Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MST — Predicate Candidate Screening
42 FDA 510(k) clearances under this product code; the 50 most recent screened below.
114 daysmedian FDA review time
280 days90th percentile
42clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K163177 | ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhan | Immco Diagnostics, Inc. | 2017-07-28 | 256 | 0 |
| K132082 | AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK | Aesku Diagnostics | 2013-12-05 | 153 | 0 |
| K113377 | GLIADIN IGA AND GLIADIN LGA | Grifols USA, LLC | 2012-12-14 | 394 | 0 |
| K113863 | QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP | Inova Diagnostics, Inc. | 2012-09-20 | 265 | 0 |
| K111414 | QUANTA FLASH (TM) DGP SCREEN | Inova Diagnostics, Inc. | 2011-10-20 | 153 | 0 |
| K093459 | ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMU | Phadia US, Inc. | 2010-08-13 | 280 | 2 |
| K091522 | IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA | Immco Diagnostics, Inc. | 2010-02-04 | 258 | 0 |
| K083053 | EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG) | Euroimmun Us, Inc. | 2009-08-07 | 297 | 0 |
| K083052 | EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA) | Euroimmun Us, Inc. | 2009-07-28 | 287 | 0 |
| K081674 | BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME H | The Binding Site, Ltd. | 2008-10-15 | 120 | 0 |
| K063775 | ELIA GLIADIN IGA, IGG AND CELIAC CONTROL | Phadia US, Inc. | 2007-03-14 | 83 | 0 |
| K070083 | QUANTA LITE H-TTG/DGP SCREEN | Inova Diagnostics, Inc. | 2007-03-12 | 62 | 0 |
| K062708 | QUANTA LITE CELIAC DGP SCREEN | Inova Diagnostics, Inc. | 2006-12-13 | 93 | 0 |
| K053383 | FIDIS CELIAC | Biomedical Diagnostics (Bmd) SA | 2006-03-29 | 114 | 0 |
| K052793 | IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, | Pharmacia Diagnostics AB | 2006-02-07 | 127 | 0 |
| K052439 | AESKULISA GLIA A AND AESKULISA GLIA G | Aesku Diagnostics | 2006-02-07 | 154 | 0 |
| K052143 | QUANTA LITE GLIADIN IGA II | Inova Diagnostics, Inc. | 2005-10-04 | 57 | 0 |
| K052142 | QUANTA LITE GLIADIN IGG II | Inova Diagnostics, Inc. | 2005-10-04 | 57 | 0 |
| K041002 | FIDIS CELIAC | Biomedical Diagnostics S.A. | 2004-09-24 | 158 | 0 |
| K041357 | VARELISA GLIADIN IGG ANTIBODIES | Sweden Diagnostics (Germany) GmbH | 2004-08-02 | 74 | 0 |
| K041354 | VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896 | Sweden Diagnostics (Germany) GmbH | 2004-07-16 | 57 | 0 |
| K012797 | DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM | Diamedix Corp. | 2001-09-28 | 38 | 0 |
| K012795 | DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM | Diamedix Corp. | 2001-09-28 | 38 | 1 |
| K002169 | GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM | Scimedx Corp. | 2000-10-19 | 93 | 0 |
| K002358 | MDI GLIADIN A TEST | Micro Detect, Inc. | 2000-10-19 | 78 | 0 |
| K002189 | GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM | Scimedx Corp. | 2000-10-19 | 92 | 0 |
| K002359 | MDI GLIADIN G TEST | Micro Detect, Inc. | 2000-10-19 | 78 | 0 |
| K001393 | THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TE | Zeus Scientific, Inc. | 2000-06-07 | 35 | 0 |
| K993250 | THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA T | Zeus Scientific, Inc. | 1999-11-12 | 45 | 0 |
| K993087 | AUTOSTAT II ANTI-GLIADIN IGG ELISA | Cogent Diagnotics , Ltd. | 1999-11-12 | 58 | 0 |
| K993086 | AUTOSTAT II ANTI-GLIADIN IGA ELISA | Cogent Diagnotics , Ltd. | 1999-11-12 | 58 | 0 |
| K990204 | GLIADIN IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1999-03-26 | 64 | 0 |
| K990207 | GLIADIN IGA ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1999-03-26 | 64 | 0 |
| K973910 | GLIADIN ANTIBODIES ELISA | Genesis Diagnostics , Ltd. | 1999-02-17 | 491 | 0 |
| K982533 | UNICAP GLIADIN IGA ASSAY | Pharmacia & Upjohn Co. | 1998-10-22 | 94 | 0 |
| K982701 | UNICAP GLIADIN IGG ASSAY | Pharmacia & Upjohn Co. | 1998-10-22 | 94 | 0 |
| K981929 | BINDAZYME ANTIGLIADIN IGG/IGA COMBI KIT | The Binding Site, Ltd. | 1998-09-03 | 118 | 0 |
| K981644 | BINDAZYME ANTIGLIADIN IGG | The Binding Site, Ltd. | 1998-09-03 | 118 | 0 |
| K964986 | QUANTA LITE IGA GLIADIN ELISA | Inova Diagnostics, Inc. | 1997-06-02 | 171 | 0 |
| K964985 | QUANTA LITE IGG GLIADIN ELISA | Inova Diagnostics, Inc. | 1997-05-30 | 168 | 0 |
| K964341 | IGA ANTI-GLIADIN (IGA-AGA) ANTIBODY TEST KIT | Immco Diagnostics, Inc. | 1997-05-30 | 211 | 0 |
| K964344 | IGG ANTI-GLIADIN (IGG-AGA) ANTIBODY TEST KIT | Immco Diagnostics, Inc. | 1997-05-30 | 211 | 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