DEN150058 - Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak (FDA 510(k) Clearance)

DEN150058 is an FDA 510(k) submission (not cleared) for the Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Leve.... 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 Not Cleared (DENG) decision on March 28, 2016 after a review of 103 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Microbiology review framework.