DGC · Ige, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5510 · Class 2
Overview
| Product Code | DGC |
|---|---|
| Device Name | Ige, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5510 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 114)
Showing 20 most recent of 114 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K231151 | Kenota 1 Total IgE; Kenota 1 (instrument) | Kenota, Inc. | May 31, 2024 | SESE |
| K214068 | Quantia IgE | Biokit, S.A. | Feb 21, 2023 | SESE |
| K220178 | Total Immunoglobulin E (IgE) | Beckman Coulter, Inc. | Mar 23, 2022 | SESE |
| K193493 | ADVIA Centaur Total IgE (tIgE) | Siemens Healthcare Diagnostics, Inc. | Jan 15, 2020 | SESE |
| K161899 | ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls | Phadia AB | Jul 28, 2016 | SESE |
| K133404 | IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH | Phadia AB | Feb 24, 2014 | SESE |
| K063425 | DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH | Dade Behring, Inc. | Feb 15, 2007 | SESE |
| K050493 | QUANTIA IGE | Biokit, S.A. | Aug 16, 2005 | SESE |
| K042241 | K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C | Kamiya Biomedical Co. | Dec 10, 2004 | SESE |
| K034057 | LACRYTEST | Adiatec SA | Mar 9, 2004 | SESE |
| K032251 | IMMUNETECH TOTAL IGE SYSTEM | Immunetech Corporation | Dec 19, 2003 | SESE |
| K024210 | IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR | Beckman Coulter, Inc. | Feb 24, 2003 | SESE |
| K010855 | RANDOX IGE | Randox Laboratories, Ltd. | May 15, 2001 | SESE |
| K002560 | SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT | The Binding Site, Ltd. | Oct 26, 2000 | SESE |
| K992528 | BIOCHECK IGE ELISA, MODEL BC-1035 | Biocheck, Inc. | Sep 21, 1999 | SESE |
| K991316 | TOUCH TEAR IGE MICROASSAY KIT | Touch Scientific, Inc. | Aug 9, 1999 | SESE |
| K991945 | PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01 | Pharmacia & Upjohn Co. | Jul 28, 1999 | SESE |
| K991787 | N LATEX IGE MONO REAGENT | Dade Behring, Inc. | Jul 7, 1999 | SESE |
| K983185 | BOEHRINGER MANNHEIM TINA-QUANT IGE TEST | Boehringer Mannheim Corp. | Nov 12, 1998 | SESE |
| K972697 | AIA-PACK IGE II ASSAY | Tosoh Medics, Inc. | Oct 3, 1997 | SESE |
Top Applicants
- Pharmacia, Inc. — 16 clearances
- Ventrex Laboratories, Inc. — 12 clearances
- Kallestad Laboratories, Inc. — 8 clearances
- Diagnostic Products Corp. — 6 clearances
- Hybritech, Inc. — 4 clearances
