Cleared is not the same as ready to buy. Company materials for this pathway still say it is not currently available for commercial sale. FDA clearance is a regulatory gate, not a delivery truck.

• Gram-negative panel focus — not a universal bug cover
• Not for yeast, Gram-positive, or polymicrobial Gram-stain pictures on this pathway
• Does not replace the positive blood culture bottle
• Does not provide organism identification by itself
• Assay times are load→results, not door-to-door sepsis care

Do not invent outcome-trial wins, prices, or “available in every hospital lab today.” Do not invent DIY home antibiotic testers. Do not treat one cleared instrument as the only invent answer.