Cleared Traditional

K982035 - OLYMPUS CALCIUM ARSENAZO III REAGENT

K982035 is an FDA 510(k) clearance for OLYMPUS CALCIUM ARSENAZO III REAGENT, manufactured by Olympus Diagnostica GmbH. The device is a Class 2 Chemistry device with product code CJY cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K982035 · Olympus Diagnostica GmbH · Chemistry device
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Jun 1998
Decision
14d
Days
Class 2
Risk

K982035 is an FDA 510(k) clearance for the OLYMPUS CALCIUM ARSENAZO III REAGENT. Classified as Azo Dye, Calcium (product code CJY), Class II - Special Controls.

Submitted by Olympus Diagnostica GmbH (Melville, US). The FDA issued a Cleared decision on June 24, 1998 after a review of 14 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 Olympus Diagnostica GmbH devices

FDA 510(k) Submission Details - K982035

510(k) Number K982035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1998
Decision Date June 24, 1998
Days to Decision 14 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
74d faster than avg
Panel avg: 88d · This submission: 14d
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 K982035.
JAS CALCIUM (ARSENAZO) REAGENT
K011441 · Jas Diagnostics, Inc. · Jul 2001
CARESIDE CALCIUM, ORIGINAL
K983789 · Careside, Inc. · Dec 1998
HICHEM CALCIUM REAGENT KIT
K981794 · Hichem Diagnostics · Jul 1998
CA
K981578 · Abbott Laboratories · Jun 1998
CA
K981232 · Abbott Mfg., Inc. · May 1998
RANDOX CALCIUM
K974607 · Randox Laboratories, Ltd. · Feb 1998