Test, Epithelial Ovarian Tumor Associated Antigen (He4)

OIU · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.6010

Classification

FDA Product Code: OIU
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.6010
Review panel: IM
Medical specialty: Immunology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

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 data

Cleared 510(k) submissions: 5
Registered establishments: 5

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown