Cleared Abbreviated

ABBOTT ARCHITECT ESTRADIOL CALIBRATORS (K032458) - FDA 510(k) Clearance

Also marketed or referenced as:
ABBOTT IMX ESTRADIOL CALIBRATOR ABBOTT IMX ESTRADIOL MODE 1 CALIBRATOR ABBOTT

Class II Chemistry device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K032458 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
56d
Days
Class 2
Risk

K032458 is an FDA 510(k) clearance for the ABBOTT ARCHITECT ESTRADIOL CALIBRATORS. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 6, 2003 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - the FDA in vitro diagnostics and chemistry framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Abbott Laboratories devices

Submission Details

510(k) Number K032458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2003
Decision Date October 06, 2003
Days to Decision 56 days
Submission Type Abbreviated
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
32d faster than avg
Panel avg: 88d · This submission: 56d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code JIT Calibrator, Secondary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIT Calibrator, Secondary

All 109
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