510(k) · Cleared
ClearedAmplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories · PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Cleared on May 10, 2016 as substantially equivalent to DEN150058 (Bio-Rad Laboratories, 2016) after a 235-day review. Its family tree reaches back 1 generation to 2016.
- Decided
- May 10, 2016
- Review
- 235 days
- Class
- Class II
- Product code
- PMN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN150058 (2016). No later device cites it as a predicate yet.
- Root · 1 generation backDEN150058 Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek…Bio-Rad Laboratories · 2016
- This deviceK152679 Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2…Bio-Rad Laboratories · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN150058 | Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level… | Bio-Rad Laboratories | 2016 | — |
| 0 (this device) | K152679 | Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek… | Bio-Rad Laboratories | 2016 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PMN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PMN device
- #1 K251526 FilmArray GI Control Panel M238score 13.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN150058 | Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and…Summary page 4…to Which Substantial Equivalence is Claimed Amplichek II Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 DEN150058 4.0 Description of Device Amplichek I is a set of quality controls consisting of four levels filled in individual… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate DEN150058.
How does its category compare?
All PMN devicesPMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PMN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PMN
90in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PMN
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PMN
1in 2023
MAUDE reports naming product code PMN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 3 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 3 | 59 | 0 | 0 |
| 2019 | 6 | 71 | 1 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 3 | 582 | 0 | 0 |
| 2023 | 4 | 90 | 0 | 1 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 6 | 85 | 0 | — |
What is it indicated for?
Amplichek I 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 quantitative detection of Human Immunodeficiency Virus Type 1 (HIV-1), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) for molecular diagnostic platforms listed in the package insert. This product is not intended to replace manufacturer controls provided with the device.
This product is not intended for use with blood donor screening assays in U.S. or Canada.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152679 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152679: Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152679
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026