Cleared Traditional

AMERLITE ESTRADIOL ASSAY, LAN.2080 (144 TEST KIT) (K884105) - FDA 510(k) Clearance

Class I Chemistry device.

K884105 · Amersham Corp. · Chemistry device
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Nov 1988
Decision
48d
Days
Class 1
Risk

K884105 is an FDA 510(k) clearance for the AMERLITE ESTRADIOL ASSAY, LAN.2080 (144 TEST KIT). Classified as Radioimmunoassay, Estradiol (product code CHP), Class I - General Controls.

Submitted by Amersham Corp. (Arlington Heights, US). The FDA issued a Cleared decision on November 16, 1988 after a review of 48 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 Amersham Corp. devices

Submission Details

510(k) Number K884105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1988
Decision Date November 16, 1988
Days to Decision 48 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 88d · This submission: 48d
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 13
Devices cleared under the same product code (CHP) and FDA review panel - the closest regulatory comparables to K884105.
ENZYMUN-TEST ESTRADIOL
K913162 · Boehringer Mannheim Corp. · Sep 1991
MILENIA ESTRADIOL
K912917 · Diagnostic Products Corp. · Jul 1991
STRATUS ESTRADIOL FLUOREMETRIC ENZYME
K910249 · Baxter Healthcare Corp · Feb 1991
TERUMO SENSIBEAD(TM) EIA ESTRADIOL KIT
K882343 · Terumo Medical Corp. · Jul 1988
DOUBLE ANTIBODY ESTRADIOL RIA KIT
K862603 · Diagnostic Products Corp. · Aug 1986
125I ESTRADIOL DIRECT RADIOIMMUNOASSAY
K853208 · Travenol Laboratories, S.A. · Aug 1985