Diastat Anti Cyclic Citrullinated Peptide Elisa, Model FCCP 200
FDA 510(k) K021516 · Axis-Shield Diagnostics, Ltd.
510(k) numberK021516
Submission
- Device name
- Diastat Anti Cyclic Citrullinated Peptide Elisa, Model FCCP 200
- Applicant
- Axis-Shield Diagnostics, Ltd.
Dundee, Scotland, GB - Received
- May 10, 2002
- Decision date
- July 23, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|---|
| K153551 | ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality…NHX · Traditional | Axis-Shield Diagnostics Limited | 08/04/2016SE |
| 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 |
More from Axis-Shield Diagnostics, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253539 | Alere NT-proBNP for Alinity iNBC · Traditional | 02/18/2026SE |
| K241176 | Alere NT-proBNP for Alinity i Reagent KitNBC · Traditional | 01/16/2025SE |
| K233541 | ARCHITECT Active-B12 (Holotranscobalamin)CDD · Traditional | 07/31/2024SE |
| K183088 | ADVIA Centaur Erythropoietin (EPO) assayGGT · Traditional | 08/02/2019SE |
| K182012 | ADVIA Centaur Calcitonin (CALCT) assayJKR · Traditional | 12/21/2018SE |
| K172133 | ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayCDD · Special | 10/27/2017SE |
| K153551 | ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality…NHX · Traditional | 08/04/2016SE |
| K160757 | ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur…CDD · Traditional | 07/26/2016SE |
| K121946 | Axis-Shield ACVTIVE-B12CDD · Traditional | 03/22/2013SE |
| K121842 | Architect HBA1C, Architect HBA1C, and Architect HBA1CLCP · Traditional | 12/12/2012SE |
Questions and answers
When was Diastat Anti Cyclic Citrullinated Peptide Elisa, Model FCCP 200 cleared by the FDA?
Diastat Anti Cyclic Citrullinated Peptide Elisa, Model FCCP 200 (K021516) received a 510(k) decision of Substantially Equivalent on July 23, 2002, 74 days after the submission was received.
What is the product code of K021516?
The FDA product code is NHX – Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp), a Class II (moderate risk) device regulated under 21 CFR 866.5775.