APAS Independence with Urine Analysis Module

K183648

Clever Culture Systems AG · cleared 2019-05-15 · product code PPU · Microbiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.3)
“APAS Independence consists of an automated plate handling mechanism to move the plates through the instrument, an imaging station to capture an image of the culture plate, combined with software for analysis of the image, determination of growth and presentation of reports.”
AlgorithmSoftware for analysis of images and interpretation of microbial colonies
source quote (p.3)
“APAS Independence consists of an automated plate handling mechanism to move the plates through the instrument, an imaging station to capture an image of the culture plate, combined with software for analysis of the image, determination of growth and presentation of reports.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Retrospective clinical

n=350 cases

endpoints: Agreement of plate designation (Positive, Review, Negative); Agreement of colony counts; Detection of colony morphologies

Bench

sample size not stated

endpoints: Repeatability of colony count as a percent coefficient of variation (%CV) within an instrument; Reproducibility of colony count as a %CV across instruments

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
—
vs code's own 3-yr baseline
0
drift signals on this device

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/K183648