June 3, 2022: FDA cleared the VITEK 2 AST-Gram Negative Omadacycline (?0.25 – ?16 µg/mL) (K213931), a miniaturized, abbreviated and automated version of the classic broth dilution method to determine the minimum inhibitory concentration of omadacycline, a new antibiotic for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).

April 29, 2022: FDA granted the De Novo request for the BioFire Joint Infection (JI) Panel (DEN200066), a multiplexed nucleic-acid-based, in vitro diagnostic test intended for the simultaneous qualitative detection and identification of multiple bacterial and yeast nucleic acids and select antimicrobial resistance genes from synovial fluid obtained from individuals suspected to have a joint infection. 

April 27, 2022: FDA cleared the EPlex Blood Culture Identification Gram Negative (BCID-GN) Panel (K213236), a multiplexed nucleic acid test intended for simultaneous qualitative detection and identification of multiple potentially pathogenic gram-negative bacterial organisms and select determinants associated with antimicrobial resistance, as well as detect several gram-positive bacteria and several Candida species all from positive blood culture. Claims were added to include the detection of nucleic acids from additional strains of E. coli, Citrobacter, Enterococcus, and Pseudomonas aeruginosa.

April 14, 2022: FDA cleared the VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 – ?4 µg/mL) (K214023), a miniaturized, abbreviated and automated version of the classic broth dilution method to determine the minimum inhibitory concentration of ciprofloxacin, an antibiotic with updated breakpoints for testing Enterobacterales and P. aeruginosa.

February 25, 2022: FDA cleared the VITEK 2 AST-Yeast Fluconazole (?0.5 – ?64 µg/mL) (K213241), a miniaturized, abbreviated and automated version of the classic broth dilution method to determine the minimum inhibitory concentration of fluconazole, an antifungal agent with updated breakpoints for testing Candida albicans, Candida parapsilosis, and Candida tropicalis.

February 4, 2022: FDA cleared the VITEK 2 AST-Gram Positive Linezolid (?0.5 – ?8 µg/mL) (K212849), a miniaturized, abbreviated and automated version of the classic broth dilution method to determine the minimum inhibitory concentration of linezolid, an antibiotic with updated breakpoints for testing Staphylococcus species

December 20, 2021: FDA cleared the Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Cefiderocol in the Dilution Range of 0.03-64 µg/mL (K203741), a miniaturized version of the classic broth dilution method to determine the minimum inhibitory concentration of Cefiderocol with additional indicated species (Acinetobacter baumannii and Serratia marcescens) and using updated breakpoints for members of the Enterobacterales order.

December 15, 2021: FDA cleared the Sensititre YeastOne Susceptibility System with Voriconazole in the Dilution Range of 0.008 – 8 ?g/mL (K211539), a micro-version of the broth dilution susceptibility test performed in multi-well microtiter plates to determine the minimum inhibitory concentration of voriconazole, an antifungal agent with new breakpoints and indications for testing Candida species.

November 12, 2021: FDA cleared the ETEST Fosfomycin (FO) (0.032-512 µg/mL) (K210757), a gradient diffusion assay to determine the minimum inhibitory concentration of Fosfomycin, an antibiotic used for the treatment of urinary tract infection.

October 28, 2021: FDA cleared the APAS Independence with IC Chromogenic MRSA BD Analysis Module and the APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module (K200839), an in vitro diagnostic test system for the automated assessment of microbial colonies on chromogenic culture media to aid in screening for methicillin-resistant Staphylococcus aureus (MRSA).

October 28, 2021: FDA cleared the VITEK 2 AST- Streptococcus Cefotaxime (?0.125 – ?8 µg/mL) (K210287), an abbreviated and automated version of a broth microdilution assay to determine the minimum inhibitory concentration of Cefotaxime with Streptococcus species.

October 27, 2021: FDA cleared the Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20 (K210873), a disk diffusion assay for in vitro susceptibility testing of Lefamulin, a first-in-class antibiotic for the treatment of community-acquired bacterial pneumonia. 

October 20, 2021: FDA cleared the MTS Piperacillin-Tazobactam 0.016/4 – 256/4 µg/mL (K211672), a gradient diffusion assay to determine the minimum inhibitory concentration of Piperacillin-Tazobactam, a combination antibiotic that is used to treat various bacterial infections.

