Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
LFX · Predicate Candidate Screening
94 FDA 510(k) clearances under this product code; the 50 most recent screened below.
140 daysmedian FDA review time
385 days90th percentile
94clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250588 | Access Rubella IgG | Beckman Coulter, Inc. | 2025-11-17 | 263 | 0 |
| K243168 | Alinity i Rubella IgG | Abbott Laboratories | 2025-06-20 | 263 | 0 |
| K122397 | LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM | DiaSorin, Inc. | 2012-09-06 | 30 | 0 |
| K093101 | MAGO 4S | Diamedix Corp. | 2011-01-21 | 477 | 0 |
| K092587 | BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI | Bio-Rad Laboratories | 2010-12-03 | 466 | 0 |
| K092322 | ELECSYS RUBELLA IGM IMMUNOASSAY | Roche Diagnostics | 2010-03-12 | 220 | 0 |
| K080766 | VIDAS RUB IGG | bioMerieux, Inc. | 2008-12-23 | 280 | 0 |
| K072617 | ELECSYS RUBELLA IGG IMMUNOASSAY | Roche Diagnostics Corp. | 2008-12-05 | 445 | 0 |
| K073390 | DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA | DiaSorin, Inc. | 2008-11-21 | 354 | 0 |
| K063186 | ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM | Zeus Scientific, Inc. | 2007-03-21 | 152 | 0 |
| K063143 | VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AN | Ortho-Clinical Diagnostics, Inc. | 2006-12-26 | 71 | 0 |
| K031606 | ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY | Beckman Coulter, Inc. | 2003-06-20 | 29 | 0 |
| K012077 | IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM | Diagnostic Products Corp. | 2002-01-10 | 192 | 0 |
| K010668 | BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY | Bayer Corp. | 2001-07-05 | 121 | 0 |
| K003412 | ADVIA CENTAUR RUBELLA IGG ASSAY | Bayer Corp. | 2001-04-13 | 162 | 0 |
| K001875 | DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM | Diamedix Corp. | 2000-08-21 | 62 | 0 |
| K993291 | COPALIS RUBELLA IGM | DiaSorin, Inc. | 2000-02-10 | 132 | 0 |
| K984180 | THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA T | Zeus Scientific, Inc. | 1999-07-20 | 239 | 1 |
| K983805 | THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA T | Zeus Scientific, Inc. | 1999-05-26 | 210 | 0 |
| K981729 | IS-RUBELLA IGG TEST SYSTEM | Diamedix Corp. | 1999-01-28 | 258 | 0 |
| K982078 | IMMULITE RUBELLA QUANTITATIVE IGG, CATALOG # LKRBQ1 (100 TES | Diagnostic Products Corp. | 1998-12-11 | 179 | 0 |
| K982281 | SERAQUEST RUBELLA IGM | Quest Intl., Inc. | 1998-10-16 | 108 | 0 |
| K971304 | QUANTA LITE REBELLA IGG | Inova Diagnostics, Inc. | 1998-01-02 | 269 | 0 |
| K963613 | IMMULITE RUBELLA IGG | Diagnostic Products Corp. | 1997-04-02 | 204 | 0 |
| K952721 | RUBASCAN CARD TEST | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1996-12-20 | 554 | 0 |
| K960358 | INCSTAR RUBELLA IGG FAST ELISA ASSAY | Incstar Corp. | 1996-10-24 | 273 | 0 |
| K960367 | INCSTAR RUBELLA IGG ELISA ASSAY | Incstar Corp. | 1996-10-24 | 273 | 1 |
| K954045 | AXSYM RUBELLA IGG ANTIBODY ASSAY | Abbott Laboratories | 1996-09-24 | 392 | 2 |
| K961053 | SERAQUEST RUBELLA IGG | Quest Intl., Inc. | 1996-09-04 | 170 | 2 |
| K951541 | IMX RUBELLA IGG | Abbott Laboratories | 1996-07-16 | 470 | 0 |
| K954318 | ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY | Abbott Laboratories | 1996-05-14 | 242 | 1 |
| K951359 | RUBELLA IGG ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO | Bayer Corp. | 1996-04-15 | 385 | 0 |
| K954687 | ACCESS RUBELLA IGG | Bio-Rad Laboratories, Inc. | 1996-04-09 | 181 | 0 |
| K950227 | RUBELISA (RUBESTAT) | Bio-Whittaker, Inc., A Cambrex Co. | 1995-08-15 | 217 | 0 |
| K941624 | RUBELLA IGG ELISA TEST | Gull Laboratories, Inc. | 1995-08-04 | 487 | 0 |
| K931059 | IMX RUBELLA IGM ANTIBODY ASSAY | Abbott Laboratories | 1994-12-19 | 658 | 1 |
| K925355 | BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST | Princeton Biomedix | 1994-07-12 | 628 | 0 |
| K922581 | BARTELS RUBELLA IGM EIA | Baxter Diagnostics, Inc. | 1992-09-17 | 113 | 0 |
| K922586 | BARTELS RUBELLA IGG EIA | Baxter Diagnostics, Inc. | 1992-09-17 | 113 | 0 |
| K921573 | RUBELLA IGM | Clark Laboratories, Inc. | 1992-08-27 | 147 | 0 |
| K914028 | RUBELLA IGM ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1992-04-22 | 225 | 0 |
| K915870 | OPUS RUBELLA TEST SYSTEM | Pb Diagnostics, Inc. | 1992-03-23 | 83 | 0 |
| K915893 | RUBELLA IGG ELISA TEST | Gull Laboratories, Inc. | 1992-03-04 | 71 | 0 |
| K914420 | ELISA RUBELLA IGM | Sclavo, Inc. | 1991-12-27 | 85 | 0 |
| K911444 | RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM | Wampole Laboratories | 1991-08-30 | 151 | 0 |
| K911393 | RUBENOSTIKA IGG MICROELISA SYSTEM | Organon Teknika Corp. | 1991-04-29 | 31 | 0 |
| K903308 | TRANSTAT-CMV(TM) | Ab Sangtec Medical | 1990-12-04 | 133 | 0 |
| K904084 | RUBELLA IGM ELISA TEST | Gull Laboratories, Inc. | 1990-12-04 | 90 | 0 |
| K905079 | ORTHO RUBELLA-M ANTIBODY ELISA TEST | Ortho Diagnostic Systems, Inc. | 1990-12-04 | 21 | 0 |
| K902571 | MODIFICATION OF SEROCARD RUBELLA IGG TEST | Disease Detection International, Inc. | 1990-09-05 | 90 | 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