Cleared Traditional

K931177 - SYNELISA CORTISOL

K931177 is an FDA 510(k) clearance for SYNELISA CORTISOL, manufactured by Elias U.S.A., Inc.. The device is a Class 2 Chemistry device with product code CGR cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K931177 · Elias U.S.A., Inc. · Chemistry device
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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

FDA 510(k) Submission Details - K931177

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
Combination Product No
PCCP Authorized No
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.

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 59
Devices cleared under the same product code (CGR) and FDA review panel - the closest regulatory comparables to K931177.
CIBA CORNING ACS CORTISOL IMMUNOASSAY
K945367 · Ciba Corning Diagnostics Corp. · May 1995
ACE CEDIA CORTISOL ASSAY
K943427 · Schiapparelli Biosystems, Inc. · Nov 1994
ACCESS CORTISOL REAGENTS
K940221 · Bio-Rad Laboratories, Inc. · Apr 1994
IMMULITE CORTISOL
K931409 · Diagnostic Products Corp. · May 1993
SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE)
K914886 · Serono-Baker Diagnostics, Inc. · Mar 1992
UBI MAGIWEL CORTISOL QUANTITATIVE
K905473 · United Biotech, Inc. · Jan 1991