Product code OIU— Immunology
ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,
- Classification name
- Test, Epithelial Ovarian Tumor Associated Antigen (He4)
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- Total cleared
- 5
- First cleared
- Most recent
FDA classification definition
“An enzyme immunometric assay for the quantitative determination of HE4 in human serum. The assay is to be used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. Serial testing for patient HE4 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer. It is not intended to estimate or assess the risk of disease outcomes of patients.”
Market context for product code OIU
FDA has cleared devices under product code OIU between 2008 and 2015, 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.
Clearances per year
- 2015
- 2012
- 2011
- 2010
- 2008
Top applicants under product code OIU
Recent clearances under product code OIU
- K151378 — Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators
- K112624 — ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5
- K103676 — FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL
- K093957 — ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,
- K072939 — HE4 EIA, MODEL: 404-10 US
Data sourced from openFDA. This site is unofficial and independent of the FDA.