Cleared Traditional

K042191 - DIAZYME POTASSIUM ENZYMATIC ASSAY KIT

K042191 is an FDA 510(k) clearance for DIAZYME POTASSIUM ENZYMATIC ASSAY KIT, manufactured by Diazyme Laboratories. The device is a Class 2 Chemistry device with product code MZV cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K042191 · Diazyme Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
78d
Days
Class 2
Risk

K042191 is an FDA 510(k) clearance for the DIAZYME POTASSIUM ENZYMATIC ASSAY KIT. Classified as Test, System, Potassium, Enzymatic Method (product code MZV), Class II - Special Controls.

Submitted by Diazyme Laboratories (San Diego, US). The FDA issued a Cleared decision on October 29, 2004 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1600 - 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.

View all Diazyme Laboratories devices

FDA 510(k) Submission Details - K042191

510(k) Number K042191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2004
Decision Date October 29, 2004
Days to Decision 78 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
10d faster than avg
Panel avg: 88d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MZV Device Classification - Class 2, Special Controls

Product Code MZV Test, System, Potassium, Enzymatic Method
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1600
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 - MZV Test, System, Potassium, Enzymatic Method

Devices cleared under the same product code (MZV) and FDA review panel - the closest regulatory comparables to K042191.
Piccolo Potassium Test System
K200865 · Abaxis, Inc. · Oct 2021
DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL
K091455 · Diazyme Laboratories · Aug 2009
MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A
K053566 · Diazyme Laboratories · Feb 2006