June 14, 2021: FDA cleared the VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 – >16/4 µg/mL) (K211136), an abbreviated and automated version of a broth microdilution assay to determine the minimum inhibitory concentration of Imipenem/Relebactam. A claim was added to the previously cleared device to include a new indicated species, Acinetobacter calcoaceticus-baumannii complex.

May 27, 2021: FDA cleared the MicroScan MICroSTREP Plus Panels With Tetracycline (0.06-16 µg/mL) (K202423), an abbreviated version of a broth microdilution assay to determine the minimum inhibitory concentration of Tetracycline with aerobic streptococci. Performance data was updated to include reanalysis of MIC results for Streptococcus pneumoniae with tetracycline using currently recognized interpretive criteria.

November 16, 2020:  MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 ?g/mL) (K202343), an abbreviated version of a broth microdilution assay to determine the minimum inhibitory concentration of Ceftazidime, a antibacterial used to treat lower respiratory tract infections, skin and skin-structure infections, bacterial septicemia, bone and joint infections, gynecologic infections, intra-abdominal infections and central nervous system infections

September 28, 2020: VITEK 2 AST-Gram Negative Ceftazidime (?0.5 – ?32 µg/mL) (K193299) an abbreviated and automated version of a broth microdilution assay to determine the minimum inhibitory concentration of Ceftazidime, a antibacterial used to treat lower respiratory tract infections, skin and skin-structure infections, bacterial septicemia, bone and joint infections, gynecologic infections, intra-abdominal infections and central nervous system infections.

September 15, 2020: Accelerate Pheno System, Accelerate PhenoTest BC Kit  (K192665) a multiplexed in vitro diagnostic test utilizing both qualitative nucleic acid fluorescence in situ hybridization (FISH) identification and quantitative antimicrobial susceptibility methods directly from positive blood culture samples. Claims were added for antimicrobial susceptibility testing of Pseudomonas aeruginosa with ceftazidime, cefepime, meropenem, piperacillin/tazobactam, and aztreonam. 

June 29, 2020: Addition of Acinetobacter spp. for testing with the MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004 – 32 µg/mL) (K201423), an abbreviated version of a broth microdilution assay to determine the minimum inhibitory concentration of Meropenem, an antibiotic for which FDA recently updated the susceptibility test interpretive criteria on the STIC website to include interpretive criteria when testing this organism group.

May 7, 2020: ETEST Plazomicin (0.016 – 256 µg/mL) (K200512) a gradient diffusion assay to determine the minimum inhibitory concentration of Plazomicin, an antibiotic for the treatment of complicated urinary tract infection

April 28, 2020: VITEK 2 AST-Gram Positive Delafloxacin (?0.015 – ?1 µg/mL) (K200590) an abbreviated and automated version of a broth microdilution assay to determine the minimum inhibitory concentration of Delafloxacin, an antibiotic approved for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI)

April 6, 2020: MTS Lefamulin 0.016 – 256 µg/mL (K200308) a gradient diffusion assay to determine the minimum inhibitory concentration of Lefamulin, a first-in-class antibiotic for the treatment of community-acquired bacterial pneumonia.

March 20, 2020: MTS Omadacycline 0.002 – 32 µg/mL (K200180) a gradient diffusion assay to determine the minimum inhibitory concentration of Omadacycline, a new antibiotic for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).

March 18, 2020: MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 – 8 µg/mL) (K193536) an abbreviated version of a broth microdilution assay to determine the minimum inhibitory concentration of Ciprofloxacin, an antibiotic for which FDA recently recognized revised interpretive criteria and published those on the FDA STIC webpage.

March 18, 2020: BioFire Blood Culture Identification 2 (BCID2) Panel (K193519) a multiplexed nucleic acid-based test for the detection and identification of multiple bacterial and yeast nucleic acids and select genetic determinants associated with antimicrobial resistance direct from positive blood culture samples.

March 13, 2020: VITEK 2 AST-Gram Negative Imipenem/Relebactam (?0.25/4 – ?16/4 µg/mL) (K193572) abbreviated and automated version of a broth microdilution assay to determine the minimum inhibitory concentration of Imipenem/Relebactam, an antibiotic approved eight months ago for the treatment of complicated urinary tract infections and complicated intra-abdominal infections.