Cleared Traditional

K894605 - DELFIA FREE THYROXINE (FT4) KIT

K894605 is the FDA 510(k) clearance for DELFIA FREE THYROXINE (FT4) KIT by Pharmacia, Inc.. It is a Class 2 Chemistry device (product code CEC) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K894605 · Pharmacia, Inc. · Chemistry device
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Sep 1989
Decision
60d
Days
Class 2
Risk

K894605 is an FDA 510(k) clearance for the DELFIA FREE THYROXINE (FT4) KIT. Classified as Radioimmunoassay, Free Thyroxine (product code CEC), Class II - Special Controls.

Submitted by Pharmacia, Inc. (Piscataway, US). The FDA issued a Cleared decision on September 18, 1989 after a review of 60 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 Pharmacia, Inc. devices

Submission Details

510(k) Number K894605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1989
Decision Date September 18, 1989
Days to Decision 60 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 88d · This submission: 60d
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 63
Devices cleared under the same product code (CEC) and FDA review panel - the closest regulatory comparables to K894605.
ABBOTT IMX FREE T4
K902834 · Abbott Laboratories · Sep 1990
ENZYMUN TEST(R) FT4 (FREE THYROXINE)
K900883 · Boehringer Mannheim Corp. · May 1990
FREE THYROXINE (FT4) RADIOIMMUNOASSAY KIT
K896222 · Nichols Institute Diagnostics · Nov 1989
AMERLEX-MAB FT4 KIT
K894091 · Amersham Corp. · Aug 1989
AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST KIT
K883123 · Amersham Corp. · Dec 1988
QLIA T UPTAKE ASSAY
K883971 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1988