DeviceClearance

Product code OOX— Hematology

AFIAS iFOB with AFIAS-50

Classification name
Automated Occult Blood Analyzer
Device class
Class 2
Regulation
21 CFR 864.6550
Advisory panel
Hematology
Total cleared
6
First cleared
Most recent

FDA classification definition

“The automated test system is intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is used for the determination of gastrointestinal bleeding.”

— U.S. Food and Drug Administration, device classification record for product code OOX under 21 CFR 864.6550, via openFDA

Market context for product code OOX

FDA has cleared 6 devices under product code OOX between 2004 and 2022, filed by 6 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.

Clearances per year

Top applicants under product code OOX

Recent clearances under product code OOX

Data sourced from openFDA. This site is unofficial and independent of the FDA.