Cleared Traditional

K951014 - ISOLAB'S T4 TEST KIT

K951014 is the FDA 510(k) clearance for ISOLAB'S T4 TEST KIT by Isolab, Inc.. It is a Class 2 Chemistry device (product code KLI) cleared through the Traditional 510(k) pathway after a 592-day FDA review.

K951014 · Isolab, Inc. · Chemistry device
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Oct 1996
Decision
592d
Days
Class 2
Risk

K951014 is an FDA 510(k) clearance for the ISOLAB'S T4 TEST KIT. Classified as Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (product code KLI), Class II - Special Controls.

Submitted by Isolab, Inc. (Akron, US). The FDA issued a Cleared decision on October 18, 1996 after a review of 592 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Isolab, Inc. devices

Submission Details

510(k) Number K951014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1995
Decision Date October 18, 1996
Days to Decision 592 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
504d slower than avg
Panel avg: 88d · This submission: 592d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 56
Devices cleared under the same product code (KLI) and FDA review panel - the closest regulatory comparables to K951014.
ABBOTT ARCHITECT TOTAL T4
K983440 · Abbott Laboratories · Nov 1998
DSL ACTIVE T4 EIA
K971269 · Diagnostic Systems Laboratories, Inc. · May 1997
SYNCHRON SYSTEMS THYROXINE REAGENT
K971203 · Beckman Instruments, Inc. · May 1997
RADIAS NEONATAL T4 ENZYME IMMUNOASSAY
K951321 · Bio-Rad · Aug 1995
RADIAS TOTAL T4 ENZYME IMMUNOASSAY
K946163 · Bio-Rad · Feb 1995
THYROXINE ENZYME IMMUNOASSAY
K944703 · Diagnostic Reagents, Inc. · Dec 1994