# 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

- Pathway: De Novo (Post-NSE)
- Applicant: Bio-Rad Laboratories
- Decided: Mar 28, 2016 after 103 days
- Product code: PMN (Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays)
- Device class: 2
- Regulation: 21 CFR 866.3920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
33 later devices descend from it; 4 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K161573: FilmArray RP EZ Control Panel M265 (2016), 25 descendants of its own
- K190222: FilmArray Pneumonia/Pneumoniaplus Control (2019), 8 descendants of its own
- K200010: FilmArray BCID2 Control Panel M416 (2020), 7 descendants of its own
- K173171: FilmArray RP2/RP2plus Control Panel (2017), 7 descendants of its own
- K163522: FilmArray Warrior Control Panel M290 (2017), 7 descendants of its own

## Indications for use
Amplichek II is intended for use as an external assayed quality control material to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Methicillin Resistant Staphylococcus aureus, Methicillin Sensitive Staphylococcus aureus, Clostridium difficile and Vancomycin-resistant Enterococci performed on Cepheid GeneXpert Systems. This product is not intended to replace manufacturer controls provided with the device. This product is only for use with assays and instruments listed in the Representative Results Chart in this labeling.

Source page: https://510kreport.com/device/DEN150058
Methodology: https://510kreport.com/methodology