Cleared Traditional

K854324 - PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY...

K854324 is the FDA 510(k) clearance for PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY... by Pantex, Div. Bio-Analysis, Inc.. It is a Class 2 Chemistry device (product code CDX) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K854324 · Pantex, Div. Bio-Analysis, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1985
Decision
38d
Days
Class 2
Risk

K854324 is an FDA 510(k) clearance for the PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Pantex, Div. Bio-Analysis, Inc. (Santa Monica, US). The FDA issued a Cleared decision on December 5, 1985 after a review of 38 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 Pantex, Div. Bio-Analysis, Inc. devices

Submission Details

510(k) Number K854324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1985
Decision Date December 05, 1985
Days to Decision 38 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 88d · This submission: 38d
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 K854324.
CIBA CORNING MAGIC(R) LITE T4 IMMUNOASSAY
K870965 · Ciba Corning Diagnostics Corp. · May 1987
IQ T4 IMMUNOASSAY
K864560 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1986
STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY
K860421 · American Dade · Feb 1986
MAGIC T4 125I RADIOIMMUNOASSAY
K831533 · Corning Medical & Scientific · Jun 1983
COAT-A-COUNT NEONATAL T4 KIT RIA KIT
K831107 · Diagnostic Products Corp. · May 1983
MONOCLONAL ANTIBODY T4 RADIO-KIT
K823265 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1982