Cleared Traditional

K100716 - AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5

K100716 is an FDA 510(k) clearance for AUDIT MICROCV D-DIMER LINEARITY SET, manufactured by Aalto Scientific, Ltd.. The device is a Class 2 Hematology device with product code GGN cleared through the Traditional 510(k) pathway after a 468-day FDA review.

K100716 · Aalto Scientific, Ltd. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
468d
Days
Class 2
Risk

K100716 is an FDA 510(k) clearance for the AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Aalto Scientific, Ltd. (Carlsbad, US). The FDA issued a Cleared decision on June 23, 2011 after a review of 468 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

View all Aalto Scientific, Ltd. devices

FDA 510(k) Submission Details - K100716

510(k) Number K100716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2010
Decision Date June 23, 2011
Days to Decision 468 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
355d slower than avg
Panel avg: 113d · This submission: 468d
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 76
Devices cleared under the same product code (GGN) and FDA review panel - the closest regulatory comparables to K100716.
I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2
K120900 · Cliniqa Corporation · May 2013
STA- COAG CONTROL (N+ABN) PLUS
K120014 · Diagnostica Stago, Inc. · Mar 2013
HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL
K113211 · Instrumentation Laboratory CO · Jan 2012
PT-MULTI-CALIBRATOR, MODEL OPAT07
K093848 · Dade Behring, Inc. · Dec 2010
CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL
K103314 · Medtronic, Inc. · Dec 2010
HEPARIN ASSAY CONTROLS
K103313 · Medtronic, Inc. · Dec 2010