Cleared Traditional

K111349 - ELECSYS SHBG CALCHECK 5

K111349 is an FDA 510(k) clearance for ELECSYS SHBG CALCHECK 5, manufactured by Roche Diagnostics. The device is a Class 1 Chemistry device with product code JJX cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K111349 · Roche Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
27d
Days
Class 1
Risk

K111349 is an FDA 510(k) clearance for the ELECSYS SHBG CALCHECK 5. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on June 9, 2011 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 devices

FDA 510(k) Submission Details - K111349

510(k) Number K111349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2011
Decision Date June 09, 2011
Days to Decision 27 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
61d faster than avg
Panel avg: 88d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

JJX Device Classification - Class 1, General Controls

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 434
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K111349.
IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS...
K111650 · Immunodiagnostic Systems , Ltd. · Sep 2011
ELECSYS N-MID OSTEOCALCIN CALCHECK 5
K112104 · Roche Diagnostics · Aug 2011
ELECSYS T3 CALCHECK 5
K111552 · Roche Diagnostics · Jul 2011
FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL
K110641 · Fujirebio Diagnostics,Inc. · May 2011
DROPPER A1C DIABETES CONTROL
K103744 · Quantimetrix Corp. · May 2011
ELECSYS PROLACTIN II CALCHECK 5
K110613 · Roche Diagnostics · May 2011