Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a manual, quantitative technique based on a physical strip with a predefined antibiotic gradient. There is no mention of computational analysis, image processing, or any terms related to AI/ML. The performance studies compare the device to a reference method, not an AI/ML model.

Therapeutic

No.
This device is designed for in vitro diagnostic testing to determine antimicrobial susceptibility, not for treating diseases or conditions.

Diagnostic

Yes

Explanation: The ETEST® device determines the Minimum Inhibitory Concentration (MIC) of different antimicrobial agents against microorganisms. This information is crucial for clinicians to determine effective treatment strategies, thereby aiding in the diagnosis and management of bacterial infections by guiding appropriate antibiotic selection.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "thin, inert and non-porous plastic strip" carrying an antibiotic gradient, which is a physical hardware component.

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 a "manual, quantitative technique for the determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria." This involves testing biological samples (bacteria) in vitro (outside the body) to provide information about a patient's potential response to an antimicrobial agent.
Device Description: The device is a strip with an antibiotic gradient designed to interact with bacteria on an agar plate to determine their susceptibility. This is a classic method used in clinical microbiology laboratories for diagnostic purposes.
Performance Studies: The performance studies compare the device's results to a reference method (CLSI broth microdilution) for determining antimicrobial susceptibility, which is a standard diagnostic procedure.
Predicate Device: The listed predicate device (ETEST® Telavancin) is also an ETEST® product used for determining antimicrobial susceptibility, further indicating that this type of device falls under the IVD category.

The entire description points to a device used in a laboratory setting to perform tests on biological samples to aid in the diagnosis and treatment of infections, which is the core definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

ETEST® is a manual, quantitative technique for the determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC, in ug/mL) of different antimicrobial agents against microorganisms tested on agar media after overnight incubation. Plazomicin has been shown to be active against most isolates of the bacteria listed below according to the FDA label for this antimicrobial agent.

ETEST® PLZ can be used to determine the MIC of Plazomicin aqainst the following microorganisms:

Active both in vitro and in clinical infections:

Escherichia coli
Klebsiella pneumoniae
Proteus mirabilis
Enterobacter cloacae

In vitro data are available for the following microorganisms, but clinical significance is unknown:

Citrobacter freundii
Citrobacter koseri
Klebsiella (Enterobacter) aerogenes
Klebsiella oxytoca
Morganella morganii
Proteus vulgaris
Providencia stuartii
Serratia marcescens

Product codes

JWY

Device Description

ETEST® is a thin, inert and non-porous plastic strip carrying the MIC reading scale in µg/mL on one side and a predefined antibiotic gradient on the other side.

When the strip is applied to an inoculated agar surface, the preformed antibiotic gradient immediately transfers into the agar matrix, then forming a stable, continuous and exponential gradient of antibiotic concentrations directly underneath the strip. Bacterial growth becomes visible during incubation, and a symmetrical inhibition ellipse centered along the strip appears. The MIC value is read from the scale in terms of ug/mL at complete inhibition of bacterial growth, where the pointed end of the ellipse intersects the strip.

ETEST® Plazomicin contains a range of plazomicin from 0.016 to 256 ug/mL.

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

Prescription Use

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

External evaluations were conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to establish the performance of ETEST® Plazomicin (PLZ) (0.016-256 ug/mL) by comparing with the CLSI broth microdilution reference method.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

ETEST® Plazomicin (PLZ) (0.016-256 ug/mL) demonstrated substantially equivalent performance when compared with the CLSI M07-A11 January 2018 broth microdilution reference method, following rules as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, issued on August 28, 2009 and following specifications as defined in CLSI M100 29th Ed. (January 2019) and 30th Ed. (January 2020).

This Premarket Notification (510[k]) presents data in support of ETEST® Plazomicin (PLZ) (0.016-256 µg/mL) for Enterobacteriaceae.

