Cleared Traditional

OLYMPUS CALCIUM REAGENT (K924435) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K924435 · Olympus Corp. · Chemistry device
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Oct 1992
Decision
48d
Days
Class 2
Risk

K924435 is an FDA 510(k) clearance for the OLYMPUS CALCIUM REAGENT. Classified as Cresolphthalein Complexone, Calcium (product code CIC), Class II - Special Controls.

Submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on October 19, 1992 after a review of 48 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 Corp. devices

Submission Details

510(k) Number K924435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1992
Decision Date October 19, 1992
Days to Decision 48 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
40d faster than avg
Panel avg: 88d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIC Cresolphthalein Complexone, 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 - CIC Cresolphthalein Complexone, Calcium

All 30
Devices cleared under the same product code (CIC) and FDA review panel - the closest regulatory comparables to K924435.
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CALCIUM TEST ITEM NUMBER 65409
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K923034 · Heraeus Kulzer, Inc. · Sep 1992
OLYMPUS CALCIUM REAGENT
K922233 · Olympus Corp. · Jul 1992
SYSTEMATE CALCIUM (EPOS APPLICATION) #65409
K905659 · Em Diagnostic Systems, Inc. · Jan 1991