Cleared Traditional

DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent (K162208) - FDA 510(k) Clearance

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

K162208 · Beckman Coulter, Inc. · Immunology device
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Jan 2017
Decision
157d
Days
Class 2
Risk

K162208 is an FDA 510(k) clearance for the DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent. 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 9, 2017 after a review of 157 days - an extended review cycle.

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. Standard predicate reliance. 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 K162208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2016
Decision Date January 09, 2017
Days to Decision 157 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 104d · This submission: 157d
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)

All 41
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