Cleared Traditional

DIAZYME HSCRP POC TEST KIT (K121558) - FDA 510(k) Clearance

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

K121558 · Diazyme Laboratories · Chemistry device
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Sep 2012
Decision
115d
Days
Class 2
Risk

K121558 is an FDA 510(k) clearance for the DIAZYME HSCRP POC TEST KIT. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on September 21, 2012 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5270 - 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 Diazyme Laboratories devices

Submission Details

510(k) Number K121558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2012
Decision Date September 21, 2012
Days to Decision 115 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 88d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DCK C-reactive Protein, Antigen, Antiserum, And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5270
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 - DCK C-reactive Protein, Antigen, Antiserum, And Control

All 54
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