Cleared Traditional

K050799 - TRIAGE D-DIMER CALIBRATION VERIFICATION...

Also marketed or referenced as:
TRIAGE(R) D-DIMER CONTROLS

K050799 is the FDA 510(k) clearance for TRIAGE D-DIMER CALIBRATION VERIFICATION... by Biosite Incorporated. It is a Class 2 Hematology device (product code GGN) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K050799 · Biosite Incorporated · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
91d
Days
Class 2
Risk

K050799 is an FDA 510(k) clearance for the TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Biosite Incorporated (San Diego, US). The FDA issued a Cleared decision on June 29, 2005 after a review of 91 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 Biosite Incorporated devices

Submission Details

510(k) Number K050799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2005
Decision Date June 29, 2005
Days to Decision 91 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
22d faster than avg
Panel avg: 113d · This submission: 91d
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 55
Devices cleared under the same product code (GGN) and FDA review panel - the closest regulatory comparables to K050799.
HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED
K082859 · Instrumentation Laboratory CO · Dec 2008
TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS
K062840 · Biosite Incorporated · Mar 2007
COAGUCHEK XS PT CONTROLS
K063823 · Roche Diagnostics Corp. · Jan 2007
CONTROL PLASMA N, PROC CONTROL PLASMA
K042333 · Dade Behring, Inc. · Dec 2004
CONTROL PLASMA N AND CONTROL PLASMA P
K042209 · Dade Behring, Inc. · Oct 2004
HEPARINASE HR ACT CONTROL, MODEL 550-12
K042175 · Medtronic Vascular · Oct 2004