FDA product code NHX: Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
NHX is the FDA product code for antibodies, anti-cyclic citrullinated peptide (ccp). It is a Class II device, regulated under 21 CFR 866.5775 and reviewed by the Immunology panel. FDA has cleared 21 510(k) submissions under NHX, from 11 different applicants. The average 510(k) review took 177 days (median 140). FDA has posted 9 recalls for NHX devices, 3 initiated in the last five years.
Definition
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.
Classification
| Field | Value |
|---|---|
| Device name | Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) |
| Device class | Class II |
| Regulation | 21 CFR 866.5775 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NHX clearance
Top NHX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Axis-Shield Diagnostics, Ltd. | 5 | 2011-08-18 |
| Inova Diagnostics, Inc. | 4 | 2015-09-21 |
| Euro-Diagnostica AB | 3 | 2010-12-01 |
| Bio-Rad Laboratories | 2 | 2011-10-26 |
| Axis-Shield Diagnostics Limited | 1 | 2016-08-04 |
6 more applicants have NHX clearances. See the full list in Caduvo.
Most recent NHX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K153551 | Axis-Shield Diagnostics Limited | ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. | 2016-08-04 | 237 |
| K143754 | Inova Diagnostics, Inc. | QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3 | 2015-09-21 | 264 |
| K121576 | Siemens Healthcare Diagnostics, Inc. | IMMULITE 2000 ANTI-CCP IGG ASSAY | 2013-04-04 | 309 |
| K112810 | Bio-Rad Laboratories | MULTI-ANALYTE DETECTION SYSTEMS | 2011-10-26 | 29 |
| K110296 | Axis-Shield Diagnostics, Ltd. | AXIS-SHIELD ANTI-CCP | 2011-08-18 | 198 |
Recalls for NHX devices
9 product recalls in 7 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2025-04-24.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2019 | 3 |
| 2023 | 2 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code NHX?
NHX is the FDA product code for antibodies, anti-cyclic citrullinated peptide (ccp). It is a Class II device, regulated under 21 CFR 866.5775 and reviewed by the Immunology panel.
What device class is NHX?
Class II, regulation 21 CFR 866.5775. Typical premarket route: 510(k).
How long does a 510(k) take for product code NHX?
Across 21 cleared submissions the average was 177 days from receipt to decision (median 140).
Which companies have the most NHX clearances?
Axis-Shield Diagnostics, Ltd. (5); Inova Diagnostics, Inc. (4); Euro-Diagnostica AB (3); Bio-Rad Laboratories (2); Axis-Shield Diagnostics Limited (1).
Have NHX devices been recalled?
Yes: 9 product recalls across 7 recall events; the most recent began 2025-04-24.
Next steps
- Run an FDA pathway report with predicate devices for product code NHX
- Run a recall and safety report across every NHX manufacturer
- Watch product code NHX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Immunology product codes · FDA product code lookup · 510(k) database search · 510(k) review times