Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NHX — Predicate Candidate Screening
21 FDA 510(k) clearances under this product code; the 50 most recent screened below.
140 daysmedian FDA review time
309 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K153551 | ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents a | Axis-Shield Diagnostics Limited | 2016-08-04 | 237 | 0 |
| K143754 | QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA | Inova Diagnostics, Inc. | 2015-09-21 | 264 | 0 |
| K121576 | IMMULITE 2000 ANTI-CCP IGG ASSAY | Siemens Healthcare Diagnostics, Inc. | 2013-04-04 | 309 | 0 |
| K112810 | MULTI-ANALYTE DETECTION SYSTEMS | Bio-Rad Laboratories | 2011-10-26 | 29 | 2 |
| K110296 | AXIS-SHIELD ANTI-CCP | Axis-Shield Diagnostics, Ltd. | 2011-08-18 | 198 | 0 |
| K093908 | CCPOINT | Euro-Diagnostica AB | 2010-12-01 | 344 | 0 |
| K093954 | BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE | Bio-Rad Laboratories | 2010-08-24 | 244 | 2 |
| K090753 | THERATEST EL-ANTI-CCP/2 | Theratest Laboratories, Inc. | 2010-03-05 | 350 | 0 |
| K091657 | IMMUNOSCAN CCPLUS | Euro-Diagnostica AB | 2009-11-19 | 163 | 1 |
| K083868 | ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST) | Axis-Shield Diagnostics, Ltd. | 2009-09-25 | 270 | 1 |
| K081338 | ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTR | Roche Diagnostics | 2008-09-11 | 121 | 2 |
| K072944 | QUANTA LITE CCP3.1 IGG/IGA ELISA | Inova Diagnostics, Inc. | 2008-03-05 | 140 | 0 |
| K070789 | EUROIMMUN ANTI-CCP ELISA | Euroimmun Us, LLC | 2007-12-31 | 284 | 0 |
| K063347 | AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS | Axis-Shield Diagnostics, Ltd. | 2007-03-20 | 134 | 0 |
| K062045 | EDIA ANTI-CCP | Euro-Diagnostica AB | 2006-12-04 | 138 | 0 |
| K061165 | ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009- | Sweden Diagnostics (Us), Inc. | 2006-08-03 | 99 | 1 |
| K052133 | IMMUNOSCAN RA ANTI-CCP TEST SYSTEM | Eurodiagnostica | 2005-12-12 | 129 | 0 |
| K052264 | QUANTA LITE CCP3 IGG ELISA | Inova Diagnostics, Inc. | 2005-11-23 | 96 | 0 |
| K023285 | DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA | Axis-Shield Diagnostics, Ltd. | 2002-10-09 | 23 | 1 |
| K021516 | DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP | Axis-Shield Diagnostics, Ltd. | 2002-07-23 | 74 | 1 |
| K020414 | QUANTA LITE CCP ELISA | Inova Diagnostics, Inc. | 2002-04-29 | 81 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda