Cleared Traditional

K051596 - STATUSFIRST CHF (CONGESTIVE HEART FAILU...

K051596 is the FDA 510(k) clearance for STATUSFIRST CHF (CONGESTIVE HEART FAILU... by Nanogen, Inc.. It is a Class 2 Chemistry device (product code NBC) cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K051596 · Nanogen, Inc. · Chemistry device
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Mar 2006
Decision
270d
Days
Class 2
Risk

K051596 is an FDA 510(k) clearance for the STATUSFIRST CHF (CONGESTIVE HEART FAILURE) NT-PROBNP, MODEL 20204. Classified as Test, Natriuretic Peptide (product code NBC), Class II - Special Controls.

Submitted by Nanogen, Inc. (San Diego, US). The FDA issued a Cleared decision on March 13, 2006 after a review of 270 days - an extended review cycle.

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 Nanogen, Inc. devices

Submission Details

510(k) Number K051596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2005
Decision Date March 13, 2006
Days to Decision 270 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
182d slower than avg
Panel avg: 88d · This submission: 270d
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.

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 K051596.
DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR
K061795 · Dade Behring, Inc. · Sep 2006
VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158
K060632 · Ortho-Clinical Diagnostics, Inc. · Jun 2006
ARCHITECT BNP ASSAY, MODEL 8K28
K060964 · Fujirebio Diagnostics,Inc. · May 2006
TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200
K052789 · Biosite Incorporated · Jan 2006
ELECSYS PROBNP IMMUNOASSAY
K051382 · Roche Diagnostics Corp. · Dec 2005
TRIAGE BNP TEST, MODEL 98000XR
K051787 · Biosite Incorporated · Sep 2005