Cleared Traditional

K941489 - ACE CLINICAL CHEMISTRY SYSTEM

K941489 is an FDA 510(k) clearance for ACE CLINICAL CHEMISTRY SYSTEM, manufactured by Schiapparelli Biosystems, Inc.. The device is a Class 2 Chemistry device with product code DIS cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K941489 · Schiapparelli Biosystems, Inc. · Chemistry device
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Jul 1994
Decision
112d
Days
Class 2
Risk

K941489 is an FDA 510(k) clearance for the ACE CLINICAL CHEMISTRY SYSTEM. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by Schiapparelli Biosystems, Inc. (Columbia, US). The FDA issued a Cleared decision on July 18, 1994 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3150 - 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 - K941489

510(k) Number K941489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1994
Decision Date July 18, 1994
Days to Decision 112 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
24d slower than avg
Panel avg: 88d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DIS Device Classification - Class 2, Special Controls

Product Code DIS Enzyme Immunoassay, Barbiturate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3150
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 - DIS Enzyme Immunoassay, Barbiturate

All 74
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K941489.
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CEDIA DAU BARBITURATE ASSAY
K942436 · Microgenics Corp. · Aug 1994
CEDIA(R) DAU BARBITURATE ASSAY, MODIFICATION
K942404 · Microgenics Corp. · Jul 1994
CEDIA DAU BARBITURATE ASSAY
K936030 · Microgenics Corp. · Mar 1994
EMIT(R) D.A.U. BARBITURATE ASSAY
K931535 · Syva Co. · Jun 1993
EMIT(R) II BARBITURATE ASSAY
K926068 · Syva Co. · Jan 1993