Cleared Traditional

K153644 - ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II

K153644 is an FDA 510(k) clearance for ELITech Clinical Systems GLUCOSE HK SL, manufactured by Elitechgroup. The device is a Class 2 Chemistry device with product code CFR cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K153644 · Elitechgroup · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
261d
Days
Class 2
Risk

K153644 is an FDA 510(k) clearance for the ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, EL.... Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Elitechgroup (Sees, FR). The FDA issued a Cleared decision on September 7, 2016 after a review of 261 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - 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 Elitechgroup devices

FDA 510(k) Submission Details - K153644

510(k) Number K153644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2015
Decision Date September 07, 2016
Days to Decision 261 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
173d slower than avg
Panel avg: 88d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CFR Device Classification - Class 2, Special Controls

Product Code CFR Hexokinase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
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 - CFR Hexokinase, Glucose

All 134
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K153644.
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