510(k) Report

FDA product code · Immunology

Anti-Mutated Citrullinated Vimentin Igg

OQZClass II21 CFR 866.5775510(k) required1 decision since 20100 recalls

1 FDA decision since 2010. No recall names this code.

For the semi-quantitative measurement of IgG class autoantibodies against mutated citrullinated vimentin (MCV) in human serum or plasma.

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 OQZ 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 · OQZ

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OQZ

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

Recalls per year · OQZ

No recall names OQZ since 2007.

Adverse event reports per year · OQZ

No MAUDE report names OQZ since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20101—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — OQZ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

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

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Related product codes

Other codes under 21 CFR 866.5775.