Cleared Traditional

K870405 - DSL ESTRADIAL RADIOIMMUNOASSAY (DSL-4400)

K870405 is the FDA 510(k) clearance for DSL ESTRADIAL RADIOIMMUNOASSAY (DSL-4400) by Diagnostic Systems Laboratories, Inc.. It is a Class 1 Chemistry device (product code CHP) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K870405 · Diagnostic Systems Laboratories, Inc. · Chemistry device
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Jun 1987
Decision
125d
Days
Class 1
Risk

K870405 is an FDA 510(k) clearance for the DSL ESTRADIAL RADIOIMMUNOASSAY (DSL-4400). Classified as Radioimmunoassay, Estradiol (product code CHP), Class I - General Controls.

Submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on June 8, 1987 after a review of 125 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Systems Laboratories, Inc. devices

Submission Details

510(k) Number K870405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1987
Decision Date June 08, 1987
Days to Decision 125 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
37d slower than avg
Panel avg: 88d · This submission: 125d
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 31
Devices cleared under the same product code (CHP) and FDA review panel - the closest regulatory comparables to K870405.
TERUMO SENSIBEAD(TM) EIA ESTRADIOL KIT
K882343 · Terumo Medical Corp. · Jul 1988
DELFIA ESTRADIOL KIT
K882173 · Pharmacia, Inc. · Jun 1988
DSL ACTIVE ESTRADIOL RIA (DSL #4300)
K873550 · Diagnostic Systems Laboratories, Inc. · Feb 1988
DOUBLE ANTIBODY ESTRADIOL RIA KIT
K862603 · Diagnostic Products Corp. · Aug 1986
125I ESTRADIOL DIRECT RADIOIMMUNOASSAY
K853208 · Travenol Laboratories, S.A. · Aug 1985
COAT-A-COUNT ESTRADIOL KIT
K840051 · Diagnostic Products Corp. · Mar 1984