510(k) Report

510(k) · Cleared

Cleared

Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit

K172613510(k) TraditionalCleared Feb 15, 2018168-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 Group, Ltd. · PCN Immunoglobulin G Kappa Heavy And Light Chain Combined

Cleared on Feb 15, 2018 as substantially equivalent to K132555 (The Binding Site, 2013) after a 168-day review. Its family tree reaches back 1 generation to 2013.

Decided
Feb 15, 2018
Review
168 days
Class
Class II
Product code
PCN
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K132555 (2013). No later device cites it as a predicate yet.

K132555 · Hevylite Human Igg Kappa Kit and Hevylite Human Igg Lambda Kit · The Binding Site · 2013201020122014201620182020
K132555 · Hevylite Human Igg Kappa Kit and Hevylite Human Igg Lambda Kit · The Binding Site · 20130
  1. Root · 1 generation backK132555 Hevylite Human Igg Kappa Kit and Hevylite Human Igg Lambda KitThe Binding Site · 2013
  2. This deviceK172613 Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda KitThe Binding Site Group, Ltd. · 2018
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K132555Hevylite Human Igg Kappa Kit and Hevylite Human Igg Lambda KitThe Binding Site2013—
0 (this device)K172613Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda KitThe Binding Site Group, Ltd.2018—
FIG. 1 — Lineage of K172613, 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 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 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K132555Hevylite Human Igg Kappa Kit and Hevylite Human Igg Lambda Kit
Summary page 6
…1. Predicate device names and predicate 510(k) number: Hevylite Human IgG Kappa Kit and Hevylite Human IgG Lambda Kit for use on the Siemens BN™II (k132555) 2. Comparison with predicate: Similarities Item Devic…
The Binding Site2013—

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.

What does this lineage say?

  • Its one ancestor has no recall.

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. 2018, 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?

The Hevylite IgG Kappa kit is a quantitative in vitro assay intended for the measurement of IgG Kappa (IgG heavy chain and Kappa light chain intact immunoglobulin) in serum using the Binding Site Optilite analyser. Measurement of Hevylite IgG Kappa is used alongside Hevylite IgG Lambda to calculate the IgG Kappa / IgG Lambda ratio. The Hevylite IgG Kappa / IgG Lambda ratio can be used when monitoring previously diagnosed IgG multiple myeloma patients and…

Read the full statement (206 words)

The Hevylite IgG Kappa kit is a quantitative in vitro assay intended for the measurement of IgG Kappa (IgG heavy chain and Kappa light chain intact immunoglobulin) in serum using the Binding Site Optilite analyser. Measurement of Hevylite IgG Kappa is used alongside Hevylite IgG Lambda to calculate the IgG Kappa / IgG Lambda ratio. The Hevylite IgG Kappa / IgG Lambda ratio can be used when monitoring previously diagnosed IgG multiple myeloma patients 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.

The Hevylite IgG Lambda kit is a quantitative in vitro assay intended for the measurement of IgG Lambda (IgG heavy chain and Lambda light chain intact immunoglobulin) in serum using the Binding Site Optilite analyser. Measurement of Hevylite IgG Lambda is used alongside Hevylite IgG Kappa to calculate the IgG Kappa / IgG Lambda ratio. The Hevylite IgG Kappa / IgG Lambda ratio can be used when monitoring previously diagnosed IgG multiple myeloma patients 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 summary.

More from The Binding Site Group, Ltd.

43 FDA decisions under this applicant name. See the company

  • K250159Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT AnalyserThe Binding Site Group, Ltd. · 20251 recall
  • K250549Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free KitThe Binding Site Group, Ltd. · 2025
  • K192116Human IgA liquid reagent kit for Use on SPAPlusThe Binding Site Group, Ltd. · 2019
  • K191985Optilite IgA KitThe Binding Site Group, Ltd. · 2019
  • K191635Optilite IgM KitThe Binding Site Group, Ltd. · 20191 recall

Recent decisions in PCN

The PCN category page

  • 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
  • K132555Hevylite Human Igg Kappa Kit and Hevylite Human Igg Lambda KitThe Binding Site · 2013

https://510kreport.com/device/K172613 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172613: Optilite Hevylite IgG Kappa Kit, Optilite Hevylite 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/K172613

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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