510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Immulite Total Ige

K931703510(k) TraditionalCleared Aug 16, 1993132-day reviewClass II21 CFR 866.5510Recalls 2

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

Diagnostic Products Corp. · JHR Radioimmunoassay, Immunoglobulins (D, E)

Cleared on Aug 16, 1993 after a 132-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 2 times.

Decided
Aug 16, 1993
Review
132 days
Class
Class II
Product code
JHR
Recalls
2
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K931703Source: FDA 510(k) database · 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 20, 2013Class IIZ-1517-2014Under Investigation by firmSiemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE Systems Total IgE assays.
Dec 20, 2013Class IIZ-1518-2014Under Investigation by firmSiemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE Systems Total IgE assays.

No ancestor or descendant has a Class I recall.

How does its category compare?

All JHR devices

JHR Radioimmunoassay, Immunoglobulins (D, E): FDA decisions, review times, recalls and adverse event reports over 20 years.

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—

More from Diagnostic Products Corp.

321 FDA decisions under this applicant name. See the company

  • K063045Immulite 2000, Immulite 2500 VancomycinDiagnostic Products Corp. · 2006
  • K034055Immulite 2500 CK-MB, 2500 Myoglobin, 2500 Stat Troponin IDiagnostic Products Corp. · 20041 recall
  • K033234Immulite 2500 Automated Immunoassay AnalyzerDiagnostic Products Corp. · 20033 recalls
  • K032881Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total TestosteroneDiagnostic Products Corp. · 20032 recalls
  • K023152Immulite 2000 Allergen-Specific IgeDiagnostic Products Corp. · 2002

Recent decisions in JHR

The JHR category page

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

https://510kreport.com/device/K931703 · printed Nov 6, 2026

Cite this page

510(k) Report. “K931703: Immulite Total Ige.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931703

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026