Cleared Traditional

K113521 - CALCIUM GEN. 2

K113521 is an FDA 510(k) clearance for CALCIUM GEN. 2, manufactured by Roche Diagnostics. The device is a Class 2 Chemistry device with product code CHW cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K113521 · Roche Diagnostics · Chemistry device
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May 2012
Decision
161d
Days
Class 2
Risk

K113521 is an FDA 510(k) clearance for the CALCIUM GEN. 2. Classified as Titrimetric With Edta And Indicator, Calcium (product code CHW), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on May 8, 2012 after a review of 161 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.

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FDA 510(k) Submission Details - K113521

510(k) Number K113521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2011
Decision Date May 08, 2012
Days to Decision 161 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 88d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CHW Device Classification - Class 2, Special Controls

Product Code CHW Titrimetric With Edta And Indicator, 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.