Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LSE — Predicate Candidate Screening
56 FDA 510(k) clearances under this product code; the 50 most recent screened below.
144 daysmedian FDA review time
314 days90th percentile
56clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233606 | ADVIA Centaur EBV-VCA IgM | Biokit, S.A. | 2024-08-07 | 272 | 0 |
| K162961 | LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIA | DiaSorin, Inc. | 2017-01-05 | 73 | 0 |
| K162959 | LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set | DiaSorin, Inc. | 2017-01-04 | 72 | 0 |
| K091260 | SERAQUEST EBV EA-D IGG TEST | Quest Intl., Inc. | 2009-06-08 | 40 | 0 |
| K073382 | PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G | Focus Diagnostics, Inc. | 2008-07-28 | 238 | 0 |
| K062211 | BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DE | Bio-Rad Laboratories, Inc. | 2006-12-08 | 129 | 2 |
| K062213 | BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DET | Bio-Rad Laboratories, Inc. | 2006-12-08 | 129 | 1 |
| K060204 | LIAISON EA IGG | DiaSorin, Inc. | 2006-10-18 | 265 | 0 |
| K033915 | MODIFICATION TO SERAQUEST EB VCA IGG | Quest Intl., Inc. | 2004-01-16 | 29 | 0 |
| K030863 | EBV VCA-P18 IGG ELISA | Panbio Limited | 2003-06-27 | 101 | 0 |
| K021793 | EBV EA-D IGG ELISA KIT, MODEL EBG-100 | Pan Bio Pty. , Ltd. | 2002-09-27 | 119 | 0 |
| K010301 | IMMUNOWELL EA (D) IGG TEST | Genbio | 2001-06-11 | 130 | 0 |
| K992587 | EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTE | Stellar Bio Systems, Inc. | 1999-12-22 | 142 | 0 |
| K991975 | SERAQUEST EB NA IGG | Quest Intl., Inc. | 1999-11-02 | 144 | 0 |
| K990410 | SERAQUEST EB VCA IGG | Quest Intl., Inc. | 1999-10-28 | 261 | 0 |
| K992191 | ETI-EA-G ASSAY | DiaSorin, Inc. | 1999-07-12 | 14 | 1 |
| K983839 | BIOTEST ANTI-EBV RECOMBINANT | Biotest Diagnostics Corp. | 1999-06-09 | 222 | 0 |
| K983841 | BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG | Biotest Diagnostics Corp. | 1999-06-09 | 222 | 0 |
| K983842 | BIOTEST ANTI-EBV RECOMBINANT, EA IGM | Biotest Diagnostics Corp. | 1999-06-09 | 222 | 0 |
| K991660 | COPALIS MULTIPLEX EBV ANTIBODY ASSAY | DiaSorin, Inc. | 1999-06-04 | 21 | 0 |
| K981812 | EBV-VCA IGG ELISA TEST SYSTEM | Diamedix Corp. | 1999-03-04 | 286 | 0 |
| K983801 | THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGM ELISA T | Zeus Scientific, Inc. | 1998-12-10 | 43 | 0 |
| K983804 | THE APTUS (AUTOMATED) APPLICATION OF THE EBV-EA IGG ELISA TE | Zeus Scientific, Inc. | 1998-12-08 | 41 | 0 |
| K982350 | EA-D IGM ELISA TEST SYSTEM | Columbia Bioscience, Inc. | 1998-11-25 | 142 | 0 |
| K982348 | EBNA-1 IGM ELISA TEST SYSTEM | Columbia Bioscience, Inc. | 1998-11-25 | 142 | 0 |
| K982352 | VCA IGM ELISA TEST SYSTEM | Columbia Bioscience, Inc. | 1998-11-25 | 142 | 0 |
| K974226 | IMMUNODOT MONO-G TEST | Genbio | 1998-09-22 | 314 | 0 |
| K974244 | IMMUNODOT MONO-M TEST | Genbio | 1998-09-22 | 314 | 0 |
| K981120 | ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA | Zeus Scientific, Inc. | 1998-08-21 | 147 | 0 |
| K973940 | IMMUNOWELL EBV VCA IGG TEST | Genbio | 1998-08-10 | 299 | 0 |
| K980596 | VCA IGM ELISA TEST SYSTEM | Clark Laboratories, Inc. | 1998-07-22 | 155 | 0 |
| K980912 | VCA IGG ELISA TEST SYSTEM | Clark Laboratories, Inc. | 1998-07-22 | 134 | 0 |
| K973123 | EA-D IGG ELISA TEST SYSTEM | Clark Laboratories, Inc. | 1998-03-26 | 218 | 0 |
| K944449 | EBV-VCA IGM ELISA TEST STSTEM | Zeus Scientific, Inc. | 1995-09-25 | 378 | 0 |
| K940093 | EBV-EA(D) IGG ELISA TEST | Gull Laboratories, Inc. | 1995-09-15 | 616 | 0 |
| K941198 | EBV LGG ELISA TEST | Gull Laboratories, Inc. | 1995-08-23 | 527 | 0 |
| K946159 | INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) IGG ELISA KI | Incstar Corp. | 1995-06-07 | 181 | 0 |
| K946157 | INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) LGM ELISA KI | Incstar Corp. | 1995-06-07 | 181 | 0 |
| K934774 | UNKNOWN | Granbio, Inc. | 1994-04-20 | 197 | 0 |
| K931443 | ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS | Ortho Diagnostic Systems, Inc. | 1993-11-05 | 228 | 0 |
| K925688 | MERIDIAN EBV-EA TEST KIT | Fuller Laboratories, Inc. | 1993-10-12 | 334 | 0 |
| K921628 | EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA | Incstar Corp. | 1992-09-14 | 161 | 0 |
| K922332 | BARTELS EPSTEIN-BARR VIRUS IGG EIA | Baxter Diagnostics, Inc. | 1992-09-02 | 112 | 0 |
| K912489 | COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYS | Immuno Concepts, Inc. | 1991-07-24 | 50 | 0 |
| K912488 | FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS | Immuno Concepts, Inc. | 1991-07-24 | 50 | 0 |
| K903612 | EBV/EA-CHECK TM TEST KIT | Diagnostic Technology, Inc. | 1990-10-16 | 68 | 0 |
| K895652 | EBV-EA IFA KIT | Organon Teknika Treyburn | 1989-12-18 | 89 | 0 |
| K894932 | FIAX EB VCA-M TEST KIT | Whittaker Bioproducts, Inc. | 1989-10-16 | 74 | 0 |
| K894235 | EB VCA STAT M TEST KIT | Whittaker Bioproducts, Inc. | 1989-08-30 | 71 | 0 |
| K883871 | EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590 | Clinical Sciences, Inc. | 1989-07-14 | 304 | 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