510(k) · Cleared
ClearedLifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Affinity Biosensors, LLC · SAN Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
Cleared on Oct 27, 2025 as substantially equivalent to K211815 (Affinity Biosensors, 2024) and 1 other predicate after a 131-day review. Its family tree reaches back 4 generations to 2017.
- Decided
- Oct 27, 2025
- Review
- 131 days
- Class
- Class II
- Product code
- SAN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to DEN160032 (2017). No later device cites it as a predicate yet.
- Root · 4 generations backDEN160032 Accelerate Pheno system, Accelerate Phenotest BC KitAccelerate Diagnotics · 2017
- 3 generations backK192665 Accelerate Pheno System, Accelerate PhenoTest BC KitAccelerate Diagnostics, Inc. · 2020 · Recalled
- 2 generations backK211815 LifeScale Gram Negative Kit (LSGN) with the LifeScale AST SystemAffinity Biosensors · 2024
- 1 generation backK241324 LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemAffinity Biosensors, LLC · 2024
- This deviceK251875 LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemAffinity Biosensors, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN160032 | Accelerate Pheno system, Accelerate Phenotest BC Kit | Accelerate Diagnotics | 2017 | — |
| −3 | K192665 | Accelerate Pheno System, Accelerate PhenoTest BC Kit | Accelerate Diagnostics, Inc. | 2020 | 2 |
| −2 | K211815 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System | Affinity Biosensors | 2024 | — |
| −1 | K241324 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system | Affinity Biosensors, LLC | 2024 | — |
| 0 (this device) | K251875 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system | Affinity Biosensors, LLC | 2025 | — |
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? (2)
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 |
|---|---|---|---|
| * | K211815 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST SystemSummary page 6…ty testing Regulation Number: 21 CFR 866.1650 Regulatory Class: Class II Product Code: SAN, LON Predicate Device: K211815/K241324 LifeScaleTM Gram Negative Kit (LSGN) with the LifeScale AST system Purpose for Submission: i. To obtain a substantial eq… | 2024 |
| * | K241324 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemSummary page 6…ng Regulation Number: 21 CFR 866.1650 Regulatory Class: Class II Product Code: SAN, LON Predicate Device: K211815/K241324 LifeScaleTM Gram Negative Kit (LSGN) with the LifeScale AST system Purpose for Submission: i. To obtain a substantial equivalenc… | 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 8 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K211815.
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. 2025, 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 LifeScale AST system is a multiplexed in vitro diagnostic test that uses a microfluidic sensor and resonant frequency to calculate organism concentration and/or mass distribution for quantitative antimicrobial susceptibility testing (AST). Testing is performed directly on blood cultures signaled as positive by a continuous monitoring blood culture system and confirmed by Gram stain. The LifeScale AST system does not provide organism identification…
Read the full statement (564 words)
The LifeScale AST system is a multiplexed in vitro diagnostic test that uses a microfluidic sensor and resonant frequency to calculate organism concentration and/or mass distribution for quantitative antimicrobial susceptibility testing (AST). Testing is performed directly on blood cultures signaled as positive by a continuous monitoring blood culture system and confirmed by Gram stain. The LifeScale AST system does not provide organism identification and is not indicated for use with polymicrobial samples. Interpretive results (Susceptible/Intermediate/Susceptible-dose dependent/Resistant) are provided for specific drug/organism combinations. Results are intended to be used 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 as needed. Additionally, subculture of positive blood culture is necessary for the susceptibility testing of organisms present in polymicrobial samples, for testing antimicrobial agents and species not indicated for testing with the device and for epidemiologic testing and for recovery of organisms present in microbial samples.
Testing is indicated for Acinetobacter spp., Enterobacterales, Pseudomonas aeruginosa, and Salmonella spp. as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). The LSGN Kit with LifeScale AST system has demonstrated acceptable performance with the following organisms :
• Amikacin: Acinetobacter spp. (A. baumannii complex, A. calcoaceticus, A. lwoffii, A. pittii, A. radioresistens, A. ursingii)
• Ampicillin: Enterobacterales (Escherichia coli, Proteus mirabilis), and Salmonella spp.
• Aztreonam: Enterobacterales (Citrobacter freundii, Citrobacter koseri, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Serratia marcescens), and Pseudomonas aeruginosa
• Cefazolin: Enterobacterales (Escherichia coli, Klebsiella pneumoniae, Klebsiella variicola
• Cefepime: Enterobacterales (Citrobacter freundii, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Serratia marcescens), and Pseudomonas aeruginosa
• Ceftazidime: Acinetobacter spp. (A. baumannii complex, A. calcoaceticus, A. lwoffii, A. pittii, A. radioresistens), Enterobacterales (Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Klebsiella variicola, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Serratia marcescens), and Pseudomonas aeruginosa
• Ceftazidime-avibactam: Enterobacterales (Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Providencia rettgeri, Providencia stuartii, Serratia marcescens)
• Ertapenem: Enterobacterales (Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Providencia rettgeri, Providencia stuartii, Serratia marcescens)
• Gentamicin: Enterobacterales (Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Klebsiella variicola, Serratia marcescens)
• Levofloxacin: Enterobacterales (Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Serratia marcescens), and Pseudomonas aeruginosa
• Meropenem: Acinetobacter spp. (A. baumannii complex, A. calcoaceticus, A. lwoffii, A. pittii, A. radioresistens, A. ursingii), Enterobacterales (Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Serratia marcescens), and Pseudomonas aeruginosa
• Meropenem-vaborbactam: Enterobacterales (Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Providencia rettgeri, Providencia stuartii, Serratia marcescens
• Piperacillin-tazobactam: Acinetobacter spp (A. baumannii complex)., Enterobacterales (Citrobacter koseri, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Serratia marcescens), and Pseudomonas aeruginosa,
• Trimethoprim-sulfamethoxazole: Enterobacterales (Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella variicola, Morganella morganii, Proteus mirabilis, 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/K251875 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251875: LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251875
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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