Cleared Traditional

K060318 - HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER

K060318 is an FDA 510(k) clearance for HEPATIC ENZYMES ON ABX PENTRA 400 CLINI..., manufactured by Horiba Abx. The device is a Class 2 Chemistry device with product code CIT cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K060318 · Horiba Abx · Chemistry device
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Aug 2006
Decision
181d
Days
Class 2
Risk

K060318 is an FDA 510(k) clearance for the HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER. Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Horiba Abx (Montpellier, FR). The FDA issued a Cleared decision on August 8, 2006 after a review of 181 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1100 - 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

FDA 510(k) Submission Details - K060318

510(k) Number K060318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2006
Decision Date August 08, 2006
Days to Decision 181 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
93d slower than avg
Panel avg: 88d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIT Device Classification - Class 2, Special Controls

Product Code CIT Nadh Oxidation/nad Reduction, Ast/sgot
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1100
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 - CIT Nadh Oxidation/nad Reduction, Ast/sgot

All 130
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