Cleared Traditional

K062319 - CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A...

K062319 is the FDA 510(k) clearance for CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A... by Roche Diagnostics Corp.. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K062319 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
35d
Days
Class 2
Risk

K062319 is an FDA 510(k) clearance for the CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360. 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 September 13, 2006 after a review of 35 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 Roche Diagnostics Corp. devices

Submission Details

510(k) Number K062319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2006
Decision Date September 13, 2006
Days to Decision 35 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
53d faster than avg
Panel avg: 88d · This submission: 35d
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 146
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K062319.
DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H
K063508 · Dade Behring, Inc. · Jan 2007
DIMENSION VISTA RF FLEX REAGENT CARTRIDGE
K062035 · Dade Behring, Inc. · Oct 2006
DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130
K062334 · Dade Behring, Inc. · Sep 2006
DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410)
K062034 · Dade Behring, Inc. · Sep 2006
DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310)
K061923 · Dade Behring, Inc. · Aug 2006
DIMENSION VISTA SYSTEM CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL - KC130)
K062122 · Dade Behring, Inc. · Aug 2006