Cleared Traditional

K930104 - ACE CLINICAL CHEMISTRY SYSTEM

K930104 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 JIX cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K930104 · Schiapparelli Biosystems, Inc. · Chemistry device
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Aug 1993
Decision
224d
Days
Class 2
Risk

K930104 is an FDA 510(k) clearance for the ACE CLINICAL CHEMISTRY SYSTEM. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Schiapparelli Biosystems, Inc. (Fairfield, US). The FDA issued a Cleared decision on August 23, 1993 after a review of 224 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 - K930104

510(k) Number K930104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1993
Decision Date August 23, 1993
Days to Decision 224 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
136d slower than avg
Panel avg: 88d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIX Device Classification - Class 2, Special Controls

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIX Calibrator, Multi-analyte Mixture

All 244
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K930104.
SIGMA CX-3 CALIBRATION STANDARD LEVEL 2
K933693 · Sigma Chemical Co. · Oct 1993
DUPONT STANDARD C FOR THE DIMENSION CLINICAL CHEMISTRY SYSTEM
K933955 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1993
SIGMA CX-3 CALIBRATION STANDARD LEVEL 1
K933702 · Sigma Chemical Co. · Oct 1993
SYSTEMATE PLUS CALIBRATOR
K925101 · Em Diagnostic Systems, Inc. · Feb 1993
ISE CALIBRATOR FOR DUPONT DIMENSION
K926518 · Alko Diagnostic Corp. · Jan 1993
ROCHE CALIBRATOR SERUM
K922043 · Roche Diagnostic Systems, Inc. · Jun 1992