Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DFH — Predicate Candidate Screening
63 FDA 510(k) clearances under this product code; the 50 most recent screened below.
75 daysmedian FDA review time
311 days90th percentile
63clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253358 | Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Huma | Diazyme Laboratories, Inc. | 2025-12-19 | 80 | 0 |
| K250549 | Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx | The Binding Site Group , Ltd. | 2025-05-23 | 87 | 0 |
| K231601 | FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level | Sebia | 2024-02-23 | 267 | 0 |
| K231290 | Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lamb | The Binding Site, Ltd. | 2024-01-24 | 265 | 0 |
| K210623 | FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Leve | Sebia | 2022-11-18 | 626 | 0 |
| K211648 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human La | Diazyme Laboratories, Inc. | 2022-09-08 | 468 | 0 |
| K220001 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human La | Diazyme Laboratories, Inc. | 2022-08-04 | 212 | 0 |
| K212379 | N Latex FLC kappa, N Latex FLC lambda | Siemens Healthcare Diagnostics Products GmbH | 2022-03-02 | 212 | 0 |
| K201496 | N Latex FLC kappa, N Latex FLC lambda | Siemens Healthcare Diagnostics Products GmbH | 2021-10-29 | 511 | 0 |
| K193047 | N Latex FLC kappa, N Latex FLC lambda | Siemens Healthcare Diagnostics Products GmbH | 2021-07-14 | 621 | 0 |
| K190879 | N Latex FLC kappa, N Latex FLC lambda | Siemens Healthcare Diagnostics Products GmbH | 2019-05-03 | 29 | 0 |
| K182098 | N Latex FLC kappa assay, N Latex FLC lambda assay | Siemens Healthcare Diagnostics Products GmbH | 2018-11-01 | 90 | 0 |
| K173732 | Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx La | The Binding Site Group , Ltd. | 2018-08-23 | 260 | 0 |
| K181438 | Diazyme Human Kappa Free Light Chain Assay; Diazyme Human La | Diazyme Laboratories, Inc. | 2018-06-26 | 25 | 0 |
| K171742 | N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Sta | Siemens Healthcare Diagnostics Products GmbH | 2017-11-17 | 158 | 0 |
| K153394 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human La | Diazyme Laboratories | 2016-11-18 | 360 | 0 |
| K150658 | Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda F | The Binding Site Group , Ltd. | 2015-08-26 | 166 | 1 |
| K120056 | HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALY | The Binding Site Group , Ltd. | 2013-04-01 | 448 | 0 |
| K083602 | KAPPA LIGHT CHAINS | SENTINEL CH. SpA | 2009-09-03 | 272 | 0 |
| K082503 | DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA | Siemens Healthcare Diagnostics | 2008-12-19 | 112 | 0 |
| K070900 | FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FO | The Binding Site, Ltd. | 2007-11-30 | 242 | 0 |
| K062372 | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPA | The Binding Site, Ltd. | 2007-06-21 | 311 | 2 |
| K051915 | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAY | The Binding Site, Ltd. | 2005-09-06 | 53 | 0 |
| K042939 | CAPILLARY'S IMMUNOTYPING (PN 2100) | Sebia, Inc. | 2005-06-27 | 245 | 0 |
| K040009 | FREELITE HUMAN KAPPA AND LAMBDA KITS | The Binding Site, Ltd. | 2004-03-11 | 69 | 0 |
| K023009 | FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON T | The Binding Site, Ltd. | 2003-01-21 | 134 | 0 |
| K003669 | KAPPA IMMAGE FREELITE KIT | The Binding Site, Ltd. | 2001-02-01 | 65 | 0 |
| K002564 | SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE | The Binding Site, Ltd. | 2000-10-26 | 70 | 0 |
| K964260 | IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGEN | Beckman Instruments, Inc. | 1997-02-10 | 108 | 0 |
| K950152 | CHEMMATE(TM) UCHL1 (CD45-RO) | Biotek Solutions, Inc. | 1995-10-27 | 283 | 0 |
| K950150 | CHEMMATE(TM) KAPPA | Biotek Solutions, Inc. | 1995-10-27 | 283 | 0 |
| K902484 | BECKMAN KAPPA LIGHT CHAIN REAGENT (ADD'L CLAIMS) | Beckman Instruments, Inc. | 1990-06-21 | 16 | 0 |
| K884597 | BECKMAN LAMBDA LIGHT CHAIN REAGENT | Beckman Instruments, Inc. | 1988-12-06 | 55 | 0 |
| K884276 | BECKMAN KAPPA LIGHT CHAIN REAGENT | Beckman Instruments, Inc. | 1988-11-16 | 35 | 0 |
| K880341 | N-IMMUNOGLOBULIN LIGHT CHAIN KIT | Behring Diagnostics, Inc. | 1988-02-17 | 22 | 0 |
| K875164 | QM300 KAPPA LIGHT CHAINS ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-01-22 | 37 | 0 |
| K855008 | QUANTIMETRIC PLUS KAPPA REAGENT KIT | Kallestad Laboratories, Inc. | 1986-02-26 | 72 | 0 |
| K842470 | TISSUE-TEK IMMUNOHISTOLOGY KIT LYSOZZM | Miles Laboratories, Inc. | 1984-08-28 | 64 | 0 |
| K842326 | AMER. HISTO-ID SYS PRIMARY KIT | Bartels Immunodiagnostic Supplies, Inc. | 1984-08-02 | 50 | 0 |
| K832266 | FITC GOAT ANTI-HUMAN KAPPA AFFINITY | Gelco Diagnostics, Inc. | 1983-10-31 | 123 | 0 |
| K832256 | GOAT ANTI-HUMAN IMMUNOGLOBULINS- | Gelco Diagnostics, Inc. | 1983-10-31 | 123 | 0 |
| K822668 | ANTISERUM TO HUMAN IGA | Amico Lab, Inc. | 1982-11-17 | 75 | 0 |
| K822676 | FITC ANTISERA TO HUMAN IGG | Amico Lab, Inc. | 1982-11-17 | 75 | 0 |
| K822666 | ANTISERUM TO HUMAN KAPPA | Amico Lab, Inc. | 1982-11-17 | 75 | 0 |
| K822677 | FITC ANTISERA TO HUMAN IGM | Amico Lab, Inc. | 1982-11-17 | 75 | 0 |
| K822673 | FITC ANTISERA TO HUMAN KAPPA | Amico Lab, Inc. | 1982-11-17 | 75 | 0 |
| K822670 | ANTISERUM TO HUMAN IGM | Amico Lab, Inc. | 1982-11-17 | 75 | 0 |
| K822667 | ANTISERUM TO HUMAN LAMBDA | Amico Lab, Inc. | 1982-11-17 | 75 | 0 |
| K822674 | FITC ANTISERA TO HUMAN LAMBDA | Amico Lab, Inc. | 1982-11-17 | 75 | 0 |
| K822679 | FITC ANTISERA TO HUMAN C3 | Amico Lab, Inc. | 1982-11-17 | 75 | 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