510(k) · Cleared
ClearedLp (a) Ultra
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SENTINEL CH. SpA · DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
Cleared on Dec 22, 2022 as substantially equivalent to K180074 (Diazyme Laboratories, Inc., 2018) after a 622-day review. Its family tree reaches back 1 generation to 2018.
- Decided
- Dec 22, 2022
- Review
- 622 days
- Class
- Class II
- Product code
- DFC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K180074 (2018). No later device cites it as a predicate yet.
- Root · 1 generation backK180074 Diazyme Lipoprotein (a) AssayDiazyme Laboratories, Inc. · 2018
- This deviceK211058 Lp (a) UltraSENTINEL CH. SpA · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K180074 | Diazyme Lipoprotein (a) Assay | Diazyme Laboratories, Inc. | 2018 | — |
| 0 (this device) | K211058 | Lp (a) Ultra | SENTINEL CH. SpA | 2022 | — |
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 DFC? 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 DFC device
- #1 K253069 Lipoprotein (a) Molarity Assayscore 11.5 · 1 generation · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K180074 | Diazyme Lipoprotein (a) AssaySummary page 4…duct Code: DFC Device Name: Lipoprotein, Low-Density, Antigen, Antiserum, Control Medical Specialty: Immunology 3. Predicate Device Diazyme Lipoprotein (a) Assay (k180074) 4. Indications for Use The Lp(a) Ultra assay is intended for in vitro diagnostic use in the immunoturbidimetric quantitati… | 2018 |
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.
- 1 other device also cites its predicate K180074.
How does its category compare?
All DFC devicesDFC Lipoprotein, Low-Density, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · DFC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DFC
Too few DFC 510(k)s in any year since 2007 to give a median.
Recalls per year · DFC
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DFC
7in 2025
MAUDE reports naming product code DFC, 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 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 2 | 16 |
| 2025 | 1 | — | 0 | 7 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Lp(a) Ultra assay is intended for in vitro diagnostic use in the immunoturbidimetric quantitative determination of
lipoprotein (a) [Lp(a)] in human serum and plasma using an automated analyzer. The measurement of Lp(a) is useful in
evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when
used in conjunction with clinical evaluation.
For In Vitro Diagnostic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211058 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211058: Lp (a) Ultra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211058
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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