510(k) · Cleared
ClearedHemosil F11 & FV Dna Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · NZB Quality Control Material, Genetics, Dna
Cleared on May 4, 2010 as substantially equivalent to K083171 (Maine Molecular Quality Controls, Inc., 2008) after a 151-day review. Its family tree reaches back 1 generation to 2008.
- Decided
- May 4, 2010
- Review
- 151 days
- Class
- Class II
- Product code
- NZB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K083171 (2008). No later device cites it as a predicate yet.
- Root · 1 generation backK083171 Introl CF Panel I Control, Model: G106Maine Molecular Quality Controls, Inc. · 2008
- This deviceK093737 Hemosil F11 & FV Dna ControlInstrumentation Laboratory CO · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K083171 | Introl CF Panel I Control, Model: G106 | Maine Molecular Quality Controls, Inc. | 2008 | — |
| 0 (this device) | K093737 | Hemosil F11 & FV Dna Control | Instrumentation Laboratory CO | 2010 | — |
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 NZB? 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? (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 |
|---|---|---|---|
| * | K083171 | Introl CF Panel I Control, Model: G106Summary page 1…tion Name: Quality Control, Genetics, DNA Regulatory Class: Class II Product Code: NZB Panel: Immunology (82) Predicate Device: K083 171 INTROLTM CF Panel I Control Device Description: HemnosiL ElI & FV DNA Control is synthetic Factor II and Facto… | 2008 |
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.
How does its category compare?
All NZB devicesNZB Quality Control Material, Genetics, Dna: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · NZB
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · NZB
Too few NZB 510(k)s in any year since 2007 to give a median.
Recalls per year · NZB
No recall names NZB since 2007.
Adverse event reports per year · NZB
No MAUDE report names NZB since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 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?
HemosIL FII & FV DNA Control is intended for in vitro diagnostic use as a heterozygous quality control to monitor analytical performance of the extraction, amplification and detection steps of the Xpert HemosIL FII & FV genotyping assay on the GeneXpert® Dx System used in the detection of both the Factor II 20210G>A and Factor V 1691G>A (Leiden) mutations.
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/K093737 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093737: Hemosil F11 & FV Dna Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093737
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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