Cleared Traditional

K142994 - IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K142994 · Immunodiagnostic Systems , Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
187d
Days
Class 2
Risk

K142994 is an FDA 510(k) clearance for the IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldostero.... Classified as Radioimmunoassay, Aldosterone (product code CJM), Class II - Special Controls.

Submitted by Immunodiagnostic Systems , Ltd. (Boldon, Tyne & Wear, GB). The FDA issued a Cleared decision on April 21, 2015 after a review of 187 days - an extended review 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: 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 Immunodiagnostic Systems , Ltd. devices

Submission Details

510(k) Number K142994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2014
Decision Date April 21, 2015
Days to Decision 187 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 88d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.