Cleared Traditional

FREE THYROXINE (FT4) RADIOIMMUNOASSAY KIT (K896222) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K896222 · Nichols Institute Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1989
Decision
18d
Days
Class 2
Risk

K896222 is an FDA 510(k) clearance for the FREE THYROXINE (FT4) RADIOIMMUNOASSAY KIT. Classified as Radioimmunoassay, Free Thyroxine (product code CEC), Class II - Special Controls.

Submitted by Nichols Institute Diagnostics (Los Angeles, US). The FDA issued a Cleared decision on November 17, 1989 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1695 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nichols Institute Diagnostics devices

Submission Details

510(k) Number K896222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1989
Decision Date November 17, 1989
Days to Decision 18 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 88d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CEC Radioimmunoassay, Free Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1695
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 - CEC Radioimmunoassay, Free Thyroxine

All 91
Devices cleared under the same product code (CEC) and FDA review panel - the closest regulatory comparables to K896222.
Access Free T4
K240273 · Beckman Coulter, Inc. · Mar 2024
Elecsys FT4 IV
K220456 · Roche Diagnostics · Apr 2023
MAGLUMI 2000 FT4
K182423 · Shenzhen New Industries Biomedical Engineering Co., Ltd. · Oct 2018
Elecsys FT4 III
K181233 · Roche Diagnostics · Sep 2018
Abbott Architect Free T4
K173122 · Abbott Laboratories · Oct 2017
ABBOTT ARCHITECT FREE T4
K123379 · Abbott Laboratories · Nov 2012