Cleared Traditional

K915235 - CLINICAL ASSAYS GAMMA COAT FREE T4 RADI...

K915235 is the FDA 510(k) clearance for CLINICAL ASSAYS GAMMA COAT FREE T4 RADI... by Incstar Corp.. It is a Class 2 Chemistry device (product code CDX) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K915235 · Incstar Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1992
Decision
67d
Days
Class 2
Risk

K915235 is an FDA 510(k) clearance for the CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Incstar Corp. (Stillwater, US). The FDA issued a Cleared decision on January 28, 1992 after a review of 67 days - a notably fast clearance cycle.

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: 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 Incstar Corp. devices

Submission Details

510(k) Number K915235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1991
Decision Date January 28, 1992
Days to Decision 67 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
21d faster than avg
Panel avg: 88d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDX Radioimmunoassay, 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 - CDX Radioimmunoassay, Total Thyroxine

All 68
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K915235.
ABBOTT TDX/TDXFLX TT4
K925109 · Abbott Laboratories · Jan 1993
TECHNICON DAX SYSTEM THYROXINE (T4) METHOD
K922945 · Heraeus Kulzer, Inc. · Oct 1992
T4 EIA BEAD ASSAY
K920766 · Tech-Co, Inc. · Apr 1992
MILENIA TOTAL T4, CATALOG: MKT41,5
K912541 · Diagnostic Products Corp. · Aug 1991
THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM
K904816 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1991
CIBA CORNING ACS T4 IMMUNOASSAY
K905532 · Ciba Corning Diagnostics Corp. · Jan 1991