Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators
FDA 510(k) K151378 · Fujirebio Diagnostics,Inc.
Submission
- Device name
- Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators
- Applicant
- Fujirebio Diagnostics,Inc.
Malvern, PA, US - Received
- May 22, 2015
- Decision date
- November 24, 2015
- 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 |
|---|---|---|---|
| K112624 | Elecsys HE4, Elecsys HE4 Calset, Elecsys Precicontrol HE4, Elecsys HE4 Calcheck 5OIU · Traditional | Roche Diagnostics | 09/10/2012SE |
| 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 Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators cleared by the FDA?
Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators (K151378) received a 510(k) decision of Substantially Equivalent on November 24, 2015, 186 days after the submission was received.
What is the product code of K151378?
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.