Product code PPU— Microbiology

“A microbial colony image assessment system is an instrument that is intended to assess the presence or absence of microbial colonies on solid microbiological culture medium, and to interpret their number, phenotypic and morphologic characteristics. This device type provides a semi-quantitative assessment of colony counts that are used as an aid in the diagnosis of urinary tract infection. All urine culture plates that are identified as positive for growth by the APAS Compact, when using its urine analysis module, must be reviewed by a trained microbiologist.”

FDA has cleared 3 devices under product code PPU between 2016 and 2026, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20261 clearance
• 20191 clearance
• 20161 clearance

• Clever Culture Systems AG2 clearances
• Copan Wasp Srl1 clearance

• K251511 — PhenoMATRIXCopan Wasp Srl·2026-01-22
• K183648 — APAS Independence with Urine Analysis ModuleClever Culture Systems AG·2019-05-15
• DEN150059 — APAS Compact with Urine Analysis ModuleClever Culture Systems AG·2016-10-06