Elecsys HE4, Elecsys HE4 Calset, Elecsys Precicontrol HE4, Elecsys HE4 Calcheck 5
FDA 510(k) K112624 · Roche Diagnostics
Submission
- Device name
- Elecsys HE4, Elecsys HE4 Calset, Elecsys Precicontrol HE4, Elecsys HE4 Calcheck 5
- Applicant
- Roche Diagnostics
Indianapolis, IN, US - Received
- September 8, 2011
- Decision date
- September 10, 2012
- 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 |
| K103676 | Fujirebio Diagnostics Tumor Marker ControlOIU · Traditional | Fujirebio Diagnostics,Inc. | 07/19/2011SE |
| 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 Elecsys HE4, Elecsys HE4 Calset, Elecsys Precicontrol HE4, Elecsys HE4 Calcheck 5 cleared by the FDA?
Elecsys HE4, Elecsys HE4 Calset, Elecsys Precicontrol HE4, Elecsys HE4 Calcheck 5 (K112624) received a 510(k) decision of Substantially Equivalent on September 10, 2012, 368 days after the submission was received.
What is the product code of K112624?
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.