Cleared Traditional

K912616 - TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES

K912616 is an FDA 510(k) clearance for TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL..., manufactured by Technicon Instruments Corp.. The device is a Class 2 Chemistry device with product code KLI cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K912616 · Technicon Instruments Corp. · Chemistry device
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Sep 1991
Decision
104d
Days
Class 2
Risk

K912616 is an FDA 510(k) clearance for the TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES. Classified as Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (product code KLI), Class II - Special Controls.

Submitted by Technicon Instruments Corp. (Tarrytown, US). The FDA issued a Cleared decision on September 25, 1991 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1700 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Technicon Instruments Corp. devices

FDA 510(k) Submission Details - K912616

510(k) Number K912616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1991
Decision Date September 25, 1991
Days to Decision 104 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 88d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLI Device Classification - Class 2, Special Controls

Product Code KLI Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1700
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 Chemistry devices follow this clearance model.

Regulatory Peers - KLI Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

All 70
Devices cleared under the same product code (KLI) and FDA review panel - the closest regulatory comparables to K912616.
VISTA THYROXINE (T-4) ASSAY -- MODIFICATION
K922433 · Syva Co. · Sep 1992
MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT
K920712 · Medix Biotech, Inc. · Mar 1992
CEDIA T4
K915194 · Boehringer Mannheim Corp. · Dec 1991
SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE)
K911217 · Serono-Baker Diagnostics, Inc. · Aug 1991
IL THYROXINE (T4) ASSAY SYSTEM
K903095 · Instrumentation Laboratory CO · Aug 1990
NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR
K897072 · Kallestad Diag, A Div. of Erbamont, Inc. · Mar 1990