510(k) Report

510(k) · Cleared

Cleared

Sigma Dianostics Auto D-Dimer Control Level 2, Model A5217

K003329510(k) TraditionalCleared Mar 1, 2001128-day reviewClass II21 CFR 864.5425

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

Sigma Diagnostics, Inc. · GGC Control, Plasma, Abnormal

Cleared on Mar 1, 2001 after a 128-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Mar 1, 2001
Review
128 days
Class
Class II
Product code
GGC
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2001: 2 descendants cleared200020052010201520202025
  1. This deviceK003329 Sigma Dianostics Auto D-Dimer Control Level 2, Model A5217Sigma Diagnostics, Inc. · 2001
  2. Descendant · cites it directly · 0 of its ownK013544 Sigma Diagnostics Auto D-Dimer Control, Level 2, Model A8096Sigma Diagnostics, Inc. · 2001
  3. Descendant · cites it directly · 0 of its ownK013545 Sigma Diagnostics Auto D-Dimer Control, Level 3, Model A8221Sigma Diagnostics, Inc. · 2001

Most influential descendants

Showing 2 of 2 · See all
  • K013544Sigma Diagnostics Auto D-Dimer Control, Level 2, Model A8096Sigma Diagnostics, Inc. · 2001 · cites it directly0descendants
  • K013545Sigma Diagnostics Auto D-Dimer Control, Level 3, Model A8221Sigma Diagnostics, Inc. · 2001 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003329Sigma Dianostics Auto D-Dimer Control Level 2, Model A5217Sigma Diagnostics, Inc.2001—
+1K013544Sigma Diagnostics Auto D-Dimer Control, Level 2, Model A8096Sigma Diagnostics, Inc.2001—
+1K013545Sigma Diagnostics Auto D-Dimer Control, Level 3, Model A8221Sigma Diagnostics, Inc.2001—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200120
FIG. 1 — Lineage of K003329, 2001–2001Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

Planning a device in GGC? 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?

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

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K013544Sigma Diagnostics Auto D-Dimer Control, Level 2, Model A8096Sigma Diagnostics, Inc.20010
K013545Sigma Diagnostics Auto D-Dimer Control, Level 3, Model A8221Sigma Diagnostics, Inc.20010

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, K013544 (Sigma Diagnostics, Inc., 2001) has gone furthest, with 0 descendants of its own.

How does its category compare?

All GGC devices

GGC Control, Plasma, Abnormal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GGC

1in 2011

2007: 12010: 12011: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GGC

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

Recalls per year · GGC

No recall names GGC since 2007.

Adverse event reports per year · GGC

1in 2021

2021: 1
2007high 1 (2021) · low 0 (2007)2025

MAUDE reports naming product code GGC, 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
20071—00
20080—00
20090—00
20101—00
20111—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—01
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Sigma Diagnostics, Inc.

164 FDA decisions under this applicant name. See the company

  • K021162Amax Density Coagulation Analyzer, Amax Denstiny Coagulation Analyzer-EU, Amax Destiny Coagulation…Sigma Diagnostics, Inc. · 2002
  • K020109Sigma Diagnostics Accuclot LA ControlSigma Diagnostics, Inc. · 2002
  • K013549Sigma Diagnostics Auto D-Dimer Calibrator, Model A7971Sigma Diagnostics, Inc. · 2001
  • K013544Sigma Diagnostics Auto D-Dimer Control, Level 2, Model A8096Sigma Diagnostics, Inc. · 2001
  • K013545Sigma Diagnostics Auto D-Dimer Control, Level 3, Model A8221Sigma Diagnostics, Inc. · 2001

Recent decisions in GGC

The GGC category page

  • K102552Hemosil LA Positive ControlInstrumentation Laboratory CO · 2011
  • K100103Specialty Assayed Control-2Helena Laboratories · 2010
  • K062306Plasmacon N, Plasmacon L-1, Plasmacon L-2R2 Diagnostics, Inc. · 2007
  • K061803Sta - Control LA 1+2Diagnostica Stago, Inc. · 2006
  • K032804Cryocheck Weak Lupus Positive ControlPrecision Biologic · 2003

https://510kreport.com/device/K003329 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003329: Sigma Dianostics Auto D-Dimer Control Level 2, Model A5217.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003329

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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