Cleared Traditional

K212778 - Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075) (FDA 510(k) Clearance)

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

K212778 · Abbott Molecular, Inc. · Microbiology device
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Jul 2022
Decision
317d
Days
Class 2
Risk

K212778 is an FDA 510(k) clearance for the Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. .... Classified as Nucleic Acid Amplification Test For The Quantitation Of Epstein-barr Virus (ebv) Dna (product code QLX), Class II - Special Controls.

Submitted by Abbott Molecular, Inc. (Des Plaines, US). The FDA issued a Cleared decision on July 15, 2022 after a review of 317 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3183 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K212778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2021
Decision Date July 15, 2022
Days to Decision 317 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
215d slower than avg
Panel avg: 102d · This submission: 317d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QLX Nucleic Acid Amplification Test For The Quantitation Of Epstein-barr Virus (ebv) Dna
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3183
Definition A Quantitative Viral Nucleic Acid Test For Transplant Patient Management Is Identified As A Device Intended For Prescription Use In The Detection Of Viral Pathogens By Measurement Of Viral Deoxyribonucleic Acid (dna) Or Ribonucleic Acid (rna) Using Specified Specimen Processing, Amplification, And Detection Instrumentation. The Test Is Intended For Use As An Aid In The Management Of Transplant Patients With Active Viral Infection Or At Risk For Developing Viral Infections. The Test Results Are Intended To Be Interpreted By Qualified Healthcare Professionals In Conjunction With Other Relevant Clinical And Laboratory Findings.
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 Microbiology devices follow this clearance model.