VITEK® 2 AST-Gram Negative Plazomicin is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 AST-Gram Negative Plazomicin is a quantitative test. Plazomicin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.

Active both in vitro and in clinical infections: Escherichia coli Klebsiella pneumoniae Enterobacter cloacae

In vitro data are available, but their clinical significance is unknown:

Citrobacter freundii Citrobacter koseri Klebsiella (Enterobacter) aerogenes Klebsiella oxytoca Proteus vulgaris Serratia marcescens

The VITEK® 2 Gram-Negative Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinicaly significant aerobic bacilli to antimicrobial agents when used as instructed.

Device Description

The principle of the VITEK® 2 AST cards is based on the microdilution minimum inhibitory concentration (MIC) technique reported by MacLowry and Marsh(4) and Gerlach(2). The VITEK® 2 AST card is essentially a miniaturized, abbreviated and automated version of the doubling dilution technique(3).

Each VITEK® 2 AST card contains 64 wells. A control well which only contains microbiological culture media is resident on all cards. The remaining wells contain premeasured portions of a specific antibiotic combined with culture media. The isolate to be tested is diluted to a standardized concentration with 0.45 - 0.5% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling, sealing and loading operation. The VITEK® 2 Systems monitor the growth of each well in the card over a defined period of time. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card.

AI/ML Overview

This document, K223478, describes the premarket notification for the VITEK® 2 AST-GN Plazomicin antimicrobial susceptibility testing system. The device is intended to determine the in vitro susceptibility of Gram-negative bacilli to Plazomicin.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for antimicrobial susceptibility testing (AST) devices are typically based on Essential Agreement (EA) and Category Agreement (CA), along with limits for Very Major Errors (VME), Major Errors (ME), and Minor Errors (mE), as defined by the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems. While the document doesn't explicitly state numerical acceptance criteria for each error type (e.g., "VME must be <X%"), it presents the achieved performance.

The reported device performance for Plazomicin testing against Enterobacteriaceae is as follows:

Performance Metric	Reported Device Performance (%)	Notes
Essential Agreement (%EA)	98.7% (847/858)	Agreement between the VITEK® 2 AST-GN Plazomicin and the CLSI Broth Microdilution reference method concerning the MIC (within +/- one doubling dilution).
Category Agreement (%CA)	99.4% (853/858)	Agreement between the VITEK® 2 AST-GN Plazomicin and the CLSI Broth Microdilution reference method concerning the interpretive category (Susceptible, Intermediate, or Resistant).
Very Major Error (VME)	0.0% (0/57)	The device reported a susceptible result, but the reference method reported a resistant result.
Major Error (ME)	0.1% (1/797)	The device reported a resistant result, but the reference method reported a susceptible result.
Minor Error (mE)	0.5% (4/858)	The device reported a susceptible or resistant result, where the reference was intermediate, or the device reported an intermediate result, where the reference was susceptible or resistant.
Reproducibility	97.0%	This indicates the consistency of the device's results when testing the same sample multiple times. The exact methodology for this calculation is not provided in detail, but it's a standard metric for AST systems.

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

Sample Size for Test Set: The number of isolates tested for performance evaluation against the "FDA (CLSI)" breakpoint (which signifies the primary clinical evaluation) was 858 isolates. Additionally, reproducibility was tested, but the sample size for that specific test is not explicitly broken down beyond the 97.0% result.
Data Provenance: The study involved an "external evaluation" conducted with "fresh and stock clinical isolates, as well as a set of challenge strains." This suggests a prospective collection of isolates for the study, encompassing both routine clinical samples and specific strains designed to challenge the system. The document does not specify the country of origin of the data.

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

This document describes a diagnostic device that performs Antimicrobial Susceptibility Testing (AST). For AST devices, the "ground truth" is typically established by a reference method, not human experts in the way it would be for imaging interpretation.

Ground Truth Establishment: The ground truth for the test set was established by the CLSI Broth Microdilution reference method. This is an internationally recognized standard laboratory procedure for determining minimum inhibitory concentrations (MICs) of antimicrobials.
Number and Qualifications of Experts: There were no human experts establishing the ground truth for this type of test by consensus reading. The ground truth is a laboratory measurement performed according to a standardized protocol.

