Cleared Abbreviated

K011658 - CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS

K011658 is an FDA 510(k) clearance for CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A..., manufactured by Rochdiag. The device is a Class 2 Chemistry device with product code JIX cleared through the Abbreviated 510(k) pathway after a 63-day FDA review.

K011658 · Rochdiag · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
63d
Days
Class 2
Risk

K011658 is an FDA 510(k) clearance for the CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Rochdiag (Indianapolis, US). The FDA issued a Cleared decision on July 31, 2001 after a review of 63 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Rochdiag devices

FDA 510(k) Submission Details - K011658

510(k) Number K011658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2001
Decision Date July 31, 2001
Days to Decision 63 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 88d · This submission: 63d
Pathway characteristics
Standards-based clearance path.

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 268
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K011658.
PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMISTRY SYSTEM
K012509 · Phoenix Diagnostics, Inc. · Oct 2001
MODIFICATION TO N PROTEIN STANDARD SL
K012470 · Dade Behring, Inc. · Sep 2001
RAICHEM MULTI-ANALYTE CALIBRATOR
K012250 · Hemagen Diagnostics, Inc. · Sep 2001
CALIBRATOR FOR AUTOMATED SYSTEMS
K011226 · Roche Diagnostics Corp. · Jun 2001
DIMENSION DRUG CALIBRATOR, MODEL DC22B
K011035 · Dade Behring, Inc. · Jun 2001
SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936
K010652 · Sigma Diagnostics, Inc. · Mar 2001