Cleared Traditional

COBAS READY CALCIUM REAGENT (K896224) - FDA 510(k) Clearance

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

K896224 · Roche Diagnostic Systems, Inc. · Chemistry device
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Aug 1990
Decision
291d
Days
Class 2
Risk

K896224 is an FDA 510(k) clearance for the COBAS READY CALCIUM REAGENT. Classified as Cresolphthalein Complexone, Calcium (product code CIC), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on August 17, 1990 after a review of 291 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K896224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1989
Decision Date August 17, 1990
Days to Decision 291 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
203d slower than avg
Panel avg: 88d · This submission: 291d
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 98
Devices cleared under the same product code (CIC) and FDA review panel - the closest regulatory comparables to K896224.
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