510(k) · Cleared
ClearedRLP Cholesterol Immunoseparation Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Otsuka Pharmaceutical Co., Ltd. · CHH Enzymatic Esterase--Oxidase, Cholesterol
Cleared on Aug 20, 1999 as substantially equivalent to K833611 (Helena Laboratories, 1984) and 1 other predicate after a 142-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Aug 20, 1999
- Review
- 142 days
- Class
- Class I
- Product code
- CHH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K833611 (1984). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK833611 Titan Gel Lipoprotein ElectrophoresisHelena Laboratories · 1984
- This deviceK991083 RLP Cholesterol Immunoseparation AssayOtsuka Pharmaceutical Co., Ltd. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K833611 | Titan Gel Lipoprotein Electrophoresis | Helena Laboratories | 1984 | — |
| 0 (this device) | K991083 | RLP Cholesterol Immunoseparation Assay | Otsuka Pharmaceutical Co., Ltd. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
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 CHH? 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 CHH device
- #1 K251091 Lipidsscore 10.9 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K833611 | Titan Gel Lipoprotein ElectrophoresisSummary page 2…tion Assay ’ 510(k) Notification Exhibit 1: Summary of Safety and Effectiveness Information III. Predicate Device(s) The Titan Gel Lipoprotein Electrophoresis System (K833611), and the REP Cholesterol Profile-15 Kit (K935162). Otsuka America Pharmaceutical, Inc. Page 2 Otsuka America Pharmaceutical, I… | 1984 |
| * | K935162 | Rep Direct-Sep Cholesterol-15 Kit; Cholesterol-8 Kit; Cholesterol-4 KitSummary page 2…y of Safety and Effectiveness Information III. Predicate Device(s) The Titan Gel Lipoprotein Electrophoresis System (K833611), and the REP Cholesterol Profile-15 Kit (K935162). Otsuka America Pharmaceutical, Inc. Page 2 Otsuka America Pharmaceutical, Inc. CONFIDENTIAL Volume 001. Page 094 === Page 3… | 1994 |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K833611.
How does its category compare?
All CHH devicesCHH Enzymatic Esterase--Oxidase, Cholesterol: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CHH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CHH
198in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CHH
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CHH
14in 2025
MAUDE reports naming product code CHH, 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 | 2 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 3 | 0 |
| 2010 | 0 | — | 2 | 10 |
| 2011 | 1 | — | 0 | 18 |
| 2012 | 4 | 198 | 0 | 11 |
| 2013 | 1 | — | 1 | 0 |
| 2014 | 1 | — | 1 | 1 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 2 | 5 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 2 | 2 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 1 | — | 0 | 14 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The RLP-Cholesterol Assay is intended for use in the quantitative determination of cholesterol contained in remnant lipoproteins in human serum or plasma. The test results are used in combination with total serum triglyceride measurements to aids in the diagnosis of familial type III hyperlipoproteinemia in patients with serum total cholesterol concentration > 200 mg/dL and triglyceride concentrations between 200 and 800 mg/dL.
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/K991083 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991083: RLP Cholesterol Immunoseparation Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991083
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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