510(k) · Cleared
ClearedRaichem HDL-Cholesterol Direct Reagent, HDL-Cholesterol Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Raichem · JIX Calibrator, Multi-Analyte Mixture
Cleared on Sep 21, 1998 as substantially equivalent to K830207 (Reagents Applications, Inc., 1983) and 1 other predicate after a 46-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Sep 21, 1998
- Review
- 46 days
- Class
- Class II
- Product code
- JIX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K830207 (1983). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK830207 Raichem HDL-Cholesterol ReagentReagents Applications, Inc. · 1983
- This deviceK982767 Raichem HDL-Cholesterol Direct Reagent, HDL-Cholesterol CalibratorRaichem · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K830207 | Raichem HDL-Cholesterol Reagent | Reagents Applications, Inc. | 1983 | — |
| 0 (this device) | K982767 | Raichem HDL-Cholesterol Direct Reagent, HDL-Cholesterol Calibrator | Raichem | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 JIX? 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? (3)
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 |
|---|---|---|---|
| * | K830207 | Raichem HDL-Cholesterol ReagentSummary page 2…rol Direct 3. Predicate Device [ CDC Designated Comparison Method: Cholesterol Reference Method Laboratory Network Raichem HDL-Cholesterol Reagent: 510(k) Docket No. K830207A Boehringer Mannheim Direct HDL-Cholesterol: 510(k) Docket No. K963213 Boehringer Mannheim C.f.a.s. HDL-C (Calibrator): 510(k) D… | 1983 |
| * | K963213 | Boehringer Mannheim Direct HDL-CholesterolSummary page 2…olesterol Reference Method Laboratory Network Raichem HDL-Cholesterol Reagent: 510(k) Docket No. K830207A Boehringer Mannheim Direct HDL-Cholesterol: 510(k) Docket No. K963213 Boehringer Mannheim C.f.a.s. HDL-C (Calibrator): 510(k) Docket No. K963213 Raichem Serum Calibrator (Ortho Automated Reference Se… | 1996 |
| * | — | Raichem Serum Calibrator (Ortho Automated Reference Serum Assayed - Marketed by Chiron… 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?
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All JIX devicesJIX Calibrator, Multi-Analyte Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIX
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JIX
29in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIX
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIX
18in 2025
MAUDE reports naming product code JIX, 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 | 6 | 53 | 2 | 140 |
| 2008 | 5 | 69 | 3 | 173 |
| 2009 | 4 | 121 | 2 | 39 |
| 2010 | 5 | 100 | 1 | 0 |
| 2011 | 7 | 77 | 2 | 9 |
| 2012 | 2 | — | 1 | 3 |
| 2013 | 4 | 50 | 0 | 24 |
| 2014 | 1 | — | 1 | 35 |
| 2015 | 3 | 29 | 0 | 4 |
| 2016 | 1 | — | 1 | 6 |
| 2017 | 0 | — | 1 | 17 |
| 2018 | 0 | — | 1 | 16 |
| 2019 | 0 | — | 1 | 12 |
| 2020 | 0 | — | 2 | 22 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 7 | 13 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 0 | 18 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
This calibrator is intended to be used for the calibration of the Raichem HDL-Cholesterol Direct assay.
This reagent is intended to be used for the quantitative determination of HDL-Cholesterol in human serum or plasma.
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/K982767 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982767: Raichem HDL-Cholesterol Direct Reagent, HDL-Cholesterol Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982767
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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