Cleared Traditional

K003329 - SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217

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

K003329 · Sigma Diagnostics, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K003329

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.

GGC Device Classification - Class 2, Special Controls

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 36
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
GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05
K993332 · Gradipore , Ltd. · Feb 2000
COAGULATION CONTROL LEVEL 2 (ABNORMAL)
K984130 · Pacific Hemostasis · Dec 1998
COAGULATION CONTROL LEVEL 3 (ABNORMAL)
K984131 · Pacific Hemostasis · Dec 1998