Who is the manufacturer of VITEK 2 AST-Yeast Caspofungin ( =8 µg/mL), VITEK 2 AST-YS Caspofungin ( =8 µg/mL), VITEK 2 AST-YS Caspofungin?

bioMerieux, Inc. filed the 510(k) submission for VITEK 2 AST-Yeast Caspofungin ( =8 µg/mL), VITEK 2 AST-YS Caspofungin ( =8 µg/mL), VITEK 2 AST-YS Caspofungin (K213899).

What is the FDA product code for VITEK 2 AST-Yeast Caspofungin ( =8 µg/mL), VITEK 2 AST-YS Caspofungin ( =8 µg/mL), VITEK 2 AST-YS Caspofungin?

LON. It is classified under 21 CFR 866.1645 as a Class 2 device in the Microbiology panel.

What is the regulatory pathway for VITEK 2 AST-Yeast Caspofungin ( =8 µg/mL), VITEK 2 AST-YS Caspofungin ( =8 µg/mL), VITEK 2 AST-YS Caspofungin?

510(k) clearance (submission type: Traditional).

Does VITEK 2 AST-Yeast Caspofungin ( =8 µg/mL), VITEK 2 AST-YS Caspofungin ( =8 µg/mL), VITEK 2 AST-YS Caspofungin use AI or machine learning?

Yes. VITEK 2 AST-Yeast Caspofungin ( =8 µg/mL), VITEK 2 AST-YS Caspofungin ( =8 µg/mL), VITEK 2 AST-YS Caspofungin (K213899) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like VITEK 2 AST-Yeast Caspofungin ( =8 µg/mL), VITEK 2 AST-YS Caspofungin ( =8 µg/mL), VITEK 2 AST-YS Caspofungin?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like VITEK 2 AST-Yeast Caspofungin ( =8 µg/mL), VITEK 2 AST-YS Caspofungin ( =8 µg/mL), VITEK 2 AST-YS Caspofungin get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin

Q: What are the predicate devices for VITEK 2 AST-Yeast Caspofungin ( =8 µg/mL), VITEK 2 AST-YS Caspofungin ( =8 µg/mL), VITEK 2 AST-YS Caspofungin?

VITEK 2 AST-Yeast Caspofungin (K151817).

K213899 · bioMerieux, Inc. · LON · Jul 12, 2022 · Microbiology

Device Facts

Record ID	K213899
Device Name	VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin
Applicant	bioMerieux, Inc.
Product Code	LON · Microbiology
Decision Date	Jul 12, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.1645
Device Class	Class 2
Attributes	AI/ML

Intended Use

VITEK® 2 AST-Yeast Caspofungin is designed for antifungal susceptibility testing of Candida species 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 antifungal agents. VITEK® 2 AST-Yeast Caspofungin is a quantitative test. Caspofungin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antifungal. Active in vitro and in clinical infections: Candida albicans Candida guilliermondii Candida krusei Candida parapsilosis Candida tropicalis The VITEK® 2 Fungal 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 yeasts to antifungal agents when used as instructed.

Device Story

VITEK 2 AST-Yeast Caspofungin is an automated, miniaturized, broth-dilution-based susceptibility test. It uses 64-well cards containing premeasured antimicrobial concentrations and nutrient media. Input: saline-diluted yeast isolate. Operation: VITEK 2 system automatically fills, seals, and incubates the card; VITEK 2 Compact requires manual preparation. System uses optical scanner to measure light attenuation every 15 minutes to monitor growth. Output: MIC values and interpretive category results (S, I, R). Used in clinical microbiology laboratories by technicians. Results assist clinicians in selecting appropriate antifungal therapy. Device performance is subject to specific limitations for certain Candida species/MIC ranges due to observed minor and very major errors.

