510(k) · Cleared
Recalled · Class II · 2023Multi-Analyte Detection Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories · NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
Cleared on Oct 26, 2011 as substantially equivalent to K093954 (Bio-Rad Laboratories, 2010) after a 29-day review. Its family tree reaches back 2 generations to 2002. It has been recalled 2 times.
- Decided
- Oct 26, 2011
- Review
- 29 days
- Class
- Class II
- Product code
- NHX
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K023285 (2002). No later device cites it as a predicate yet.
- Root · 2 generations backK023285 Diastat Anti Cyclic Citrullinated Peptide (Anti-CCP) ElisaAxis-Shield Diagnostics, Ltd. · 2002 · Recalled
- 1 generation backK093954 Bioplex 2200 Anti-CCP Kit on the Bioplex 2200 Multi-Analyte…Bio-Rad Laboratories · 2010 · Recalled
- This deviceK112810 Multi-Analyte Detection SystemsBio-Rad Laboratories · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K023285 | Diastat Anti Cyclic Citrullinated Peptide (Anti-CCP) Elisa | Axis-Shield Diagnostics, Ltd. | 2002 | 1 |
| −1 | K093954 | Bioplex 2200 Anti-CCP Kit on the Bioplex 2200 Multi-Analyte Detection System | Bio-Rad Laboratories | 2010 | 2 |
| 0 (this device) | K112810 | Multi-Analyte Detection Systems | Bio-Rad Laboratories | 2011 | — |
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 |
|---|---|---|---|
| * | K093954 | Bioplex 2200 Anti-CCP Kit on the Bioplex 2200 Multi-Analyte Detection SystemSummary page 1…Immunology IRegulation Number 21 CER 866.5775 Product Code NHX Legally Marketed Predicate Device BioPlex® 2200 Anti-CCP Kit, k093954 Intended Use/Indications For Use The BioPlex® 2200 Anti-CCP kit is a multiplex flow immunoassay intended for the semi- quant… | 2010 |
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 |
|---|---|---|---|---|
| Feb 21, 2023 | Class II | Z-1378-2023 | Under Investigation by firm | Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at… |
| Feb 21, 2023 | Class II | Z-1377-2023 | Under Investigation by firm | Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 7.9 years on median.
- 2 of the 2 ancestors have a recall of any class.
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. 2011, 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 BioPlex® 2200 Anti-CCP kit is a multiplex flow immunoassay intended for the semi-quantitative detection of IgG antibodies to Cyclic Citrullinated Peptide (CCP) in human serum or plasma (EDTA and sodium heparin). Detection of CCP antibodies is used as an aid in the diagnosis of rheumatoid arthritis and should be used in conjunction with other clinical findings and laboratory results. The BioPlex 2200 Anti-CCP kit is intended for use with the Bio-Rad…
Read the full statement (146 words)
The BioPlex® 2200 Anti-CCP kit is a multiplex flow immunoassay intended for the semi-quantitative detection of IgG antibodies to Cyclic Citrullinated Peptide (CCP) in human serum or plasma (EDTA and sodium heparin). Detection of CCP antibodies is used as an aid in the diagnosis of rheumatoid arthritis and should be used in conjunction with other clinical findings and laboratory results.
The BioPlex 2200 Anti-CCP kit is intended for use with the Bio-Rad BioPlex 2200 system..
The BioPlex 2200 Anti-CCP Calibrator Set is intended for the calibration of the BioPlex 2200 Anti-CCP Reagent Pack.
The BioPlex 2200 Anti-CCP Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 instrument and BioPlex 2200 Anti-CCP Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 Anti-CCP Control Set has not been established with any other Anti-CCP assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112810 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112810: Multi-Analyte Detection Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112810
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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