Cleared Traditional

K033061 - CALIBRATING MATERIAL

K033061 is an FDA 510(k) clearance for CALIBRATING MATERIAL, manufactured by Diamond Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code JIX cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K033061 · Diamond Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
39d
Days
Class 2
Risk

K033061 is an FDA 510(k) clearance for the CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Diamond Diagnostics, Inc. (Holliston, US). The FDA issued a Cleared decision on November 7, 2003 after a review of 39 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 Diamond Diagnostics, Inc. devices

FDA 510(k) Submission Details - K033061

510(k) Number K033061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2003
Decision Date November 07, 2003
Days to Decision 39 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
49d faster than avg
Panel avg: 88d · This submission: 39d
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 244
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K033061.
BAYER SPECIAL CHEMISTRY CALIBRATORS
K033380 · Bayer Diagnostics Corp. · Dec 2003
OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071
K032665 · Olympus America, Inc. · Nov 2003
MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS)
K033501 · Roche Diagnostics Corp. · Nov 2003
MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2
K032287 · Beckman Coulter, Inc. · Aug 2003
RANDOX LIQUID PROTEIN CALIBRATOR
K031608 · Randox Laboratories, Ltd. · Aug 2003
TOX AMMONIA CALIBRATOR
K031683 · Bayer Healthcare, LLC · Aug 2003