Cleared Traditional

K050817 - T-TEK

K050817 is the FDA 510(k) clearance for T-TEK by R2 Diagnostics, Inc.. It is a Class 2 Hematology device (product code GJA) cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K050817 · R2 Diagnostics, Inc. · Hematology device
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Dec 2005
Decision
256d
Days
Class 2
Risk

K050817 is an FDA 510(k) clearance for the T-TEK. Classified as Test, Thrombin Time (product code GJA), Class II - Special Controls.

Submitted by R2 Diagnostics, Inc. (South Bend, US). The FDA issued a Cleared decision on December 12, 2005 after a review of 256 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7875 - 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 R2 Diagnostics, Inc. devices

Submission Details

510(k) Number K050817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2005
Decision Date December 12, 2005
Days to Decision 256 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
143d slower than avg
Panel avg: 113d · This submission: 256d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GJA Test, Thrombin Time
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7875
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 - GJA Test, Thrombin Time

All 17
Devices cleared under the same product code (GJA) and FDA review panel - the closest regulatory comparables to K050817.
ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589
K982209 · Sigma Diagnostics, Inc. · Oct 1998
BC THROMBIN REAGENT
K970645 · Behring Diagnostics, Inc. · May 1997
BIOMERIEUX HEMOLAB THROMBICALCI-TEST
K925493 · Biomerieux Vitek, Inc. · Apr 1994
TEST THROMBIN
K930157 · Behring Diagnostics, Inc. · May 1993
THROMBIN CLOTTING TIME REAGENT
K920147 · Helena Laboratories · May 1992
TT AND HNTT BY HEMOCHRON
K900126 · International Technidyne Corp. · Feb 1990