Cleared Traditional

K040972 - CALCIUM, AZO DYE REAGENT

K040972 is an FDA 510(k) clearance for CALCIUM, manufactured by Genchem, Inc.. The device is a Class 2 Chemistry device with product code CJY cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K040972 · Genchem, Inc. · Chemistry device
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Dec 2004
Decision
257d
Days
Class 2
Risk

K040972 is an FDA 510(k) clearance for the CALCIUM, AZO DYE REAGENT. Classified as Azo Dye, Calcium (product code CJY), Class II - Special Controls.

Submitted by Genchem, Inc. (Brea, US). The FDA issued a Cleared decision on December 27, 2004 after a review of 257 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1145 - 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 Genchem, Inc. devices

FDA 510(k) Submission Details - K040972

510(k) Number K040972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2004
Decision Date December 27, 2004
Days to Decision 257 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
169d slower than avg
Panel avg: 88d · This submission: 257d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 43
Devices cleared under the same product code (CJY) and FDA review panel - the closest regulatory comparables to K040972.
CALCIUM
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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
MODIFICATION TO RAICHEM CALCIUM REAGENT
K022049 · Hemagen Diagnostics, Inc. · Jul 2002
JAS CALCIUM (ARSENAZO) REAGENT
K011441 · Jas Diagnostics, Inc. · Jul 2001