Cleared Traditional

K903913 - PARAMAX URINE/CSF CALIBRATOR LEVEL I AN...

K903913 is the FDA 510(k) clearance for PARAMAX URINE/CSF CALIBRATOR LEVEL I AN... by Baxter Healthcare Corp. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K903913 · Baxter Healthcare Corp · Chemistry device
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Sep 1990
Decision
34d
Days
Class 2
Risk

K903913 is an FDA 510(k) clearance for the PARAMAX URINE/CSF CALIBRATOR LEVEL I AND II. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on September 27, 1990 after a review of 34 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K903913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1990
Decision Date September 27, 1990
Days to Decision 34 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
54d faster than avg
Panel avg: 88d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 225
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K903913.
PARAMAX(R) ELECTROLYTE CALIBRATOR 1&2/MODIFICATION
K910309 · Baxter Healthcare Corp · Mar 1991
ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LINEAR CALIBR
K904767 · Analytical Control Systems, Inc. · Dec 1990
HI CHEM PROTEIN/LIPIDS LINEARITY
K903888 · Hichem Diagnostics · 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