4. Adjudication Method for the Test Set

Since the ground truth is established by a standardized laboratory reference method (CLSI Broth Microdilution), no adjudication method (like 2+1 or 3+1 consensus) was used or needed in the traditional sense for diagnostic systems relying on human interpretation. The comparison is directly between the device's output and the MIC values from the reference method.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned or performed. This device is an automated laboratory instrument for determining antimicrobial susceptibility, not an imaging AI tool designed to assist human readers. Therefore, the concept of human readers improving with AI assistance is not applicable here.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance study was conducted. The VITEK® 2 AST-GN Plazomicin system, including its "Growth Pattern Analysis (GPA)" algorithms, performs the susceptibility testing automatically. The performance metrics (Essential Agreement, Category Agreement, and Error Rates) presented in Table 2 are the direct output of the device compared to the reference method, without human intervention in the interpretation of the VITEK 2 results themselves.

7. Type of Ground Truth Used

The type of ground truth used was an established laboratory reference method: the CLSI Broth Microdilution method. This method provides quantitative Minimum Inhibitory Concentration (MIC) values, which are then categorized (Susceptible, Intermediate, Resistant) based on breakpoints.

8. Sample Size for the Training Set

The document does not provide information on the sample size for a training set. For AST devices, the "training" of the algorithm typically involves a robust development process using a large library of characterized isolates to optimize the growth pattern analysis (GPA) algorithms to accurately predict MICs. This development phase is usually distinct from the clinical validation study described here. The 858 isolates represent the test set for performance validation.

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

The document does not describe how the ground truth for the training set (if a distinct one was used for specific algorithm development) was established. However, it's highly probable that similar to the test set, the ground truth for any algorithm development or "training" would also rely on established reference methods like CLSI Broth Microdilution to characterize the isolates used in that phase.

Summary

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February 16, 2023

bioMerieux, Inc Cherece Jones Staff Regulatory Affairs Specialist 595 Anglum Rd. Hazelwood, Missouri 63042

Re: K223478

Trade/Device Name: VITEK 2 AST-Gram Negative Plazomicin (<0.5 - >16 µg/mL); VITEK® 2 AST-GN Plazomicin (≤0.5 - ≥16 µg/mL); VITEK 2 AST-GN Plazomicin Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: Class II Product Code: LON, LTT, LTW Dated: November 17, 2022 Received: November 18, 2022

Dear Cherece Jones:

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

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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 803) 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 (OS) 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 -S

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

Enclosure

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Indications for Use

510(k) Number (if known)

K223478

Device Name

VITEK® 2 AST-GN Plazomicin (<0.5 - >16 ug/mL)

Indications for Use (Describe)

Active both in vitro and in clinical infections: Escherichia coli Klebsiella pneumoniae Enterobacter cloacae

In vitro data are available, but their clinical significance is unknown:

Citrobacter freundii Citrobacter koseri Klebsiella (Enterobacter) aerogenes Klebsiella oxytoca Proteus vulgaris Serratia marcescens

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

VITEK® 2 AST-Gram Negative Plazomicin (≤0.5 - ≥16 µg/mL)

A. 510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum RoadHazelwood, MO 63042
Contact Person:	Cherece L. JonesStaff Regulatory Affairs Specialist
Phone Number:	314 -731-8684
Fax Number:	314-731-8689
Date of Preparation:	November 17, 2022
B. Device Name:
Formal/Trade Name:	VITEK® 2 AST-Gram Negative Plazomicin (≤0.5 - ≥16µg/mL)
Classification Name:	21 CFR 866.1645Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility System
Product Code(s):	LON, LTT, LTW
Common Name:	VITEK® 2 AST-GN Plazomicin (≤0.5 - ≥16 µg/mL)
C. Predicate Device:	VITEK® 2 AST-GN Gentamicin (≤ 1 –≥16 µg/mL)(K163563)

D. Device Description:

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E. Substantial Equivalence Information:

VITEK® 2 AST-GN Plazomicin (<0.5 - >16 ug/mL) is substantially equivalent to VITEK® 2 AST-GN Gentamicin (≤ 1 - ≥16 ug/mL) (K163563). A summary of the similarities and differences of the VITEK® 2 AST-GN Plazomicin (≤0.5 - ≥16 µg/mL) and VITEK® 2 AST-GN Gentamicin (≤ 1 ->16 ug/mL) (K163563) are provided in Table 1 below:

