ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.
FDA 510(k) K153551 · Axis-Shield Diagnostics Limited
510(k) numberK153551
Submission
- Device name
- ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.
- Applicant
- Axis-Shield Diagnostics Limited
Dundee, GB - Received
- December 11, 2015
- Decision date
- August 4, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NHX – Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5775
- Specialty
- Immunology
The device is used for the detection of anti-cyclic citrullinated peptide (CCP) antibodies in human serum or plasma as an aid in the diagnosis of rheumatoid arthritis.
Other 510(k)s with product code NHX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143754 | QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3NHX · Traditional | Inova Diagnostics, Inc. | 09/21/2015SE |
| K121576 | Immulite 2000 Anti-Ccp Igg AssayNHX · Traditional | Siemens Healthcare Diagnostics, Inc. | 04/04/2013SE |
| K112810 | Multi-Analyte Detection SystemsNHX · Special | Bio-Rad Laboratories | 10/26/2011SE |
| K110296 | Axis-Shield Anti-CcpNHX · Traditional | Axis-Shield Diagnostics, Ltd. | 08/18/2011SE |
| K093908 | CcpointNHX · Traditional | Euro-Diagnostica AB | 12/01/2010SE |
| K093954 | Bioplex 2200 Anti-Ccp Kit on the Bioplex 2200 Multi-Analyte Detection SystemNHX · Traditional | Bio-Rad Laboratories | 08/24/2010SE |
| K090753 | Theratest EL-ANTI-CCP/2NHX · Traditional | Theratest Laboratories, Inc. | 03/05/2010SE |
| K091657 | Immunoscan CcplusNHX · Traditional | Euro-Diagnostica AB | 11/19/2009SE |
| K083868 | Architect Anti-Ccp (100 Test), Architect Anti-Ccp (500 Test), Models 1P65-25, 1P65-35NHX · Traditional | Axis-Shield Diagnostics, Ltd. | 09/25/2009SE |
| K081338 | Roche Elecsys Anti-Ccp Immunoassay, Roche Elecsys Precicontrol Anti-CcpNHX · Traditional | Roche Diagnostics | 09/11/2008SE |
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Questions and answers
When was ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. cleared by the FDA?
ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. (K153551) received a 510(k) decision of Substantially Equivalent on August 4, 2016, 237 days after the submission was received.
What is the product code of K153551?
The FDA product code is NHX – Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp), a Class II (moderate risk) device regulated under 21 CFR 866.5775.