Cleared Traditional

K920047 - IMX ESTRADIOL

K920047 is an FDA 510(k) clearance for IMX ESTRADIOL, manufactured by Abbott Laboratories. The device is a Class 1 Chemistry device with product code CHP cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K920047 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1992
Decision
43d
Days
Class 1
Risk

K920047 is an FDA 510(k) clearance for the IMX ESTRADIOL. Classified as Radioimmunoassay, Estradiol (product code CHP), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on February 18, 1992 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1260 - 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K920047

510(k) Number K920047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1992
Decision Date February 18, 1992
Days to Decision 43 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
45d faster than avg
Panel avg: 88d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

CHP Device Classification - Class 1, General Controls

Product Code CHP Radioimmunoassay, Estradiol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1260
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CHP Radioimmunoassay, Estradiol

All 33
Devices cleared under the same product code (CHP) and FDA review panel - the closest regulatory comparables to K920047.
OPUS ESTRADIOL
K933066 · Pb Diagnostic Systems, Inc. · Sep 1993
COTUBE ESTRADIOL RADIOIMMUNOASSAY
K931740 · Bio-Rad · Aug 1993
VIDAS ESTRADIOL (E2) ASSAY
K925498 · Biomerieux Vitek, Inc. · Feb 1993
ENZYMUN-TEST ESTRADIOL
K913162 · Boehringer Mannheim Corp. · Sep 1991
MILENIA ESTRADIOL
K912917 · Diagnostic Products Corp. · Jul 1991
STRATUS ESTRADIOL FLUOREMETRIC ENZYME
K910249 · Baxter Healthcare Corp · Feb 1991