Cleared Traditional

K163498 - VALIDATE Heparin Calibration Verification/Linearity Test Kit

K163498 is an FDA 510(k) clearance for VALIDATE Heparin Calibration Verificati..., manufactured by Maine Standards Company, LLC. The device is a Class 2 Hematology device with product code GGN cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K163498 · Maine Standards Company, LLC · Hematology device
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Mar 2017
Decision
93d
Days
Class 2
Risk

K163498 is an FDA 510(k) clearance for the VALIDATE Heparin 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 March 16, 2017 after a review of 93 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 Maine Standards Company, LLC devices

FDA 510(k) Submission Details - K163498

510(k) Number K163498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2016
Decision Date March 16, 2017
Days to Decision 93 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
20d faster than avg
Panel avg: 113d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGN Device Classification - Class 2, Special Controls

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 91
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