510(k) · Cleared
ClearedASTar BC G- Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Q-Linea AB · SAN Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
Cleared on Apr 15, 2026 as substantially equivalent to K221688 (Q-Linea AB, 2024) after a 149-day review. Its family tree reaches back 2 generations to 2017.
- Decided
- Apr 15, 2026
- Review
- 149 days
- Class
- Class II
- Product code
- SAN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN160032 (2017). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SAN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new SAN device
- #1 K211815 LifeScale Gram Negative Kit (LSGN) with the…score 13.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K221688 | ASTar BC G- Kit and ASTar InstrumentSummary page 7…testing Regulation Number: 21 CFR 866.1650 Regulatory Class: Class II Product Code: SAN, LON Predicate Device: K221688 ASTar BC G- Kit with ASTar Instrument 2.1 Purpose for the Submission With this submission Q-linea aims to expand existing ASTa… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 7.2 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All SAN devicesSAN Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SAN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SAN
577in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · SAN
No recall names SAN since 2007.
Adverse event reports per year · SAN
No MAUDE report names SAN since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 4 | 577 | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 3 | 169 | 0 | — |
What is it indicated for?
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…
Read the full statement (757 words)
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)
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253573 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253573: ASTar BC G- Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253573
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026