Cleared Traditional

ACE(TM) CEDIA(R) FERRITIN ASSAY (K950393) - FDA 510(k) Clearance

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

K950393 · Schiapparelli Biosystems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
104d
Days
Class 2
Risk

K950393 is an FDA 510(k) clearance for the ACE(TM) CEDIA(R) FERRITIN ASSAY. Classified as Radioimmunoassay (two-site Solid Phase), Ferritin (product code JMG), Class II - Special Controls.

Submitted by Schiapparelli Biosystems, Inc. (Columbia, US). The FDA issued a Cleared decision on May 16, 1995 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5340 - 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

Submission Details

510(k) Number K950393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1995
Decision Date May 16, 1995
Days to Decision 104 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 88d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JMG Radioimmunoassay (two-site Solid Phase), Ferritin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5340
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 - JMG Radioimmunoassay (two-site Solid Phase), Ferritin

All 23
Devices cleared under the same product code (JMG) and FDA review panel - the closest regulatory comparables to K950393.
Access Ferritin
K234052 · Beckman Coulter, Inc. · Mar 2024
FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020
K052082 · Beckman Coulter, Inc. · Aug 2005
TINA-QUANT FERRITIN ASSAY
K964282 · Boehringer Mannheim Corp. · Jul 1997
ELECSYS FERRITIN
K971833 · Boehringer Mannheim Corp. · Jun 1997
IMMULITE FERRITIN
K925848 · Diagnostic Products Corp. · Jan 1993
COBAS CORE FERRITIN EIA
K920829 · Roche Diagnostic Systems, Inc. · Jun 1992