Cleared Traditional

K030006 - ATAC PAK ALBUMIN REAGENT

K030006 is an FDA 510(k) clearance for ATAC PAK ALBUMIN REAGENT, manufactured by Elan Diagnostics. The device is a Class 2 Chemistry device with product code CIX cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K030006 · Elan Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
64d
Days
Class 2
Risk

K030006 is an FDA 510(k) clearance for the ATAC PAK ALBUMIN REAGENT. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Elan Diagnostics (Brea, US). The FDA issued a Cleared decision on March 7, 2003 after a review of 64 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Elan Diagnostics devices

FDA 510(k) Submission Details - K030006

510(k) Number K030006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2003
Decision Date March 07, 2003
Days to Decision 64 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
24d faster than avg
Panel avg: 88d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIX Device Classification - Class 2, Special Controls

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 106
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K030006.
S40 CLINICAL ANALYZER, S TEST ALB
K072143 · Alfa Wassermann Diagnostic Technologies, Inc. · Jul 2008
ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL
K060434 · Horiba Abx · Jun 2007
ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2
K033009 · Roche Diagnostics Corp. · Oct 2003
VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4
K023875 · Ortho-Clinical Diagnostics, Inc. · Dec 2002
WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300
K012329 · Wiener Laboratories Saic · Sep 2001
OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER
K011720 · Olympus America, Inc. · Jun 2001