Cleared Traditional

K203270 - IMMULITE/IMMULITE 1000 Cortisol

K203270 is an FDA 510(k) clearance for IMMULITE/IMMULITE 1000 Cortisol, manufactured by Siemens Healthcare Diagnostics Products, Ltd.. The device is a Class 2 Chemistry device with product code CGR cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K203270 · Siemens Healthcare Diagnostics Products, Ltd. · Chemistry device
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Jan 2021
Decision
71d
Days
Class 2
Risk

K203270 is an FDA 510(k) clearance for the IMMULITE/IMMULITE® 1000 Cortisol. Classified as Radioimmunoassay, Cortisol (product code CGR), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics Products, Ltd. (Caemarfon, GB). The FDA issued a Cleared decision on January 15, 2021 after a review of 71 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. 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 Siemens Healthcare Diagnostics Products, Ltd. devices

FDA 510(k) Submission Details - K203270

510(k) Number K203270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2020
Decision Date January 15, 2021
Days to Decision 71 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
17d faster than avg
Panel avg: 88d · This submission: 71d
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 K203270.
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
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
NICHOLS ADVANTAGE CORTISOL
K042689 · Nichols Institute Diagnostics · Dec 2004