Cleared Traditional

K894204 - CALCIUM (ARSENAZO III) REAGENT

K894204 is the FDA 510(k) clearance for CALCIUM (ARSENAZO III) REAGENT by Sigma Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CJY) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K894204 · Sigma Diagnostics, Inc. · Chemistry device
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Oct 1989
Decision
107d
Days
Class 2
Risk

K894204 is an FDA 510(k) clearance for the CALCIUM (ARSENAZO III) REAGENT. Classified as Azo Dye, Calcium (product code CJY), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on October 4, 1989 after a review of 107 days - within the typical 510(k) review window.

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 Sigma Diagnostics, Inc. devices

Submission Details

510(k) Number K894204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1989
Decision Date October 04, 1989
Days to Decision 107 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 88d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 32
Devices cleared under the same product code (CJY) and FDA review panel - the closest regulatory comparables to K894204.
COULTER CALCIUM REAGENT
K900231 · Coulter Corp. · Apr 1990
CALCIUM, CATALOGUE NUMBER140-20
K895873 · Diagnostic Chemicals, Ltd. (Usa) · Dec 1989
CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION
K894476 · Catachem, Inc. · Oct 1989
BIOTROL CALCIUM MONOREACTIF
K891061 · Biotrol, USA, Inc. · Aug 1989
HI CHEM CALCIUM REAGENT #88808
K890584 · Hichem Diagnostics · Apr 1989
CALCIUM PLUS PROCEDURE
K890302 · Data Medical Associates, Inc. · Feb 1989