Cleared Traditional

K950393 - ACE(TM) CEDIA FERRITIN ASSAY

K950393 is an FDA 510(k) clearance for ACE(TM) CEDIA FERRITIN ASSAY, manufactured by Schiapparelli Biosystems, Inc.. The device is a Class 2 Chemistry device with product code JMG cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K950393 · Schiapparelli Biosystems, Inc. · Chemistry device
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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

FDA 510(k) Submission Details - K950393

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
Combination Product No
PCCP Authorized No
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.

JMG Device Classification - Class 2, Special Controls

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 18
Devices cleared under the same product code (JMG) and FDA review panel - the closest regulatory comparables to K950393.
FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020
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K920829 · Roche Diagnostic Systems, Inc. · Jun 1992