Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LGD — Predicate Candidate Screening
106 FDA 510(k) clearances under this product code; the 50 most recent screened below.
126 daysmedian FDA review time
310 days90th percentile
106clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242022 | Access Toxo IgG | Beckman Coulter, Inc. | 2025-03-28 | 260 | 0 |
| K242095 | Access Toxo IgM II | Beckman Coulter, Inc. | 2024-10-11 | 86 | 0 |
| K233932 | Alinity i Toxo IgM | Abbott Laboratories | 2024-08-30 | 260 | 0 |
| K210596 | ARCHITECT Toxo IgG | Abbott Laboratories | 2022-05-19 | 444 | 0 |
| K162678 | Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl | Roche Diagnostics | 2017-06-23 | 270 | 0 |
| K142826 | ADVIA Centaur Toxoplasma M (Toxo M) | Siemens Healthcare Diagnostics, Inc. | 2015-12-22 | 448 | 0 |
| K132234 | LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II | DiaSorin, Inc. | 2013-08-28 | 41 | 0 |
| K131441 | LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II | DiaSorin, Inc. | 2013-08-09 | 81 | 0 |
| K101946 | VIDAS TOXO IGG AVIDITY | bioMerieux, Inc. | 2011-05-18 | 310 | 0 |
| K102681 | ADVIA CENTAUR TOXOPLASMA IGG (TOXO G) | Siemens Healthcare Diagnostics, Inc. | 2011-05-04 | 229 | 0 |
| K090847 | PLATELIA TOXO IGM KIT MODEL 26211 | Bio-Rad Laboratories | 2009-07-01 | 93 | 1 |
| K073501 | ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTR | Roche Diagnostics Corp. | 2008-06-09 | 179 | 0 |
| K080869 | ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO | Beckman Coulter, Inc. | 2008-05-23 | 53 | 0 |
| K052499 | DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS | Diasorin S.P.A | 2006-02-08 | 148 | 0 |
| K032162 | ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY | Beckman Coulter, Inc. | 2003-08-08 | 24 | 0 |
| K031506 | ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY | Beckman Coulter, Inc. | 2003-06-02 | 19 | 0 |
| K013839 | BIO-RAD PLATELIA TOXO IGG TMB | Bio-Rad | 2002-09-30 | 315 | 0 |
| K013837 | BIO-RAD PLATELIA TOXO IGM TMB | Bio-Rad | 2002-09-30 | 315 | 0 |
| K012075 | IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 200 | Diagnostic Products Corp. | 2002-01-10 | 192 | 0 |
| K012183 | BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY | Bayer Diagnostics Corp. | 2001-12-27 | 168 | 0 |
| K010755 | BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY | Bayer Corp. | 2001-08-20 | 160 | 0 |
| K003259 | ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSA | Beckman Coulter, Inc. | 2001-06-13 | 238 | 0 |
| K002453 | ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSA | Beckman Coulter, Inc. | 2000-08-31 | 21 | 0 |
| K001707 | DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM | Diamedix Corp. | 2000-07-07 | 32 | 0 |
| K993319 | VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210 | bioMerieux, Inc. | 2000-05-22 | 231 | 0 |
| K984317 | THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGG ELIS | Zeus Scientific, Inc. | 1999-01-22 | 50 | 0 |
| K984170 | THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGM ELIS | Zeus Scientific, Inc. | 1999-01-19 | 60 | 0 |
| K973448 | ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANA | Beckman Instruments, Inc. | 1998-09-17 | 371 | 0 |
| K981498 | IS-TOXOPLASMA IGG TEST SYSTEM | Diamedix Corp. | 1998-08-21 | 116 | 0 |
| K971441 | QUANTA LITE TOXOPLASMA IGG | Inova Diagnostics, Inc. | 1997-12-02 | 228 | 0 |
| K971989 | TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO | Bayer Corp. | 1997-10-22 | 146 | 0 |
| K971672 | SERAQUEST TOXOPLASMA IGM | Quest Intl., Inc. | 1997-10-21 | 167 | 0 |
| K963289 | INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY | Incstar Corp. | 1997-05-01 | 253 | 0 |
| K962936 | IMMULITE TOXOPLASMA QUANTITATIVE IGG | Diagnostic Products Corp. | 1997-04-24 | 269 | 0 |
| K962343 | TOXO IGG ELISA TEST | Gull Laboratories, Inc. | 1997-03-24 | 279 | 0 |
| K963296 | INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565) | Incstar Corp. | 1996-12-16 | 117 | 0 |
| K963297 | INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560) | Incstar Corp. | 1996-12-16 | 117 | 0 |
| K954576 | AXSYM TOXO IGM | Abbott Laboratories | 1996-08-23 | 326 | 1 |
| K954575 | AXSYM TOXO IGG ANTIBODY ASSAY | Abbott Laboratories | 1996-08-16 | 319 | 1 |
| K955760 | TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM | Bayer Corp. | 1996-08-02 | 226 | 0 |
| K960092 | SERAQUEST TOXOPLASMA IGG | Quest Intl., Inc. | 1996-06-17 | 158 | 0 |
| K944867 | TOXOSTAT | Bio-Whittaker, Inc., A Cambrex Co. | 1996-05-14 | 595 | 0 |
| K950671 | IMMULITE TOXOPLASMA GONDII IGG | Diagnostic Products Corp. | 1996-02-23 | 375 | 0 |
| K951495 | ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM | Bio-Rad Laboratories, Inc. | 1995-12-20 | 264 | 0 |
| K951636 | IMX TOXO IGG | Abbott Laboratories | 1995-08-01 | 116 | 0 |
| K945634 | IMX(R) TOXO IGM | Abbott Laboratories | 1995-04-27 | 162 | 0 |
| K931334 | VIDAS TOXO COMPETITION (TXC) ASSAY | Biomerieux Vitek, Inc. | 1993-06-21 | 97 | 0 |
| K922737 | VIDAS TOXO IG6 ASSAY (TX6) | Biomerieux Vitek, Inc. | 1993-05-11 | 337 | 0 |
| K923166 | VIDAS TOXOPLASMA GONDII IGM ASSSAY | Biomerieux Vitek, Inc. | 1993-02-25 | 241 | 0 |
| K921523 | OPUS(R) TOXO-G TEST SYSTEM | Pb Diagnostics, Inc. | 1992-09-14 | 167 | 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