Cleared Traditional

K883453 - ROCHE REAGENT FOR CALCIUM

K883453 is the FDA 510(k) clearance for ROCHE REAGENT FOR CALCIUM by Roche Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CJY) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K883453 · Roche Diagnostic Systems, Inc. · Chemistry device
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Oct 1988
Decision
74d
Days
Class 2
Risk

K883453 is an FDA 510(k) clearance for the ROCHE REAGENT FOR CALCIUM. Classified as Azo Dye, Calcium (product code CJY), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on October 25, 1988 after a review of 74 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 Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K883453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1988
Decision Date October 25, 1988
Days to Decision 74 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
14d faster than avg
Panel avg: 88d · This submission: 74d
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 27
Devices cleared under the same product code (CJY) and FDA review panel - the closest regulatory comparables to K883453.
CALCIUM (ARSENAZO III) REAGENT
K894204 · Sigma Diagnostics, Inc. · Oct 1989
BIOTROL CALCIUM MONOREACTIF
K891061 · Biotrol, USA, Inc. · Aug 1989
CALCIUM PLUS PROCEDURE
K890302 · Data Medical Associates, Inc. · Feb 1989
RAICHEM(TM) CALCIUM REAGENT (SINGLE STABLE LIQUID)
K880576 · Reagents Applications, Inc. · Jun 1988
ULTRACHEM CA, ITEM #64975
K813040 · Harleco · Nov 1981
CALCIUM SET, ITEM NO. 65004
K771928 · Harleco · Nov 1977