Cleared Traditional

K862204 - RSL (125I) ALDOSTERONE KIT

K862204 is an FDA 510(k) clearance for RSL (125I) ALDOSTERONE KIT, manufactured by Radioassay Systems Laboratories, Inc.. The device is a Class 2 Chemistry device with product code CJM cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K862204 · Radioassay Systems Laboratories, Inc. · Chemistry device
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Sep 1986
Decision
107d
Days
Class 2
Risk

K862204 is an FDA 510(k) clearance for the RSL (125I) ALDOSTERONE KIT. Classified as Radioimmunoassay, Aldosterone (product code CJM), Class II - Special Controls.

Submitted by Radioassay Systems Laboratories, Inc. (Carson, US). The FDA issued a Cleared decision on September 25, 1986 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1045 - 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 Radioassay Systems Laboratories, Inc. devices

FDA 510(k) Submission Details - K862204

510(k) Number K862204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1986
Decision Date September 25, 1986
Days to Decision 107 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 88d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CJM Device Classification - Class 2, Special Controls

Product Code CJM Radioimmunoassay, Aldosterone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1045
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CJM Radioimmunoassay, Aldosterone

All 10
Devices cleared under the same product code (CJM) and FDA review panel - the closest regulatory comparables to K862204.
NICHOLS ADVANTAGE ALDOSTERONE ASSAY
K032188 · Nichols Institute Diagnostics · Jul 2003
DSL ACTIVE ALDOSTERONE RIA (DSL 8600)
K943397 · Diagnostic Systems Laboratories, Inc. · Feb 1995
DSL ACTIVE ALDOSTERONE (DSL 8600)
K921205 · Diagnostic Systems Laboratories, Inc. · Jul 1992
COAT-A-COUNT NO-EXTRACTION ALDOSTERONE
K831178 · Diagnostic Products Corp. · May 1983
ALDOCTK-125
K800775 · Sorin Biomedica, Fiat, USA, Inc. · Apr 1980
125I-ALDOSTERONE RIA DIAG. KIT
K781504 · Abbott Laboratories · Nov 1978