510(k) Report

FDA product code · Immunology

Radioimmunoassay, Immunoglobulins (D, E)

JHRClass II21 CFR 866.5510510(k) required9 decisions since 19840 recalls

9 FDA decisions since 1984. No recall names this code. The most-cited predicate is K984326, named by 1 later device.

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 JHR 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 · JHR

FDA has decided no JHR device since 2007.

Median 510(k) review, days · JHR

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

Recalls per year · JHR

No recall names JHR since 2007.

Adverse event reports per year · JHR

3in 2025

2013: 12015: 62016: 22017: 12018: 32019: 12023: 42024: 22025: 3
2007high 6 (2015) · low 0 (2007)2025

MAUDE reports naming product code JHR, not matched to any one device; reports are not rates.

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
20130—01
20140—00
20150—06
20160—02
20170—01
20180—03
20190—01
20200—00
20210—00
20220—00
20230—04
20240—02
20250—03
20260—0—
FIG. 1 — JHR by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in JHR? 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 JHR devices cite most?

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

  • K984326Elecys Ige AssayBoehringer Mannheim Corp. · 19991cites it
  • K061970Elecsys Ige II ImmunoassayRoche Diagnostics · 20061cites it

Which JHR devices have the deepest lineage?

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

  • K061970Elecsys Ige II ImmunoassayRoche Diagnostics · 20061generation

What has FDA decided in JHR lately?

  • K061970Elecsys Ige II ImmunoassayRoche Diagnostics · 2006
  • K984326Elecys Ige AssayBoehringer Mannheim Corp. · 1999
  • K960067Immilite Total IgeDiagnostic Products Corp. · 19961 recall
  • K931703Immulite Total IgeDiagnostic Products Corp. · 19932 recalls
  • K903000Turbo-Rast Specific Ige AssayVentrex Laboratories, Inc. · 1990
  • K901859Coat-a-Count Total Ige Irma, Catalog #IKIE1, IKIE2Diagnostic Products Corp. · 1990

All 9 JHR 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