DeviceClearance

Product code OKM— Immunology

QUANTA LITE OMP PLUS ELISA

Classification name
Antibodies, Outer-Membrane Proteins
Device class
Class 2
Regulation
21 CFR 866.5785
Advisory panel
Immunology
Total cleared
1
First cleared
Most recent

FDA classification definition

“For the detection of anti-outer membrane protein (anti-OMP) antibodies in human serum. To aid in the diagnosis of Crohn's Disease.”

— U.S. Food and Drug Administration, device classification record for product code OKM under 21 CFR 866.5785, via openFDA

Market context for product code OKM

FDA has cleared 1 device under product code OKM, all in 2008, filed by 1 applicant company. 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.

Top applicants under product code OKM

Recent clearances under product code OKM

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