ASTar BC G- Kit
Q-Linea AB · K253573
FDA-authorized Predetermined Change Control Plan
- Company
- Q-Linea AB
- 510(k)/De Novo #
- K253573
- Decision date
- 2026-04-15
- Panel
- Microbiology
- Pathway
- 510(k)
- Category
- AI hardware
- PCCP type
- Panel expansion
- Monitoring commitment
- Unknown
What this PCCP covers. Permits panel or organism expansion
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- K260281VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)BIOMERIEUX2026-03-26Non-AIUnknown
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Want the monitoring teardown?
We read the PCCP for ASTar BC G- Kit, then map the post-market monitoring that its modification protocol requires, including the deployment-period evidence most teams can't reconstruct at modification time. Sentir is the independent system of record that produces it.
Book a callSource: U.S. FDA public records (openFDA 510(k)/De Novo databases and accessdata.fda.gov). PCCP type and category are editorial classifications based on public documents, not official FDA designations.
This page is a factual summary of public FDA records. Sentir Health is not affiliated with or endorsed by the named companies or the U.S. Food and Drug Administration. Spot an error? Request a correction.