Cleared Traditional

K902675 - MULTI ANALYTE MIXTURE

K902675 is an FDA 510(k) clearance for MULTI ANALYTE MIXTURE, 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 42-day FDA review.

K902675 · Phoenix Diagnostics, Inc. · Chemistry device
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Jul 1990
Decision
42d
Days
Class 2
Risk

K902675 is an FDA 510(k) clearance for the MULTI ANALYTE MIXTURE, CALIBRATORS. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Phoenix Diagnostics, Inc. (Medfield, US). The FDA issued a Cleared decision on July 31, 1990 after a review of 42 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 - K902675

510(k) Number K902675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1990
Decision Date July 31, 1990
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 88d · This submission: 42d
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 K902675.
ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LINEAR CALIBR
K904767 · Analytical Control Systems, Inc. · Dec 1990
HI CHEM PROTEIN/LIPIDS LINEARITY
K903888 · Hichem Diagnostics · Sep 1990
PARAMAX URINE/CSF CALIBRATOR LEVEL I AND II
K903913 · Baxter Healthcare Corp · Sep 1990
COBAS READY CALIBRATOR KIT
K897097 · Roche Diagnostic Systems, Inc. · Jun 1990
CALIBRATORS, CONTROL MATERIALS, ELECTRODES & TUBE
K897177 · Nova Biomedical Corp. · Mar 1990
ROCHE STANDARDS FOR THE COBAS ISE MODULE
K897071 · Roche Diagnostic Systems, Inc. · Mar 1990