K112624 is an FDA 510(k) clearance for the ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5. This device is classified as a Test, Epithelial Ovarian Tumor Associated Antigen (he4) (Class II - Special Controls, product code OIU).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on September 10, 2012, 368 days after receiving the submission on September 8, 2011.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010. 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..
| 510(k) Number | K112624 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 2011 |
| Decision Date | September 10, 2012 |
| Days to Decision | 368 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | OIU — Test, Epithelial Ovarian Tumor Associated Antigen (he4) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6010 |
| 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. |