Cleared Abbreviated

K053291 - FERRITIN CALIBRATOR SET, CATALOG NO. 8203

K053291 is an FDA 510(k) clearance for FERRITIN CALIBRATOR SET, manufactured by Reference Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code JIT cleared through the Abbreviated 510(k) pathway after a 108-day FDA review.

K053291 · Reference Diagnostics, Inc. · Chemistry device
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Mar 2006
Decision
108d
Days
Class 2
Risk

K053291 is an FDA 510(k) clearance for the FERRITIN CALIBRATOR SET, CATALOG NO. 8203. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Reference Diagnostics, Inc. (Bedford, US). The FDA issued a Cleared decision on March 13, 2006 after a review of 108 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 Reference Diagnostics, Inc. devices

FDA 510(k) Submission Details - K053291

510(k) Number K053291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2005
Decision Date March 13, 2006
Days to Decision 108 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 88d · This submission: 108d
Pathway characteristics
Standards-based clearance path.

JIT Device Classification - Class 2, Special Controls

Product Code JIT Calibrator, Secondary
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.

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All 206
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