Cleared Traditional

INDIKO (K110035) - FDA 510(k) Clearance

Class I Chemistry device.

K110035 · Thermofisher Scientific OY · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
174d
Days
Class 1
Risk

K110035 is an FDA 510(k) clearance for the INDIKO. Classified as Analyzer, Chemistry (photometric, Discrete), For Clinical Use (product code JJE), Class I - General Controls.

Submitted by Thermofisher Scientific OY (Vantaa, FI). The FDA issued a Cleared decision on June 28, 2011 after a review of 174 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2160 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Thermofisher Scientific OY devices

Submission Details

510(k) Number K110035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2011
Decision Date June 28, 2011
Days to Decision 174 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 88d · This submission: 174d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2160
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 - JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use

All 207
Devices cleared under the same product code (JJE) and FDA review panel - the closest regulatory comparables to K110035.
Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode
K183375 · Horiba, Ltd. · Feb 2019
ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER
K974779 · Abbott Laboratories · Feb 1998
ABBOTT AXSYM SYSTEM
K974651 · Abbott Laboratories · Feb 1998
ABBOTT PROJECT I, SPECTRUM
K945566 · Abbott Laboratories · Jun 1995
ABBOTT AXSYM II SYSTEM
K950915 · Abbott Laboratories · May 1995
VISTA IMMUNOASSAY SYSTEM -- MODIFICATION
K922139 · Syva Co. · Jul 1992