Studybox Research 510(k) Clinical Studies
Rapid Antimicrobial Susceptibility Test
Clinical and analytical performance to support substantial equivalence.
Studybox
510(k) Clinical Studies
Antimicrobial susceptibility test systems are evaluated against reference broth microdilution for every antimicrobial-organism pair claimed, using an established framework of essential agreement, categorical agreement and error categories, with very major errors, false susceptibility, carrying the greatest weight. Rapid phenotypic and genotypic systems that work from positive blood cultures compress a process that normally takes a day or more into hours, and the evaluation adds a clinical specimen workflow component to what has traditionally been an isolate-based analytical study.
The challenge set defines the study. Each drug needs enough resistant isolates to estimate the very major error rate, and contemporary resistance mechanisms must be represented; fresh clinical isolates are supplemented with characterized challenge strains, and the two sources are reported separately. Breakpoints change independently of the device as FDA recognizes updated interpretive criteria, so the protocol states which breakpoints apply and how changes during the study are handled. This is laboratory work; Studybox supports it through protocol design, site selection, isolate and specimen logistics and data management rather than through the waived-setting network.
- Analyte
- Phenotypic susceptibility (minimum inhibitory concentration or category) or genotypic resistance markers for bacterial isolates, including systems working directly from positive blood cultures
- Therapeutic area
- Antimicrobial Susceptibility (AST)
- Specimens
- Venous Whole Blood
- Intended-use settings
- hospital POC
- Operators
- Clinical microbiology laboratory personnel; these systems are not intended for waived settings.
- Comparator
- Typically CLSI reference broth microdilution performed contemporaneously on the same isolate, with results interpreted using FDA-recognized susceptibility test interpretive criteria.
510(k) Studies specifics
What Changes for This Assay on This Pathway.
- Each antimicrobial-organism combination is a separate claim with its own agreement and error-rate analysis against reference broth microdilution run contemporaneously with controlled inoculum and quality control strains.
- Interpretive categories must use FDA-recognized susceptibility test interpretive criteria; if these differ from current CLSI breakpoints, the submission addresses the discrepancy and labeling follows the FDA-recognized values.
- Direct-from-positive-blood-culture systems need the clinical specimen arm to show that the result from the bottle agrees with the result from the subsequently isolated organism, and that polymicrobial cultures are correctly flagged.
- Challenge isolates with specific resistance mechanisms are typically required to supplement fresh isolates for drugs where resistance is uncommon, and a pre-submission is typical to agree on the challenge set and the organism-drug matrix.
Endpoints the study must support
- Essential agreement (MIC within one doubling dilution) and categorical agreement with the reference method for each antimicrobial-organism combination
- Very major error (false susceptible), major error (false resistant) and minor error rates for each combination
- Reproducibility across sites and days on a defined isolate set and, for direct-from-positive-blood-culture systems, agreement in the clinical specimen workflow and organism identification concordance
- Time to result relative to standard-of-care AST where a turnaround claim is made
Enrollment realities
Driven by the number of resistant isolates per drug rather than by patients; fresh clinical isolates are collected at multiple hospital laboratories over months and supplemented with characterized challenge strains. Direct-from-specimen arms depend on positive blood culture volume at participating hospitals.
How Studybox runs it
Pre-Qualified Sites, Embedded Coordinators.
Our 100+ pre-qualified U.S. sites are matched to the intended-use population and setting, with Studybox coordinators embedded on site for recruitment, consent, specimen handling, and data capture. Typical activation is about four weeks. How we run 510(k) clinical studies →
Relevant FDA guidance
FAQ
Rapid Antimicrobial Susceptibility Test Study Questions.
01 Who operates the rapid antimicrobial susceptibility test in a 510(k) studies study?
Clinical microbiology laboratory personnel; these systems are not intended for waived settings.
02 What is the comparator for a rapid antimicrobial susceptibility test study?
Typically CLSI reference broth microdilution performed contemporaneously on the same isolate, with results interpreted using FDA-recognized susceptibility test interpretive criteria.
03 What drives enrollment for a rapid antimicrobial susceptibility test study?
Driven by the number of resistant isolates per drug rather than by patients; fresh clinical isolates are collected at multiple hospital laboratories over months and supplemented with characterized challenge strains. Direct-from-specimen arms depend on positive blood culture volume at participating hospitals.
Let's talk IVD research
Planning a rapid antimicrobial susceptibility test study?
Tell us the intended use and setting. We'll come back with a site plan, operator strategy, and a realistic activation timeline for the 510(k) studies pathway.