Cleared Traditional

K003329 - SIGMA DIANOSTICS AUTO D-DIMER CONTROL L...

K003329 is the FDA 510(k) clearance for SIGMA DIANOSTICS AUTO D-DIMER CONTROL L... by Sigma Diagnostics, Inc.. It is a Class 2 Hematology device (product code GGC) cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K003329 · Sigma Diagnostics, Inc. · Hematology device
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Mar 2001
Decision
128d
Days
Class 2
Risk

K003329 is an FDA 510(k) clearance for the SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217. Classified as Control, Plasma, Abnormal (product code GGC), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on March 1, 2001 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sigma Diagnostics, Inc. devices

Submission Details

510(k) Number K003329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2000
Decision Date March 01, 2001
Days to Decision 128 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 113d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGC Control, Plasma, Abnormal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - GGC Control, Plasma, Abnormal

All 29
Devices cleared under the same product code (GGC) and FDA review panel - the closest regulatory comparables to K003329.
LYPHOCHEK HEMOSTASIS, MODELS 798, 799
K020878 · Bio-Rad · Apr 2002
SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL
K020109 · Sigma Diagnostics, Inc. · Feb 2002
K-ASSAY D-DIMER CONTROLS
K012422 · Kamiya Biomedical Co. · Aug 2001
LA POSITIVE CONTROL PLASMA
K961370 · Medical Diagnostic Technologies, Inc. · May 1996
AT-III CONTROL PLASMA KIT
K955040 · American Bioproducts Co. · Jan 1996
STA-COAG CONTROL [P] PLUS KIT
K952338 · American Bioproducts Co. · Sep 1995