Cleared Traditional

K003328 - ACCUCLOT CONTROL I, MODEL A4089

K003328 is an FDA 510(k) clearance for ACCUCLOT CONTROL I, manufactured by Sigma Diagnostics, Inc.. The device is a Class 2 Hematology device with product code GIZ cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K003328 · Sigma Diagnostics, Inc. · Hematology device
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Mar 2001
Decision
128d
Days
Class 2
Risk

K003328 is an FDA 510(k) clearance for the ACCUCLOT CONTROL I, MODEL A4089. Classified as Plasma, Control, Normal (product code GIZ), 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 - K003328

510(k) Number K003328 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.

GIZ Device Classification - Class 2, Special Controls

Product Code GIZ Plasma, Control, Normal
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 - GIZ Plasma, Control, Normal

All 15
Devices cleared under the same product code (GIZ) and FDA review panel - the closest regulatory comparables to K003328.
DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS
K042941 · Dade Behring, Inc. · Dec 2004
CONTROL PLASMA N
K023309 · Dade Behring, Inc. · Nov 2002
CONTROL PLASMA N
K001256 · Dade Behring, Inc. · May 2000
COAGULATION CONTROL LEVEL 1 (NORMAL)
K984129 · Pacific Hemostasis · Dec 1998
ACCUCOLOR HIGH CALIBRATOR (A3089)
K973274 · Sigma Diagnostics, Inc. · Oct 1997
THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS
K961814 · Cardiovascular Diagnostics, Inc. · Aug 1996