VITEK® 2 AST-Gram Negative Ciprofloxacin (≤ 0.06 -> 4 ug/mL) is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 AST-Gram Negative Ciprofloxacin is a quantitative test. Ciprofloxacin 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 Citrobacter Koseri Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Morganella morganii Proteus mirabilis Proteus vulgaris Providencia rettgeri Providencia stuartii Pseudomonas aeruginosa Salmonella typhi Serratia marcescens Shigella sonnei

In vitro data available but clinical significance is unknown: Enterobacter aerogenes Klebsiella oxytoca Salmonella enteritidis

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.

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(1) and Gerlach(2). The VITEK® 2 AST card is essentially a miniaturized, abbreviated and automated version of the doubling dilution technique(3).Ciprofloxacin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.

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 poltions 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 repo1t is generated that contains the MIC value along with the interpretive categoly result for each antibiotic contained on the card.

AI/ML Overview

The VITEK® 2 AST-Gram Negative Ciprofloxacin (≤ 0.06 -> 4 ug/mL) device is an automated system for antimicrobial susceptibility testing of Gram-negative bacilli. The study presented aims to demonstrate its substantial equivalence to a predicate device and its acceptable performance against a reference method.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria & Reported Device Performance

Acceptance Criteria	Reported Device Performance
Overall Essential Agreement (EA) with CLSI broth microdilution reference method ≥ 90%	97.2% Essential Agreement (overall)
Overall Category Agreement (CA) with CLSI broth microdilution reference method ≥ 90%	95.5% Category Agreement (overall)
Reproducibility acceptable	Acceptable Reproducibility
Quality Control acceptable	Acceptable Quality Control
Essential Agreement per organism group:
Enterobacteriaceae (excluding Salmonella)	97.9%
Pseudomonas aeruginosa	93.6%
Salmonella	100.0%
Category Agreement per organism group:
Enterobacteriaceae (excluding Salmonella)	95.2%
Pseudomonas aeruginosa	96.6%
Salmonella	100.0%

Note on Essential Agreement (EA): Essential Agreement is defined as the agreement between the test device's MIC (Minimum Inhibitory Concentration) results and the reference method's MIC results within a specified range (typically ±1 doubling dilution).
Note on Category Agreement (CA): Category Agreement refers to the categorical agreement between the test device's interpretive results (Susceptible, Intermediate, Resistant) and the reference method's interpretive results. It distinguishes between:

VME (Very Major Error): False Susceptible (device says susceptible, reference says resistant).
ME (Major Error): False Resistant (device says resistant, reference says susceptible).
mE (Minor Error): Agreement on S/I/R, but not on the exact MIC (e.g., device says susceptible, reference says intermediate, or vice versa).

2. Sample Size and Data Provenance

Test Set Sample Size: The exact total number of isolates used in the external evaluation is not explicitly stated as a single number. However, the study involved "fresh and stock clinical isolates, as well as a set of challenge strains." The performance data is broken down by organism group, suggesting a sufficiently diverse test set was used to meet FDA guidance for AST systems.
Data Provenance: The document states "An external evaluation was conducted." While the specific country of origin is not explicitly mentioned, given the FDA submission, it's highly probable the data was primarily collected in the United States. The study used both "fresh and stock clinical isolates" which implies a mix of retrospective (stock) and prospective (fresh) data collection.

3. Number of Experts and Qualifications for Ground Truth

This device is an in vitro diagnostic for antimicrobial susceptibility testing, comparing its results to a gold-standard laboratory reference method (CLSI broth microdilution). Therefore, the "experts" in this context are the laboratory technicians and microbiologists performing the CLSI broth microdilution method accurately, and the established CLSI guidelines and FDA-recognized breakpoints for interpretation. There is no mention of human readers/interpreters in the traditional sense of medical imaging or clinical diagnosis.

4. Adjudication Method for the Test Set

Not applicable in the conventional sense. The "adjudication" is the direct comparison of the VITEK 2's automated results against the established CLSI broth microdilution reference method and the application of FDA-recognized breakpoints. Discrepancies are categorized as VME, ME, or mE.