New Device andPredicate Device:	New Device:VITEK® 2 AST-Gram NegativePlazomicin ( $\le 0.5 - \ge 16$ µg/mL)	Predicate Device:VITEK® 2 AST-GN Gentamicin( $\le 1 - \ge 16$ µg/mL) (K163563)
General Device Characteristic Similarities
Intended Use	The VITEK® 2 Gram-NegativeSusceptibility Card is intended foruse with the VITEK® 2 Systems inclinical laboratories as an in vitro testto determine the susceptibility ofclinically significant aerobic Gram-negative bacilli to antimicrobialagents when used as instructed.	The VITEK® 2 AntimicrobialSusceptibility Test (AST) is intendedto be used with the VITEK® 2 Systemsfor the automated quantitative orqualitative susceptibility testing ofisolated colonies for the mostclinically significant aerobic gram-negative bacilli, Staphylococcus spp.,Enterococcus spp., Streptococcus spp.and clinically significant yeast.
Test Methodology	Automated quantitative antimicrobialsusceptibility test for use with theVITEK® 2 and VITEK® 2 CompactSystems to determine the in vitrosusceptibility of microorganisms	Same
Inoculum	Saline suspension of organism	Same
Test Card	Gram-Negative (AST-GN)	Same
New Device and Predicate Device:	New Device:VITEK® 2 AST-Gram NegativePlazomicin (≤0.5 - ≥16 µg/mL)	Predicate Device:VITEK® 2 AST-GN Gentamicin(≤1–≥16 µg/mL) (K163563)
	Susceptibility Card
Analysis Algorithms	Growth Pattern Analysis (GPA)	Same
Instrument	VITEK® 2 and VITEK® 2 Compact Systems	Same
General Device Characteristic Differences
Indications for Use	VITEK® 2 AST-Gram NegativePlazomicin is designed forantimicrobial susceptibility testing ofGram negative bacilli and is intendedfor use with the VITEK® 2 andVITEK® 2 Compact Systems as alaboratory aid in the determination ofin vitro susceptibility to antimicrobialagents. VITEK® 2 AST-GramNegative Plazomicin is a quantitativetest. Plazomicin has been shown tobe active against most strains of themicroorganisms listed below,according to the FDA label for thisantimicrobial.	VITEK® 2 Gram Negative Gentamicinis designed for antimicrobialsusceptibility testing of Gram negativebacilli and is intended for use with theVITEK® 2 and VITEK® 2 CompactSystems as a laboratory aid in thedetermination of in vitro susceptibilityto antimicrobial agents. VITEK® 2Gram Negative Gentamicin is aquantitative test. Gentamicin has beenshown to be active against most strainsof the microorganisms listed below,according to the FDA label for thisantimicrobial.
	Active both in vitro and in clinicalinfections:Escherichia coliKlebsiella pneumoniaeEnterobacter cloacae	Active in vitro and in clinicalinfectionsCitrobacter speciesEnterobacter speciesEscherichia coliKlebsiella speciesProteus speciesSerratia speciesPseudomonas aeruginosa
	In vitro data are available, but theirclinical significance is unknown:Citrobacter freundiiCitrobacter koseriKlebsiella (Enterobacter) aerogenesKlebsiella oxytocaProteus vulgarisSerratia marcescens
	The VITEK® 2 Gram-NegativeSusceptibility Card is intended foruse with the VITEK® 2 Systems inclinical laboratories as an in vitro testto determine the susceptibility ofclinically significant aerobic Gram-negative bacilli to antimicrobial	The VITEK® 2 AntimicrobialSusceptibility Test (AST) is intendedto be used with the VITEK® 2 Systemsfor the automated quantitative orqualitative susceptibility testing ofisolated colonies for the mostclinically significant aerobic gram-negative bacilli, Staphylococcus spp.,Enterococcus spp., Streptococcus spp.and clinically significant yeast.

Table 1: Substantial Equivalence

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New Device andPredicate Device:	New Device:VITEK® 2 AST-Gram NegativePlazomicin (≤0.5 - ≥16 µg/mL)	Predicate Device:VITEK® 2 AST-GN Gentamicin(≤ 1 –≥16 µg/mL) (K163563)
	agents when used as instructed.
Antimicrobial Agent	Plazomicin	Gentamicin
Concentrations	2, 4, 8 µg/mL	4, 8, 32 µg/mL

F. Intended Use:

The VITEK® 2 Gram-Negative Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed.

