# K253573: ASTar BC G- Kit

- Pathway: 510(k) (Traditional)
- Applicant: Q-Linea AB
- Decided: Apr 15, 2026 after 149 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: 2 generations back to DEN160032 (2017). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221688: ASTar BC G- Kit and ASTar Instrument, Q-Linea AB (2024) Summary page 7.

## 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. Testing is indicated for Acinetobacter spp., Enterobacterales, and Pseudomonas aeruginosa, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). The ASTar BC G- Kit with ASTar System has demonstrated acceptable performance with the following organisms: Amikacin: Acinetobacter spp. (Acinetobacter baumannii complex), Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens) Ampicillin: Enterobacterales (Escherichia coli, Proteus mirabilis) Ampicillin-sulbactam: Acinetobacter spp. (Acinetobacter baumannii complex), Enterobacterales (Citrobacter koseri, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae group, Morganella morganii, Proteus mirabilis, Proteus vulgaris) Aztreonam: Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens), and Pseudomonas aeruginosa Cefazolin: Enterobacterales (Citrobacter koseri, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae group, Proteus mirabilis) Cefepime: Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Proteus mirabilis, Proteus vulgaris, Serratia marcescens), and Pseudomonas aeruginosa Cefotaxime: Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae group, Proteus mirabilis, Proteus vulgaris, Serratia marcescens) Cefoxitin: Enterobacterales (Citrobacter koseri, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae group, Proteus mirabilis) Ceftazidime: Acinetobacter spp. (Acinetobacter baumannii complex), Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens) Ceftazidime-avibactam: Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens), and Pseudomonas aeruginosa Ceftolozane-tazobactam: Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae group, Proteus mirabilis, Proteus vulgaris, Serratia marcescens), and Pseudomonas aeruginosa Ceftriaxone: Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Proteus mirabilis, Proteus vulgaris, Serratia marcescens) Cefuroxime: Enterobacterales (Citrobacter koseri, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae group, Proteus mirabilis) Ciprofloxacin: Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens), and Pseudomonas aeruginosa Ertapenem: Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae group, Proteus mirabilis, Proteus vulgaris, Serratia marcescens) Gentamicin: Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Klebsiella oxytoca, Klebsiella pneumoniae group, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens) Levofloxacin: Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens), Pseudomonas aeruginosa Meropenem: Acinetobacter spp. (Acinetobacter baumannii complex), Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens), and Pseudomonas aeruginosa Meropenem-vaborbactam: Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens) Piperacillin-tazobactam: Acinetobacter spp. (Acinetobacter baumannii complex), Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae group, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens) Tigecycline: Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Serratia marcescens) Tobramycin: Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Proteus mirabilis, Proteus vulgaris), and Pseudomonas aeruginosa Trimethoprim-sulfamethoxazole: Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Morganella morganii, Proteus vulgaris)

Source page: https://510kreport.com/device/K253573
Methodology: https://510kreport.com/methodology