Cleared Traditional

K032188 - NICHOLS ADVANTAGE ALDOSTERONE ASSAY

K032188 is the FDA 510(k) clearance for NICHOLS ADVANTAGE ALDOSTERONE ASSAY by Nichols Institute Diagnostics. It is a Class 2 Chemistry device (product code CJM) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K032188 · Nichols Institute Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
14d
Days
Class 2
Risk

K032188 is an FDA 510(k) clearance for the NICHOLS ADVANTAGE ALDOSTERONE ASSAY. Classified as Radioimmunoassay, Aldosterone (product code CJM), Class II - Special Controls.

Submitted by Nichols Institute Diagnostics (San Clemente, US). The FDA issued a Cleared decision on July 31, 2003 after a review of 14 days - a notably fast clearance cycle.

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: 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 Nichols Institute Diagnostics devices

Submission Details

510(k) Number K032188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2003
Decision Date July 31, 2003
Days to Decision 14 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 88d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 Consultant

California Department of Health Services

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - CJM Radioimmunoassay, Aldosterone

Devices cleared under the same product code (CJM) and FDA review panel - the closest regulatory comparables to K032188.
NICHOLS ADVANTAGE ALDOSTERONE ASSAY
K050784 · Nichols Institute Diagnostics · Jun 2005
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
125I-ALDOSTERONE RIA DIAG. KIT
K781504 · Abbott Laboratories · Nov 1978
125 I ALDOSTERONE RIA KIT
K771526 · Diagnostic Products Corp. · Aug 1977