K-number	K250454
Device name	HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)
Applicant	Hardy Diagnostics
Product code	JTN
Device class	Class II
Decision date	May 15, 2025
Decision	Substantially Equivalent
Regulation	866.1620

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) is an antimicrobial susceptibility test disc used for semi-quantitative in vitro testing of bacterial susceptibility via the Kirby-Bauer agar diffusion method. It is specifically indicated for determining susceptibility of Enterobacterales to the antibiotic combination Aztreonam/Avibactam.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary. The document confirms substantial equivalence was determined and references an enclosure, but does not provide the specific comparative reasoning, predicate device identification, or technical justification for the SE determination within the pages provided.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)

Everything you need for a 510(k) submission. Nothing you don't.