Cleared Traditional

K781599 - I-ESTRIOL TEST SET

K781599 is the FDA 510(k) clearance for I-ESTRIOL TEST SET by Wien Laboratories, Inc.. It is a Class 1 Hematology device (product code CGI) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K781599 · Wien Laboratories, Inc. · Hematology device
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Oct 1978
Decision
29d
Days
Class 1
Risk

K781599 is an FDA 510(k) clearance for the I-ESTRIOL TEST SET. Classified as Radioimmunoassay, Estriol (product code CGI), Class I - General Controls.

Submitted by Wien Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 17, 1978 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1265 - the FDA hematology device 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 Wien Laboratories, Inc. devices

Submission Details

510(k) Number K781599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1978
Decision Date October 17, 1978
Days to Decision 29 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 113d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CGI Radioimmunoassay, Estriol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1265
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 - CGI Radioimmunoassay, Estriol

All 28
Devices cleared under the same product code (CGI) and FDA review panel - the closest regulatory comparables to K781599.
TOTAL ESTRIOL RIA KIT
K800036 · Amersham Corp. · Jan 1980
RIA, QUANTIMUNE E3
K781850 · Bio-Rad · Jan 1979
DIRECT ESTRIOL RIA KIT
K781546 · Immunalysis Corporation · Dec 1978
HUMAN FOLLICLE STIMULATING HORMONE
K780016 · Pcl-Ria, Inc. · Feb 1978
UNCONJUGATED ESTRIOL RIA KIT
K772215 · Amersham Corp. · Dec 1977
RIA-120 AND ESTRIOL REAGENT SYSTEM
K770465 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1977