Product code DFH
- Device name
- Kappa, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5550
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253358 | Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay | Diazyme Laboratories, Inc. | 2025-12-19 |
| K250549 | Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit | The Binding Site Group , Ltd. | 2025-05-23 |
| K231601 | FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 | Sebia | 2024-02-23 |
| K231290 | Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit | The Binding Site, Ltd. | 2024-01-24 |
| K210623 | FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 | Sebia | 2022-11-18 |
| K211648 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay | Diazyme Laboratories, Inc. | 2022-09-08 |
| K220001 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay | Diazyme Laboratories, Inc. | 2022-08-04 |
| K212379 | N Latex FLC kappa, N Latex FLC lambda | Siemens Healthcare Diagnostics Products GmbH | 2022-03-02 |
| K201496 | N Latex FLC kappa, N Latex FLC lambda | Siemens Healthcare Diagnostics Products GmbH | 2021-10-29 |
| K193047 | N Latex FLC kappa, N Latex FLC lambda | Siemens Healthcare Diagnostics Products GmbH | 2021-07-14 |
| K190879 | N Latex FLC kappa, N Latex FLC lambda | Siemens Healthcare Diagnostics Products GmbH | 2019-05-03 |
| K182098 | N Latex FLC kappa assay, N Latex FLC lambda assay | Siemens Healthcare Diagnostics Products GmbH | 2018-11-01 |
| K173732 | Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit | The Binding Site Group , Ltd. | 2018-08-23 |
| K181438 | Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay | Diazyme Laboratories, Inc. | 2018-06-26 |
| K171742 | N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2 | Siemens Healthcare Diagnostics Products GmbH | 2017-11-17 |
| K153394 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain Calibrator | Diazyme Laboratories | 2016-11-18 |
| K150658 | Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit | The Binding Site Group , Ltd. | 2015-08-26 |
| K120056 | HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER | The Binding Site Group , Ltd. | 2013-04-01 |
| K083602 | KAPPA LIGHT CHAINS | SENTINEL CH. SpA | 2009-09-03 |
| K082503 | DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL | Siemens Healthcare Diagnostics | 2008-12-19 |
| K070900 | FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT | The Binding Site, Ltd. | 2007-11-30 |
| K062372 | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER | The Binding Site, Ltd. | 2007-06-21 |
| K051915 | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZER | The Binding Site, Ltd. | 2005-09-06 |
| K042939 | CAPILLARY'S IMMUNOTYPING (PN 2100) | Sebia, Inc. | 2005-06-27 |
| K040009 | FREELITE HUMAN KAPPA AND LAMBDA KITS | The Binding Site, Ltd. | 2004-03-11 |
| K023009 | FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI 911/912 ANALYZER | The Binding Site, Ltd. | 2003-01-21 |
| K003669 | KAPPA IMMAGE FREELITE KIT | The Binding Site, Ltd. | 2001-02-01 |
| K002564 | SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT | The Binding Site, Ltd. | 2000-10-26 |
| K964260 | IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT IMMAGE IMMUNOCHEMISTRY SYSTEM LAMDA LIGHT CHAIN (LAM) REAG | Beckman Instruments, Inc. | 1997-02-10 |
| K950152 | CHEMMATE(TM) UCHL1 (CD45-RO) | Biotek Solutions, Inc. | 1995-10-27 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05051700021104 | Freelite® Human Kappa Free Kit for use on the Roche cobas® c Systems | THE BINDING SITE GROUP LIMITED | 2026-02-02 |
| 03607360051023 | FLC Kappa | SEBIA | 2023-03-31 |
| 03607360051122 | FLC Control Level 1 | SEBIA | 2023-03-31 |
| 03607360051139 | FLC Control Level 2 | SEBIA | 2023-03-31 |
| 05051700019866 | Optilite Freelite Mx Kappa Free Kit | THE BINDING SITE GROUP LIMITED | 2018-11-16 |
| 00630414237480 | N FLC CONTROL SL1 | Siemens Healthcare Diagnostics Products GmbH | 2018-10-08 |
| 00630414237497 | N FLC STANDARD SL | Siemens Healthcare Diagnostics Products GmbH | 2018-10-08 |
| 00842768031434 | N FLC Supplementary Reagent | Siemens Healthcare Diagnostics Products GmbH | 2018-02-20 |
| 05051700019651 | Optilite Freelite Kappa Free Bulk Kit | THE BINDING SITE GROUP LIMITED | 2017-04-25 |
| 05051700006293 | Freelite® Human Kappa Free Kit for use on the Siem | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 00842768024436 | Dimension Vista® Flex® reagent cartridge LAMBDA | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 00842768012709 | N Antiserum to Human-Ig/L-chain, L-type | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 00842768012686 | N Antiserum to Human-Ig/L-chain, K-type | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 00842768006357 | DImension Vista® Protein 1 Control H (high) | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| B1761170 | Antiserum to Human Kappa (free and bound) | KENT LABORATORIES INC | 2016-09-24 |
| 05051700017794 | Optilite Freelite Kappa Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700016063 | Freelite® Human Kappa Free Kit for use on the Roch | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700012355 | Freelite® Human Kappa Free Kit for use on the Roche Cobas Integra® - Bulk kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700012188 | Freelite® Human Kappa Free Kit for use on the SPAP | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700012096 | Freelite® Human Kappa Free Kit for use on the Roch | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700010146 | Sheep Anti-Human Kappa Free Light Chains Immunofix | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700006378 | Freelite® Human Kappa Free Kit for use on the Siem | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700006354 | Freelite® Human Kappa Free Kit for use on the SPAP | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700006347 | Freelite® Human Kappa Free Kit for use on the Roche Cobas Integra® | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700006323 | Freelite® Human Kappa Free Kit for use on the Beck | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700006316 | Freelite® Human Kappa Free Kit for use on the HITA | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700006279 | Freelite® Human Kappa Free Kit for use on the Siem | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05700572000693 | Poly Rb A-Hu Kappa Free LC | Dako Denmark ApS | 2016-09-16 |
| 05700572000884 | Poly Rb A-Hu Kappa LC | Dako Denmark ApS | 2016-09-16 |
| 15099590230494 | IMMAGE | Beckman Coulter, Inc. | 2016-08-24 |