Cleared Special

K062128 - THE DIMENSION VISTA FLEX REAGENT CARTRI...

K062128 is the FDA 510(k) clearance for THE DIMENSION VISTA FLEX REAGENT CARTRI... by Dade Behring, Inc.. It is a Class 2 Chemistry device (product code JHS) cleared through the Special 510(k) pathway after a 26-day FDA review.

K062128 · Dade Behring, Inc. · Chemistry device
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Aug 2006
Decision
26d
Days
Class 2
Risk

K062128 is an FDA 510(k) clearance for the THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS. Classified as Differential Rate Kinetic Method, Cpk Or Isoenzymes (product code JHS), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on August 21, 2006 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1215 - 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 Dade Behring, Inc. devices

Submission Details

510(k) Number K062128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2006
Decision Date August 21, 2006
Days to Decision 26 days
Submission Type Special
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
62d faster than avg
Panel avg: 88d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1215
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 - JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes

All 16
Devices cleared under the same product code (JHS) and FDA review panel - the closest regulatory comparables to K062128.
IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS)
K981495 · Diagnostic Products Corp. · Jun 1998
ACS CKMB II IMMUNOASSAY
K962126 · Ciba Corning Diagnostics Corp. · Jun 1996
ACCESS CK-MB REAGENTS
K945083 · Bio-Rad Laboratories, Inc. · Nov 1994
ROCHE ISOMUNE- CK
K903025 · Roche Diagnostic Systems, Inc. · Aug 1990
STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
K900806 · Baxter Healthcare Corp · Mar 1990
UNI-FAST CREATINE KINASE TEST (CK)
K872029 · Sclavo, Inc. · Jun 1987