Cleared Abbreviated

K012250 - RAICHEM MULTI-ANALYTE CALIBRATOR

K012250 is the FDA 510(k) clearance for RAICHEM MULTI-ANALYTE CALIBRATOR by Hemagen Diagnostics, Inc.. It is a Class 2 Chemistry device (product code JIX) cleared through the Abbreviated 510(k) pathway after a 69-day FDA review.

K012250 · Hemagen Diagnostics, Inc. · Chemistry device
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Sep 2001
Decision
69d
Days
Class 2
Risk

K012250 is an FDA 510(k) clearance for the RAICHEM MULTI-ANALYTE CALIBRATOR. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Hemagen Diagnostics, Inc. (Columbia, US). The FDA issued a Cleared decision on September 24, 2001 after a review of 69 days - a notably fast clearance 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Hemagen Diagnostics, Inc. devices

Submission Details

510(k) Number K012250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2001
Decision Date September 24, 2001
Days to Decision 69 days
Submission Type Abbreviated
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
19d faster than avg
Panel avg: 88d · This submission: 69d
Pathway characteristics
Standards-based clearance path.

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 204
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K012250.
RAICHEM LIPID CALIBRATOR
K022767 · Hemagen Diagnostics, Inc. · Sep 2002
DC-UIBC-CO2-CAL, MODEL SE-153
K013178 · Diagnostic Chemicals , Ltd. · Dec 2001
MODIFICATION TO N PROTEIN STANDARD SL
K012470 · Dade Behring, Inc. · Sep 2001
CALIBRATOR FOR AUTOMATED SYSTEMS
K011226 · Roche Diagnostics Corp. · Jun 2001
DIMENSION DRUG CALIBRATOR, MODEL DC22B
K011035 · Dade Behring, Inc. · Jun 2001
SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936
K010652 · Sigma Diagnostics, Inc. · Mar 2001