Cleared Traditional

K033873 - ELECSYS C-PEPTIDE CALSET

K033873 is the FDA 510(k) clearance for ELECSYS C-PEPTIDE CALSET by Roche Diagnostics Corp.. It is a Class 2 Toxicology device (product code JIX) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K033873 · Roche Diagnostics Corp. · Toxicology device
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Feb 2004
Decision
60d
Days
Class 2
Risk

K033873 is an FDA 510(k) clearance for the ELECSYS C-PEPTIDE CALSET. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on February 13, 2004 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1150 - the FDA toxicology device 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 Roche Diagnostics Corp. devices

Submission Details

510(k) Number K033873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2003
Decision Date February 13, 2004
Days to Decision 60 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 87d · This submission: 60d
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 Toxicology devices follow this clearance model.

Regulatory Peers - JIX Calibrator, Multi-analyte Mixture

All 146
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K033873.
N APOLIPOPROTEIN STANDARD SERUM
K041870 · Dade Behring, Inc. · Jul 2004
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K040264 · Roche Diagnostics Corp. · Apr 2004
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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