LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
Affinity Biosensors, LLC · K251875
FDA-authorized Predetermined Change Control Plan
- Company
- Affinity Biosensors, LLC
- 510(k)/De Novo #
- K251875
- Decision date
- 2025-10-27
- Panel
- Microbiology
- Pathway
- 510(k)
- Category
- Non-AI
- PCCP type
- Unknown
- Monitoring commitment
- Unknown
Other Microbiology PCCPs
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- K260447ETEST Gepotidacin (GEP) (0.016-256 µg/mL)bioMérieux SA2026-04-21Non-AIPanel expansion
- K260696MTS Gepotidacin 0.016-256 µg/mLLiofilchem s.r.l.2026-04-17Non-AIPanel expansion
- K260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc.2026-04-15Non-AIUnknown
- K253573ASTar BC G- KitQ-Linea AB2026-04-15AI hardwarePanel expansion
- K260281VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)BIOMERIEUX2026-03-26Non-AIUnknown
Want the monitoring teardown?
We read the PCCP for LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system, 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.