510(k) · Cleared
ClearedHevylite Human Iga Kappa Kit for Use on Siemens Bnii, Hevylite Human Iga Lambda Kit for Use on Siemens Bnii
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Binding Site · OPX Immunoglobulin A Kappa Heavy & Light Chain Combined
Cleared on Mar 18, 2014 after a 62-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Mar 18, 2014
- Review
- 62 days
- Class
- Class II
- Product code
- OPX
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OPX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All OPX devicesOPX Immunoglobulin A Kappa Heavy & Light Chain Combined: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · OPX
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · OPX
Too few OPX 510(k)s in any year since 2007 to give a median.
Recalls per year · OPX
No recall names OPX since 2007.
Adverse event reports per year · OPX
2in 2012
MAUDE reports naming product code OPX, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Hevylite Human IgA Kappa is a quantitative in vitro assay performed on the Siemens BN' It nephelonieter for the mecasurement of IIgA Kappa (IgA heavy chain and Kappa light chain intact immunoglobulin) in serom. Measurement of Hevylile Human IgA Kappa is used alongside Hevylite Human IgA Lambda to calculate the ]&A Kappa I IgA Lambda ratio. Ihe I levylite I luman IgA Kappa/I IgA Lambda ratio can be used when monitoring previously diagnosed tgA multiple…
Read the full statement (210 words)
Hevylite Human IgA Kappa is a quantitative in vitro assay performed on the Siemens BN' It nephelonieter for the mecasurement of IIgA Kappa (IgA heavy chain and Kappa light chain intact immunoglobulin) in serom. Measurement of Hevylile Human IgA Kappa is used alongside Hevylite Human IgA Lambda to calculate the ]&A Kappa I IgA Lambda ratio. Ihe I levylite I luman IgA Kappa/I IgA Lambda ratio can be used when monitoring previously diagnosed tgA multiple mycloma and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including imniunofixation. bone marrow and urine assessments.
Hevylite Human IgA Lambda is a quantitative in vitmo assay performed on the Sicrmens I)N I I nephelomecter for the measuremnt of IgA Lambda (lgA heavy chain and Lambda light chain intact imniunoglobulin) in serum. Measurement or alevylit Human IgA Lambda is used alongside Hevylite Human IgA Kappa to calculate the IgA Kappa / IgA Lambhda ratio.T1k I tevylite Itluman IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple mycloma and is used in conjlunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon oilier tests including immunofixation, bone marrow and urine assessments.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K140105 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140105: Hevylite Human Iga Kappa Kit for Use on Siemens Bnii, Hevylite Human Iga Lambda Kit for Use on Siemens Bnii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140105
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026