Cleared Traditional

K061795 - DIMENSION VISTA PBNP FLEX REAGENT CARTR...

K061795 is the FDA 510(k) clearance for DIMENSION VISTA PBNP FLEX REAGENT CARTR... by Dade Behring, Inc.. It is a Class 2 Chemistry device (product code NBC) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K061795 · Dade Behring, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
80d
Days
Class 2
Risk

K061795 is an FDA 510(k) clearance for the DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR. Classified as Test, Natriuretic Peptide (product code NBC), Class II - Special Controls.

Submitted by Dade Behring, Inc. (P.O. Box 6101, Newark, US). The FDA issued a Cleared decision on September 11, 2006 after a review of 80 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dade Behring, Inc. devices

Submission Details

510(k) Number K061795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2006
Decision Date September 11, 2006
Days to Decision 80 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
8d faster than avg
Panel avg: 88d · This submission: 80d
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 38
Devices cleared under the same product code (NBC) and FDA review panel - the closest regulatory comparables to K061795.
ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET
K072437 · Roche Diagnostics · Feb 2008
STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM
K071834 · Dade Behring, Inc. · Aug 2007
DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A
K071767 · Dade Behring, Inc. · Aug 2007
VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158
K060632 · Ortho-Clinical Diagnostics, Inc. · Jun 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