Cleared Traditional

K050817 - T-TEK

K050817 is an FDA 510(k) clearance for T-TEK, manufactured by R2 Diagnostics, Inc.. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K050817

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
Combination Product No
PCCP Authorized No
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.

GJA Device Classification - Class 2, Special Controls

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 18
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 CLOT TIME TEST PROCEDURE
K923220 · Medical Laboratory Automation Systems, Inc. · Sep 1992
THROMBIN CLOTTING TIME REAGENT
K920147 · Helena Laboratories · May 1992