Cleared Traditional

K052007 - ABX PENTRA 400 CLINICAL CHEMISTRY ANALY...

K052007 is the FDA 510(k) clearance for ABX PENTRA 400 CLINICAL CHEMISTRY ANALY... by Horiba Abx. It is a Class 2 Chemistry device (product code CFR) cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K052007 · Horiba Abx · Chemistry device
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Dec 2005
Decision
144d
Days
Class 2
Risk

K052007 is an FDA 510(k) clearance for the ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE). Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Horiba Abx (Montpellier, FR). The FDA issued a Cleared decision on December 16, 2005 after a review of 144 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 K052007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2005
Decision Date December 16, 2005
Days to Decision 144 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
56d slower than avg
Panel avg: 88d · This submission: 144d
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 K052007.
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GLUCOSE
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RAICHEM GLUCOSE UV (LIQUID)
K041052 · Hemagen Diagnostics, Inc. · Jun 2004
GLUCOSE FLEX REAGENT CARTRIDGE (GLUC)
K031135 · Dade Behring, Inc. · Jun 2003