Cleared Traditional

K940267 - ACE CLINICAL CHEMISTRY SYSTEM

K940267 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 KXT cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K940267 · Schiapparelli Biosystems, Inc. · Chemistry device
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May 1994
Decision
102d
Days
Class 2
Risk

K940267 is an FDA 510(k) clearance for the ACE CLINICAL CHEMISTRY SYSTEM. Classified as Enzyme Immunoassay, Digoxin (product code KXT), Class II - Special Controls.

Submitted by Schiapparelli Biosystems, Inc. (Fairfield, US). The FDA issued a Cleared decision on May 3, 1994 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3320 - 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 - K940267

510(k) Number K940267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1994
Decision Date May 03, 1994
Days to Decision 102 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
14d slower than avg
Panel avg: 88d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KXT Device Classification - Class 2, Special Controls

Product Code KXT Enzyme Immunoassay, Digoxin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3320
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 - KXT Enzyme Immunoassay, Digoxin

All 73
Devices cleared under the same product code (KXT) and FDA review panel - the closest regulatory comparables to K940267.
EMIT 2000 DIGOXIN ASSAY
K943500 · Syva Co. · Nov 1994
DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET
K940569 · Sigma Diagnostics, Inc. · Jul 1994
CEDIA DIGOXIN PLUS ASSAY
K941255 · Microgenics Corp. · Jun 1994
EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MODIFICATION
K934135 · Syva Co. · Apr 1994
CEDIA DIGOXIN PLUS ASSAY
K934168 · Microgenics Corp. · Dec 1993
ACA(R) DIGOXIN ANALYTICAL TEST PACK (DGN)
K932732 · Dupont Medical Products · Nov 1993