510(k) K112624
K112624 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5". The FDA issued a decision of Substantially Equivalent on September 10, 2012. The device falls under product code OIU (Test, Epithelial Ovarian Tumor Associated Antigen (He4)), a Class II device regulated under 21 CFR 866.6010. Roche Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 10, 2012
- Date Received
- September 8, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Epithelial Ovarian Tumor Associated Antigen (He4)
- Device Class
- Class II
- Regulation Number
- 866.6010
- Review Panel
- IM
- Submission Type
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.