Cleared Traditional

K862603 - DOUBLE ANTIBODY ESTRADIOL RIA KIT

K862603 is the FDA 510(k) clearance for DOUBLE ANTIBODY ESTRADIOL RIA KIT by Diagnostic Products Corp.. It is a Class 1 Chemistry device (product code CHP) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K862603 · Diagnostic Products Corp. · Chemistry device
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Aug 1986
Decision
42d
Days
Class 1
Risk

K862603 is an FDA 510(k) clearance for the DOUBLE ANTIBODY ESTRADIOL RIA KIT. 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 August 19, 1986 after a review of 42 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 K862603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1986
Decision Date August 19, 1986
Days to Decision 42 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
46d faster than avg
Panel avg: 88d · This submission: 42d
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 K862603.
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
125I ESTRADIOL DIRECT RADIOIMMUNOASSAY
K853208 · Travenol Laboratories, S.A. · Aug 1985
COAT-A-COUNT ESTRADIOL KIT
K840051 · Diagnostic Products Corp. · Mar 1984
LEECO E2 QUANT DIAG. TEST KIT
K834586 · Leeco Diagnostics, Inc. · Mar 1984