Lambda, Antigen, Antiserum, Control
FDA product code DEH · Class II (moderate risk) · 21 CFR 866.5550 · Immunology
53510(k) clearances
0PMA approvals
4recalls
Manufacturers
- Ventana Medical Systems, Inc. 17
- Dako Corp. 9
- The Binding Site, Ltd. 7
- Kallestad Laboratories, Inc. 4
- Biotek Solutions, Inc. 4
- Icl Scientific 2
- Gelco Diagnostics, Inc. 2
- G.D. Searle and Co. 1
- Protos Laboratories 1
- Diagnostica, Inc. 1
- Bartels Immunodiagnostic Supplies, Inc. 1
- Kallestad Diag, A Div. of Erbamont, Inc. 1
- Beckman Instruments, Inc. 1
- SENTINEL CH. SpA 1
- The Binding Site Group , Ltd. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K172471 | VENTANA CD30 (Ber-H2) RxDx AssayDEH · Traditional | Ventana Medical Systems, Inc. | 05/08/2018SE |
| K140396 | Freelite Human Lambda Free KitDEH · Traditional | The Binding Site Group , Ltd. | 04/16/2014SE |
| K083601 | Lambda Light ChainsDEH · Traditional | SENTINEL CH. SpA | 06/22/2009SE |
| K033811 | Freelite Human Kappa and Lambda Free Kits for Use on the Olympus Au AnalyzerDEH · Traditional | The Binding Site, Ltd. | 01/30/2004SE |
| K031016 | Freelite Human Kappa and Lambda Free Kits for Use on the Dad Behring Nephelometer IIDEH · Traditional | The Binding Site, Ltd. | 07/15/2003SE |
| K023131 | Freelite Human Lambda Free KitDEH · Traditional | The Binding Site, Ltd. | 01/21/2003SE |
| K010441 | Freelite Kappa Free KitDEH · Traditional | The Binding Site, Ltd. | 04/26/2001SE |
| K010440 | Freelite Lambda Free KitDEH · Traditional | The Binding Site, Ltd. | 04/26/2001SE |
| K003671 | Lambda Immage Freelite KitDEH · Traditional | The Binding Site, Ltd. | 02/01/2001SE |
| K002563 | Sheep Anti-Human Lambda Free Light Chain Immunofixation Grade KitDEH · Traditional | The Binding Site, Ltd. | 10/26/2000SE |
| K971905 | Dako Mouse Anti Human Cytokeratin, High Molecular Weight, Clone 34BE12, Monoclonal…DEH · Traditional | Dako Corp. | 12/12/1997SE |
| K965022 | Monoclonal Mouse Anti-Human CD30, KI-1 Antigen, BER-H2 Antibody for Immunoenzymatic…DEH · Traditional | Dako Corp. | 11/06/1997SE |
| K940583 | Ventana CD45 Primary AntibodyDEH · Traditional | Ventana Medical Systems, Inc. | 10/20/1997SE |
| K973393 | Chemmate LcaDEH · Traditional | Ventana Medical Systems, Inc. | 09/25/1997SE |
| K941514 | Ventana ANTI-S100 Primary AntibodyDEH · Traditional | Ventana Medical Systems, Inc. | 04/25/1997SE |
| K941170 | Ventana Anti-Melanoma Primary AntibodyDEH · Traditional | Ventana Medical Systems, Inc. | 04/22/1997SE |
| K941707 | Anti-Muscle Actin Primary AntibodyDEH · Traditional | Ventana Medical Systems, Inc. | 04/21/1997SE |
| K941784 | Ventana ANTI-CD8 Primary AntibodyDEH · Traditional | Ventana Medical Systems, Inc. | 02/14/1997SE |
| K941604 | Ventana ANTI-CD4 Primary AntibodyDEH · Traditional | Ventana Medical Systems, Inc. | 02/14/1997SE |
| K941516 | Ventanna Anti-Desmin Primary AntibodyDEH · Traditional | Ventana Medical Systems, Inc. | 02/10/1997SE |
| K941397 | Anti-Vimentin Primary AntibodyDEH · Traditional | Ventana Medical Systems, Inc. | 02/10/1997SE |
| K941782 | Ventana ANTI-CD5 Primary AntibodyDEH · Traditional | Ventana Medical Systems, Inc. | 09/10/1996SE |
| K951965 | Dako Labeled Streptavidin-Biotin 2 Kit, and EnvisionDEH · Traditional | Dako Corp. | 07/05/1996SE |
| K950148 | Chemmate(Tm) CD43DEH · Traditional | Biotek Solutions, Inc. | 07/02/1996SE |
| K941505 | Ventanna ANTI-CD3 Primary AntibodyDEH · Traditional | Ventana Medical Systems, Inc. | 05/30/1996SE |
| K941173 | Anti-Keratin-Hmw Primary Anti-BodyDEH · Traditional | Ventana Medical Systems, Inc. | 03/22/1996SE |
| K935161 | Keratin Primary AntibodyDEH · Traditional | Ventana Medical Systems, Inc. | 03/22/1996SE |
