Cleared Traditional

K860823 - ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT (FDA 510(k) Clearance)

Class I Chemistry device.

K860823 · Cis-Us, Inc. · Chemistry device
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Aug 1986
Decision
168d
Days
Class 1
Risk

K860823 is an FDA 510(k) clearance for the ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT. Classified as Radioimmunoassay, Prolactin (lactogen) (product code CFT), Class I - General Controls.

Submitted by Cis-Us, Inc. (Lake Success, US). The FDA issued a Cleared decision on August 19, 1986 after a review of 168 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1625 - 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 Cis-Us, Inc. devices

Submission Details

510(k) Number K860823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1986
Decision Date August 19, 1986
Days to Decision 168 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 88d · This submission: 168d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CFT Radioimmunoassay, Prolactin (lactogen)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1625
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.