# K241324: LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system

- Pathway: 510(k) (Traditional)
- Applicant: Affinity Biosensors, LLC
- Decided: Oct 23, 2024 after 166 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: 3 generations back to DEN160032 (2017). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211815: LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System, Affinity Biosensors (2024) Summary page 6.

## Most influential descendants
- K251875: LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system (2025), 0 descendants of its own

## Indications for use
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. The LifeScale AST System and the LifeScale Gram-negative Panel (LSGN) are indicated for testing of positive blood culture samples confirmed by Gram stain as containing Gram-negative organisms for the following antimicrobial agents and specific target organisms identified below: • Amikacin: Acinetobacter spp., Escherichia coli, Klebsiella pneumoniae, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella variicola, Pseudomonas aeruginosa • Ampicillin: Escherichia coli • Aztreonam: Escherichia coli, Klebsiella pneumoniae, Klebsiella aerogenes, Klebsiella oxytoca • Cefazolin: Escherichia coli, Klebsiella pneumoniae, Klebsiella variicola • Cefepime: Escherichia coli, Klebsiella pneumoniae, Klebsiella aerogenes, Klebsiella oxytoca, Pseudomonas aeruginosa • Ceftazidime: Acinetobacter spp. (other than Acinetobacter ursingii), Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella variicola, Klebsiella pneumoniae, Pseudomonas aeruginosa • Ceftazidime-avibactam: Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca • Ertapenem: Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae, Klebsiella oxytoca • Gentamicin: Escherichia coli, Klebsiella pneumoniae, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella variicola, Pseudomonas aeruginosa • Levofloxacin: Escherichia coli, Klebsiella pneumoniae, Klebsiella aerogenes, Klebsiella oxytoca, Pseudomonas aeruginosa • Meropenem: Acinetobacter spp., Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Pseudomonas aeruginosa • Meropenem-vaborbactam: Escherichia coli, Klebsiella pneumoniae, Klebsiella aerogenes, Klebsiella oxytoca • Piperacillin-tazobactam: Acinetobacter spp., Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa • Trimethoprim-sulfamethoxazole: Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella variicola

Source page: https://510kreport.com/device/K241324
Methodology: https://510kreport.com/methodology