Accelerate Pheno System, Accelerate PhenoTest BC Kit

K192665

Accelerate Diagnostics, Inc. · cleared 2020-09-15 · product code PRH · Microbiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.9)
“The Accelerate Pheno™ system leverages Morphokinetic Cellular Analysis (MCA) technology to measure distinct morphokinetic features of live microbial cells responding to antimicrobials to generate susceptibility results. MCA is a computer vision based analytical method that uses digital microscopy inputs and machine learning technology to observe individual live cells and microcolonies (or clones) and recognize patterns of change over time.”
Algorithmcomputer vision based analytical method that uses digital microscopy inputs and machine learning technology to observe individual live cells and microcolonies (or clones) and recognize patterns of change over time
source quote (p.9)
“MCA is a computer vision based analytical method that uses digital microscopy inputs and machine learning technology to observe individual live cells and microcolonies (or clones) and recognize patterns of change over time. This technology tracks and analyzes multiple morphological and kinetic changes of individual cells and microcolonies under a variety of conditions. These changes include morphokinetic features such as cell morphology, mass as measured by light intensity of a growing microcolony, division rate, anomalous growth patterns, and heterogeneity.”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedYes
source quote (p.23)
“Software verification and validation testing were conducted and documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered to have a “moderate" level of concern, since a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.”

Validation studies (2)

Retrospective clinical

n=144 other · 1 site(s)

endpoints: essential agreement; categorical agreement

standards: FDA Class II Special Controls Guidance document

Bench

sample size not stated · 1 site(s)

endpoints: reproducibility; best-case EA rate; worst-case EA rate

standards: FDA's AST Class II Special Controls guidance

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
-100%
vs code's own 3-yr baseline
0
drift signals on this device

Recalls attributed to this device

  • Recalling firm matches this device's applicant (Accelerate Diagnostics Inc) — same firm and product code, not necessarily this device · initiated 2022-10-17

    Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus and Streptococcus spp.

    recall event 91075 (openFDA)

  • Recalling firm matches this device's applicant (Accelerate Diagnostics Inc) — same firm and product code, not necessarily this device · initiated 2022-10-17

    Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus and Streptococcus spp.

    recall event 91075 (openFDA)

  • Recalling firm matches this device's applicant (Accelerate Diagnostics Inc) — same firm and product code, not necessarily this device · initiated 2018-03-14

    The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU).

    recall event 79631 (openFDA)

  • Recalling firm matches this device's applicant (Accelerate Diagnostics Inc) — same firm and product code, not necessarily this device · initiated 2017-03-13

    Rare isolates of Enterobacteriaceae may generate a susceptible meropenem Minimum Inhibitory Concentration (MIC) using the affected device and a resistant result by broth microdilution. In order to mitigate any risk associated with these rare isolates, the firm has implemented an Expert Rule that suppresses the meropenem result for isolates that display a profile consistent with those that generated a false-susceptible result. The firm has responded to this risk by implementing a set of suppression rules, in a software update, to prevent incorrect results.

    recall event 82216 (openFDA)

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Microbiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K192665