# K211815: LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System

- Pathway: 510(k) (Traditional)
- Applicant: Affinity Biosensors
- Decided: Apr 2, 2024 after 1,026 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.
2 later devices descend from it; 2 cite 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)
- K192665: Accelerate Pheno System, Accelerate PhenoTest BC Kit, Accelerate Diagnostics, Inc. (2020) Summary page 5.

## Most influential descendants
- K241324: LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system (2024), 1 descendant of its own
- 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/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, for epidemiologic testing and for recovery of organisms present in microbial samples. The LifeScale Gram Negative Kit (LSGN) is intended for use with the LifeScale AST system for in vitro testing of positive blood culture samples confirmed by Gram stain as containing gram-negative bacilli for the antimicrobial agents and specific target organisms identified below: • Ampicillin: Escherichia coli • Aztreonam: Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca • Cefazolin: Klebsiella pneumoniae, Klebsiella variicola • Ceftazidime: Acinetobacter baumannii, Acinetobacter baumannii/nosocomialis group, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella variicola, Pseudomonas aeruginosa • Ertapenem: Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca • Trimethoprim-Sulfamethoxazole: Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella variicola

Source page: https://510kreport.com/device/K211815
Methodology: https://510kreport.com/methodology