Cleared Special

K050202 - CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS

K050202 is an FDA 510(k) clearance for CORTISOL AND CORTISOL CALIBRATORS ON TH..., manufactured by Beckman Coulter, Inc.. The device is a Class 2 Chemistry device with product code CGR cleared through the Special 510(k) pathway after a 12-day FDA review.

K050202 · Beckman Coulter, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K050202

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
77d faster than avg
Panel avg: 89d · This submission: 12d
Pathway characteristics
Modification to existing cleared device.

CGR Device Classification - Class 2, Special Controls

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 81
Devices cleared under the same product code (CGR) and FDA review panel - the closest regulatory comparables to K050202.
CORTISOL ELISA
K062626 · Ibl-Hamburg GmbH · Dec 2006
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS
K060480 · Ortho-Clinical Diagnostics · Jul 2006
IBL CORTISOL LIA TEST KIT
K052359 · Lehnus & Associates Consulting · Oct 2005
NICHOLS ADVANTAGE CORTISOL
K042689 · Nichols Institute Diagnostics · Dec 2004
CORTISOL LIA
K010790 · Kmi Diagnostics, Inc. · Jan 2002
NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005
K984520 · Nichols Institute Diagnostics · Feb 1999
K050202 · CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
Download PDF FDA Summary Beckman Coulter, Inc.