Cleared Traditional

ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL (K060434) - FDA 510(k) Clearance

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

K060434 · Horiba Abx · Chemistry device
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Jun 2007
Decision
469d
Days
Class 2
Risk

K060434 is an FDA 510(k) clearance for the ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN .... Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Horiba Abx (Montpellier, FR). The FDA issued a Cleared decision on June 5, 2007 after a review of 469 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1035 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Horiba Abx devices

Submission Details

510(k) Number K060434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2006
Decision Date June 05, 2007
Days to Decision 469 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
381d slower than avg
Panel avg: 88d · This submission: 469d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIX Bromcresol Green Dye-binding, Albumin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1035
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 - CIX Bromcresol Green Dye-binding, Albumin

All 119
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