Radioimmunoassay, Immunoreactive Insulin
FDA product code CFP · Class I (low risk) · 21 CFR 862.1405 · Clinical Chemistry
27510(k) clearances
0PMA approvals
7recalls
Manufacturers
- Micromedic Systems 2
- Ventrex Laboratories, Inc. 2
- Bd Becton Dickinson Vacutainer Systems Preanalytic 2
- Icl Scientific 1
- American Laboratory Products Co., Ltd. 1
- Tosoh Corp. 1
- Boehringer Mannheim Corp. 1
- Helena Laboratories 1
- Cambridge Medical Technology 1
- Pharmacia, Inc. 1
- Sorin Biomedica, Fiat, USA, Inc. 1
- Wako Chemicals USA, Inc. 1
- Immuchem Corp. 1
- Diagnostic Products Corp. 1
- Clinical Assays, Inc. 1
- Corning Medical & Scientific 1
- Endocrine-Metabolic Center 1
- Serono Laboratories, Inc. 1
- Inter Science Institute 1
- Radioassay Systems Laboratories, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K963911 | Alpco/Mercodia Insulin ElisaCFP · Traditional | American Laboratory Products Co., Ltd. | 11/01/1996SE |
| K953084 | Access Ultrasensitive Insulin AssayCFP · Traditional | Bio-Rad Laboratories, Inc. | 09/25/1995SE |
| K920109 | Imx InsulinCFP · Traditional | Abbott Laboratories | 05/07/1992SE |
| K914820 | DSL Insulin Ria (DSL 1600)CFP · Traditional | Diagnostic Systems Laboratories, Inc. | 01/09/1992SE |
| K903628 | Aia-Pack IriCFP · Traditional | Tosoh Corp. | 09/07/1990SE |
| K901135 | Enzymun Test(R) InsulinCFP · Traditional | Boehringer Mannheim Corp. | 04/03/1990SE |
| K896572 | Rep(Tm) Spe PLUS-30 ProceduresCFP · Traditional | Helena Laboratories | 01/11/1990SE |
| K890837 | Ria-Gnost InsulinCFP · Traditional | Cambridge Medical Technology | 04/26/1989SE |
| K851071 | Pharmacia Insulin RiaCFP · Traditional | Pharmacia, Inc. | 04/12/1985SE |
| K841573 | Insulin Radioimmunoassay KitCFP · Traditional | Sorin Biomedica, Fiat, USA, Inc. | 05/16/1984SE |
| K823939 | Wako Insulin TestCFP · Traditional | Wako Chemicals USA, Inc. | 01/28/1983SE |
| K822509 | Covalent Coat Ria KitCFP · Traditional | Immuchem Corp. | 09/28/1982SE |
| K821861 | Coat-A-Count Insulin KitCFP · Traditional | Diagnostic Products Corp. | 07/08/1982SE |
| K821374 | Enzymune-Test InsulinCFP · Traditional | Icl Scientific | 05/28/1982SE |
| K812227 | Gammacoat (125) Insulin RadioimmunoassayCFP · Traditional | Clinical Assays, Inc. | 09/24/1981SE |
| K811953 | Immophase Insulin (125I) RadioassayCFP · Traditional | Corning Medical & Scientific | 07/23/1981SE |
| K811423 | Ventre/SepCFP · Traditional | Ventrex Laboratories, Inc. | 06/09/1981SE |
| K811144 | Aria II Insulin RiaCFP · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 05/15/1981SE |
| K792279 | Autopak 12 Insulin Test Delivery SystemCFP · Traditional | Micromedic Systems | 12/06/1979SE |
| K791707 | Centria Insulin RiaCFP · Traditional | Ventrex Laboratories, Inc. | 10/17/1979SE |
| K790630 | Ria, Insulin, Double AntibodyCFP · Traditional | Endocrine-Metabolic Center | 07/24/1979SE |
| K781285 | Insulin Ria KitCFP · Traditional | Serono Laboratories, Inc. | 08/14/1978SE |
| K781086 | Insulin AutopakCFP · Traditional | Micromedic Systems | 08/14/1978SE |
| K771947 | Insulin Ria ModuleCFP · Traditional | Inter Science Institute | 01/20/1978SE |
| K772281 | RSL Insulin KitCFP · Traditional | Radioassay Systems Laboratories, Inc. | 01/06/1978SE |
| K771979 | Centria Insulin RiaCFP · Traditional | Union Carbide Corp. | 11/17/1977SE |
| K771628 | Nsulin Ria Kit 125ICFP · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 09/20/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0921-2025 Class II | DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361The user of the assay may either face a failure message during re-calibration of the Hybrid.XL instrument… | DRG International, Inc. | 10/07/2024Open, Classified |
| Z-0981-2024 Class II | Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer…There is an issue with the Access Ultrasensitive Insulin assay protocol file (APF) for use with the DxI 9000… | Beckman Coulter, Inc. | 11/21/2023Open, Classified |
| Z-2076-2018 Class II | ST-AIA PACK IRI; Part Number: 025260 Assay, DiabetesAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | Tosoh Bioscience Inc | 03/05/2018Terminated |
| Z-2086-2017 Class II | ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 02230141, for…Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay recover approximately 40% higher than the World… | Siemens Healthcare Diagnostics, Inc | 04/05/2017Terminated |
| Z-1701-2012 | IMMULITE 2000 --- Insulin --- Catalog Number: L2KIN2 (200 test), L2KIN6 (600 tests) ---…Siemens Healthcare Diagnostics has observed a negative bias in the Immulite Insulin assay. | Siemens Healthcare Diagnostics | 04/30/2012Terminated |
| Z-1700-2012 | IMMULITE --- Insulin --- Catalog Number: LKIN1 (100 test), LKIN5 (500 tests) --- Test…Siemens Healthcare Diagnostics has observed a negative bias in the Immulite Insulin assay. | Siemens Healthcare Diagnostics | 04/30/2012Terminated |
| Z-1160-2008 | Access Ultrasensitive Insulin Assay Kit, Part Number 33410. The product is a…False negative results when used to test serum samples (as compared to plasma samples). | Beckman Coulter Inc | 09/19/2007Terminated |