Clinical Evidence

Bench testing only. Reanalysis of 599 clinical and 75 challenge isolates (C. albicans, C. guilliermondii, C. krusei, C. parapsilosis, C. tropicalis). Performance evaluated against CLSI broth microdilution reference method. Overall Category Agreement (CA) was 97.5% (automatic) and 91.4-92.6% (manual). Observed minor and very major errors led to specific reporting limitations. Trending analysis showed a systematic bias toward lower MIC values compared to the reference method.

Technological Characteristics

Miniaturized, automated broth microdilution card. 64-well format. Sensing: Transmittance optics (visible light attenuation). Energy: Electrical (automated system). Connectivity: Networked (VITEK 2 system). Software: Growth pattern analysis algorithm. Sterilization: Not specified.

Indications for Use

Indicated for antifungal susceptibility testing of Candida species (C. albicans, C. guilliermondii, C. krusei, C. parapsilosis, C. tropicalis) in clinical laboratories using VITEK 2 or VITEK 2 Compact systems. Prescription use only. Limitations apply for specific MIC ranges for C. krusei, C. albicans, and C. tropicalis requiring alternative testing methods.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

VITEK 2 AST-Yeast Caspofungin (K151817)

Related Devices

K151817 — VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL · bioMerieux, Inc. · Feb 18, 2016
K101566 — VITEK 2 YEAST CASPOFUNGIN · bioMerieux, Inc. · Sep 28, 2010
K151923 — VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) · bioMerieux, Inc. · Mar 25, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right of it is the FDA logo, with the letters 'FDA' in a blue square and the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. July 13, 2022 bioMerieux, Inc. Esther Hernandez Regulatory Affairs Specialist 595 Anglum Road Hazelwood, Missouri 63042 Re: K213899 Trade/Device Name: VITEK 2 AST-Yeast Caspofungin (<0.125 - >8 ug/mL), VITEK 2 AST-YS Caspofungin (≤0.125 - ≥8 ug/mL), VITEK 2 AST-YS Caspofungin 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 Dear Esther Hernandez: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated July 12, 2022. Specifically, FDA is updating this SE Letter to provide the correct Indications for Use form (FORM FDA 3881) as an administrative correction. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Ribhi Shawar, Ph.D., OHT7: Office of In Vitro Diagnostics, 301-796-6698, Ribhi.Shawar@fda.hhs.gov. Sincerelv. # Natasha Griffin -S Ribhi Shawar, Ph.D. Branch Chief Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration. The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. Underneath the square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue. July 12, 2022 bioMerieux, Inc. Esther Hernandez Regulatory Affairs Specialist 595 Anglum Road Hazelwood, Missouri 63042 Re: K213899 Trade/Device Name: VITEK 2 AST-Yeast Caspofungin (≤0.125 - ≥8 µg/mL), VITEK 2 AST-YS Caspofungin (<0.125 - >8 ug/mL), VITEK 2 AST-YS Caspofungin 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 13, 2021 Received: December 14, 2021 Dear Esther Hernandez: 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. {2}------------------------------------------------ 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 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, # Natasha Griffin -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 {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213899 Device Name VITEK® 2 AST-Yeast Caspofungin (≤ 0.125 - ≥8 µg/mL) #### Indications for Use (Describe) VITEK® 2 AST-Yeast Caspofungin is designed for antifungal susceptibility testing of Candida species and is intended for use with the VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antifungal agents. VITEK® 2 AST-Yeast Caspofungin is a quantitative test. Caspofungin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antifungal. Active in vitro and in clinical infections: Candida albicans Candida guillermondii Candida krusei Candida parapsilosis Candida tropicalis The VITEK® 2 Fungal 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 yeasts to antifungal agents when used as instructed. | 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. