510(k) · Cleared
ClearedImmulite 2000 Anti-CCP Igg Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
Cleared on Apr 4, 2013 as substantially equivalent to K023285 (Axis-Shield Diagnostics, Ltd., 2002) and 1 other predicate after a 309-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Apr 4, 2013
- Review
- 309 days
- Class
- Class II
- Product code
- NHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K001015 (2000). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK001015 Elecsys Thyroglobulin CalcheckRoche Diagnostics Corp. · 2000
- 4 generations backK020883 Elecsys Probnp CalcheckRoche Diagnostics Corp. · 2002
- 3 generations backK031698 Elecys SHBG CalcheckRoche Diagnostics Corp. · 2003
- 2 generations backK040157 Elecsys C-Peptide CalcheckRoche Diagnostics Corp. · 2004
- 1 generation backK091601 Elecys Anti-CCP CalcheckRoche Diagnostics Corp. · 2009
- This deviceK121576 Immulite 2000 Anti-CCP Igg AssaySiemens Healthcare Diagnostics, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001015 | Elecsys Thyroglobulin Calcheck | Roche Diagnostics Corp. | 2000 | — |
| −4 | K020883 | Elecsys Probnp Calcheck | Roche Diagnostics Corp. | 2002 | — |
| −3 | K031698 | Elecys SHBG Calcheck | Roche Diagnostics Corp. | 2003 | — |
| −2 | K040157 | Elecsys C-Peptide Calcheck | Roche Diagnostics Corp. | 2004 | — |
| −1 | K091601 | Elecys Anti-CCP Calcheck | Roche Diagnostics Corp. | 2009 | — |
| 0 (this device) | K121576 | Immulite 2000 Anti-CCP Igg Assay | Siemens Healthcare Diagnostics, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
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? (2)
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 |
|---|---|---|---|
| * | K023285 | Diastat Anti Cyclic Citrullinated Peptide (Anti-CCP) ElisaSummary page 2…atrix J. Substantial Predicate device name: DIASTATTM Anti-Cyclic Citrullinated Equivalence Peptide (anti-CCP) ELISA Information: 510(k) number: k023285 Comparison with predicate: A comparison of the device features, intended use, laboratory data… | 2002 |
| * | K091601 | Elecys Anti-CCP CalcheckSummary page 13…igen; and for antibodies to hepatitis C. J. Substantial Predicate device name: Elecsys Anti-CCP CalCheck Equivalence Information: 510(k) number: K091601 *Traditional 5 10(k) Premnarket Notificati… | 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 4 other devices also cite its predicate K023285.
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. 2013, 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 IMMULITE 2000 Anti-CCP IgG assay is an in vitro diagnostic immunoassay for the semi-quantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum (including Serum Separator Tubes) or plasma (EDTA or lithium heparin) on the IMMULITE 2000 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…
Read the full statement (121 words)
The IMMULITE 2000 Anti-CCP IgG assay is an in vitro diagnostic immunoassay for the semi-quantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum (including Serum Separator Tubes) or plasma (EDTA or lithium heparin) on the IMMULITE 2000 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.
The IMMULITE 2000 Anti-CCP IgG Calibration Verification Material (CVM) is for in vitro diagnostic use, as a control for calibration verification of the IMMULITE 2000 Anti-CCP IgG assay on the IMMULITE 2000 system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121576 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121576: Immulite 2000 Anti-CCP Igg Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121576
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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