Cleared Traditional

K901939 - NEOCOAT T4

K901939 is the FDA 510(k) clearance for NEOCOAT T4 by Neometrics, Inc.. It is a Class 2 Chemistry device (product code CDX) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K901939 · Neometrics, Inc. · Chemistry device
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May 1990
Decision
31d
Days
Class 2
Risk

K901939 is an FDA 510(k) clearance for the NEOCOAT T4. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Neometrics, Inc. (E. Northport, US). The FDA issued a Cleared decision on May 31, 1990 after a review of 31 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 Neometrics, Inc. devices

Submission Details

510(k) Number K901939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1990
Decision Date May 31, 1990
Days to Decision 31 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 88d · This submission: 31d
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 56
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K901939.
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
CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4
K901475 · Baxter Healthcare Corp · Jun 1990
TECHNICON RA SYSTEM THYROXINE T4 METHOD
K894575 · Technicon Instruments Corp. · Oct 1989
DELFIA THYROXINE (T4) KIT
K883559 · Pharmacia, Inc. · Dec 1988
IMMPULSE T4 ASSAY REAGENTS
K875081 · Sclavo, Inc. · Feb 1988