510(k) · Cleared
ClearedeQUANT System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avails Medical, Inc. · QZX Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing
Cleared on Feb 8, 2024 as substantially equivalent to K192665 (Accelerate Diagnostics, Inc., 2020) after a 254-day review. Its family tree reaches back 2 generations to 2017. 2 later devices descend from it.
- Decided
- Feb 8, 2024
- Review
- 254 days
- Class
- Class II
- Product code
- QZX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN160032 (2017). 2 later devices descend from it, 1 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 deviceK231536 eQUANT SystemAvails Medical, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK223493 PBC Separator with Selux AST SystemSelux Diagnostics, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK244044 PBC Separator with Selux AST SystemSelux Diagnostics, Inc. · 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) | K231536 | eQUANT System | Avails Medical, Inc. | 2024 | — |
| +1 | K223493 | PBC Separator with Selux AST System | Selux Diagnostics, Inc. | 2024 | — |
| +2 | K244044 | PBC Separator with Selux AST System | Selux Diagnostics, Inc. | 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 QZX? 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 QZX device
- #1 K223493 PBC Separator with Selux AST Systemscore 10.4 · 3 generations · no Class I recall
- #2 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…ystem for multiplexed antimicrobial susceptibility testing Product Code: QZX, JTN Predicate Device: Accelerate Pheno System, Accelerate PhenoTest BC Kit (K192665) 3. Device Description Summary The eQUANT™ System is an automated system that uses potentiometric sensing of changes in oxidatio… | 2020 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223493 | PBC Separator with Selux AST System | 2024 | 1 |
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, K223493 (Selux Diagnostics, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K192665.
How does its category compare?
All QZX devicesQZX Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QZX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QZX
Too few QZX 510(k)s in any year since 2007 to give a median.
Recalls per year · QZX
No recall names QZX since 2007.
Adverse event reports per year · QZX
No MAUDE report names QZX 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 | 2 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The eQUANT System is an automated inoculum preparation system that uses potentiometric sensing of oxidation-reduction potential changes due to pathogen metabolism to generate a 0.5 McFarland-equivalent suspension (the eMcFarland or eMcF) from positive blood culture samples that can be used for direct, qualitative in vitro susceptibility testing by the agar disk diffusion test method (Kirby-Bauer). Samples are processed directly from blood culture samples…
Read the full statement (419 words)
The eQUANT System is an automated inoculum preparation system that uses potentiometric sensing of oxidation-reduction potential changes due to pathogen metabolism to generate a 0.5 McFarland-equivalent suspension (the eMcFarland or eMcF) from positive blood culture samples that can be used for direct, qualitative in vitro susceptibility testing by the agar disk diffusion test method (Kirby-Bauer). Samples are processed directly from blood culture samples identified as positive by a continuous monitoring blood culture system and confirmed as Gram-negative rods by Gram stain. Organism identification must be confirmed by an FDA cleared device for direct testing from positive blood culture before processing samples on the eQUANT System.
Evaluation of the eQUANT System’s inoculum preparation was conducted for use with agar disk diffusion susceptibility testing and performance was demonstrated for the following antimicrobial agents with Enterobacterales species, Acinetobacter species and Pseudomonas aeruginosa as identified below:
Amoxicillin/clavulanate- Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis
Ampicillin- Escherichia coli
Aztreonam- Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, and Pseudomonas aeruginosa
Cefazolin- Klebsiella pneumoniae
Cefepime- Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, and Pseudomonas aeruginosa
Ceftriaxone- Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Serratia marcescens
Ertapenem- Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Serratia marcescens
Gentamicin- Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, and Pseudomonas aeruginosa
Levofloxacin- Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, and Pseudomonas aeruginosa
Meropenem- Acinetobacter spp., Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, and Pseudomonas aeruginosa
Piperacillin/tazobactam- Acinetobacter spp., Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, and Pseudomonas aeruginosa
Tobramycin- Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, and Pseudomonas aeruginosa
Susceptibility test 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231536 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231536: eQUANT System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231536
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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