Cleared Traditional

K103531 - PRESTIGE 24I

Also marketed or referenced as:
BIOLIS 24I MGC 240

K103531 is an FDA 510(k) clearance for PRESTIGE 24I, manufactured by Tokyo Boeki Medisys, Inc.. The device is a Class 2 Chemistry device with product code CFR cleared through the Traditional 510(k) pathway after a 365-day FDA review.

K103531 · Tokyo Boeki Medisys, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K103531

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.

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 133
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K103531.
ADVIA CHEMISTRY GLUH_3 REAGENTS
K120681 · Siemens Healthcare Diagnostics, Inc. · May 2012
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU)
K120369 · Hitachi Chemical Diagnostics, Inc. · May 2012
BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER
K112377 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Mar 2012
PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT
K103788 · HORIBA ABX SAS · Nov 2011
ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429
K101854 · Siemens Healthcare Diagnostics · Mar 2011
COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY
K092603 · Roche Diagnostics · Dec 2009