Cleared Traditional

K811371 - NATAL-TEC ESTRIOL

K811371 is the FDA 510(k) clearance for NATAL-TEC ESTRIOL by Armkel, LLC. It is a Class 1 Chemistry device (product code CGI) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K811371 · Armkel, LLC · Chemistry device
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May 1981
Decision
15d
Days
Class 1
Risk

K811371 is an FDA 510(k) clearance for the NATAL-TEC ESTRIOL. Classified as Radioimmunoassay, Estriol (product code CGI), Class I - General Controls.

Submitted by Armkel, LLC (Mchenry, US). The FDA issued a Cleared decision on May 29, 1981 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1265 - 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 Armkel, LLC devices

Submission Details

510(k) Number K811371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1981
Decision Date May 29, 1981
Days to Decision 15 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 88d · This submission: 15d
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 25
Devices cleared under the same product code (CGI) and FDA review panel - the closest regulatory comparables to K811371.
QUANTIMUNE ESTRIOL RIA
K820728 · Bio-Rad · Apr 1982
COAT-A-COUNT FREE & TOTAL ESTRIOL KIT
K812768 · Diagnostic Products Corp. · Jan 1982
QUANTIMUNE ESTRIOL RIA
K811709 · Bio-Rad · Jul 1981
AMERLEX ESTRIOL RIA KIT
K810667 · Amersham Corp. · Mar 1981
QUANTIMUNE E3 RIA
K802944 · Bio-Rad · Dec 1980
ARIA II 125- I-ESTRIOL SYSTEM
K801735 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1980