510(k) · Cleared
Recalled · Class II · 2020Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Binding Site Group, Ltd. · DFH Kappa, Antigen, Antiserum, Control
Cleared on Aug 23, 2018 as substantially equivalent to K040009 (The Binding Site, Ltd., 2004) after a 260-day review. Its family tree reaches back 1 generation to 2004. It has been recalled once.
- Decided
- Aug 23, 2018
- Review
- 260 days
- Class
- Class II
- Product code
- DFH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K040009 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK040009 Freelite Human Kappa and Lambda KitsThe Binding Site, Ltd. · 2004
- This deviceK173732 Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda…The Binding Site Group, Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K040009 | Freelite Human Kappa and Lambda Kits | The Binding Site, Ltd. | 2004 | — |
| 0 (this device) | K173732 | Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit | The Binding Site Group, Ltd. | 2018 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DFH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DFH device
- #1 K253358 Diazyme Human Kappa (k) Free Light Chain…score 10.5 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040009 | Freelite Human Kappa and Lambda KitsSummary page 6…10(k) number: Freelite® Human Kappa Free Kit for use on the Siemens BN™II (K) and Freelite® Human Lambda Free Kit for use on the Siemens BN™II (K040009) Optilite Freelite Mx Kappa Free and Lambda Free Kits… | 2004 |
| † | K110035 | Indiko | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 18, 2020 | Class II | Z-0943-2021 | Under Investigation by firm | Due to customer complaints of positive bias impacting quality control. The high and low level controls are demonstrating a positive bias compared to assigned values. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K040009.
How does its category compare?
All DFH devicesDFH Kappa, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · DFH
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DFH
340in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DFH
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DFH
10in 2025
MAUDE reports naming product code DFH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 3 | 90 | 0 | 0 |
| 2019 | 1 | — | 0 | 4 |
| 2020 | 0 | — | 1 | 0 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 4 | 340 | 0 | 11 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 2 | — | 0 | 13 |
| 2025 | 2 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Optilite Freelite Mx Kappa Free Kit is intended for the quantitative in vitro measurement of Kappa free light chains in serum and urine using the Binding Site Optilite analyser. Measurement of free light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenström’s macroglobulinaemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus (SLE) in…
Read the full statement (144 words)
The Optilite Freelite Mx Kappa Free Kit is intended for the quantitative in vitro measurement of Kappa free light chains in serum and urine using the Binding Site Optilite analyser. Measurement of free light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenström’s macroglobulinaemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings.
The Optilite Freelite Mx Lambda Free Kit is intended for the quantitative in vitro measurement of Lambda free light chains in serum and urine using the Binding Site Optilite analyser. Measurement of free light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenström’s macroglobulinaemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173732 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173732: Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173732
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026