Cleared Traditional

K860830 - TECHNICON H.1 SYSTEM, T LYMPHOCYTES METHOD

K860830 is an FDA 510(k) clearance for TECHNICON H.1 SYSTEM, manufactured by Technicon Instruments Corp.. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K860830

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.

LIZ Device Classification - Class 2, Special Controls

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