Cleared Special

DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623 (K082645) - FDA 510(k) Clearance

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K082645 · Siemens Healthcare Diagnostics · Chemistry device
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Optimized for regulatory review, auditing and printing
Sep 2008
Decision
11d
Days
Class 2
Risk

K082645 is an FDA 510(k) clearance for the DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CAR.... Classified as Test, Natriuretic Peptide (product code NBC), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on September 22, 2008 after a review of 11 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Siemens Healthcare Diagnostics devices

Submission Details

510(k) Number K082645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2008
Decision Date September 22, 2008
Days to Decision 11 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 88d · This submission: 11d
Pathway characteristics
Modification to existing cleared device.

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 24
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K092649 · Roche Diagnostics Corp. · Feb 2010
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VIDAS NT-PROBNP ASSAY, MODEL: 30 449
K073091 · bioMerieux, Inc. · Feb 2008
ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET
K072437 · Roche Diagnostics · Feb 2008