Cleared Traditional

K152961 - VALIDATE D-Dimer Calibration Verificati...

K152961 is the FDA 510(k) clearance for VALIDATE D-Dimer Calibration Verificati... by Maine Standards Company, LLC. It is a Class 2 Hematology device (product code GGN) cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K152961 · Maine Standards Company, LLC · Hematology device
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Jun 2016
Decision
240d
Days
Class 2
Risk

K152961 is an FDA 510(k) clearance for the VALIDATE D-Dimer Calibration Verification/Linearity Test Kit. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Maine Standards Company, LLC (Cumberland Foreside, US). The FDA issued a Cleared decision on June 3, 2016 after a review of 240 days - an extended review cycle.

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 Maine Standards Company, LLC devices

Submission Details

510(k) Number K152961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2015
Decision Date June 03, 2016
Days to Decision 240 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
127d slower than avg
Panel avg: 113d · This submission: 240d
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.

Regulatory Peers - GGN Plasma, Coagulation Control

All 56
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