Cleared Traditional

K944085 - ACE(TM) CEDIA PHENYTOIN ASSAY

K944085 is an FDA 510(k) clearance for ACE(TM) CEDIA PHENYTOIN ASSAY, manufactured by Schiapparelli Biosystems, Inc.. The device is a Class 2 Chemistry device with product code DIP cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K944085 · Schiapparelli Biosystems, Inc. · Chemistry device
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Dec 1994
Decision
128d
Days
Class 2
Risk

K944085 is an FDA 510(k) clearance for the ACE(TM) CEDIA(R) PHENYTOIN ASSAY. Classified as Enzyme Immunoassay, Diphenylhydantoin (product code DIP), Class II - Special Controls.

Submitted by Schiapparelli Biosystems, Inc. (Columbia, US). The FDA issued a Cleared decision on December 28, 1994 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3350 - 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 - K944085

510(k) Number K944085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1994
Decision Date December 28, 1994
Days to Decision 128 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
40d slower than avg
Panel avg: 88d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DIP Device Classification - Class 2, Special Controls

Product Code DIP Enzyme Immunoassay, Diphenylhydantoin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3350
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 - DIP Enzyme Immunoassay, Diphenylhydantoin

All 39
Devices cleared under the same product code (DIP) and FDA review panel - the closest regulatory comparables to K944085.
CEDIA PHENYTOIN II ASSAY
K963840 · Boehringer Mannheim Corp. · Nov 1996
IL TEST PHENYTION CALIBRATORS
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PHENYTION EIA TEST
K945725 · Diagnostic Reagents, Inc. · Feb 1995
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE PHENYTOIN
K941142 · Eastman Kodak Company · Jun 1994
PARAMAX(R) PHENYTOIN REAGENT
K932686 · Baxter Diagnostics, Inc. · Nov 1993
EMIT(R) 2000 PHENYTOIN ASSAY/CALIBRATORS
K913429 · Syva Co. · Aug 1991