Fujirebio Diagnostics Tumor Marker Control
FDA 510(k) K103676 · Fujirebio Diagnostics,Inc.
Submission
- Device name
- Fujirebio Diagnostics Tumor Marker Control
- Applicant
- Fujirebio Diagnostics,Inc.
Malvern, PA, US - Received
- December 16, 2010
- Decision date
- July 19, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OIU – Test, Epithelial Ovarian Tumor Associated Antigen (He4)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6010
- Specialty
- Immunology
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…
Other 510(k)s with product code OIU
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K151378 | Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 CalibratorsOIU · Traditional | Fujirebio Diagnostics,Inc. | 11/24/2015SE |
| K112624 | Elecsys HE4, Elecsys HE4 Calset, Elecsys Precicontrol HE4, Elecsys HE4 Calcheck 5OIU · Traditional | Roche Diagnostics | 09/10/2012SE |
| K093957 | Architect HE4, Architect HE4 Calibrators and Architect HE4 Controls, Models 2, 2P54…OIU · Traditional | Fujirebio Diagnostics,Inc. | 03/18/2010SE |
| K072939 | HE4 Eia, Model: 404-10 USOIU · Traditional | Fujirebio Diagnostics,Inc. | 06/09/2008SE |
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Questions and answers
When was Fujirebio Diagnostics Tumor Marker Control cleared by the FDA?
Fujirebio Diagnostics Tumor Marker Control (K103676) received a 510(k) decision of Substantially Equivalent on July 19, 2011, 215 days after the submission was received.
What is the product code of K103676?
The FDA product code is OIU – Test, Epithelial Ovarian Tumor Associated Antigen (He4), a Class II (moderate risk) device regulated under 21 CFR 866.6010.