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 · SAN Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
Cleared on Apr 2, 2024 as substantially equivalent to K192665 (Accelerate Diagnostics, Inc., 2020) after a 1,026-day review. Its family tree reaches back 2 generations to 2017. 2 later devices descend from it.
- Decided
- Apr 2, 2024
- Review
- 1,026 days
- Class
- Class II
- Product code
- SAN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN160032 (2017). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backDEN160032 Accelerate Pheno system, Accelerate Phenotest BC KitAccelerate Diagnotics · 2017
- 1 generation backK192665 Accelerate Pheno System, Accelerate PhenoTest BC KitAccelerate Diagnostics, Inc. · 2020 · Recalled
- This deviceK211815 LifeScale Gram Negative Kit (LSGN) with the LifeScale AST SystemAffinity Biosensors · 2024
- Descendant · cites it directly · 1 of its ownK241324 LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemAffinity Biosensors, LLC · 2024
- Descendant · cites it directly · 0 of its ownK251875 LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemAffinity Biosensors, LLC · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN160032 | Accelerate Pheno system, Accelerate Phenotest BC Kit | Accelerate Diagnotics | 2017 | — |
| −1 | K192665 | Accelerate Pheno System, Accelerate PhenoTest BC Kit | Accelerate Diagnostics, Inc. | 2020 | 2 |
| 0 (this device) | 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 | — |
| +1 | K251875 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system | Affinity Biosensors, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
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 K260160 VITEK REVEAL GN AST Assay and VITEK REVEAL AST…score 11.9 · 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 |
|---|---|---|---|
| * | K192665 | Accelerate Pheno System, Accelerate PhenoTest BC KitSummary page 5…Product Code: SAN Additional Product Code: LON Classification: Class II Predicate Device: Accelerate Pheno system, Accelerate PhenoTest BC Kit (K192665) 3. Device Description Summary The LifeScale AST system is an in vitro diagnostic test designed to quantitatively assess antimic… | 2020 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 7 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K241324 (Affinity Biosensors, LLC, 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K192665.
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. 2024, 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 (254 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/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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211815 · printed Nov 5, 2026
Cite this page
510(k) Report. “K211815: 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 5, 2026. https://510kreport.com/device/K211815
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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