Cleared Traditional

K870405 - DSL ESTRADIAL RADIOIMMUNOASSAY (DSL-4400)

K870405 is an FDA 510(k) clearance for DSL ESTRADIAL RADIOIMMUNOASSAY (DSL-4400), manufactured by Diagnostic Systems Laboratories, Inc.. The device is a Class 1 Chemistry device with 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

FDA 510(k) Submission Details - K870405

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.

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 42
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
ESTRADIOL MAIA RIA KIT MAGNETIC SEPARATION PHASE
K861361 · Serono Diagnostics, Inc. · Jun 1986
125I ESTRADIOL DIRECT RADIOIMMUNOASSAY
K853208 · Travenol Laboratories, S.A. · Aug 1985