Cleared Traditional

K223038 - Access Cortisol

K223038 is an FDA 510(k) clearance for Access Cortisol, manufactured by Beckman Coulter, Inc.. The device is a Class 2 Chemistry device with product code CGR cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K223038 · Beckman Coulter, Inc. · Chemistry device
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Feb 2023
Decision
132d
Days
Class 2
Risk

K223038 is an FDA 510(k) clearance for the Access Cortisol. 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 8, 2023 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1205 - 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 Beckman Coulter, Inc. devices

FDA 510(k) Submission Details - K223038

510(k) Number K223038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2022
Decision Date February 08, 2023
Days to Decision 132 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
44d slower than avg
Panel avg: 88d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 53
Devices cleared under the same product code (CGR) and FDA review panel - the closest regulatory comparables to K223038.
Access Cortisol
K242190 · Beckman Coulter, Inc. · Mar 2025
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
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS
K060480 · Ortho-Clinical Diagnostics · Jul 2006
CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
K050202 · Beckman Coulter, Inc. · Feb 2005