Cleared Special

CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS (K050202) - FDA 510(k) Clearance

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K050202 · Beckman Coulter, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
12d
Days
Class 2
Risk

K050202 is an FDA 510(k) clearance for the CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS. Classified as Radioimmunoassay, Cortisol (product code CGR), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on February 9, 2005 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1205 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Beckman Coulter, Inc. devices

Submission Details

510(k) Number K050202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2005
Decision Date February 09, 2005
Days to Decision 12 days
Submission Type Special
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
76d faster than avg
Panel avg: 88d · This submission: 12d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code CGR Radioimmunoassay, Cortisol
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1205
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 - CGR Radioimmunoassay, Cortisol

All 83
Devices cleared under the same product code (CGR) and FDA review panel - the closest regulatory comparables to K050202.
Access Cortisol
K242190 · Beckman Coulter, Inc. · Mar 2025
Access Cortisol
K223038 · Beckman Coulter, Inc. · Feb 2023
IDS Cortisol
K202136 · Immunodiagnostic Systems , Ltd. · Apr 2021
IMMULITE® 2000 Cortisol
K202826 · Siemens Healthcare Diagnostics Products, Ltd. · Jan 2021
IMMULITE/IMMULITE® 1000 Cortisol
K203270 · Siemens Healthcare Diagnostics Products, Ltd. · Jan 2021
IMMULITE CORTISOL
K931409 · Diagnostic Products Corp. · May 1993