Cleared Traditional

K081276 - ABX PENTRA GLUCOSE HK CP

K081276 is the FDA 510(k) clearance for ABX PENTRA GLUCOSE HK CP by Horiba Abx. It is a Class 2 Chemistry device (product code CFR) cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K081276 · Horiba Abx · Chemistry device
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Sep 2008
Decision
130d
Days
Class 2
Risk

K081276 is an FDA 510(k) clearance for the ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Horiba Abx (Montpellier, FR). The FDA issued a Cleared decision on September 12, 2008 after a review of 130 days - within the typical 510(k) review window.

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 Horiba Abx devices

Submission Details

510(k) Number K081276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2008
Decision Date September 12, 2008
Days to Decision 130 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
42d slower than avg
Panel avg: 88d · This submission: 130d
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 108
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K081276.
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
EASYRA GLU-H REAGENT, MODEL 10200
K092506 · Medica Corp. · Sep 2009
APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201
K080123 · Wako Chemicals USA, Inc. · Jul 2008
BS-200 CHEMISTRY ANALYZER, MODE BS-200
K072018 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Feb 2008
POINTE 360
K062118 · Pointe Scientific, Inc., · Jul 2007