Cleared Traditional

K860830 - TECHNICON H.1 SYSTEM

K860830 is the FDA 510(k) clearance for TECHNICON H.1 SYSTEM by Technicon Instruments Corp.. It is a Class 2 Hematology device (product code LIZ) cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K860830 · Technicon Instruments Corp. · Hematology device
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Sep 1986
Decision
187d
Days
Class 2
Risk

K860830 is an FDA 510(k) clearance for the TECHNICON H.1 SYSTEM, T LYMPHOCYTES METHOD. Classified as Assay, T Lymphocyte Surface Marker (product code LIZ), Class II - Special Controls.

Submitted by Technicon Instruments Corp. (Tarrytown, US). The FDA issued a Cleared decision on September 8, 1986 after a review of 187 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 Technicon Instruments Corp. devices

Submission Details

510(k) Number K860830 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 05, 1986
Decision Date September 08, 1986
Days to Decision 187 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 113d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LIZ Assay, T Lymphocyte Surface Marker
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 - LIZ Assay, T Lymphocyte Surface Marker

Devices cleared under the same product code (LIZ) and FDA review panel - the closest regulatory comparables to K860830.
TBM-REAGENT FOR T,B CELL & MONOCYTES
K843062 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1985
ANTI-LEU-4 FITC LYSIN C BUFFER
K842218 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1984
QUANTIGEN T & B CELL ASSAY
K831053 · Bio-Rad · Aug 1983
ORTHO SPECTRUM III & ORTHO-MUNE OK
K820643 · Ortho Diagnostic Systems, Inc. · Jul 1982