Cleared Traditional

T-TEK (K050817) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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.