510(k) · Cleared
ClearedHDL Uni-Paks (Pta), Catalogue Number 215-51
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Chemicals, Ltd. · LBR Ldl & Vldl Precipitation, Hdl
Cleared on Apr 21, 1998 after a 60-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 21, 1998
- Review
- 60 days
- Class
- Class I
- Product code
- LBR
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LBR? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All LBR devicesLBR Ldl & Vldl Precipitation, Hdl: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LBR
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · LBR
Too few LBR 510(k)s in any year since 2007 to give a median.
Recalls per year · LBR
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LBR
8in 2025
MAUDE reports naming product code LBR, 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 | 1 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 0 | — | 4 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 1 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 1 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Foe the quantitative determination of HDL-Cholesterol in serum. For IN VITRO diagnostic use. Barr, et.al. (1) in 1951 first reported the inverse relationship between high density lipoproteins (HDL) and coronary heart disease. Since that time, several procedures have been used to separate HDL including ultracentrifugation, electrophoresis, and precipitation. With the precipitation methods (heparin/manganese, dextran sulfate/magnesium…
Read the full statement (132 words)
Foe the quantitative determination of HDL-Cholesterol in serum.
For IN VITRO diagnostic use.
Barr, et.al. (1) in 1951 first reported the inverse relationship between high density lipoproteins (HDL) and coronary heart disease. Since that time, several procedures have been used to separate HDL including ultracentrifugation, electrophoresis, and precipitation. With the precipitation methods (heparin/manganese, dextran sulfate/magnesium, phosphotungstate/magnesium, and polyethylene glycol), the very low density lipoproteins (VLDL) and the low density lipoproteins (LDL) are first selectively precipitated and then the supernatant containing HDL is removed. Cholesterol concentration in the supernatant is then assayed to determine HDL-Cholestcrol concentration using an enzymatic total cholesterol procedure. The procedure for HDL-Cholesterol precipitation in this formulation is a modification of the Burnstein and Samaille (2) method and uses phosphotungstate and magnesium ions to precipitate the LDL and VLDL f(ractions.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980770 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980770: HDL Uni-Paks (Pta), Catalogue Number 215-51.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980770
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026