Cleared Traditional

K130122 - BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER (FDA 510(k) Clearance)

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

K130122 · Beckman Coulter, Inc. · Immunology device
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Jan 2014
Decision
355d
Days
Class 2
Risk

K130122 is an FDA 510(k) clearance for the BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULI.... Classified as Method, Nephelometric, Immunoglobulins (g, A, M) (product code CFN), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on January 7, 2014 after a review of 355 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - the FDA immunology device 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Beckman Coulter, Inc. devices

Submission Details

510(k) Number K130122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2013
Decision Date January 07, 2014
Days to Decision 355 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
251d slower than avg
Panel avg: 104d · This submission: 355d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CFN Method, Nephelometric, Immunoglobulins (g, A, M)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 Immunology devices follow this clearance model.

Regulatory Peers - CFN Method, Nephelometric, Immunoglobulins (g, A, M)

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