Cleared Traditional

K933066 - OPUS ESTRADIOL

K933066 is the FDA 510(k) clearance for OPUS ESTRADIOL by Pb Diagnostic Systems, Inc.. It is a Class 1 Chemistry device (product code CHP) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K933066 · Pb Diagnostic Systems, Inc. · Chemistry device
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Sep 1993
Decision
78d
Days
Class 1
Risk

K933066 is an FDA 510(k) clearance for the OPUS ESTRADIOL. Classified as Radioimmunoassay, Estradiol (product code CHP), Class I - General Controls.

Submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on September 8, 1993 after a review of 78 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 Pb Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K933066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1993
Decision Date September 08, 1993
Days to Decision 78 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 88d · This submission: 78d
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 31
Devices cleared under the same product code (CHP) and FDA review panel - the closest regulatory comparables to K933066.
CIBA CORNING ACS ESTRADIOL IMMUNOASSAY
K932715 · Ciba Corning Diagnostics Corp. · Dec 1993
AIA-PACK E2 ASSAY
K932084 · Tosoh Medics, Inc. · Nov 1993
STRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAY
K933464 · Baxter Diagnostics, Inc. · Oct 1993
COTUBE ESTRADIOL RADIOIMMUNOASSAY
K931740 · Bio-Rad · Aug 1993
VIDAS ESTRADIOL (E2) ASSAY
K925498 · Biomerieux Vitek, Inc. · Feb 1993
IMX ESTRADIOL
K920047 · Abbott Laboratories · Feb 1992