Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
LLL — Predicate Candidate Screening
181 FDA 510(k) clearances under this product code; the 50 most recent screened below.
75 daysmedian FDA review time
231 days90th percentile
181clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253367 | EliA CTD 13 Screen | Phadia AB | 2026-06-25 | 268 | 0 |
| K250666 | Alegria Flash CTD Screen | Zeus Scientific | 2025-10-22 | 231 | 0 |
| K250408 | Alegria Flash ENA Screen | Zeus Scientific | 2025-09-19 | 218 | 0 |
| K213403 | Aptiva CTD Essential Reagent | Inova Diagnostics, Inc. | 2023-09-29 | 711 | 0 |
| K190710 | EliA SymphonyS Immunoassay | Phadia AB | 2019-11-29 | 255 | 0 |
| K180975 | QUANTA Flash HMGCR Reagents | Inova Diagnostics, Inc. | 2018-06-25 | 73 | 0 |
| K152635 | QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA | Inova Diagnostics, Inc. | 2016-06-01 | 260 | 0 |
| K151429 | QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA | Inova Diagnostics, Inc. | 2016-02-12 | 260 | 0 |
| K142781 | ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhance | Immco Diagnostics, Inc. | 2015-03-31 | 186 | 0 |
| K141328 | QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLA | Inova Diagnostics, Inc. | 2015-02-12 | 267 | 0 |
| K141210 | QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA | Inova Diagnostics, Inc. | 2015-01-29 | 265 | 0 |
| K122923 | QUANTA FLASH ENA7 | Inova Diagnostics, Inc. | 2013-05-07 | 225 | 0 |
| K112996 | EUROIMMUN ANTI-ENA POOL ELISA (IGG) | Euroimmun US | 2013-04-09 | 550 | 0 |
| K113143 | IMMULISA SCI-70 ANTIBODY ELISA | Immco Diagnostics, Inc. | 2011-12-02 | 38 | 0 |
| K102607 | FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS | Biomedical Diagnostics (Bmd) SA | 2010-12-03 | 84 | 0 |
| K072149 | ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83 | Phadia US, Inc. | 2008-01-15 | 165 | 0 |
| K053653 | FIDIS CONNECTIVE 10, MODEL MX006 | Biomedical Diagnostics (Bmd) SA | 2006-03-13 | 73 | 0 |
| K050286 | FIDIS CONNECTIVE 8 | Biomedical Diagnostics (Bmd) SA | 2005-10-03 | 238 | 0 |
| K043067 | ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 8 | Bioarray Solutions, Ltd. | 2005-05-31 | 204 | 0 |
| K041753 | AESKULISA ENA 6 S | Aesku Diagnostics | 2004-07-14 | 15 | 0 |
| K040160 | QUANTA PLEX SLE PROFILE 8 | Inova Diagnostics, Inc. | 2004-03-08 | 45 | 0 |
| K033528 | MESACUP-2 TEST JO-1, MODEL 10756 | Rhigene, Inc. | 2003-12-22 | 45 | 0 |
| K032469 | AESKULISA ANA 8PRO | Aesku, Inc. | 2003-12-16 | 127 | 0 |
| K031450 | QUANTA PLEX ENA PROFILE 6 | Inova Diagnostics, Inc. | 2003-06-25 | 49 | 0 |
| K030681 | QUANTA PLEX ENA PROFILE 5 | Inova Diagnostics, Inc. | 2003-04-24 | 50 | 0 |
| K011140 | QUANTA PLEX ENA PROFILE 4 | Inova Diagnostics, Inc. | 2001-07-27 | 105 | 0 |
| K010146 | ENA EIA KIT RANGE | The Binding Site, Ltd. | 2001-03-01 | 43 | 0 |
| K010147 | ENA EIA KIT | The Binding Site, Ltd. | 2001-03-01 | 43 | 0 |
| K010148 | ENA SCREEN EIA KIT | The Binding Site, Ltd. | 2001-02-23 | 37 | 0 |
| K003054 | AUTOSTAT II ENA-6 PROFILE ELISA | Cogent Diagnotics , Ltd. | 2000-10-13 | 11 | 0 |
| K003057 | AUTOSTAT II ENA-4 PROFILE ELISA | Cogent Diagnotics , Ltd. | 2000-10-13 | 11 | 0 |
| K000749 | RHIGENE MESACUP2 TEST- SSA | Rhigene, Inc. | 2000-05-09 | 62 | 0 |
| K000750 | RHIGENE MESACUP2 TEST- SCL-70 | Rhigene, Inc. | 2000-05-09 | 62 | 0 |
| K000751 | RHIGENE MESACUP2 TEST- SSB | Rhigene, Inc. | 2000-05-09 | 62 | 0 |
| K000489 | ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST | Helix Diagnostics, Inc. | 2000-04-05 | 51 | 0 |
| K993839 | ENA PROFILE ELISA TEST SYSTEM | Trinity Biotech USA | 2000-01-12 | 61 | 0 |
| K993971 | MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOAN | Micro Detect, Inc. | 2000-01-11 | 49 | 0 |
| K994029 | MDI SM TEST | Micro Detect, Inc. | 2000-01-11 | 46 | 0 |
| K991657 | QUANTA LITE ANA ELISA | Inova Diagnostics, Inc. | 1999-06-17 | 35 | 0 |
| K990798 | AUTOSTAT II ANTI-JO-1 ELISA | Cogent Diagnotics , Ltd. | 1999-04-28 | 49 | 0 |
| K990626 | AUTOSTAT II ANTI-SS-B/LA ELISA | Cogent Diagnotics , Ltd. | 1999-04-28 | 62 | 0 |
| K990797 | AUTOSTAT II ANTI-SCL-70 ELISA | Cogent Diagnotics , Ltd. | 1999-04-28 | 49 | 0 |
| K990627 | AUTOSTAT II ANTI-SS-A/RO ELISA | Cogent Diagnotics , Ltd. | 1999-04-28 | 62 | 0 |
| K983921 | AUTOSTAT II ENA SCREEN ELISA | Cogent Diagnotics , Ltd. | 1998-12-28 | 54 | 0 |
| K984462 | LIQUICHEK ENA CONTROL, EIA SCREEN, MODEL NO. 206 | Bio-Rad | 1998-12-22 | 6 | 0 |
| K983426 | THE APTUS (AUTOMATED) APPLICATION OF THE SSA ELISA TEST SYST | Zeus Scientific, Inc. | 1998-11-18 | 50 | 0 |
| K983376 | THE APTUS (AUTOMATED) APPLICATON OF THE ENA SCREEN ELISA TES | Zeus Scientific, Inc. | 1998-11-18 | 54 | 0 |
| K983425 | THE APTUS (AUTOMATED)APPLICATION OF THE SSB ELISA TEST SYSTE | Zeus Scientific, Inc. | 1998-11-18 | 50 | 0 |
| K983423 | THE APTUS (AUTOMATED) APPLICATION OF THE SCL-70 ELISA TEST S | Zeus Scientific, Inc. | 1998-11-18 | 50 | 0 |
| K983464 | THE APTUS (AUTOMATED) APPLICATION OF THE JO-1 ELISA TEST SYS | Zeus Scientific, Inc. | 1998-11-18 | 48 | 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