Cleared Special

K022049 - MODIFICATION TO RAICHEM CALCIUM REAGENT

K022049 is an FDA 510(k) clearance for MODIFICATION TO RAICHEM CALCIUM REAGENT, manufactured by Hemagen Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CJY cleared through the Special 510(k) pathway after a 25-day FDA review.

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.

FDA 510(k) Submission Details - K022049

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 89d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

CJY Device Classification - Class 2, Special Controls

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.
CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91
K051757 · Diagnostic Chemicals , Ltd. · Nov 2005
CALCIUM, AZO DYE REAGENT
K040972 · Genchem, Inc. · Dec 2004
WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER LAB.CA-COLOR ARSENAZO III AA, MODEL 8 X 20 5
K021334 · Wiener Laboratories Saic · Sep 2002
JAS CALCIUM (ARSENAZO) REAGENT
K011441 · Jas Diagnostics, Inc. · Jul 2001
CARESIDE CALCIUM, ORIGINAL
K983789 · Careside, Inc. · Dec 1998
HICHEM CALCIUM REAGENT KIT
K981794 · Hichem Diagnostics · Jul 1998
K022049 · MODIFICATION TO RAICHEM CALCIUM REAGENT
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