G. Performance Overview and Conclusion:

VITEK® 2 AST-GN Plazomicin (≤0.5 - ≥16 µg/mL) demonstrated substantially equivalent performance when compared with the CLSI Broth Microdilution reference method, as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems: Guidance for Industry and FDA (Issued August 28, 2009).

The Premarket Notification (510[k]) presents data in support of VITEK® 2 AST-GN Plazomicin (≤0.5 - >16 ug/mL). An external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to confirm the acceptability of AST-GN Plazomicin by comparing its performance with the CLSI broth microdilution reference method incubated at 16-24 hours. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.

The VITEK® 2 AST-GN Plazomicin (<0.5 - >16 µg/mL) demonstrated acceptable performance as presented in Table 2 below:

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Table 2: VITEK® 2 AST-GN Plazomicin Performance

Antimicrobial	AntimicrobialCode	AntibioticVersion	Bp1	Comment	Essential Agreement Category% Error				Category Agreement% Error				%Reproducibility
					%EA	VME	ME	mE	%CA	VME	ME	mE
Plazomicin	PLZ	(plz01n)	FDA(CLSI)	#, EEnterobacteriaceae	(847/858)98.7	N/A	N/A	N/A	(853/858)99.4	(0/57)0.0	(1/797)0.1	(4/858)0.5	97.0

The VITEK® 2 AST-GN Plazomicin MIC values tended to be in exact agreement or at least one doubling dilution lower when testing E. coli, and S. marcescens compared to the CLSI reference broth microdilution.

The VITEK® 2 AST-GN Plazomicin MIC values tended to be one doubling dilution higher when testing K. pneumoniae compared to the CLSI reference broth microdilution.

1 Abbreviations - Bp = breakpoint committee; EA = essential agreement; CA = category agreement; VME = Very Major Error (susceptible result with resistant reference result); ME = Major Error (resistant with susceptible reference result); mE = minor Error (susceptible or resistant result with an intermediate reference result, or an intermediate result with a susceptible or resistant reference result).

Key: # = US Food and Drug Administration 510(k) cleared

E = External performance data

H. Quality Control:

CLSI® Quality Control Organisms VITEK® 2 Results
Antimicrobic	Code	E. coliATCC® 25922™	P. aeruginosaATCC® 27853™
Plazomicin	plz01n	≤0.5 - 2◊(FDA/CLSI broth dilution expectedQC range = 0.25 – 2 μg/mL)	1 - 4

Numerical values are expressed in ug/mL

· Does not include the full CLSI/FDA-recommended dilution range for QC testing with this organism.

Results for the VITEK® 2 AST-GN Plazomicin (≤0.5 - ≥16 µg/mL) were within the expected QC results range >95% of the time for both dilution options of the VITEK® 2 and manual dilution on the VITEK® 2 Compact.

I. Limitations:

Perform an alternative method of testing prior to reporting of results for the following antibiotic/organism combination(s):

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Plazomicin (plz01n): Morganella morganii, Proteus mirabilis, Providencia stuartii ●
The ability of the AST card to detect resistance with the following combination(s) is unknown because resistant strains were not available at the time of comparative testing:
Plazomicin (plz01n): Citrobacter freundii, Citrobacter koseri, Klebsiella (Enterobacter) aerogenes, Klebsiella oxytoca, Proteus vulgaris, and Serratia marcescens

J. References:

1. MacLowry, J.D. and Marsh, H.H., Semi-automatic Microtechnique for Serial Dilution Antibiotic Sensitivity Testing in the Clinical laboratory, Journal of Laboratory Clinical Medicine, 72:685-687, 1968.
Gerlach, E.H., Microdilution 1: A Comparative Study, p. 63-76. Current Techniques for 2. Antibiotic Susceptibility Testing. A. Balows (ed.), Charles C. Thomas, Springfield, IL, 1974.
Barry, A.L., The Antimicrobic Susceptibility Test, Principles and Practices, Lea and Febiger, 3. Philadelphia, PA, 1976.

Regulation Number and Section

§ 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.

(a)
Identification. A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”