Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DHR — Predicate Candidate Screening
144 FDA 510(k) clearances under this product code; the 50 most recent screened below.
52 daysmedian FDA review time
182 days90th percentile
144clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192727 | K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) | Kamiya Biomedical Company | 2020-05-20 | 236 | 0 |
| K190088 | QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents | Inova Diagnostics, Inc. | 2019-04-17 | 90 | 0 |
| K182747 | EliA RF IgM Immunoassay | Phadia AB | 2018-12-18 | 81 | 0 |
| K162263 | Optilite Rheumatoid Factor Kit | The Binding Site Group , Ltd. | 2017-05-03 | 265 | 0 |
| K160070 | Rheumatoid Factor (RF) Kit for use on SPAPLUS | The Binding Site Group , Ltd. | 2016-12-07 | 329 | 0 |
| K143736 | ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced R | Immco Diagnostics, Inc. | 2015-09-23 | 267 | 0 |
| K102673 | RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM | Phadia US, Inc. | 2011-09-30 | 379 | 0 |
| K100499 | ORGENTEC RHEUMATOID FACTOR EIA | Orgentec Diagnostika GmbH | 2010-10-27 | 247 | 0 |
| K083080 | IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGN | Sqi Diagnostics Systems | 2009-10-29 | 378 | 0 |
| K071247 | N LATEX RF KIT | Dade Behring, Inc. | 2007-08-08 | 96 | 0 |
| K060201 | OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WI | Olympus America, Inc. | 2006-06-06 | 131 | 0 |
| K041891 | MININEPH HUMAN RHEUMATOID FACTOR KIT | The Binding Site | 2004-11-05 | 116 | 0 |
| K041863 | VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODU | Ortho-Clinical Diagnostics, Inc. | 2004-09-20 | 73 | 1 |
| K033802 | ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM | Zeus Scientific, Inc. | 2004-02-27 | 81 | 0 |
| K032535 | MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACT | Roche Diagnostics Corp. | 2003-09-10 | 23 | 0 |
| K024067 | RHEUMATOID FACTOR (RF) | Abbott Laboratories | 2003-01-15 | 36 | 0 |
| K020972 | WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET | Wako Chemicals USA, Inc. | 2002-09-09 | 167 | 0 |
| K021394 | DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM | Diamedix Corp. | 2002-07-09 | 68 | 0 |
| K002609 | TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM | Roche Diagnostics Corp. | 2000-09-05 | 14 | 1 |
| K000534 | COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II | Roche Diagnostics Corp. | 2000-04-05 | 48 | 0 |
| K993557 | AUTOSTAT II RHEUMATOID FACTOR IGA ELISA | Cogent Diagnotics , Ltd. | 2000-03-03 | 135 | 0 |
| K994338 | AUTOSTAT II RHEUMATOID FACTOR IGM ELISA | Cogent Diagnotics , Ltd. | 2000-02-03 | 42 | 0 |
| K993843 | MDI RF TEST | Micro Detect, Inc. | 2000-01-11 | 60 | 0 |
| K993304 | AUTOSTAT II RHEUMATOID FACTOR IGG ELISA | Cogent Diagnotics , Ltd. | 1999-12-06 | 63 | 0 |
| K991467 | K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET | Kamiya Biomedical Co. | 1999-06-10 | 44 | 0 |
| K991409 | K-ASSAY RHEUMATOID FACTOR | Kamiya Biomedical Co. | 1999-06-09 | 48 | 0 |
| K990587 | ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01 | Bio-Rad | 1999-04-07 | 43 | 0 |
| K990035 | RF | Abbott Laboratories | 1999-03-08 | 61 | 0 |
| K984045 | RF CONTROL FOR IMMUNOTURBIDIMETRIC ASSAYS | Kamiya Biomedical Co. | 1999-01-25 | 73 | 0 |
| K983418 | THE APTUS(AUTOMATED)APPLICATION OF THE RHEUMATOID FACTOR IGM | Zeus Scientific, Inc. | 1998-11-18 | 50 | 0 |
| K983084 | QUANTA LITE RF IGA ELISA | Inova Diagnostics, Inc. | 1998-11-04 | 62 | 0 |
| K983083 | QUANTA LITE RF IGG ELISA | Inova Diagnostics, Inc. | 1998-11-04 | 62 | 0 |
| K981496 | COLOR-SLIDE RF | Seradyn, Inc. | 1998-06-15 | 49 | 0 |
| K974889 | DIAMEDIX IS-RF TEST SYSTEM | Diamedix Corp. | 1998-03-06 | 66 | 0 |
| K974370 | RAPET RF | Stanbio Laboratory | 1998-02-17 | 89 | 0 |
| K972456 | RHEUMACOL RHEUMATOID FACTOR TEST | Immunostics Inc., | 1997-11-25 | 147 | 0 |
| K973464 | QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL) | Instrumentation Laboratory CO | 1997-10-22 | 40 | 0 |
| K972220 | RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KI | Randox Laboratories, Ltd. | 1997-09-09 | 89 | 0 |
| K971602 | ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT | Beckman Instruments, Inc. | 1997-06-27 | 57 | 0 |
| K971614 | QUANTA LITE RF IGM | Inova Diagnostics, Inc. | 1997-06-20 | 49 | 0 |
| K971379 | TINAQUANT RHEUMATOID FACTOR ASSAY | Boehringer Mannheim Corp. | 1997-06-17 | 64 | 0 |
| K971788 | SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX | Beckman Instruments, Inc. | 1997-06-03 | 20 | 2 |
| K970373 | RAICHEM RHEUMATOID FACTOR SPIA | Henage Diagnostics, Inc. | 1997-04-17 | 73 | 0 |
| K962729 | HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY | Hycor Biomedical, Inc. | 1997-03-07 | 249 | 0 |
| K962050 | THERATEST EL-RFSCR | Theratest Laboratories, Inc. | 1996-12-16 | 202 | 0 |
| K964415 | N-ASSAY TIA RHEUMATOID FACTOR TEST KIT | Kamiya Technology Services | 1996-12-13 | 73 | 0 |
| K964418 | N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET | Kamiya Technology Services | 1996-12-13 | 73 | 0 |
| K962015 | RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST | Teco Diagnostics | 1996-11-25 | 187 | 0 |
| K963048 | IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT | Beckman Instruments, Inc. | 1996-11-04 | 90 | 2 |
| K961545 | QUALITROL RF CONTROLS | Consolidated Technologies, Inc. | 1996-09-24 | 155 | 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