DeviceClearance

Product code OAU— Immunology

WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401

Classification name
Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma
Device class
Class 2
Regulation
21 CFR 866.6030
Advisory panel
Immunology
Total cleared
1
First cleared
Most recent

FDA classification definition

“The test is intended to quantitatively measure dcp in human serum and use as an aid in the risk assessment of patients with chronic liver disease for progression to hepatocellular carcinoma (hcc) in conjunction with other laboratory findings, imaging studies and clinical assessment for risk assessment of patients with chronic liver disease for progression to hepatocellular carcinoma.”

— U.S. Food and Drug Administration, device classification record for product code OAU under 21 CFR 866.6030, via openFDA

Market context for product code OAU

FDA has cleared 1 device under product code OAU, all in 2007, 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 OAU

Recent clearances under product code OAU

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