Sample size for Enterobacteriaceae: N is not explicitly stated in numerical format next to 'Strains (N)', but the breakdown includes: Escherichia coli (78), Klebsiella pneumoniae (89), Proteus mirabilis (63), Enterobacter cloacae (60), Citrobacter freundii (59), Citrobacter koseri (34), Klebsiella (Enterobacter) aerogenes (38), Klebsiella oxytoca (39), Morganella morganii (31). Proteus vulgaris (34), Providencia stuartii (35) and Serratia marcescens (38).

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

Essential Agreement (EA) = 99.0%
Category Agreement (CA) = 92.8%

EA = % of MIC values within +/- 1 dilution of the reference method.

Predicate Device(s)

K180936

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 866.1640 Antimicrobial susceptibility test powder.

(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a larger font size than the name. The name is written as "U.S. FOOD & DRUG ADMINISTRATION".

May 7, 2020

bioMérieux S.A. Alexia Bosquet Regulatory Affairs Specialist 376 Chemin de l'Orme Marcy L'Etoile, 69280 France

Re: K200512

Trade/Device Name: ETEST Plazomicin (PLZ) (0.016-256 µg/mL) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY Dated: February 28, 2020 Received: March 2, 2020

Dear Alexia Bosquet:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

1

for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Ribhi Shawar, Ph.D. (ABMM) Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K200512

Device Name ETEST® PLAZOMICIN (PLZ) (0.016-256 µg/mL)

Indications for Use (Describe)

ETEST® is a manual, quantitative technique for the determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC, in ug/mL) of different antimicrobial agents against microorganisms tested on agar media after overnight incubation. Plazomicin has been shown to be active against most isolates of the bacteria listed below according to the FDA label for this antimicrobial agent.

ETEST® PLZ can be used to determine the MIC of Plazomicin aqainst the following microorganisms:

Active both in vitro and in clinical infections:

Escherichia coli
Klebsiella pneumoniae
Proteus mirabilis
Enterobacter cloacae

In vitro data are available for the following microorganisms, but clinical significance is unknown:

Citrobacter freundii
Citrobacter koseri
Klebsiella (Enterobacter) aerogenes
Klebsiella oxytoca
Morganella morganii
Proteus vulgaris
Providencia stuartii
Serratia marcescens

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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ETEST® PLAZOMICIN (PLZ) (0.016-256 µg/mL)

A. 510(k) Submission Information:

Submitter's Name:	bioMerieux SA
Address:	376 Chemin de l'Orme
69280 Marcy-l'Etoile, FRANCE
Contact Person:	Alexia Bosquet
Regulatory Affairs Specialist
Phone Number:	+33 (0)4 78 87 50 20
Date of Preparation:	February 28th, 2020

B. Device Name:

Formal/Trade Name:	ETEST® PLAZOMICIN (PLZ) (0.016–256 µg/mL)
Classification Name:	21 CFR 866.1640
	Manual Antimicrobial Susceptibility Test Systems
Product Code: JWY
Common Name(s):	ETEST® PLAZOMICIN; ETEST® PLZ
C. Predicate Device:	ETEST® Telavancin (TLA) (0.002-32 µg/mL) (K180936)

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Image /page/4/Picture/0 description: The image shows the logo for bioMérieux, a French multinational biotechnology company. The logo is a circle divided into two sections. The top half of the circle is a solid dark blue color, and the text "BIOMÉRIEUX" is written in white, sans-serif font in the center of the blue section. The bottom half of the circle is a gradient that transitions from yellow to green.

D. Device Description:

ETEST® is a thin, inert and non-porous plastic strip carrying the MIC reading scale in µg/mL on one side and a predefined antibiotic gradient on the other side.

When the strip is applied to an inoculated agar surface, the preformed antibiotic gradient immediately transfers into the agar matrix, then forming a stable, continuous and exponential gradient of antibiotic concentrations directly underneath the strip. Bacterial growth becomes visible during incubation, and a symmetrical inhibition ellipse centered along the strip appears. The MIC value is read from the scale in terms of ug/mL at complete inhibition of bacterial growth, where the pointed end of the ellipse intersects the strip.

