Cleared Traditional

K223867 - IDS ACTH II (FDA 510(k) Clearance)

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

K223867 · Immunodiagnostic Systems Limited · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
238d
Days
Class 2
Risk

K223867 is an FDA 510(k) clearance for the IDS ACTH II. Classified as Radioimmunoassay, Acth (product code CKG), Class II - Special Controls.

Submitted by Immunodiagnostic Systems Limited (Boldon, GB). The FDA issued a Cleared decision on August 18, 2023 after a review of 238 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1025 - 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 Limited devices

Submission Details

510(k) Number K223867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2022
Decision Date August 18, 2023
Days to Decision 238 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
150d slower than avg
Panel avg: 88d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CKG Radioimmunoassay, Acth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1025
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.