Cleared Traditional

K143720 - Dimension Vista MMB Assay

K143720 is an FDA 510(k) clearance for Dimension Vista MMB Assay, manufactured by Siemens Healthcare Diagnostics. The device is a Class 2 Chemistry device with product code JHY cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K143720 · Siemens Healthcare Diagnostics · Chemistry device
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Sep 2015
Decision
263d
Days
Class 2
Risk

K143720 is an FDA 510(k) clearance for the Dimension Vista MMB Assay. Classified as Colorimetric Method, Cpk Or Isoenzymes (product code JHY), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on September 18, 2015 after a review of 263 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1215 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Healthcare Diagnostics devices

FDA 510(k) Submission Details - K143720

510(k) Number K143720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2014
Decision Date September 18, 2015
Days to Decision 263 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
175d slower than avg
Panel avg: 88d · This submission: 263d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHY Device Classification - Class 2, Special Controls

Product Code JHY Colorimetric 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 - JHY Colorimetric Method, Cpk Or Isoenzymes

All 34
Devices cleared under the same product code (JHY) and FDA review panel - the closest regulatory comparables to K143720.
ELECSYS CK-MB STAT IMMUNOASSAY
K140404 · Roche Diagnostics · May 2014
ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY
K132571 · Roche Diagnostics · Oct 2013
SPIFE CK KIT, MODEL 3332, 3333
K022757 · Helena Laboratories · Oct 2002
MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB
K022654 · Roche Diagnostics Corp. · Aug 2002
ELECSYS CK-MB STAT
K974421 · Boehringer Mannheim Corp. · Dec 1997
CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO
K961412 · Bayer Corp. · Jun 1996