Cleared Traditional

K000576 - ELECSYS CORTISOL CALCHECK

K000576 is an FDA 510(k) clearance for ELECSYS CORTISOL CALCHECK, manufactured by Roche Diagnostics Corp.. The device is a Class 2 Chemistry device with product code JIX cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K000576 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
28d
Days
Class 2
Risk

K000576 is an FDA 510(k) clearance for the ELECSYS CORTISOL CALCHECK. 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 March 21, 2000 after a review of 28 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

FDA 510(k) Submission Details - K000576

510(k) Number K000576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2000
Decision Date March 21, 2000
Days to Decision 28 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
60d faster than avg
Panel avg: 88d · This submission: 28d
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 263
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K000576.
SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936
K010652 · Sigma Diagnostics, Inc. · Mar 2001
N PROTEIN STANDARD SL
K002804 · Dade Behring, Inc. · Oct 2000
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K001484 · Alko Diagnostic Corp. · Jun 2000
K-ASSAY MULTI-ANALYTE CALIBRATOR
K993853 · Kamiya Biomedical Co. · Dec 1999
K-ASSAY APO A1/B CALIBRATOR SET
K993606 · Kamiya Biomedical Co. · Nov 1999
HDL-C/LDL-C CALIBRATOR, MODEL 1913-003
K993098 · Data Medical Associates, Inc. · Oct 1999