Cleared Traditional

K894200 - FREE T3 RADIOIMMUNOASSAY KIT

K894200 is an FDA 510(k) clearance for FREE T3 RADIOIMMUNOASSAY KIT, manufactured by Advanced Magnetics, Inc.. The device is a Class 2 Chemistry device with product code CDP cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K894200 · Advanced Magnetics, Inc. · Chemistry device
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Sep 1989
Decision
101d
Days
Class 2
Risk

K894200 is an FDA 510(k) clearance for the FREE T3 RADIOIMMUNOASSAY KIT. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Advanced Magnetics, Inc. (Cambridge, US). The FDA issued a Cleared decision on September 25, 1989 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1710 - 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 Advanced Magnetics, Inc. devices

FDA 510(k) Submission Details - K894200

510(k) Number K894200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1989
Decision Date September 25, 1989
Days to Decision 101 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 88d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDP Device Classification - Class 2, Special Controls

Product Code CDP Radioimmunoassay, Total Triiodothyronine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1710
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 - CDP Radioimmunoassay, Total Triiodothyronine

All 119
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K894200.
ABBOTT TDX TOTAL T3 PLUS
K894238 · Abbott Laboratories · Oct 1989
MILENIA(TM) TOTAL T4 (MKT41,5)
K895840 · Diagnostic Products Corp. · Oct 1989
STRATUS(R) TOTAL TRIIODOTHYRONINE (T3) F.E.I.
K894993 · Baxter Healthcare Corp · Oct 1989
AMERLITE FT3 ASSAY, LAN.0007/2007 240/144 TEST KIT
K885195 · Amersham Corp. · Feb 1989
DELFIA TRIIODOTHYRONINE (T3) KIT
K883810 · Pharmacia, Inc. · Dec 1988
STRATUS TOTAL TRIIODOTHYRONINE T3 FLUORO. ENZYME
K883479 · Baxter Healthcare Corp · Oct 1988