510(k) Report

510(k) · Cleared

Cleared

Hevylite Human Igg Kappa Kit and Hevylite Human Igg Lambda Kit

K132555510(k) TraditionalCleared Dec 20, 2013128-day reviewClass II21 CFR 866.5510

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

The Binding Site · PCN Immunoglobulin G Kappa Heavy And Light Chain Combined

Cleared on Dec 20, 2013 after a 128-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.

Decided
Dec 20, 2013
Review
128 days
Class
Class II
Product code
PCN
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2018: 1 descendant cleared2010201520202025
  1. This deviceK132555 Hevylite Human Igg Kappa Kit and Hevylite Human Igg Lambda KitThe Binding Site · 2013
  2. Descendant · cites it directly · 0 of its ownK172613 Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda KitThe Binding Site Group, Ltd. · 2018

Most influential descendants

Showing 1 of 1 · See all
  • K172613Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda KitThe Binding Site Group, Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K132555Hevylite Human Igg Kappa Kit and Hevylite Human Igg Lambda KitThe Binding Site2013—
+1K172613Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda KitThe Binding Site Group, Ltd.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
FIG. 1 — Lineage of K132555, 2013–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 PCN? 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
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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K172613Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda KitThe Binding Site Group, Ltd.20180

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.

What does this lineage say?

  • Of its descendants, K172613 (The Binding Site Group, Ltd., 2018) has gone furthest, with 0 descendants of its own.

How does its category compare?

All PCN devices

PCN Immunoglobulin G Kappa Heavy And Light Chain Combined: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · PCN

1in 2018

2013: 12016: 12018: 1
2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PCN

Too few PCN 510(k)s in any year since 2007 to give a median.

Recalls per year · PCN

No recall names PCN since 2007.

Adverse event reports per year · PCN

No MAUDE report names PCN since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20131—00
20140—00
20150—00
20161—00
20170—00
20181—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

Hevylite Human IgG Kappa is a quantitative in vitro assay performed on the Siemens BN II nephelometer for the measurement of IgG Kappa (IgG heavy chain and Kappa light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgG Kappa is used alongside Hevylite Human IgG Lambda to calculate the IgG Kappa / IgG Lambda ratio. The Hevylite Human IgG Kappa / IgG Lambda ratio can be used when monitoring previously diagnosed IgG multiple myeloma…

Read the full statement (208 words)

Hevylite Human IgG Kappa is a quantitative in vitro assay performed on the Siemens BN II nephelometer for the measurement of IgG Kappa (IgG heavy chain and Kappa light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgG Kappa is used alongside Hevylite Human IgG Lambda to calculate the IgG Kappa / IgG Lambda ratio. The Hevylite Human IgG Kappa / IgG Lambda ratio can be used when monitoring previously diagnosed IgG multiple myeloma and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments.

Hevylite Human IgG Lambda is a quantitative in vitro assay performed on the Siemens BN II nephelometer for the measurement of IgG Lambda (IgG heavy chain and Lambda light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgG Lambda is used alongside Hevylite Human IgG Kappa to calculate the IgG Kappa / IgG Lambda ratio. The Hevylite Human IgG Kappa / IgG Lambda ratio can be used when monitoring previously diagnosed IgG multiple myeloma and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments.

Indications for use as stated in the FDA 510(k) statement.

More from The Binding Site

10 FDA decisions under this applicant name. See the company

  • K140105Hevylite Human Iga Kappa Kit for Use on Siemens Bnii, Hevylite Human Iga Lambda Kit for Use on Siemens BniiThe Binding Site · 2014
  • K103824Human Iga Liquid Reagent Kit for Use on Spa PlusThe Binding Site · 2012
  • K100455Spaplus AnalyzerThe Binding Site · 2010
  • K092450Human Igd Kit for Use on SpaplusThe Binding Site · 2009
  • K072166Cystatin C Kit for Use on the Spaplus AnalyzerThe Binding Site · 2008

Recent decisions in PCN

The PCN category page

  • K172613Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda KitThe Binding Site Group, Ltd. · 2018
  • K161854Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUSThe Binding Site Group, Ltd. · 2016

https://510kreport.com/device/K132555 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132555: Hevylite Human Igg Kappa Kit and Hevylite Human Igg Lambda Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132555

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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