Cleared Traditional

K894476 - CALCIUM (ARSENAZO III) FOR MANUAL/AUTO ...

K894476 is the FDA 510(k) clearance for CALCIUM (ARSENAZO III) FOR MANUAL/AUTO ... by Catachem, Inc.. It is a Class 2 Chemistry device (product code CJY) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K894476 · Catachem, Inc. · Chemistry device
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Oct 1989
Decision
86d
Days
Class 2
Risk

K894476 is an FDA 510(k) clearance for the CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION. Classified as Azo Dye, Calcium (product code CJY), Class II - Special Controls.

Submitted by Catachem, Inc. (Port Chester, US). The FDA issued a Cleared decision on October 12, 1989 after a review of 86 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Catachem, Inc. devices

Submission Details

510(k) Number K894476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1989
Decision Date October 12, 1989
Days to Decision 86 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
2d faster than avg
Panel avg: 88d · This submission: 86d
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 K894476.
CALCIUM:ARSENAZO III
K902476 · Amresco, Inc. · Jul 1990
COULTER CALCIUM REAGENT
K900231 · Coulter Corp. · Apr 1990
CALCIUM, CATALOGUE NUMBER140-20
K895873 · Diagnostic Chemicals, Ltd. (Usa) · Dec 1989
CALCIUM (ARSENAZO III) REAGENT
K894204 · Sigma Diagnostics, Inc. · Oct 1989
BIOTROL CALCIUM MONOREACTIF
K891061 · Biotrol, USA, Inc. · Aug 1989
HI CHEM CALCIUM REAGENT #88808
K890584 · Hichem Diagnostics · Apr 1989