Cleared Traditional

K022516 - ELECSYS PROBNP IMMUNOASSAY

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

K022516 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Roche Diagnostics Corp. devices

FDA 510(k) Submission Details - K022516

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.

NBC Device Classification - Class 2, Special Controls

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.

Regulatory Peers - NBC Test, Natriuretic Peptide

All 40
Devices cleared under the same product code (NBC) and FDA review panel - the closest regulatory comparables to K022516.
BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
K032525 · Bayer Healthcare, LLC · Sep 2003
ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
K031038 · Bayer Healthcare, LLC · Jun 2003
TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL
K030286 · Biosite Incorporated · Feb 2003
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
K021317 · Biosite Incorporated · Jul 2002
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000
K010266 · Biosite Incorporated · Mar 2001
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
DEN000010 · Biosite Incorporated · Nov 2000