510(k) · Cleared
Recalled · Class II · 2019ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axis-Shield Diagnostics Limited · NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
Cleared on Aug 4, 2016 as substantially equivalent to K083868 (Axis-Shield Diagnostics, Ltd., 2009) after a 237-day review. Its family tree reaches back 1 generation to 2009. It has been recalled once.
- Decided
- Aug 4, 2016
- Review
- 237 days
- Class
- Class II
- Product code
- NHX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K083868 (2009). No later device cites it as a predicate yet.
- Root · 1 generation backK083868 Architect Anti-CCP (100 Test), Architect Anti-CCP (500 Test), Models…Axis-Shield Diagnostics, Ltd. · 2009 · Recalled
- This deviceK153551 ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and…Axis-Shield Diagnostics Limited · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K083868 | Architect Anti-CCP (100 Test), Architect Anti-CCP (500 Test), Models 1P65-25… | Axis-Shield Diagnostics, Ltd. | 2009 | 1 |
| 0 (this device) | K153551 | ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators… | Axis-Shield Diagnostics Limited | 2016 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NHX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K083868 | Architect Anti-CCP (100 Test), Architect Anti-CCP (500 Test), Models 1P65-25, 1P65-35Summary page 5…Classification: Class I Classification Panel: Clinical Chemistry Product Code: JJX Legally marketed device to which equivalency is claimed: ARCHITECT Anti‐CCP Assay (K083868) Intended Use of Device: The ADVIA Centaur® anti‐CCP IgG (aCCP) assay is for in vitro diagnostic use in the semi‐ quantitative… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 14, 2019 | Class II | Z-2754-2019 | Under Investigation by firm | Atellica IM anti-CCP IgG (aCCP) Test Definition (TDef) Mitigation Failure-reagent carryover mitigation for the Testosterone II (TSTII) assay is unable to be completed as defined in the aCCP Test Definition (TDef). The issue occurs on an… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
How does its category compare?
All NHX devicesNHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · NHX
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · NHX
344in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHX
No recall names NHX since 2007.
Adverse event reports per year · NHX
3in 2025
MAUDE reports naming product code NHX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 3 | 344 | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 4 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ADVIA Centaur® anti-CCP IgG (aCCP) assay is for in vitro diagnostic use in the semi-quantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum or plasma (K2-EDTA and lithium heparin) using the ADVIA Centaur XP system. Detection of anti-CCP antibodies is used as an aid in the diagnosis of Rheumatoid Arthritis (RA) and should be used in conjunction with other clinical information.…
Read the full statement (154 words)
The ADVIA Centaur® anti-CCP IgG (aCCP) assay is for in vitro diagnostic use in the semi-quantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum or plasma (K2-EDTA and lithium heparin) using the ADVIA Centaur XP system. Detection of anti-CCP antibodies is used as an aid in the diagnosis of Rheumatoid Arthritis (RA) and should be used in conjunction with other clinical information. Autoantibody levels represent one parameter in a multi-criteria diagnostic process, encompassing both clinical and laboratory-based assessments.
Quality Control:
The ADVIA Centaur® Anti-CCP IgG (aCCP) quality control material is for in vitro diagnostic use to monitor the precision and accuracy of the ADVIA Centaur aCCP assay using the ADVIA Centaur systems.
Master Curve Material (MCM):
The ADVIA Centaur® Anti-CCP IgG (aCCP) Master Curve Material (MCM) is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur aCCP assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153551 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153551: ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153551
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026