510(k) Report

De Novo · Granted

Granted

Endotoxin Activity Assay (Eaa) Device

DEN030002De NovoGranted Jun 16, 200363-day reviewClass II21 CFR 866.3210

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

Spectral Diagnostics, Inc. · NGS Assay, Endotoxin Activity, Chemiluminescent

Granted on Jun 16, 2003 as a new device type through De Novo after a 63-day review. 3 later devices descend from it.

Decided
Jun 16, 2003
Review
63 days
Class
Class II
Product code
NGS
Recalls
None

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2008: 1 descendant cleared2024: 1 descendant cleared200020052010201520202025
  1. This deviceDEN030002 Endotoxin Activity Assay (Eaa) DeviceSpectral Diagnostics, Inc. · 2003
  2. Descendant · cites it directly · 2 of its ownK040887 B-R-a-H-M-S PCT LiaBrahms Aktiengesellschaft · 2005
  3. Descendant · 2 generations on · 1 of its ownK070310 B R a H M S PCT Sensitive Kryptor Test SystemBrahms Aktiengesellschaft · 2008
  4. Descendant · 3 generations on · 0 of its ownK240041 IVD CAPSULE PSP; abioSCOPEAbionic SA · 2024

Most influential descendants

Showing 3 of 3 · See all
  • K040887B-R-a-H-M-S PCT LiaBrahms Aktiengesellschaft · 2005 · cites it directly2descendants
  • K070310B R a H M S PCT Sensitive Kryptor Test SystemBrahms Aktiengesellschaft · 2008 · 2 generations on1descendant
  • K240041IVD CAPSULE PSP; abioSCOPEAbionic SA · 2024 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)DEN030002Endotoxin Activity Assay (Eaa) DeviceSpectral Diagnostics, Inc.2003—
+1K040887B-R-a-H-M-S PCT LiaBrahms Aktiengesellschaft2005—
+2K070310B R a H M S PCT Sensitive Kryptor Test SystemBrahms Aktiengesellschaft2008—
+3K240041IVD CAPSULE PSP; abioSCOPEAbionic SA2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200810
202410
FIG. 1 — Lineage of DEN030002, 2003–2024Source: 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 De Novo database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NGS? 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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Does it have a predicate?

De Novo decisions do not claim a predicate device.

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K040887B-R-a-H-M-S PCT LiaBrahms Aktiengesellschaft20052

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?

  • Of its descendants, K040887 (Brahms Aktiengesellschaft, 2005) has gone furthest, with 2 descendants of its own.

How does its category compare?

All NGS devices

NGS Assay, Endotoxin Activity, Chemiluminescent: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NGS

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NGS

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

Recalls per year · NGS

No recall names NGS since 2007.

Adverse event reports per year · NGS

8in 2013

2013: 8
2007high 8 (2013) · low 0 (2007)2025

MAUDE reports naming product code NGS, 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—08
20140—00
20150—00
20160—00
20170—00
20180—00
20191—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Spectral Diagnostics, Inc.

12 FDA decisions under this applicant name. See the company

  • K052519Spectral West Nile Virus Igm Status TestSpectral Diagnostics, Inc. · 2006
  • K030057Spectral Cardiac Status CK-MB/Myoglobin/Troponin I 3-in-1 TestSpectral Diagnostics, Inc. · 2003
  • K022409Spectral's Cardiac Status CK-MB Rapid TestSpectral Diagnostics, Inc. · 2002
  • K020950Spectral's 2 in 1 (Tni-Myo)Spectral Diagnostics, Inc. · 2002
  • K014105Spectral's Troponin ISpectral Diagnostics, Inc. · 2002

Recent decisions in NGS

The NGS category page

  • K183176Endotoxin Activity Assay (EAA)Spectral Medical, Inc. · 2019

https://510kreport.com/device/DEN030002 · printed Nov 6, 2026

Cite this page

510(k) Report. “DEN030002: Endotoxin Activity Assay (Eaa) Device.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN030002

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