); 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.

4

Page 2 - Ms. Nancy Weaver

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office or In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Foil, arthyx

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

5

Indications for Use

510(k) Number (if known):_|KD9 102 Y

Device Name: chromID™ MRSA Agar

Indications For Use:

chromID™ MRSA agar is a selective and differential chromogenic medium for the qualitative detection of nasal colonization by methicillin-resistant S. aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings. The test is performed on anterior nares swab specimens from patients and healthcare workers to screen for MRSA colonization. chromID™ MRSA agar is not intended to diagnose MRSA infection nor to guide or monitor treatment for infections.

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)

Ludella Poole

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

S10(k) K091024

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