Cleared Traditional

PRESTIGE 24I (K103531) - FDA 510(k) Clearance

Also marketed or referenced as:
BIOLIS 24I MGC 240

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K103531 · Tokyo Boeki Medisys, Inc. · Chemistry device
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Dec 2011
Decision
365d
Days
Class 2
Risk

K103531 is an FDA 510(k) clearance for the PRESTIGE 24I. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Tokyo Boeki Medisys, Inc. (Durham, US). The FDA issued a Cleared decision on December 1, 2011 after a review of 365 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Tokyo Boeki Medisys, Inc. devices

Submission Details

510(k) Number K103531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2010
Decision Date December 01, 2011
Days to Decision 365 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
277d slower than avg
Panel avg: 88d · This submission: 365d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 144
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K103531.
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K191899 · Roche Diagnostics · Aug 2019
ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM
K170316 · Abbott Laboratories · Oct 2017
GLUCOSE
K060383 · Abbott Laboratories · May 2006