Cleared Traditional

K050799 - TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS

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

K050799 is an FDA 510(k) clearance for TRIAGE D-DIMER CALIBRATION VERIFICATION..., manufactured by Biosite Incorporated. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K050799

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.

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
Devices cleared under the same product code (GGN) and FDA review panel - the closest regulatory comparables to K050799.
TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS
K062840 · Biosite Incorporated · Mar 2007
COAGUCHEK XS PT CONTROLS
K063823 · Roche Diagnostics Corp. · Jan 2007
BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR
K051472 · Hyphen Biomed · Dec 2005
BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA
K043451 · Hyphen Biomed · Mar 2005
PEFAKIT APC-R FACTOR V LEIDEN CONTROLS
K042760 · Pentapharm , Ltd. · Dec 2004
CONTROL PLASMA N, PROC CONTROL PLASMA
K042333 · Dade Behring, Inc. · Dec 2004