Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LLM — Predicate Candidate Screening
27 FDA 510(k) clearances under this product code; the 50 most recent screened below.
193 daysmedian FDA review time
465 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233605 | ADVIA Centaur EBV-EBNA IgG | Biokit, S.A. | 2024-08-07 | 272 | 0 |
| K040120 | DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM | DiaSorin, Inc. | 2005-04-29 | 465 | 0 |
| K984133 | THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST | Zeus Scientific, Inc. | 1999-01-11 | 54 | 0 |
| K973941 | IMMUNOWELL EBNA IGG TEST | Genbio | 1998-08-10 | 299 | 0 |
| K980598 | EBNA-1 IGM ELISA TEST SYSTEM | Clark Laboratories, Inc. | 1998-05-01 | 73 | 0 |
| K951549 | EBNA IGG EIA TEST SYSTEM | Immunoprobe, Inc. | 1996-04-29 | 391 | 0 |
| K951822 | EBNA ENZYME IMMUNOASSAY KIT | Granbio, Inc. | 1996-02-15 | 301 | 0 |
| K935730 | EBNA IGG ELISA TEST | Gull Laboratories, Inc. | 1995-09-19 | 657 | 0 |
| K946353 | EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORES | Mrl Diagnostics | 1995-07-21 | 203 | 0 |
| K946158 | INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT | Incstar Corp. | 1995-06-09 | 183 | 1 |
| K932742 | EBNA IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1995-05-05 | 696 | 0 |
| K925690 | MERIDIAN EBNA TEST KIT | Fuller Laboratories, Inc. | 1993-10-12 | 334 | 0 |
| K930002 | ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA | Ortho Diagnostic Systems, Inc. | 1993-07-16 | 193 | 0 |
| K911473 | EBNA STAT TEST KIT | Whittaker Bioproducts, Inc. | 1991-09-25 | 174 | 0 |
| K911569 | EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST | Ortho Diagnostic Systems, Inc. | 1991-06-10 | 63 | 0 |
| K895708 | EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI) | Immuno Concepts, Inc. | 1989-12-11 | 77 | 0 |
| K895707 | EBNA ANTIBODY TEST SYSTEM (IMMUNOENZYME ANTIBODY) | Immuno Concepts, Inc. | 1989-12-08 | 74 | 0 |
| K894626 | EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN | Bion Ent., Ltd. | 1989-10-16 | 88 | 0 |
| K891542 | EBNA-CHECK(TM) TEST KIT | Diagnostic Technology, Inc. | 1989-06-20 | 95 | 0 |
| K883601 | EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550 | Clinical Sciences, Inc. | 1989-05-11 | 261 | 0 |
| K883600 | EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550 | Clinical Sciences, Inc. | 1989-05-11 | 261 | 0 |
| K882440 | EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN ANTIBODY TEST | Zeus Scientific, Inc. | 1988-12-15 | 184 | 0 |
| K875203 | DU PONT EBNA-IGG ANTIBODY ELISA KIT | E.I. Dupont DE Nemours & Co., Inc. | 1988-08-30 | 256 | 0 |
| K875170 | EBNA ANTIBODY | Hillcrest Biologicals | 1988-05-23 | 158 | 0 |
| K880043 | EBV-NA TEST | Gull Laboratories, Inc. | 1988-03-24 | 78 | 0 |
| K871298 | EBNA ACIF ASSAY KIT | Granbio, Inc. | 1987-06-25 | 86 | 0 |
| K840417 | EBNA ACIF KIT | Litton Bionetics | 1984-12-27 | 331 | 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