Cleared Traditional

K020129 - PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE

K020129 is an FDA 510(k) clearance for PHOENIX ELETROLYTE CALIBRATION SET FOR ..., manufactured by Phoenix Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code JIX cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K020129 · Phoenix Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
18d
Days
Class 2
Risk

K020129 is an FDA 510(k) clearance for the PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Phoenix Diagnostics, Inc. (Natick, US). The FDA issued a Cleared decision on February 1, 2002 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 Phoenix Diagnostics, Inc. devices

FDA 510(k) Submission Details - K020129

510(k) Number K020129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2002
Decision Date February 01, 2002
Days to Decision 18 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
70d faster than avg
Panel avg: 88d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIX Device Classification - Class 2, Special Controls

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIX Calibrator, Multi-analyte Mixture

All 282
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K020129.
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K012987 · Phoenix Diagnostics, Inc. · Nov 2001
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K012509 · Phoenix Diagnostics, Inc. · Oct 2001