Cleared Traditional

K933464 - STRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAY

K933464 is an FDA 510(k) clearance for STRATUS ESTRADIOL FLUOROMETRIC ENZYME I..., manufactured by Baxter Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code CHP cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K933464 · Baxter Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K933464

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 88d · This submission: 98d
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 42
Devices cleared under the same product code (CHP) and FDA review panel - the closest regulatory comparables to K933464.
IMMULITE ESTRADIOL
K932926 · Diagnostic Products Corp. · Jan 1994
CIBA CORNING ACS ESTRADIOL IMMUNOASSAY
K932715 · Ciba Corning Diagnostics Corp. · Dec 1993
AIA-PACK E2 ASSAY
K932084 · Tosoh Medics, Inc. · Nov 1993
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