Cleared Traditional

K941171 - TECHNICON H* 3 RTC SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)

K941171 is an FDA 510(k) clearance for TECHNICON H* 3 RTC SYSTEM (IN-VITRO DIA..., manufactured by Miles, Inc.. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 275-day FDA review.

K941171 · Miles, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
275d
Days
Class 2
Risk

K941171 is an FDA 510(k) clearance for the TECHNICON H* 3 RTC SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM). Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Miles, Inc. (Tarrytown, US). The FDA issued a Cleared decision on December 14, 1994 after a review of 275 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 Miles, Inc. devices

FDA 510(k) Submission Details - K941171

510(k) Number K941171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1994
Decision Date December 14, 1994
Days to Decision 275 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
162d slower than avg
Panel avg: 113d · This submission: 275d
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 304
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K941171.
ONYX
K943967 · Coulter Corp. · Mar 1995
SYSMEX K-4500
K943894 · Sysmex Corp. · Feb 1995
MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD2, CLONE MT910 FITC-CONJUGATED, (ANTI-CD2,FITC, MT910)
K945692 · Dako Corp. · Jan 1995
MONOCLONAL MOUSE ANTI-HUMAN B-CELL
K943284 · Dako Corp. · Nov 1994
MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25
K944253 · Dako Corp. · Nov 1994
MONOCLONAL MOUSE ANTI-HUMAN T-CELL
K942797 · Dako Corp. · Nov 1994