Cleared Traditional

SYNELISA CORTISOL (K931177) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K931177 · Elias U.S.A., Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1993
Decision
202d
Days
Class 2
Risk

K931177 is an FDA 510(k) clearance for the SYNELISA CORTISOL. Classified as Radioimmunoassay, Cortisol (product code CGR), Class II - Special Controls.

Submitted by Elias U.S.A., Inc. (Osceola, US). The FDA issued a Cleared decision on September 27, 1993 after a review of 202 days - an extended review 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: 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 Elias U.S.A., Inc. devices

Submission Details

510(k) Number K931177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1993
Decision Date September 27, 1993
Days to Decision 202 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d slower than avg
Panel avg: 88d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K931177.
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
CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
K050202 · Beckman Coulter, Inc. · Feb 2005