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ 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 section is blue and contains the company name "BIOMÉRIEUX" in white, sans-serif font. The bottom section is a gradient of yellow and green. # 510(k) SUMMARY ### VITEK® 2 AST-YS Caspofungin #### A. 510(k) Submission Information: | Submitter's Name: | bioMérieux, Inc. | |----------------------|-------------------------------------------------------------------------------------------------------------------------------------| | Address: | 595 Anglum Road Hazelwood, MO 63042 | | Contact Person: | Esther Hernandez Regulatory Affairs Specialist | | Phone Number: | 314-731-8841 | | Fax Number: | 314-731-8689 | | Date of Preparation: | December 8, 2021 | | Device Name: | | | Formal/Trade Name: | VITEK® 2 AST-Yeast Caspofungin (≤ 0.125 – ≥8 µg/mL) | | Classification Name: | 21 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Product Code LON, LTT, LTW | | Common Name: | VITEK® 2 AST-YS Caspofungin | | Predicate Device: | VITEK® 2 AST-Yeast Caspofungin (K151817) | #### D. Device Description: B. C. 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). 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 bacterial or yeast isolate to be tested is diluted to a standardized concentration with 0.45 - 0.5% saline before being used to rehydrate the {5}------------------------------------------------ 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. VITEK® 2 AST-YS Caspofungin has the following concentrations in the card: 0.125, 0.5, 2, and 8 (equivalent standard method concentration by efficacy in ug/mL). #### E. Substantial Equivalence Information The similarities and differences of the VITEK 2 AST-YS Caspofungin when compared to the predicate device, VITEK 2 AST-YS Caspofungin (K151817), are described in the following table. The only difference between both devices are the Indications for Use and the breakpoints used to analyze the data performance. The below table provides the similarities and differences: | Item | Device: VITEK® 2 AST-YS Caspofungin | Predicate: VITEK® 2 AST-YS Caspofungin (K151817) | |--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | VITEK® 2 AST-Yeast Caspofungin is designed for antifungal susceptibility testing of Candida species 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 antifungal agents. VITEK® 2 AST-Yeast Caspofungin is a quantitative test. Caspofungin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antifungal. Active in vitro and in clinical infections: Candida albicans Candida guilliermondii Candida krusei Candida parapsilosis Candida tropicalis The VITEK® 2 Fungal Susceptibility Card is intended for use with the | VITEK® 2 AST-Yeast Caspofungin is designed for antifungal susceptibility testing of Candida species 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 antifungal agents. VITEK® 2 AST-Yeast Caspofungin is a quantitative test. Caspofungin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antifungal. Active in vitro and in clinical infections: Candida albicans Candida glabrata Candida guilliermondii Candida krusei Candida parapsilosis Candida tropicalis The VITEK® 2 Antimicrobial | {6}------------------------------------------------ | | VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed. | Susceptibility Test (AST) is intended to for use with the VITEK 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for most clinically significant aerobic Gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinical significant yeast. | |---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Test Methodology | Automated quantitative antimicrobial susceptibility test for use with the VITEK® 2 and VITEK® 2 Compact Systems to determine the in vitro susceptibility of yeast. | Same | | Antimicrobial Agent | Caspofungin | Same | | Inoculum | Saline suspension of organism | Same | | Test Card | VITEK® 2 Yeast (AST) Susceptibility Test Card | Same | | Analysis Algorithms | Discriminant Analysis | Same | | Instrument | VITEK® 2 and VITEK® 2 Compact Systems | Same | | Concentrations | 0.125, 0.5, 2, 8 | Same | | | Differences | | | Indications for Use | Candida albicans Candida guilliermondii Candida krusei Candida parapsilosis Candida tropicalis | Candida albicans Candida glabrata Candida guilliermondii Candida krusei Candida parapsilosis Candida tropicalis | | Breakpoints for Candida spp. | Candida albicans: ≤0.25 (S), 0.5 (I), ≥1 (R) Candida guilliermondii: ≤2 (S), 4 (I), ≥8 (R) Candida krusei: ≤0.25 (S), 0.5 (I), ≥1 (R) Candida parapsilosis: ≤2 (S), 4 (I), ≥8 (R) Candida tropicalis: ≤0.25 (S), 0.5 (I), ≥1 (R) | Candida spp.: ≤2 (S), - (I), - (R) | #### F. Intended Use: VITEK® 2 AST-Yeast Caspofungin is designed for antifungal susceptibility testing of Candida species 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 antifungal agents. VITEK® 2 AST-Yeast Caspofungin is a quantitative test. Caspofungin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antifungal. {7}------------------------------------------------ Active in vitro and in clinical infections: Candida albicans Candida guilliermondii Candida krusei Candida parapsilosis Candida tropicalis The VITEK® 2 Fungal 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 yeasts to antifungal agents when used as instructed. #### G. Performance Overview: VITEK® 2 AST-YS Caspofungin 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 (Traditional 510[k]) presents data in support of VITEK® 2 AST-YS Caspofungin. 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-YS Caspofungin by comparing its performance with the CLSI broth microdilution reference method incubated at 24 hours (or up to 48 hours for isolates that show insufficient growth at 24 hours). The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms. VITEK® 2 AST-YS Caspofungin demonstrated acceptable performance of 99.9% overall Essential Agreement and 97.5% overall Category Agreement with the reference method. | Antimicrobial | Anti- microbial Code | Antibiotic Version | Bp1 | Comment | Essential Agreement | | | | Category Agreement | | | | %Repro- ducibility | | | | |-----------------|----------------------------|-----------------------|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|-----|-----|-----|--------------------|----------------|----------------|-----------------|-----------------------|--|--|--| | | | | | | % Error | | | | % Error | | | | | | | | | | | | | | % EA | VME | ME | mE | % CA | VME | ME | mE | | | | | | Caspofungi n | CAS | cas02n | CLSI (FDA) | #, E, | (679/680) 99.9 | N/A | N/A | N/A | (663/680) 97.5 | (2/2) 100.0 | (0/663) 0.0 | (15/680) 2.2 | 96.7 | | | | | | | | | VITEK 2 Caspofungin MIC values tended to be in exact agreement or at least one doubling dilution lower when testing Candida albicans, Candida guilliermondii, Candida krusei, Candida parapsilosis, and Candida tropicalis compared to the broth microdilution reference method. One very major error was observed for C. albicans and one very major error was observed for C. tropicalis using the VITEK 2 (both the automatic and manual dilution methods). Each very major error was the only resistant isolate tested and was within essential agreement with the reference method. One very major error was observed for C. tropicalis using the VITEK 2 Compact. This very major error was the only resistant isolate tested and was not within essential agreement with the reference method | | | | | | | | | | | | | ' Abbreviations - Bo=breakpont committee; EA=estegory.ggeement; VME=Very Major Eror(susceptibleresulty: ME=Septibleressult; ME Major Enor (resistant result); mE = minor Error (susceptible or resistant result with an internediate reference result, or an internediate result, or an internediate result with a susceptible or resistant reference result). #=US Food and Drug Administration 510(k) cleared CLSI = Clinical and Laboratory Standards Institute {8}------------------------------------------------ E = External performance data N/A = Not applicable Reproducibility and Quality Control demonstrated acceptable results. #### H. Conclusion: The performance data presented in this submission support a substantial equivalence decision. VITEK® 2 AST-Yeast Caspofungin (≤ 0.125 ->8 µg/mL) is substantially equivalent to VITEK® 2 AST-Yeast Caspofungin (K151817). #### 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. - 2. Gerlach, E.H., Microdilution 1: A Comparative Study, p. 63-76. Current Techniques for Antibiotic Susceptibility Testing. A. Balows (ed.), Charles C. Thomas, Springfield, IL, 1974. - 3. Barry, A.L., The Antimicrobic Susceptibility Test, Principles and Practices, Lea and Febiger, Philadelphia, PA, 1976.

VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin

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VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin

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