| K936111 | Chemmate Special Stain LCA-CD45DEH · Traditional | Biotek Solutions, Inc. | 02/27/1996SE |
| K940331 | Keratin Primary AntibodyDEH · Traditional | Ventana Medical Systems, Inc. | 02/26/1996SE |
| K950149 | Chemmate(Tm) LambdaDEH · Traditional | Biotek Solutions, Inc. | 12/06/1995SE |
| K940424 | Ventana Blue Detection KitDEH · Traditional | Ventana Medical Systems, Inc. | 11/06/1995SE |
| K950151 | Chemmate(Tm) L26 (CD20)DEH · Traditional | Biotek Solutions, Inc. | 10/04/1995SE |
| K931192 | Dako Rabbit Anti-Cow S-100 Polyclonal AntibodyDEH · Traditional | Dako Corp. | 04/20/1995SE |
| K924804 | Dako Mouse Anti-Human T-CellDEH · Traditional | Dako Corp. | 11/21/1994SE |
| K932136 | Dako Mouse Anti-Human Melanoma (Dako ANTI-HMB45)DEH · Traditional | Dako Corp. | 06/13/1994SE |
| K924726 | Dako Mouse Anti-Human B-Cell (DAKO-C020-L26 Mono AntiDEH · Traditional | Dako Corp. | 06/13/1994SE |
| K932326 | Psa Antibody KitDEH · Traditional | Ventana Medical Systems, Inc. | 08/06/1993SE |
| K896918 | Mouse Anti-Human Leucocyte Antigen & Dako Pap KitDEH · Traditional | Dako Corp. | 08/27/1990SE |
| K902485 | Beckman Lambda Light Chain Reagent (Add'L Claims)DEH · Traditional | Beckman Instruments, Inc. | 06/21/1990SE |
| K875165 | QM300 Lambda Light Chains Antibody PackDEH · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 01/22/1988SE |
| K855013 | Quantimetric Plus Support PackDEH · Traditional | Kallestad Laboratories, Inc. | 02/26/1986SE |
| K855007 | Quantimetric Plus Lambda Reagent KitDEH · Traditional | Kallestad Laboratories, Inc. | 02/26/1986SE |
| K852999 | Qvantimetric 2KAPPA and Lambda Test KitDEH · Traditional | Kallestad Laboratories, Inc. | 10/21/1985SE |
| K842328 | Amer. Histo-Id Sys Primary Lambda ChainDEH · Traditional | Bartels Immunodiagnostic Supplies, Inc. | 08/03/1984SE |
| K841864 | Quantimetric TM 2 Kappa & Lambda KitDEH · Traditional | Kallestad Laboratories, Inc. | 07/11/1984SE |
| K832270 | Goat Anti-Human LambaDEH · Traditional | Gelco Diagnostics, Inc. | 10/31/1983SE |
| K832261 | Goat Anti-Human Lamba AffinityDEH · Traditional | Gelco Diagnostics, Inc. | 10/28/1983SE |
| K812662 | Immunogl. Fract. of Rabbit Antis./LambdaDEH · Traditional | Dako Corp. | 09/29/1981SE |
| K791283 | Anti-Human Lambda SerumDEH · Traditional | Diagnostica, Inc. | 11/27/1979SE |
| K791115 | Goar Anti-Human Lamboda ChainDEH · Traditional | Protos Laboratories | 08/03/1979SE |
| K781220 | Anti-Human Lambda SerumDEH · Traditional | Icl Scientific | 07/27/1978SE |
| K781025 | Lambda Serum (Free) Anti-HumanDEH · Traditional | Icl Scientific | 07/27/1978SE |
| K771768 | Goat Lambda-Light Chain Anti-Human SerumDEH · Traditional | G.D. Searle and Co. | 10/07/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0274-2022 Class II | Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human…Due to calibration curves producing a higher activity than routinely expected and that there may be a… | The Binding Site Group, Ltd. | 10/15/2021Terminated |
| Z-1053-2017 Class II | Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S…A change in the calibration curve causing an increase in false prozone flags. | The Binding Site Group, Ltd. | 10/28/2016Terminated |
| Z-1043-2017 Class II | Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing…Batch numbers listed are reporting Lambda Free Light Chain results >114mg/L that are on average 33% lower… | The Binding Site Group, Ltd. | 07/05/2016Terminated |
| Z-1050-2017 Class II | Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and…Calibration curve activity has increased over time in the kit lots listed. | The Binding Site Group, Ltd. | 11/28/2012Terminated |