# K221688: ASTar BC G- Kit and ASTar Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Q-Linea AB
- Decided: Apr 26, 2024 after 686 days
- Product code: SAN (Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples)
- Device class: 2
- Regulation: 21 CFR 866.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN160032 (2017). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN160032: Accelerate Pheno system, Accelerate Phenotest BC Kit, Accelerate Diagnotics (2017) Summary page 5.

## Most influential descendants
- K253573: ASTar BC G- Kit (2026), 0 descendants of its own

## Indications for use
Intended Use: The ASTar System is intended to be used for the automated quantitative susceptibility testing for most clinically significant microorganisms. The ASTar System does not provide organism identification. Indications for Use: The ASTar System, comprised of the ASTar Instrument with the ASTar BC G− Kit (ASTar BC G− Consumable kit, ASTar BC G− Frozen insert, and ASTar BC G− Kit software), utilizes high-speed, time-lapse microscopy imaging of bacteria for the in vitro, quantitative determination of antimicrobial susceptibility of on-panel gram-negative bacteria. The test is performed directly on positive blood culture samples signaled as positive by a continuous monitoring blood culture system and confirmed to contain gram-negative bacilli by Gram stain. Organism identification is required for AST result interpretation and reporting. Test results from the ASTar BC G− Kit should be interpreted in conjunction with other clinical and laboratory findings. Standard laboratory protocols for processing positive blood cultures should be followed to ensure availability of isolates for supplemental testing. Sub-culturing is necessary to support further testing for: bacteria and antimicrobials not on the ASTar BC G− panel, where inconclusive results are obtained, epidemiologic testing, recovery of organisms present in microbial samples, and susceptibility testing of bacteria in polymicrobial samples. The ASTar BC G− Kit tests the following antimicrobial agents with the following bacterial species: Amikacin: Citrobacter freundii, Enterobacter cloacae complex, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens Ampicillin: Escherichia coli, Proteus mirabilis Ampicillin-sulbactam: Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris Aztreonam: Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Serratia marcescens Cefazolin: Klebsiella pneumoniae Cefepime: Citrobacter freundii, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens Ceftazidime: Enterobacter cloacae complex, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Serratia marcescens Ceftazidime-avibactam: Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Klebsiella oxytoca, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens Cefuroxime: Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis Ciprofloxacin: Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens Gentamicin: Citrobacter freundii, Citrobacter koseri, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens Levofloxacin: Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens Meropenem: Acinetobacter baumannii, Citrobacter freundii, Citrobacter koseri, Escherichia coli, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens Meropenem-vaborbactam: Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Serratia marcescens Piperacillin-tazobactam: Citrobacter koseri, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Serratia marcescens Tigecycline: Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Serratia marcescens Tobramycin: Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Serratia marcescens Trimethoprim-sulfamethoxazole: Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus vulgaris

Source page: https://510kreport.com/device/K221688
Methodology: https://510kreport.com/methodology