Cleared Traditional

K943427 - ACE CEDIA CORTISOL ASSAY

K943427 is an FDA 510(k) clearance for ACE CEDIA CORTISOL ASSAY, manufactured by Schiapparelli Biosystems, Inc.. The device is a Class 2 Chemistry device with product code CGR cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K943427 · Schiapparelli Biosystems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
136d
Days
Class 2
Risk

K943427 is an FDA 510(k) clearance for the ACE CEDIA CORTISOL ASSAY. Classified as Radioimmunoassay, Cortisol (product code CGR), Class II - Special Controls.

Submitted by Schiapparelli Biosystems, Inc. (Fairfield, US). The FDA issued a Cleared decision on November 28, 1994 after a review of 136 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 Schiapparelli Biosystems, Inc. devices

FDA 510(k) Submission Details - K943427

510(k) Number K943427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1994
Decision Date November 28, 1994
Days to Decision 136 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
48d slower than avg
Panel avg: 88d · This submission: 136d
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 51
Devices cleared under the same product code (CGR) and FDA review panel - the closest regulatory comparables to K943427.
NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KIT
K962208 · Nichols Institute Diagnostics · Apr 1997
ACCESS CORTISOL ASSAY (MODIFICATION)
K954733 · Bio-Rad Laboratories, Inc. · Dec 1995
CIBA CORNING ACS CORTISOL IMMUNOASSAY
K945367 · Ciba Corning Diagnostics Corp. · May 1995
ACCESS CORTISOL REAGENTS
K940221 · Bio-Rad Laboratories, Inc. · Apr 1994
SYNELISA CORTISOL
K931177 · Elias U.S.A., Inc. · Sep 1993
IMMULITE CORTISOL
K931409 · Diagnostic Products Corp. · May 1993