QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3
FDA 510(k) K143754 · Inova Diagnostics, Inc.
510(k) numberK143754
Submission
- Device name
- QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3
- Applicant
- Inova Diagnostics, Inc.
San Diego, CA, US - Received
- December 31, 2014
- Decision date
- September 21, 2015
- 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 |
|---|---|---|---|
| K153551 | ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality…NHX · Traditional | Axis-Shield Diagnostics Limited | 08/04/2016SE |
| 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 QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3 cleared by the FDA?
QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3 (K143754) received a 510(k) decision of Substantially Equivalent on September 21, 2015, 264 days after the submission was received.
What is the product code of K143754?
The FDA product code is NHX – Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp), a Class II (moderate risk) device regulated under 21 CFR 866.5775.