Cleared Traditional

K060585 - ROCHE ELECSYS- ACTH

K060585 is the FDA 510(k) clearance for ROCHE ELECSYS- ACTH by Roche Diagnostics Corp.. It is a Class 2 Chemistry device (product code CKG) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K060585 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
57d
Days
Class 2
Risk

K060585 is an FDA 510(k) clearance for the ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH. Classified as Radioimmunoassay, Acth (product code CKG), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on May 3, 2006 after a review of 57 days - a notably fast clearance 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: 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 Roche Diagnostics Corp. devices

Submission Details

510(k) Number K060585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2006
Decision Date May 03, 2006
Days to Decision 57 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
31d faster than avg
Panel avg: 88d · This submission: 57d
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.

Regulatory Peers - CKG Radioimmunoassay, Acth

All 9
Devices cleared under the same product code (CKG) and FDA review panel - the closest regulatory comparables to K060585.
IDS ACTH II
K223867 · Immunodiagnostic Systems Limited · Aug 2023
NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE
K962601 · Nichols Institute Diagnostics · Dec 1996
IMMULITE ACTH
K960066 · Diagnostic Products Corp. · Feb 1996
MODIFIED DSL-2300 ACTH RIA
K900147 · Diagnostic Systems Laboratories, Inc. · Mar 1990
ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBES
K882741 · Nichols Institute Diagnostics · Aug 1988
ACTH NORMAL RANGE
K842249 · Diagnostic Systems Laboratories, Inc. · Aug 1984