Cleared Traditional

K152679 - Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak (FDA 510(k) Clearance)

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

K152679 · Bio-Rad Laboratories · Microbiology device
May 2016
Decision
235d
Days
Class 2
Risk

K152679 is an FDA 510(k) clearance for the Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek.... Classified as Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays (product code PMN), Class II - Special Controls.

Submitted by Bio-Rad Laboratories (Irvine, US). The FDA issued a Cleared decision on May 10, 2016 after a review of 235 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3920 - 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K152679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2015
Decision Date May 10, 2016
Days to Decision 235 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 174d · This submission: 235d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3920
Definition Assayed External Quality Control Material To Monitor The Performance Of Microbiology Nucleic Acid Assays For In Vitro Diagnostic Use.
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.

Regulatory Peers - PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays

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