Cleared Traditional

K082091 - TRI T-STAT REAGENT ASSAY (DRIED FORM) M...

K082091 is the FDA 510(k) clearance for TRI T-STAT REAGENT ASSAY (DRIED FORM) M... by Reametrix, Inc.. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K082091 · Reametrix, Inc. · Hematology device
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Apr 2009
Decision
265d
Days
Class 2
Risk

K082091 is an FDA 510(k) clearance for the TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-00. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Reametrix, Inc. (San Carlos, US). The FDA issued a Cleared decision on April 15, 2009 after a review of 265 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - 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 Reametrix, Inc. devices

Submission Details

510(k) Number K082091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2008
Decision Date April 15, 2009
Days to Decision 265 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
152d slower than avg
Panel avg: 113d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKZ Counter, Differential Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
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 - GKZ Counter, Differential Cell

All 194
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