Cleared Traditional

K082091 - TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-00

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

K082091 · Reametrix, Inc. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K082091

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
Combination Product No
PCCP Authorized No
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.

GKZ Device Classification - Class 2, Special Controls

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 380
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K082091 · TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-00
Download PDF FDA Summary Reametrix, Inc.