Cleared Special

DIMENSION VISTA FLEX REAGENT CARTRIDGES (K061655) - FDA 510(k) Clearance

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

K061655 · Dade Behring, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
27d
Days
Class 2
Risk

K061655 is an FDA 510(k) clearance for the DIMENSION VISTA FLEX REAGENT CARTRIDGES. Classified as Colorimetry, Acetaminophen (product code LDP), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on July 10, 2006 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3030 - 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 K061655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2006
Decision Date July 10, 2006
Days to Decision 27 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
61d faster than avg
Panel avg: 88d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LDP Colorimetry, Acetaminophen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3030
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 - LDP Colorimetry, Acetaminophen

All 35
Devices cleared under the same product code (LDP) and FDA review panel - the closest regulatory comparables to K061655.
Acetaminophen
K202644 · Sekisui Diagnostics P.E.I., Inc. · Feb 2022
SEKURE Acetaminophen L3K Assay
K180835 · Sekisui Diagnostics P.E.I., Inc. · Feb 2019
EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL
K002974 · Dade Behring, Inc. · Oct 2000
AXSYM ACETAMINOPHEN
K953094 · Abbott Laboratories · Aug 1995
EMIT QST ACETAMINOPHEN ASSAY
K844962 · Syva Co. · Jan 1985
TDX ACETAMINOPHEN
K840941 · Abbott Laboratories · May 1984