510(k) · Cleared
ClearedCystic Fibrosis Genotyping Assay, Model 6L20-01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Celera Diagnostics · NUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
Cleared on Sep 7, 2007 as substantially equivalent to DEN050004 (Tm Bioscience Corporation, 2005) after a 416-day review. Its family tree reaches back 1 generation to 2005.
- Decided
- Sep 7, 2007
- Review
- 416 days
- Class
- Class II
- Product code
- NUA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN050004 (2005). No later device cites it as a predicate yet.
- Root · 1 generation backDEN050004 Tag-IT Cystic Fibrosis KitTm Bioscience Corporation · 2005
- This deviceK062028 Cystic Fibrosis Genotyping Assay, Model 6L20-01Celera Diagnostics · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN050004 | Tag-IT Cystic Fibrosis Kit | Tm Bioscience Corporation | 2005 | — |
| 0 (this device) | K062028 | Cystic Fibrosis Genotyping Assay, Model 6L20-01 | Celera Diagnostics | 2007 | — |
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 NUA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | DEN050004 | Tag-IT Cystic Fibrosis Kit Our reading of the summary gave K043011, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN050004, Tag-IT Cystic Fibrosis Kit (Tm Bioscience Corporation), granted May 9, 2005; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2005 |
| * | — | bidirectional DNA sequence analysis Named without a submission number |
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.
- 5 other devices also cite its predicate DEN050004.
How does its category compare?
All NUA devicesNUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · NUA
2in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · NUA
254in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUA
No recall names NUA since 2007.
Adverse event reports per year · NUA
1in 2013
MAUDE reports naming product code NUA, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 4 | 254 | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Cystic Fibrosis Genotyping Assay is a qualitative in vitro diagnostic device used to genotype a panel of mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in genomic DNA isolated from human whole blood specimens. The panel includes mutations and variants recommended by the American College of Medical Genetics (ACMG, 2004) and the American College of Obstetricians and Gynecologists (ACOG, 2005) plus…
Read the full statement (126 words)
The Cystic Fibrosis Genotyping Assay is a qualitative in vitro diagnostic device used to genotype a panel of mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in genomic DNA isolated from human whole blood specimens. The panel includes mutations and variants recommended by the American College of Medical Genetics (ACMG, 2004) and the American College of Obstetricians and Gynecologists (ACOG, 2005) plus additional multiethnic mutations. The Cystic Fibrosis Genotyping Assay provides information intended to be used for carrier screening in adults of reproductive age, as an aid in newborn screening, and in confirmatory diagnostic testing in newborns and children.
This test is not indicated for use in fetal diagnostic or pre-implantation testing. This test is also not indicated for stand-alone diagnostic purposes.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K062028 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062028: Cystic Fibrosis Genotyping Assay, Model 6L20-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062028
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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