Cleared Traditional

SYSTEMATE PLUS CALIBRATOR (K925101) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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 301
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K925101.
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K123372 · Abbott Laboratories · Jan 2013
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K103403 · Abbott Laboratories · Feb 2011
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K080607 · Roche Diagnostics Corp. · May 2008
DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H
K072435 · Dade Behring, Inc. · Oct 2007
DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H
K063508 · Dade Behring, Inc. · Jan 2007