Cleared Traditional

K912917 - MILENIA ESTRADIOL

K912917 is the FDA 510(k) clearance for MILENIA ESTRADIOL by Diagnostic Products Corp.. It is a Class 1 Chemistry device (product code CHP) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K912917 · Diagnostic Products Corp. · Chemistry device
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Jul 1991
Decision
27d
Days
Class 1
Risk

K912917 is an FDA 510(k) clearance for the MILENIA ESTRADIOL. Classified as Radioimmunoassay, Estradiol (product code CHP), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on July 30, 1991 after a review of 27 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K912917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1991
Decision Date July 30, 1991
Days to Decision 27 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
61d faster than avg
Panel avg: 88d · This submission: 27d
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 29
Devices cleared under the same product code (CHP) and FDA review panel - the closest regulatory comparables to K912917.
VIDAS ESTRADIOL (E2) ASSAY
K925498 · Biomerieux Vitek, Inc. · Feb 1993
IMX ESTRADIOL
K920047 · Abbott Laboratories · Feb 1992
ENZYMUN-TEST ESTRADIOL
K913162 · Boehringer Mannheim Corp. · Sep 1991
STRATUS ESTRADIOL FLUOREMETRIC ENZYME
K910249 · Baxter Healthcare Corp · Feb 1991
MODIFIED DELFIA ESTRADIOL KIT
K902358 · Pharmacia, Inc. · Jun 1990
AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081
K896270 · Amersham Corp. · Dec 1989