Cleared Traditional

K023268 - PHOENIX ISE STANDARD A

K023268 is an FDA 510(k) clearance for PHOENIX ISE STANDARD A, 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 46-day FDA review.

K023268 · Phoenix Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
46d
Days
Class 2
Risk

K023268 is an FDA 510(k) clearance for the PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS. 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 November 15, 2002 after a review of 46 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 - K023268

510(k) Number K023268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2002
Decision Date November 15, 2002
Days to Decision 46 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
42d faster than avg
Panel avg: 88d · This submission: 46d
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 252
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K023268.
SETPOINT CHEMISTRY CALIBRATOR
K030169 · Bayer Healthcare, LLC · Jan 2003
LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS
K030074 · Cliniqa Corporation · Jan 2003
VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
K023876 · Ortho-Clinical Diagnostics, Inc. · Dec 2002
RANDOX APOLIPOPROTEIN CALIBRATOR
K023158 · Randox Laboratories, Ltd. · Oct 2002
RAICHEM LIPID CALIBRATOR
K022767 · Hemagen Diagnostics, Inc. · Sep 2002
PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE
K020129 · Phoenix Diagnostics, Inc. · Feb 2002