Cleared Traditional

K170864 - VALIDATE D-Dimer Calibration Verificati...

K170864 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 90-day FDA review.

K170864 · Maine Standards Company, LLC · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
90d
Days
Class 2
Risk

K170864 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 21, 2017 after a review of 90 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

Submission Details

510(k) Number K170864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2017
Decision Date June 21, 2017
Days to Decision 90 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
23d faster than avg
Panel avg: 113d · This submission: 90d
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
Devices cleared under the same product code (GGN) and FDA review panel - the closest regulatory comparables to K170864.
DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC
K120977 · International Technidyne Corp. · Jul 2013
I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2
K120900 · Cliniqa Corporation · May 2013
HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL
K113211 · Instrumentation Laboratory CO · Jan 2012
AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5
K100716 · Aalto Scientific, Ltd. · Jun 2011
PT-MULTI-CALIBRATOR, MODEL OPAT07
K093848 · Dade Behring, Inc. · Dec 2010
CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL
K103314 · Medtronic, Inc. · Dec 2010