Cleared Traditional

K933678 - SIGMA CALCIUM REAGENT

K933678 is an FDA 510(k) clearance for SIGMA CALCIUM REAGENT, manufactured by Sigma Chemical Co.. The device is a Class 2 Chemistry device with product code CJY cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K933678 · Sigma Chemical Co. · Chemistry device
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Mar 1994
Decision
225d
Days
Class 2
Risk

K933678 is an FDA 510(k) clearance for the SIGMA CALCIUM REAGENT. Classified as Azo Dye, Calcium (product code CJY), Class II - Special Controls.

Submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on March 11, 1994 after a review of 225 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 Sigma Chemical Co. devices

FDA 510(k) Submission Details - K933678

510(k) Number K933678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1993
Decision Date March 11, 1994
Days to Decision 225 days
Submission Type Traditional
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
137d slower than avg
Panel avg: 88d · This submission: 225d
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 K933678.
SYNERMED CALCIUM REAGENT KIT
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HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808
K941764 · Hi Chem, Inc. · May 1994
CALCIUM (AZ III) REAGENT
K922835 · King Diagnostics, Inc. · Aug 1992
CALCIUM:ARSENAZO III
K902476 · Amresco, Inc. · Jul 1990
COULTER CALCIUM REAGENT
K900231 · Coulter Corp. · Apr 1990