Cleared Traditional

K142132 - POOL NORM (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K142132 · Diagnostics Stago S.A.S. · Hematology device
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Dec 2014
Decision
130d
Days
Class 2
Risk

K142132 is an FDA 510(k) clearance for the POOL NORM. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Diagnostics Stago S.A.S. (Gennevilliers, FR). The FDA issued a Cleared decision on December 12, 2014 after a review of 130 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 Diagnostics Stago S.A.S. devices

Submission Details

510(k) Number K142132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2014
Decision Date December 12, 2014
Days to Decision 130 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
17d slower than avg
Panel avg: 113d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGN Plasma, Coagulation Control
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.