Cleared Traditional

K130321 - LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS

K130321 is an FDA 510(k) clearance for LIAISON ALDOSTERONE, manufactured by Diasorin. The device is a Class 2 Chemistry device with product code CJM cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K130321 · Diasorin · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
60d
Days
Class 2
Risk

K130321 is an FDA 510(k) clearance for the LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CAL.... Classified as Radioimmunoassay, Aldosterone (product code CJM), Class II - Special Controls.

Submitted by Diasorin (Stillwater, US). The FDA issued a Cleared decision on April 9, 2013 after a review of 60 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 Diasorin devices

FDA 510(k) Submission Details - K130321

510(k) Number K130321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2013
Decision Date April 09, 2013
Days to Decision 60 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 88d · This submission: 60d
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 9
Devices cleared under the same product code (CJM) and FDA review panel - the closest regulatory comparables to K130321.
IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers
K142994 · Immunodiagnostic Systems , Ltd. · Apr 2015
NICHOLS ADVANTAGE ALDOSTERONE ASSAY
K050784 · Nichols Institute Diagnostics · Jun 2005
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