Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
MSV · Predicate Candidate Screening
46 FDA 510(k) clearances under this product code; the 50 most recent screened below.
81 daysmedian FDA review time
345 days90th percentile
46clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243979 | Aptiva APS IgA Reagent | Inova Diagnostics, Inc. | 2026-02-06 | 410 | 0 |
| K181329 | EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA | Phadia AB | 2018-06-25 | 38 | 0 |
| K162788 | ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhance | Immco Diagnostics, Inc. | 2017-06-19 | 259 | 0 |
| K152875 | QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Contr | Inova Diagnostics, Inc. | 2015-12-21 | 82 | 0 |
| K141274 | QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿ | Inova Diagnostics, Inc. | 2015-02-13 | 273 | 0 |
| K112414 | ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY | Phadia US, Inc. | 2012-06-22 | 305 | 0 |
| K091556 | HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTRO | Instrumentation Laboratory CO | 2010-05-21 | 359 | 0 |
| K092757 | THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI | Thera-Test Laboratories, Inc. | 2009-10-09 | 30 | 0 |
| K072032 | IGG ANTI-ATHEROX TEST KIT | Corgenix, Inc. | 2008-04-04 | 255 | 0 |
| K062217 | AESKULSKA BETA2-GLYCO-A | Aesku, Inc. | 2006-12-13 | 134 | 0 |
| K040449 | VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND | Pharmacia Deutschland GmbH | 2004-05-11 | 81 | 0 |
| K040450 | VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND | Pharmacia Deutschland GmbH | 2004-05-11 | 81 | 0 |
| K040451 | VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND | Pharmacia Deutschland GmbH | 2004-05-11 | 81 | 0 |
| K040452 | VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 A | Pharmacia Deutschland GmbH | 2004-05-11 | 81 | 0 |
| K030701 | IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA | Immco Diagnostics, Inc. | 2003-09-09 | 187 | 0 |
| K030702 | IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA | Immco Diagnostics, Inc. | 2003-09-09 | 187 | 0 |
| K031208 | REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001 | Corgenix, Inc. | 2003-07-07 | 81 | 0 |
| K031177 | DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M | Axis-Shield Diagnostics, Ltd. | 2003-06-19 | 66 | 0 |
| K030397 | AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA | Hycor Biomedical , Ltd. | 2003-03-21 | 43 | 0 |
| K022944 | AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA | Hycor Biomedical, Inc. | 2002-12-18 | 104 | 0 |
| K022945 | AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA | Hycor Biomedical, Inc. | 2002-12-18 | 104 | 0 |
| K021610 | QAB2A IGM ELISA KIT HRP | Cheshire Diagnostics , Ltd. | 2002-07-12 | 57 | 0 |
| K021611 | QAB2A IGG ELISA KIT HRP | Cheshire Diagnostics , Ltd. | 2002-07-12 | 57 | 0 |
| K020695 | QAB2A IGG ELISA KIT | Cheshire Diagnostics , Ltd. | 2002-04-19 | 46 | 0 |
| K013956 | DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN | Diamedix Corp. | 2002-01-08 | 39 | 0 |
| K013628 | DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM | Diamedix Corp. | 2001-12-21 | 46 | 0 |
| K013077 | REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT | Corgenix, Inc. | 2001-09-28 | 14 | 0 |
| K013079 | REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT | Corgenix, Inc. | 2001-09-28 | 14 | 0 |
| K013080 | REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT | Corgenix, Inc. | 2001-09-28 | 14 | 0 |
| K991801 | BINDAZYME ANTI-B2 GP1 IGG EIA TEST KIT | The Binding Site, Ltd. | 2000-05-05 | 345 | 0 |
| K991802 | BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT | The Binding Site, Ltd. | 2000-05-05 | 345 | 0 |
| K991803 | BINDAZYME ANTI B2 GP1 IGM EIA TEST KIT. | The Binding Site, Ltd. | 2000-05-05 | 345 | 0 |
| K991804 | BINDAZYME ANTI-B2 SCREEN EIA TEST KIT. | The Binding Site, Ltd. | 2000-05-05 | 345 | 0 |
| K992224 | VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT | Hemagen Diagnostics, Inc. | 1999-08-30 | 60 | 0 |
| K992241 | VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT | Hemagen Diagnostics, Inc. | 1999-08-30 | 60 | 0 |
| K992243 | VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT | Hemagen Diagnostics, Inc. | 1999-08-30 | 60 | 0 |
| K982434 | REAADS IGA ANTI-B2GP 1 TEST KIT | Corgenix, Inc. | 1998-12-22 | 161 | 0 |
| K982391 | REAADS IGG ANTI-B2GPI TEST KIT | Corgenix, Inc. | 1998-12-07 | 151 | 0 |
| K982433 | REAADS IGM ANTI-B2GP1 TEST KIT | Corgenix, Inc. | 1998-12-07 | 146 | 0 |
| K982879 | SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY | Shield Diagnostics, Ltd. | 1998-10-15 | 62 | 1 |
| K980230 | QUANTA LITE B2 GPI SCREEN | Inova Diagnostics, Inc. | 1998-03-24 | 61 | 0 |
| K972790 | THE THERATEST EL-B2GP1 (IGM, IGG, IGA) AND EL-B2GP1SCR | Theratest Laboratories, Inc. | 1997-12-05 | 130 | 0 |
| K973882 | EL-B2GP1SCR | Theratest Laboratories, Inc. | 1997-12-05 | 52 | 0 |
| K973006 | QUANTA LITE B2 GPI IGA | Inova Diagnostics, Inc. | 1997-10-20 | 68 | 0 |
| K973014 | QUANTA LITE B2GPI IGM | Inova Diagnostics, Inc. | 1997-10-20 | 68 | 0 |
| K970551 | QUANTA LITE B2GPI IGG | Inova Diagnostics, Inc. | 1997-06-24 | 132 | 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