Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LJM — Predicate Candidate Screening
112 FDA 510(k) clearances under this product code; the 50 most recent screened below.
83 daysmedian FDA review time
181 days90th percentile
112clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K182353 | EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Im | Phadia AB | 2018-11-27 | 90 | 0 |
| K151559 | ImmuLisa Enhanced Centromere Antibody ELISA | Immco Diagnostics, Inc. | 2016-03-11 | 275 | 0 |
| K140493 | ELIA SCL-70S IMMUNOASSAY | Phadia GmbH | 2014-10-30 | 245 | 0 |
| K123880 | QUANTA FLASH CENTROMERE | Inova Diagnostics, Inc. | 2014-02-07 | 417 | 0 |
| K131330 | GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN | Gold Standard Diagnostics | 2014-01-28 | 265 | 0 |
| K131185 | ANA SCREEN ELISA (IGG) | Euroimmun US | 2013-07-15 | 80 | 0 |
| K083188 | VARELISA RECOMBI ANA SCREEN, MODEL 12 596 | Phadia US, Inc. | 2009-03-13 | 135 | 0 |
| K050967 | VARELISA RECOMBI CTD SCREEN, MODEL 13096 | Sweden Diagnostics (Germany) GmbH | 2005-06-28 | 71 | 0 |
| K050625 | VARELISA RECOMBI ANA PROFILE, MODEL 18496 | Sweden Diagnostics (Germany) GmbH | 2005-04-26 | 46 | 0 |
| K041102 | IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA | Immco Diagnostics, Inc. | 2004-10-26 | 182 | 0 |
| K040953 | AESKULISA ANA HEP-2 | Aesku, Inc. | 2004-06-23 | 72 | 0 |
| K040810 | VARELISA HISTONE ANTIBODIES, MODEL 16496 | Pharmacia Deutschland GmbH | 2004-05-14 | 46 | 0 |
| K040291 | EL-ANA PROFILES: ANTI-CHROMATIN | Theratest Laboratories, Inc. | 2004-03-11 | 34 | 0 |
| K040200 | MESACUP-2 TEST CENP-B | Rhigene, Inc. | 2004-03-04 | 35 | 0 |
| K030929 | ANA DETECT | Orgentec Diagnostika GmbH | 2003-05-02 | 39 | 0 |
| K024031 | THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE | Theratest Laboratories, Inc. | 2003-02-06 | 62 | 0 |
| K022018 | RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560 | Rhigene, Inc. | 2002-07-05 | 15 | 0 |
| K004019 | ANA EIA DIAGNOSTIC TEST KIT | The Binding Site, Ltd. | 2001-02-15 | 50 | 0 |
| K003959 | QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA | Inova Diagnostics, Inc. | 2001-01-22 | 32 | 0 |
| K002559 | EL-ANA PROFILES-2K1 | Theratest Laboratories, Inc. | 2000-09-12 | 26 | 0 |
| K000879 | THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST S | Zeus Scientific, Inc. | 2000-05-22 | 63 | 0 |
| K000880 | THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST S | Zeus Scientific, Inc. | 2000-05-22 | 63 | 0 |
| K000934 | MDI SCL-70 TEST | Micro Detect, Inc. | 2000-04-07 | 15 | 0 |
| K994071 | RHIGENE ANA ELISA TEST SYSTEM | Rhigene, Inc. | 2000-01-18 | 47 | 0 |
| K993635 | MDI SM/RNP TEST | Micro Detect, Inc. | 2000-01-10 | 75 | 0 |
| K993636 | MDI SS-A TEST | Micro Detect, Inc. | 2000-01-10 | 75 | 0 |
| K993108 | VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96 | Pharmacia & Upjohn Co. | 1999-11-12 | 56 | 0 |
| K993109 | VARELISA RECOMBI ANA PROFILE | Pharmacia & Upjohn Co. | 1999-11-12 | 56 | 0 |
| K992041 | RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11 | Immuno Concepts, Inc. | 1999-07-23 | 36 | 0 |
| K983655 | AUTOSTAT II ANA SCREEN ELISA | Cogent Diagnotics , Ltd. | 1999-01-28 | 101 | 0 |
| K983378 | THE APTUS (AUTOMATED) APPLICATION OF THE ANA SCREEN ELISA TE | Zeus Scientific, Inc. | 1998-11-18 | 54 | 0 |
| K980810 | SERAQUEST ANTI-SSA | Quest Intl., Inc. | 1998-05-12 | 70 | 0 |
| K980337 | DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM | Helix Diagnostics, Inc. | 1998-05-12 | 104 | 0 |
| K964385 | ELIAS ANA-HEP-2 | Elias U.S.A., Inc. | 1997-03-06 | 122 | 0 |
| K962450 | HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE | Hycor Biomedical, Inc. | 1996-11-25 | 160 | 0 |
| K962062 | ORGENTEC ANTI-SM ELISA | American Laboratory Products Co., Ltd. | 1996-11-18 | 174 | 0 |
| K962057 | ORGENTEC ANTI-RNP/SM ELISA | American Laboratory Products Co., Ltd. | 1996-11-18 | 174 | 0 |
| K962055 | ORGENTEC ANTI-SCL 70 ELISA | American Laboratory Products Co., Ltd. | 1996-11-15 | 171 | 0 |
| K962054 | ORGENTEC ANTI-SS-A(RO) ELISA | American Laboratory Products Co., Ltd. | 1996-11-15 | 171 | 0 |
| K962052 | ORGENTEC ABTI-SS-BB(LA) ELISA | American Laboratory Products Co., Ltd. | 1996-11-15 | 171 | 0 |
| K962053 | ORGENTEC ANTI-JO-1 ELISA | American Laboratory Products Co., Ltd. | 1996-11-15 | 171 | 0 |
| K963291 | VARELISA ANA (4) PROFILE | Elias U.S.A., Inc. | 1996-09-30 | 40 | 0 |
| K954814 | ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAY | Orgentec | 1996-04-18 | 182 | 0 |
| K954829 | ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAY | Orgentec | 1996-04-18 | 181 | 0 |
| K954815 | ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY | Orgentec | 1996-04-18 | 182 | 0 |
| K954832 | ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAY | Orgentec | 1996-04-18 | 181 | 0 |
| K955481 | THERATEST KIT (MODIFICATION) | Theratest Laboratories, Inc. | 1996-03-06 | 112 | 0 |
| K954380 | QUANTA LITE SSDNA | Inova Diagnostics, Inc. | 1996-02-29 | 163 | 0 |
| K952490 | IMAGETITER INSTRUMENT, ANA TEST KIT & CALIBRATOR SERUM | Roche Image Analysis Systems | 1995-12-15 | 199 | 0 |
| K954106 | THERATEST LAB, INC., EL-ANASCR KIT | Theratest Laboratories, Inc. | 1995-11-14 | 105 | 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