Cleared Traditional

K993332 - GRADIPLASMA LA HIGH

K993332 is the FDA 510(k) clearance for GRADIPLASMA LA HIGH by Gradipore , Ltd.. It is a Class 2 Hematology device (product code GGC) cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K993332 · Gradipore , Ltd. · Hematology device
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Feb 2000
Decision
135d
Days
Class 2
Risk

K993332 is an FDA 510(k) clearance for the GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05. Classified as Control, Plasma, Abnormal (product code GGC), Class II - Special Controls.

Submitted by Gradipore , Ltd. (North Ryde, AU). The FDA issued a Cleared decision on February 16, 2000 after a review of 135 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 Gradipore , Ltd. devices

Submission Details

510(k) Number K993332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1999
Decision Date February 16, 2000
Days to Decision 135 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 113d · This submission: 135d
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 30
Devices cleared under the same product code (GGC) and FDA review panel - the closest regulatory comparables to K993332.
SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL
K020109 · Sigma Diagnostics, Inc. · Feb 2002
K-ASSAY D-DIMER CONTROLS
K012422 · Kamiya Biomedical Co. · Aug 2001
SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217
K003329 · Sigma Diagnostics, Inc. · Mar 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