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

No, an MRMC comparative effectiveness study was not done. This is an in vitro diagnostic device that automates antimicrobial susceptibility testing. The study design involves comparing the device's performance to a recognized reference laboratory method, not to human interpretation of images or clinical data in a multi-reader setting.

6. Standalone Performance

Yes, standalone performance was done. The entire study is a measure of the standalone performance of the VITEK® 2 AST-GN Ciprofloxacin system as it provides automated results, which are then compared directly against the CLSI broth microdilution reference method. There is no human-in-the-loop component in the "performance" assessment itself, although human operators are required to run the VITEK 2 system and the reference method.

7. Type of Ground Truth Used

The ground truth used was the CLSI (Clinical and Laboratory Standards Institute) broth microdilution reference method for antimicrobial susceptibility testing, interpreted using FDA-recognized breakpoints. This is considered the gold standard for AST.

8. Sample Size for the Training Set

The document does not explicitly state the sample size used for training the VITEK® 2 AST-GN Ciprofloxacin system. The VITEK® 2 system's core "Analysis Algorithms" are described as "Growth Pattern Analysis," which implies a rule-based or machine learning approach that would have been developed and "trained" or validated using a large dataset of bacterial growth patterns under different antimicrobial concentrations. This initial development and training would have occurred prior to this specific submission for Ciprofloxacin, likely on a broader range of antimicrobials and organisms. This submission focuses on the validation of the specific Ciprofloxacin card against the established reference method.

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

While not explicitly detailed for a "training set" in this document, the general principle for establishing ground truth for AST systems (including for algorithm development/training) would involve:
- Using known strains and clinical isolates.
- Performing parallel testing with the gold-standard CLSI broth microdilution method.
- Correlating growth patterns (e.g., turbidity changes over time) observed by the VITEK 2 system with the MIC values determined by the reference method.
- Establishing the interpretive categories (Susceptible, Intermediate, Resistant) based on FDA-recognized and CLSI breakpoints applied to the reference method MICs.
- Developing and refining the algorithms (e.g., growth pattern analysis) to accurately predict MICs and interpretive categories from the VITEK 2's optical density measurements.

Summary

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April 14, 2022

bioMerieux, Inc Kyle Olney Regulatory Affairs Specialist 595 Anglum Rd. Hazelwood, Missouri 63042

Re: K214023

Trade/Device Name: VITEK 2 AST-Gram Negative Ciprofloxacin (<0.06 - >4 ug/mL) 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: December 21, 2021 Received: December 22, 2021

Dear Kyle Olney:

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

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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 (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

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Indications for Use

510(k) Number (if known)

K214023

Device Name

VITEK 2 AST-GN Ciprofloxacin (≤ 0.06 -> 4 ug/mL)

Indications for Use (Describe)

In vitro data available but clinical significance is unknown: Enterobacter aerogenes Klebsiella oxytoca Salmonella enteritidis

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/4/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with a blue top half and a green bottom half. The word "BIOMÉRIEUX" is written in white letters across the blue half of the circle.

VITEK® 2 AST-GN Ciprofloxacin (≤ 0.06 -> 4 µg/mL) Traditional 510(k) Submission

510(k) SUMMARY

VITEK® 2 AST-GN Ciprofloxacin

510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum RoadHazelwood, MO 63042
Contact Person:	Kyle J. OlneyRegulatory Affairs Specialist
Phone Number:	314-731-8666
Fax Number:	314-731-8689
Date of Preparation:	December 21, 2021
Device Name:
Formal/Trade Name:	VITEK® 2 AST-GN Ciprofloxacin (≤ 0.06 ->µg/mL)
Classification Name:	21 CFR 866.1645
Product Codes:	LON, LTT, and LTW
Common Name:	VITEK® 2 AST-GN Ciprofloxacin
Predicate Device:	VITEK® 2 GN Eravacycline (K191766)

D. 510(k) Summary:

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VITEK® 2 AST-GN Ciprofloxacin (≤ 0.06 -> 4 ug/mL) Traditional 510(k) Submission

