Cleared Traditional

K043125 - ORION DIAGNOSTICA UNIQ PINP RIA

K043125 is an FDA 510(k) clearance for ORION DIAGNOSTICA UNIQ PINP RIA, manufactured by Orion Diagnostica, OY. The device is a Class 2 Chemistry device with product code CIN cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K043125 · Orion Diagnostica, OY · Chemistry device
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May 2005
Decision
173d
Days
Class 2
Risk

K043125 is an FDA 510(k) clearance for the ORION DIAGNOSTICA UNIQ PINP RIA. Classified as Electrophoretic Separation, Alkaline Phosphatase Isoenzymes (product code CIN), Class II - Special Controls.

Submitted by Orion Diagnostica, OY (Espoo, FI). The FDA issued a Cleared decision on May 4, 2005 after a review of 173 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1050 - 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 Orion Diagnostica, OY devices

FDA 510(k) Submission Details - K043125

510(k) Number K043125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2004
Decision Date May 04, 2005
Days to Decision 173 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 88d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIN Device Classification - Class 2, Special Controls

Product Code CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1050
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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