Cleared Traditional

K022516 - ELECSYS PROBNP IMMUNOASSAY

K022516 is the FDA 510(k) clearance for ELECSYS PROBNP IMMUNOASSAY by Roche Diagnostics Corp.. It is a Class 2 Chemistry device (product code NBC) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K022516 · Roche Diagnostics Corp. · Chemistry device
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Nov 2002
Decision
112d
Days
Class 2
Risk

K022516 is an FDA 510(k) clearance for the ELECSYS PROBNP IMMUNOASSAY. Classified as Test, Natriuretic Peptide (product code NBC), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on November 19, 2002 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1117 - 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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Submission Details

510(k) Number K022516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2002
Decision Date November 19, 2002
Days to Decision 112 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
24d slower than avg
Panel avg: 88d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NBC Test, Natriuretic Peptide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1117
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.