Cleared Traditional

K071767 - DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A

K071767 is an FDA 510(k) clearance for DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, manufactured by Dade Behring, Inc.. The device is a Class 2 Chemistry device with product code NBC cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K071767 · Dade Behring, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
36d
Days
Class 2
Risk

K071767 is an FDA 510(k) clearance for the DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A. 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 August 4, 2007 after a review of 36 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.

FDA 510(k) Submission Details - K071767

510(k) Number K071767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2007
Decision Date August 04, 2007
Days to Decision 36 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
52d faster than avg
Panel avg: 88d · This submission: 36d
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 45
Devices cleared under the same product code (NBC) and FDA review panel - the closest regulatory comparables to K071767.
PATHFAST NTPROBNP AND D-DIMER TESTS
K072189 · Mitsubishi Kagaku Iatron · Feb 2008
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
DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR
K061795 · Dade Behring, Inc. · Sep 2006
I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)
K053597 · I-Stat Corporation · Jul 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
K071767 · DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A
Download PDF FDA Summary Dade Behring, Inc.