Cleared Traditional

STRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAY (K933464) - FDA 510(k) Clearance

Class I Chemistry device.

K933464 · Baxter Diagnostics, Inc. · Chemistry device
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Oct 1993
Decision
98d
Days
Class 1
Risk

K933464 is an FDA 510(k) clearance for the STRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAY. Classified as Radioimmunoassay, Estradiol (product code CHP), Class I - General Controls.

Submitted by Baxter Diagnostics, Inc. (Mcgaw Park, US). The FDA issued a Cleared decision on October 22, 1993 after a review of 98 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Baxter Diagnostics, Inc. devices

Submission Details

510(k) Number K933464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1993
Decision Date October 22, 1993
Days to Decision 98 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 88d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 49
Devices cleared under the same product code (CHP) and FDA review panel - the closest regulatory comparables to K933464.
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COAT-A-COUNT(R) ESTRADIOL-6
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IMMULITE ESTRADIOL
K932926 · Diagnostic Products Corp. · Jan 1994
COTUBE ESTRADIOL RADIOIMMUNOASSAY
K931740 · Bio-Rad · Aug 1993
IMX ESTRADIOL
K920047 · Abbott Laboratories · Feb 1992