E. Substantial Equivalence Information:

VITEK® 2 AST-GN Ciprofloxacin (≤ 0.06 -> 4 µg/mL) is substantially equivalent to VITEK® 2 GN Eravacycline (K191766). A summary of the similarities VITEK® 2 AST-GN Ciprofloxacin (≤ 0.06 -> 4 µg/mL) and VITEK® 2 GN Eravacycline (K191766). are provided in Table 1 below:

New Device andPredicate Device:	Device:VITEK® 2 AST-GN Ciprofloxacin (0.06->4 µg/mL)	Predicate:VITEK® 2 AST-GN Eravacycline (K191766)
General Device Characteristic Similarities
IntendedUse/Indications forUse	VITEK® 2 AST-Gram NegativeCiprofloxacin is 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 susceptibility toantimicrobial agents. VITEK® 2 AST-Gram Negative Ciprofloxacin is aquantitative test.The VITEK® 2 Gram-NegativeSusceptibility Card is intended for use withthe VITEK® 2 Systems in clinicallaboratories as an in vitro test to determinethe susceptibility of clinically significantaerobic Gram-negative bacilli toantimicrobial agents when used asinstructed.	VITEK® 2 AST-Gram Negative Eravacycline isdesigned for antimicrobial susceptibility testing ofGram negative bacilli and is intended for use withthe VITEK® 2 and VITEK® 2 Compact Systemsas a laboratory aid in the determination of in vitrosusceptibility to antimicrobial agents. VITEK® 2AST-Gram Negative Eravacycline is aquantitative test.The VITEK® 2 Gram-Negative Susceptibility Cardis intended for use with the VITEK® 2 Systems inclinical laboratories as an in vitro test to determinethe susceptibility of clinically significant aerobicGram-negative bacilli to antimicrobial agents whenused as instructed.
New Device andPredicate Device:	Device:VITEK® 2 AST-GN Ciprofloxacin (0.06 $≥$ 4µg/mL)	Predicate:VITEK® 2 AST-GN Eravacycline (K191766)
	General Device Characteristic Similarities
Test Methodology	Automated quantitative antimicrobialsusceptibility test for use with the VITEK® 2 andVITEK® 2 Compact Systems to determine the in vitro susceptibility of Gram negative bacilli	Same
Inoculum	Saline suspension of organism	Same
Test Card	VITEK®2 Gram Negative Susceptibility Test Card	Same
Instrument	VITEK®2 and VITEK®2 Compact Systems	Same
Analysis Algorithms	Growth Pattern Analysis	Same
Differences
AntimicrobialAgent	Ciprofloxacin	Eravacycline
AntimicrobialConcentrations	0.06, 0.12, 0.5, 1	0.25, 1, 2, 4
Indications forUse	Ciprofloxacin has been shown to be active againstmost strains of the microorganisms listed below,according to the FDA label for this antimicrobial.Active both in vitro and in clinical infections:Citrobacter koseriCitrobacter freundiiEnterobacter cloacaeEscherichia coliKlebsiella pneumoniaeMorganella morganiiProteus mirabilisProteus vulgarisProvidencia rettgeriProvidencia stuartiiPseudomonas aeruginosaSalmonella typhiSerratia marcescensShigella sonneiIn vitro data available but clinical significance isunknown:Klebsiella (Enterobacter) aerogenes	Eravacycline has been shown to be active againstmost strains of the microorganisms listed below,according to the FDA label for this antimicrobial.Active in vitro and in clinical infections:Citrobacter freundiiEnterobacter cloacaeEscherichia coliKlebsiella oxytocaKlebsiella pneumoniaeIn vitro data are available, but clinical significance isunknown:Citrobacter koseriKlebsiella (Enterobacter) aerogenes)

Table 1: Substantial Equivalence

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VITEK® 2 AST-GN Ciprofloxacin (≤ 0.06 – ≥ 4 µg/mL)

Traditional 510(k) Submission

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Image /page/7/Picture/0 description: The image shows the logo for bioMérieux. The logo consists of a blue circle on top of a yellow and green circle. The word "BIOMÉRIEUX" is written in white letters in the center of the blue circle.

VITEK® 2 AST-GN Ciprofloxacin (≤ 0.06 -> 4 ug/mL) Traditional 510(k) Submission

Klebsiella oxytoca
Salmonella enteritidis

F. Intended Use:

The antimicrobial presented in VITEK® 2 AST-GN Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK® 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.

