510(k) · Cleared

Recalled · 2008

Diamedix IS-Measles Igg Test System

K974552510(k) TraditionalCleared Jan 28, 199855-day reviewClass I21 CFR 866.3520Recalls 1

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

Diamedix Corp. · LJB Enzyme Linked Immunoabsorbent Assay, Rubeola Igg

Cleared on Jan 28, 1998 after a 55-day review. The FDA summary names its predicate without a number. It has been recalled once.

Decided: Jan 28, 1998
Review: 55 days
Class: Class I
Product code: LJB
Recalls: 1
Predicates: 0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K974552Source: FDA 510(k) database · How lineage is built

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 LJB? 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.

Type	Number	Device	Applicant	Decided	Recalls
*	—	Diamedix Measles IgG Microassay Named without a submission number			—

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

Date	Class	Recall	Root cause	Reason
Oct 10, 2008	Not classified	Z-0607-2009	Other	Possible false-negative test results: The Sample A Diluent Lot # 50768 assigned to Is-Measles IgG Lot #'s 41108 and 41108B has higher conductivity than normal, which can sporadically interfere with the MAGO Plus/Aptus sensing of and…

No ancestor or descendant has a Class I recall.

How does its category compare?

All LJB devices

LJB Enzyme Linked Immunoabsorbent Assay, Rubeola Igg: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LJB

FDA has decided no LJB device since 2007.

Median 510(k) review, days · LJB

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

Recalls per year · LJB

1in 2025

2007high 3 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LJB

2in 2022

2007high 11 (2020) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	3	0
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	0	3
2016	—	0	8
2017	—	0	0
2018	—	0	1
2019	—	0	3
2020	—	0	11
2021	—	1	0
2022	—	1	2
2023	—	0	0
2024	—	0	0
2025	—	1	0
2026	—	0	—

What is it indicated for?

The Diamedix Is-Measles IgG test system is an Enzyme Immunoassay (EIA) for the semi-quantitative detection of IgG antibodies in human serum to measles virus as an aid in the assessment of the patient's immunological response to measles virus, to determine the immune status of individuals, and, when evaluating paired sera, as an aid in the diagnosis of measles infection.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K974552 · printed Nov 6, 2026

Cite this page

510(k) Report. “K974552: Diamedix IS-Measles Igg Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974552

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026