Cleared Traditional

K852537 - T-3 RIASSAY

K852537 is the FDA 510(k) clearance for T-3 RIASSAY by Ria Diagnostics. It is a Class 2 Chemistry device (product code CDP) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K852537 · Ria Diagnostics · Chemistry device
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Aug 1985
Decision
59d
Days
Class 2
Risk

K852537 is an FDA 510(k) clearance for the T-3 RIASSAY. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Ria Diagnostics (Santa Fe Springs, US). The FDA issued a Cleared decision on August 12, 1985 after a review of 59 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K852537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1985
Decision Date August 12, 1985
Days to Decision 59 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 88d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 97
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K852537.
IMMUBEAD T3 ENZYME IMMUNOASSAY KIT
K872191 · Immunotech Corp. · Aug 1987
DELFIA(TM) TRIIODOTHYRONINE (T3) KIT
K864452 · Lkb Instruments, Inc. · Feb 1987
AMERLEX-M T3 RIA KIT FOR SERUM AND PLASMA
K860252 · Amersham Corp. · Feb 1986
TDX TOTAL T3
K851676 · Abbott Laboratories · May 1985
AMERLEX-M FREE T-3 RIA
K842949 · Amersham Corp. · Sep 1984
CORNING IMMO PHASE FREE T3
K840222 · Corning Medical & Scientific · May 1984