The isolate to be tested is diluted to a standardized concentration in 0.45 - 0.50% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling and sealing operation. The VITEK® 2 monitors the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card.

Ciprofloxacin 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: Citrobacter koseri Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Morganella morganii Proteus mirabilis Proteus vulgaris Providencia rettgeri Providencia stuartii Pseudomonas aeruginosa

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Image /page/8/Picture/0 description: The image shows the logo for bioMérieux, a French multinational biotechnology company. The logo consists of a circle divided into two sections. The top section is a dark blue color and contains the company name "BIOMÉRIEUX" in white, sans-serif font. The bottom section is a gradient of yellow and green.

Salmonella typhi Serratia marcescens Shigella sonnei

In vitro data available but clinical significance is unknown: Klebsiella aerogenes Klebsiella oxytoca Salmonella enteritidis

G. Performance Overview and Conclusion:

To update the VITEK 2 Gram Negative Ciprofloxacin device labeling to include updated FDArecognized breakpoints for Enterobacterales (excludes Salmonella) and Pseudomonas aeruginosa as published in the FDA STIC website. Breakpoints for Salmonella, as well as the FDA indications for use remain unchanged. Previously obtained QC and reproducibility data is applicable to this reevaluation.

VITEK® 2 AST-GN Ciprofloxacin (< 0.06 - >4 ug/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 Ciprofloxacin. 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 VITEK® 2 AST-GN Ciprofloxacin by comparing its performance with the CLSI broth microdilution reference method incubated at 16-20 hrs. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms. - VITEK® 2 AST-GN Ciprofloxacin demonstrated acceptable performance of 97.2% overall Essential Agreement and 95.5% overall Category Agreement with the reference method. Reproducibility and Quality Control demonstrated acceptable results.

The VITEK® 2 AST-GN Ciprofloxacin (≤0.06 ->4 µg/mL) demonstrated acceptable performance as presented in Table 2 below:

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Image /page/9/Picture/0 description: The image shows the logo for bioMérieux, a French multinational biotechnology company. The logo consists of a circle divided into two sections. The top section is a dark blue color and contains the company name "BIOMÉRIEUX" in white, sans-serif font. The bottom section is a gradient of yellow and green.

VITEK® 2 AST-GN Ciprofloxacin (≤ 0.06 -> 4 ug/mL) Traditional 510(k) Submission

100

Table 2: VITEK® 2 AST-GN Ciprofloxacin Performance Essential Agreement Category Agreement % Reproducibility % % Error Antimicrobial Antibiotic Bp1 Comment2 Antimicrobial Code Version % EA VME ME mE % CA VME ME mE CIP cip02n CLSI #, E (FDA)* Enterobacteriaceae 97.9 N/A N/A 95.2 4.6 N/A 0.4 0.1 (excluding Salmonella) #, E Ciprofloxacin 93.6 N/A N/A N/A 96.6 0.0 3.4 0.0 Pseudomonas aeruginosa #, E 100.0 0.0 N/A N/A N/A 100.0 0.0 0.0 Salmonella

VITEK® 2 Systems Ciprofloxacin MIC values for Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus vulgaris, Providencia stuartii, Pseudomonas aeruginosa and Salmonella species tended to be in exact ageement or at least one doubling dilution higher than the reference method.

*For specific information regarding susceptive criteria and associated test methods and quality controls standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.

Kev:

= US Food and Drug Administration 510(k) cleared

E = External performance data

Quality Control demonstrated acceptable results.

H. References

1. MacLowly, J.D. and Marsh, H.H., Semi-automatic Microtechnique for Serial Dilution Antibiotic Sensitivity Testing in the Clinical laborato1y, Journal ofLaborato1y Clinical Medicine, 72:685-687, 1968.
1. Gerlach, E.H., Microdilution 1: A Comparative Study, p. 63-76. CU1Tent Techniques for Antibiotic Susceptibility Testing. A. Balows (ed.), Charles C. Thomas, Springfield, IL,1974.
1. Barry, A.L., The Antimicrobic Susceptibility Test, Principles and Practices, Lea and Febiger, 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.”