Cleared Traditional

K880242 - KONE CALCIUM TEST

K880242 is an FDA 510(k) clearance for KONE CALCIUM TEST, manufactured by The Rupp & Bowman Co.. The device is a Class 2 Chemistry device with product code CJY cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K880242 · The Rupp & Bowman Co. · Chemistry device
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Optimized for regulatory review, auditing and printing
Mar 1988
Decision
55d
Days
Class 2
Risk

K880242 is an FDA 510(k) clearance for the KONE CALCIUM TEST. Classified as Azo Dye, Calcium (product code CJY), Class II - Special Controls.

Submitted by The Rupp & Bowman Co. (Irving, US). The FDA issued a Cleared decision on March 15, 1988 after a review of 55 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 The Rupp & Bowman Co. devices

FDA 510(k) Submission Details - K880242

510(k) Number K880242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1988
Decision Date March 15, 1988
Days to Decision 55 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 88d · This submission: 55d
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 45
Devices cleared under the same product code (CJY) and FDA review panel - the closest regulatory comparables to K880242.
ROCHE REAGENT FOR CALCIUM
K883453 · Roche Diagnostic Systems, Inc. · Oct 1988
RAICHEM(TM) CALCIUM REAGENT (SINGLE STABLE LIQUID)
K880576 · Reagents Applications, Inc. · Jun 1988
SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER
K880949 · Advanced Biomedical Methods, Inc. · Apr 1988
ULTRACHEM CA, ITEM #64975
K813040 · Harleco · Nov 1981
CALCIUM SET, ITEM NO. 65004
K771928 · Harleco · Nov 1977
ULTRACHEM CALCIUM
K770817 · Harleco · Jul 1977