Cleared Traditional

K052789 - TRIAGE BNP TEST FOR BECKMAN COULTER IMM...

K052789 is the FDA 510(k) clearance for TRIAGE BNP TEST FOR BECKMAN COULTER IMM... by Biosite Incorporated. It is a Class 2 Chemistry device (product code NBC) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K052789 · Biosite Incorporated · Chemistry device
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Optimized for regulatory review, auditing and printing
Jan 2006
Decision
112d
Days
Class 2
Risk

K052789 is an FDA 510(k) clearance for the TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200. Classified as Test, Natriuretic Peptide (product code NBC), Class II - Special Controls.

Submitted by Biosite Incorporated (San Diego, US). The FDA issued a Cleared decision on January 23, 2006 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 Biosite Incorporated devices

Submission Details

510(k) Number K052789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2005
Decision Date January 23, 2006
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.

Regulatory Peers - NBC Test, Natriuretic Peptide

All 39
Devices cleared under the same product code (NBC) and FDA review panel - the closest regulatory comparables to K052789.
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
ELECSYS PROBNP IMMUNOASSAY
K051382 · Roche Diagnostics Corp. · Dec 2005
TRIAGE BNP TEST, MODEL 98000XR
K051787 · Biosite Incorporated · Sep 2005
ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
K051265 · Bayer Healthcare, LLC · Jun 2005