Cleared Traditional

K925101 - SYSTEMATE PLUS CALIBRATOR

K925101 is the FDA 510(k) clearance for SYSTEMATE PLUS CALIBRATOR by Em Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K925101 · Em Diagnostic Systems, Inc. · Chemistry device
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Feb 1993
Decision
138d
Days
Class 2
Risk

K925101 is an FDA 510(k) clearance for the SYSTEMATE PLUS CALIBRATOR. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on February 23, 1993 after a review of 138 days - within the typical 510(k) review window.

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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K925101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1992
Decision Date February 23, 1993
Days to Decision 138 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
50d slower than avg
Panel avg: 88d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 201
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K925101.
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
ROCHE CALIBRATOR SERUM
K922043 · Roche Diagnostic Systems, Inc. · Jun 1992
CIBA CORNING ACS FOLATE IMMUNOASSAY
K921678 · Ciba Corning Diagnostics Corp. · Jun 1992
IL TEST(TM) CALIBRATION SET SP
K914909 · Instrumentation Laboratory CO · Jan 1992