ETEST® Plazomicin contains a range of plazomicin from 0.016 to 256 ug/mL.

E. Intended Use:

ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria and fastidious bacteria. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC, in ug/mL) of different antimicrobial agents against microorganisms tested on agar media after overnight incubation.

Plazomicin has been shown to be active against most isolates of the bacteria listed below according to the FDA label for this antimicrobial agent.

ETEST® PLZ can be used to determine the MIC of Plazomicin against the following microorganisms:

Active both in vitro and in clinical infections:

-Escherichia coli
-Klebsiella pneumoniae
-Proteus mirabilis
Enterobacter cloacae -

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Image /page/5/Picture/0 description: The image is a logo for the company BIOMÉRIEUX. The logo is a circle with two different colored sections. The top section is a dark blue color and contains the company name in white, sans-serif font. The bottom section is a gradient of yellow and green.

In vitro data are available for the following microorganisms, but clinical significance is unknown:

Citrobacter freundii -
Citrobacter koseri -
-Klebsiella (Enterobacter) aerogenes
Klebsiella oxytoca -
Morganella morganii -
-Proteus vulgaris
Providencia stuartii -
Serratia marcescens -

F. Summary of the technological characterictics of the new device in comparison to those of the predicate device.

The similarities and differences of ETEST® Plazomicin (PLZ) when compared to the predicate device, ETEST® Telavancin (TLA) (K180936) are described in the table below:

	Test Device	Predicate Device
	Similarities
	ETEST® Plazomicin (PLZ)
(0.016-256 µg/mL)	ETEST® Telavancin (TLA)
(0.002-32 µg/mL) (K180936)
Intended Use	ETEST® is a manual, quantitative
technique for determination of
antimicrobial susceptibility of
non-fastidious Gram-negative and
Gram-positive aerobic bacteria
and fastidious bacteria.

The system comprises a
predefined antibiotic gradient
which is used to determine the
Minimum Inhibitory
Concentration (MIC, in µg/mL) of
different antimicrobial agents
against microorganisms tested on
agar media after overnight | ETEST® is a quantitative
technique for determination of
antimicrobial susceptibility of both
non-fastidious Gram-negative and
Gram-positive aerobic bacteria
such as Enterobacteriaceae,
Pseudomonas, Staphylococcus,
and Enterococcus species and
fastidious bacteria, such as
anaerobes, N. gonorrhoeae, S.
pneumoniae, Streptococcus and
Haemophilus species.

The system comprises a
predefined antibiotic gradient |
| Test Device | Predicate Device | |
| incubation.
Plazomicin has been shown to be
active against most isolates of the
bacteria listed below according to
the FDA label for this
antimicrobial agent.

ETEST® PLZ can be used to
determine the MIC of Plazomicin
against the following
microorganisms:

Active both in vitro and in clinical
infections:

Escherichia coli
Klebsiella pneumoniae
Proteus mirabilis
Enterobacter cloacae

In vitro data are available for the
following microorganisms, but
clinical significance is unknown:

Citrobacter freundii
Citrobacter koseri
Klebsiella (Enterobacter)
aerogenes
Klebsiella oxytoca
Morganella morganii
Proteus vulgaris
Providencia stuartii
Serratia marcescens | which is used to determine the
Minimum Inhibitory
Concentration (MIC), in µg/mL, of
different antimicrobial agents
against microorganisms as tested
on agar media using overnight
incubation.

Telavancin has been shown to be
active against the Gram-positive
aerobic microorganisms listed
below according to the FDA label
for this antimicrobial agent.

