K093957 is an FDA 510(k) clearance for the ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,. This device is classified as a Test, Epithelial Ovarian Tumor Associated Antigen (he4) (Class II - Special Controls, product code OIU).
Submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on March 18, 2010, 85 days after receiving the submission on December 23, 2009.
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 | K093957 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2009 |
| Decision Date | March 18, 2010 |
| Days to Decision | 85 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. |