Cleared Traditional

K882343 - TERUMO SENSIBEAD(TM) EIA ESTRADIOL KIT

K882343 is an FDA 510(k) clearance for TERUMO SENSIBEAD(TM) EIA ESTRADIOL KIT, manufactured by Terumo Medical Corp.. The device is a Class 1 Chemistry device with product code CHP cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K882343 · Terumo Medical Corp. · Chemistry device
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Jul 1988
Decision
24d
Days
Class 1
Risk

K882343 is an FDA 510(k) clearance for the TERUMO SENSIBEAD(TM) EIA ESTRADIOL KIT. Classified as Radioimmunoassay, Estradiol (product code CHP), Class I - General Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on July 1, 1988 after a review of 24 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 Terumo Medical Corp. devices

FDA 510(k) Submission Details - K882343

510(k) Number K882343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1988
Decision Date July 01, 1988
Days to Decision 24 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
64d faster than avg
Panel avg: 88d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

CHP Device Classification - Class 1, General Controls

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 37
Devices cleared under the same product code (CHP) and FDA review panel - the closest regulatory comparables to K882343.
AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081
K896270 · Amersham Corp. · Dec 1989
ESTRADIOL MAIACLONE RADIOIMMUNOASSAY KIT
K890645 · Serono-Baker Diagnostics, Inc. · Mar 1989
AMERLITE ESTRADIOL ASSAY, LAN.2080 (144 TEST KIT)
K884105 · Amersham Corp. · Nov 1988
DELFIA ESTRADIOL KIT
K882173 · Pharmacia, Inc. · Jun 1988
DSL ACTIVE ESTRADIOL RIA (DSL #4300)
K873550 · Diagnostic Systems Laboratories, Inc. · Feb 1988
DSL ESTRADIAL RADIOIMMUNOASSAY (DSL-4400)
K870405 · Diagnostic Systems Laboratories, Inc. · Jun 1987