Active both in vitro and in clinical
infections:
• Staphylococcus aureus
(including methicillin
resistant isolates)

95% of the time. | Results within expected range
95% of the time. |
| Meets Guidance
Document
Performance
Requirements | Yes | Yes |
| Differencies | | |
| | ETEST® Plazomicin (PLZ)
(0.016-256 µg/mL) | ETEST® Telavancin (TLA)
(0.002-32 µg/mL) (K180936) |
| Antimicrobial
Agent | Plazomicin | Telavancin |
| Claimed species | Enterobacteriaceae | Staphylococcus aureus (including
methicillin resistant isolates)

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Image /page/6/Picture/1 description: The image shows a semi-circle shape with a gradient of colors. The left side of the semi-circle is a bright yellow color, which gradually transitions to a green color on the right side. The semi-circle is positioned against a white background, which makes the colors stand out. The overall effect is a smooth and visually appealing gradient.

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G. Performance Overview

ETEST® Plazomicin (PLZ) (0.016-256 ug/mL) demonstrated substantially equivalent performance when compared with the CLSI M07-A11 January 2018 broth microdilution reference method, following rules as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, issued on August 28, 2009 and following specifications as defined in CLSI M100 29th Ed. (January 2019) and 30th Ed. (January 2020).

This Premarket Notification (510[k]) presents data in support of ETEST® Plazomicin (PLZ) (0.016-256 µg/mL) for Enterobacteriaceae.

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Image /page/8/Picture/0 description: The image shows the logo for bioMérieux, a French multinational biotechnology company. The logo is a circle with the top half in dark blue and the bottom half in a gradient of yellow to green. The company name, "BIOMÉRIEUX", is written in white, sans-serif font across the center of the blue portion of the circle.

External evaluations were conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to establish the performance of ETEST® Plazomicin (PLZ) (0.016-256 ug/mL) by comparing with the CLSI broth microdilution reference method.

ETEST® Plazomicin (PLZ) (0.016-256 µg/mL) demonstrated acceptable performance as presented in Table 1 below:

| | Strains
(N) | % Essential
Agreement
(EA)a) | % Category
Agreement
(CA) |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|---------------------------------|
| Enterobacteriaceaeb)c)d)e)f) | રેતે જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દ | 99.0 | 92.8 |

Table 1: Performance Characteristics for ETEST® Plazomicin

Notes:

EA = % of MIC values within ± 1 dilution of the reference method. a)
b) The performance data presented for Enterobacteriaceae include Escherichia coli (78), Klebsiella pneumoniae (89), Proteus mirabilis (63), Enterobacter cloacae (60), Citrobacter freundii (59), Citrobacter koseri (34), Klebsiella (Enterobacter) aerogenes (38), Klebsiella oxytoca (39), Morganella morganii (31). Proteus vulgaris (34), Providencia stuartii (35) and Serratia marcescens (38).
The optional inoculator and ETEST® strip applicator can be used for plate inoculation and c) applying ETEST® strips onto agar media. In the ETEST® Plazomicin clinical studies, swabs and the Inoculator RETRO C80™ were used for plate inoculation/streaking and forceps and the Vacuum Pen NEMA C88TM were used for ETEST® strip application.
d) The Category Agreement was 90% and all categorical errors were minor and within essential agreement, except for one isolate of Serratia marcescens.
e) ETEST® Plazomicin MIC values tended to be in exact agreement or one doubling dilution lower when testing Morganella morganii compared to the reference broth microdilution method.
ETEST® Plazomicin MIC values tended to be in exact agreement or at least one doubling f) dilution higher when testing Klebsiella (Enterobacter) aerogenes and Klebsiella pneumoniae compared to the CLSI reference broth microdilution method. However, this trending did not impact the Essential or Category Agreement (Klebsiella aerogenes EA:100%, CA:100%; Klebsiella pneumoniae EA:100%; CA:98.9%).

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Limitations:

The ability of ETEST Plazomicin to detect the following resistant isolates is unknown because a sufficient number of resistant isolates were not available at the time of comparative testing: Cirrobacter koseri, Serratia marcescens.

Reproducibility and Quality Control demonstrated acceptable results.

Conclusion:

The performance data presented in this submission support a substantial equivalence decision. ETEST® Plazomicin (PLZ) (0.016-256 µg/mL) is substantially equivalent to ETEST® Telavancin (TLA) (0.002-32 µg/mL) (K180936).