510(k) Report

510(k) · Cleared

Cleared

Euroimmun Hippocampus/Cerebellum/Glutamate Receptor/Ifa Biochip Mosaic Test System

K100017510(k) TraditionalCleared Sep 13, 2010252-day reviewClass II21 CFR 866.5660

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

Euroimmun Us, Inc. · OSK Anti-Glutamate Receptor (Type Nmda) Ifa

Cleared on Sep 13, 2010 as substantially equivalent to K083850 (Euroimmun Us, Inc., 2009) after a 252-day review. Its family tree reaches back 1 generation to 2009.

Decided
Sep 13, 2010
Review
252 days
Class
Class II
Product code
OSK
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K083850 (2009). No later device cites it as a predicate yet.

K083850 · Euroimmun Anca Ifa Europlus Granulocyte Biochip Mosaic Test Systems · Euroimmun Us, Inc. · 20092006200820102012
K083850 · Euroimmun Anca Ifa Europlus Granulocyte Biochip Mosaic Test Systems · Euroimmun Us, Inc. · 20090
  1. Root · 1 generation backK083850 Euroimmun Anca Ifa Europlus Granulocyte Biochip Mosaic Test SystemsEuroimmun Us, Inc. · 2009
  2. This deviceK100017 Euroimmun Hippocampus/Cerebellum/Glutamate Receptor/Ifa Biochip…Euroimmun Us, Inc. · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K083850Euroimmun Anca Ifa Europlus Granulocyte Biochip Mosaic Test SystemsEuroimmun Us, Inc.2009—
0 (this device)K100017Euroimmun Hippocampus/Cerebellum/Glutamate Receptor/Ifa Biochip Mosaic Test…Euroimmun Us, Inc.2010—
FIG. 1 — Lineage of K100017, 2009–2010Source: FDA 510(k) summaries, read by 510(k) Report · 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), 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 OSK? 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.

TypeNumberDeviceApplicantDecidedRecalls
*K083850Euroimmun Anca Ifa Europlus Granulocyte Biochip Mosaic Test Systems
Summary page 2
…alence Information: 1. Predicate device name Cs): EUROIMMUN ANCA IFA Granulocyte BIOCHIP MosaiCTm Test System. 2. Predicate 510(k) number(s): K083850 3. Comparison with predicate: The EUROIMMUN ANCA IFA Granulocyte BIOCHIP MoSaicTM Test System was choosen as a devi…
Euroimmun Us, Inc.2009—

What descends from it?

No later submission names this one as a predicate yet.

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.

How does its category compare?

All OSK devices

OSK Anti-Glutamate Receptor (Type Nmda) Ifa: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · OSK

1in 2010

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

2026 to Oct 25, outlined.

Median 510(k) review, days · OSK

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

Recalls per year · OSK

No recall names OSK since 2007.

Adverse event reports per year · OSK

No MAUDE report names OSK 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—

What is it indicated for?

The EUROIMMUN Anti-Glutamate receptor (type NMDA) IFA is intended for the qualitative determination of autoantibodies against glutamate receptor (type NMDA) in human serum. It is used as an aid in the diagnosis of anti-glutamate receptor (type NMDA) autoimmune encephalitis in conjunction with other laboratory and clinical findings.

Indications for use as stated in the FDA summary.

More from Euroimmun Us, Inc.

19 FDA decisions under this applicant name. See the company

  • K193115EUROIMMUN Anti-BP230-CF ELISA (IgG)Euroimmun Us, Inc. · 2020
  • K183313EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)Euroimmun Us, Inc. · 2019
  • K172582EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPatternEuroimmun Us, Inc. · 2018
  • K172252EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternEuroimmun Us, Inc. · 2018
  • K172244EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPatternEuroimmun Us, Inc. · 2018

https://510kreport.com/device/K100017 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100017: Euroimmun Hippocampus/Cerebellum/Glutamate Receptor/Ifa Biochip Mosaic 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/K100017

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026