Cleared Abbreviated

K110394 - ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)

K110394 is an FDA 510(k) clearance for ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN..., manufactured by Vital Diagnostics (Manufacturing) Ptyltd. The device is a Class 2 Chemistry device with product code JIX cleared through the Abbreviated 510(k) pathway after a 118-day FDA review.

K110394 · Vital Diagnostics (Manufacturing) Ptyltd · Chemistry device
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Jun 2011
Decision
118d
Days
Class 2
Risk

K110394 is an FDA 510(k) clearance for the ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON). Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Vital Diagnostics (Manufacturing) Ptyltd (Noble Park, AU). The FDA issued a Cleared decision on June 9, 2011 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - the FDA in vitro diagnostics and chemistry framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Vital Diagnostics (Manufacturing) Ptyltd devices

FDA 510(k) Submission Details - K110394

510(k) Number K110394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2011
Decision Date June 09, 2011
Days to Decision 118 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 88d · This submission: 118d
Pathway characteristics
Standards-based clearance path.

JIX Device Classification - Class 2, Special Controls

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIX Calibrator, Multi-analyte Mixture

All 260
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K110394.
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