510(k) Report

FDA product code · Immunology

Immunoglobulin G Kappa Heavy And Light Chain Combined

PCNClass II21 CFR 866.5510510(k) required3 decisions since 20130 recalls

3 FDA decisions since 2013. No recall names this code. The most-cited predicate is K132555, named by 1 later device.

Intended for the in-vitro quantification of IgG kappa concentration in human serum.

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

FIG. A — Illustration, immunology panel

Twenty years of PCN at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

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—
FIG. 1 — PCN by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PCN? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do PCN devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K132555Hevylite Human Igg Kappa Kit and Hevylite Human Igg Lambda KitThe Binding Site · 20131cites it

Which PCN devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K172613Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda KitThe Binding Site Group, Ltd. · 20181generation

What has FDA decided in PCN lately?

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

All 3 PCN decisions →

Related product codes

Other codes under 21 CFR 866.5510.

DGP Ige, Fitc, Antigen, Antiserum, ControlPCO Immunoglobulin G Lambda Heavy And Light Chain…CZN Iga, Fitc, Antigen, Antiserum, ControlCFQ Radioimmunoassay, Immunoglobulins (G, A, M)DEW Igg, Antigen, Antiserum, ControlPDE Immunoglobulin M Kappa Heavy And Light Chain…DAH Gamma Globulin, Antigen, Antiserum, ControlPDF Immunoglobulin M Lambda Heavy And Light Chain…DFO Igg, Rhodamine, Antigen, Antiserum, ControlMLH Strip, Hama Igg, Elisa, In Vitro Test SystemCZK Iga, Rhodamine, Antigen, Antiserum, ControlDAA Igg, Peroxidase, Antigen, Antiserum, Control