Cleared Traditional

K896224 - COBAS READY CALCIUM REAGENT

K896224 is an FDA 510(k) clearance for COBAS READY CALCIUM REAGENT, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Chemistry device with product code CIC cleared through the Traditional 510(k) pathway after a 291-day FDA review.

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

FDA 510(k) Submission Details - K896224

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.

CIC Device Classification - Class 2, Special Controls

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 89
Devices cleared under the same product code (CIC) and FDA review panel - the closest regulatory comparables to K896224.
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K901226 · Technicon Instruments Corp. · Apr 1990
ABBOTT SPECTRUM(R) CALCIUM REAGENT
K894407 · Abbott Laboratories · Sep 1989