Cleared Special

MODIFICATION TO RAICHEM CALCIUM REAGENT (K022049) - FDA 510(k) Clearance

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K022049 · Hemagen Diagnostics, Inc. · Chemistry device
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Jul 2002
Decision
25d
Days
Class 2
Risk

K022049 is an FDA 510(k) clearance for the MODIFICATION TO RAICHEM CALCIUM REAGENT. Classified as Azo Dye, Calcium (product code CJY), Class II - Special Controls.

Submitted by Hemagen Diagnostics, Inc. (Columbia, US). The FDA issued a Cleared decision on July 19, 2002 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1145 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Hemagen Diagnostics, Inc. devices

Submission Details

510(k) Number K022049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2002
Decision Date July 19, 2002
Days to Decision 25 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 88d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code CJY Azo Dye, Calcium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1145
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 - CJY Azo Dye, Calcium

All 46
Devices cleared under the same product code (CJY) and FDA review panel - the closest regulatory comparables to K022049.
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CALCIUM
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SIGMA CALCIUM REAGENT
K933678 · Sigma Chemical Co. · Mar 1994