Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
DGC — Predicate Candidate Screening
114 FDA 510(k) clearances under this product code; the 50 most recent screened below.
45 daysmedian FDA review time
123 days90th percentile
114clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231151 | Kenota 1 Total IgE; Kenota 1 (instrument) | Kenota, Inc. | 2024-05-31 | 403 | 0 |
| K214068 | Quantia IgE | Biokit, S.A. | 2023-02-21 | 421 | 0 |
| K220178 | Total Immunoglobulin E (IgE) | Beckman Coulter, Inc. | 2022-03-23 | 61 | 0 |
| K193493 | ADVIA Centaur Total IgE (tIgE) | Siemens Healthcare Diagnostics, Inc. | 2020-01-15 | 29 | 0 |
| K161899 | ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control | Phadia AB | 2016-07-28 | 17 | 0 |
| K133404 | IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE | Phadia AB | 2014-02-24 | 110 | 1 |
| K063425 | DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBR | Dade Behring, Inc. | 2007-02-15 | 94 | 0 |
| K050493 | QUANTIA IGE | Biokit, S.A. | 2005-08-16 | 169 | 0 |
| K042241 | K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-09 | Kamiya Biomedical Co. | 2004-12-10 | 113 | 0 |
| K034057 | LACRYTEST | Adiatec SA | 2004-03-09 | 70 | 0 |
| K032251 | IMMUNETECH TOTAL IGE SYSTEM | Immunetech Corporation | 2003-12-19 | 150 | 0 |
| K024210 | IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE I | Beckman Coulter, Inc. | 2003-02-24 | 66 | 0 |
| K010855 | RANDOX IGE | Randox Laboratories, Ltd. | 2001-05-15 | 54 | 1 |
| K002560 | SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT | The Binding Site, Ltd. | 2000-10-26 | 70 | 0 |
| K992528 | BIOCHECK IGE ELISA, MODEL BC-1035 | Biocheck, Inc. | 1999-09-21 | 55 | 0 |
| K991316 | TOUCH TEAR IGE MICROASSAY KIT | Touch Scientific, Inc. | 1999-08-09 | 112 | 0 |
| K991945 | PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01 | Pharmacia & Upjohn Co. | 1999-07-28 | 49 | 0 |
| K991787 | N LATEX IGE MONO REAGENT | Dade Behring, Inc. | 1999-07-07 | 43 | 0 |
| K983185 | BOEHRINGER MANNHEIM TINA-QUANT IGE TEST | Boehringer Mannheim Corp. | 1998-11-12 | 62 | 0 |
| K972697 | AIA-PACK IGE II ASSAY | Tosoh Medics, Inc. | 1997-10-03 | 77 | 0 |
| K964152 | UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH | Pharmacia, Inc. | 1997-04-23 | 189 | 0 |
| K940183 | HY-TEC TOTAL IGE ENZYME IMMUNOASSAY | Hycor Biomedical, Inc. | 1994-05-17 | 125 | 0 |
| K934594 | MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM | Ciba Corning Diagnostics Corp. | 1994-04-21 | 209 | 0 |
| K930890 | COBAS(R) CORE IGE TOTAL EIA | Roche Diagnostic Systems, Inc. | 1993-08-05 | 164 | 0 |
| K933180 | QUANTA LITE MITOCHONDRIA M2 ELISA | Inova Diagnostics, Inc. | 1993-08-05 | 36 | 0 |
| K930984 | ACCESS(R) TOTAL IGE ASSAY | Bio-Rad Laboratories, Inc. | 1993-06-09 | 104 | 0 |
| K923832 | PHARMACIA CAP SYSTEM IGE FEIA -- MODIFICATION | Kabi Pharmacia, Inc. | 1992-11-25 | 120 | 0 |
| K922047 | IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064 | Medix Biotech, Inc. | 1992-08-05 | 96 | 0 |
| K920372 | ACS TOTAL IGE IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1992-04-08 | 71 | 0 |
| K912800 | KALLESTEAD TOTAL IGE MICROPLATE KIT | Bio-Rad Laboratories, Inc. | 1991-07-25 | 30 | 0 |
| K910419 | BIOCLONE'S ELEGANCE IGE ELISA KIT | Bioclone Australia Pty , Ltd. | 1991-06-21 | 142 | 0 |
| K911631 | PHARMACIA SPECIFIC IGE CONTROL | Pharmacia, Inc. | 1991-04-24 | 13 | 0 |
| K910082 | POSITIVE CONTROL PAD FOR TOTAL IGE TEST DIPSTICK | Quidel Corp. | 1991-03-12 | 63 | 0 |
| K905612 | VENTREX COATED TUBE IGE RADIOIMMUNOASSAY | Ventrex Laboratories, Inc. | 1991-02-21 | 69 | 0 |
| K903738 | QUIDEL ALLERGEN SCREEN POSITIVE CONTROL | Quidel Corp. | 1990-10-15 | 60 | 0 |
| K903195 | LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM ASSAY | London Diagnostics, Inc. | 1990-08-02 | 14 | 0 |
| K900108 | 3M MULTI-ALLER. IGE FASTSCREEN S9 W1,6,9,10,11,12 | 3M Company | 1990-02-21 | 43 | 0 |
| K900244 | 3M MULTI-ALLERGEN IGE FASTSCREEN(TM) S8 | 3M Company | 1990-02-21 | 35 | 0 |
| K895914 | ABBOTT IMX IGE | Abbott Laboratories | 1989-11-13 | 34 | 0 |
| K895004 | MILENIA(TM) TOTAL IGE (MKIE1,5) | Diagnostic Products Corp. | 1989-09-28 | 51 | 0 |
| K895294 | PROGENE IGE BEAD EIA | Progene Corp. | 1989-09-21 | 27 | 0 |
| K893951 | PHARMACIA CAP SYSTEM IGE RIA AND FEIA | Pharmacia, Inc. | 1989-07-14 | 43 | 0 |
| K892197 | ALATOP (TM) CATALOG # AKAL1 | Diagnostic Products Corp. | 1989-06-02 | 60 | 0 |
| K890530 | N LATEX IGE KIT (IMMUNOGLOBULIN E REAGENTS) | Behring Diagnostics, Inc. | 1989-03-27 | 53 | 0 |
| K885307 | FLIPSCREEN (TM) TOTAL E IMMUNOASSAY | Alerchek, Inc. | 1989-03-08 | 71 | 0 |
| K884545 | DELFIA (TM) HIGE KIT | Pharmacia, Inc. | 1988-11-10 | 10 | 0 |
| K882625 | PHARMACIA IGE RIA ULTRA | Pharmacia, Inc. | 1988-08-08 | 42 | 0 |
| K882626 | PHARMACIA IGE EIA ULTRA | Pharmacia, Inc. | 1988-08-04 | 38 | 0 |
| K881892 | PHARMACIA IGE RIACT | Pharmacia, Inc. | 1988-06-10 | 37 | 0 |
| K874541 | RRT TOTAL IGE TEST KIT | Incstar Corp. | 1988-02-17 | 106 | 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