510(k) · Cleared
ClearedLyphochek Whole Blood Metals Control Levels 1,2,3, Models 527, 528, 529
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Jan 29, 1999 as substantially equivalent to K980871 (Bio-Rad, 1998) after a 44-day review. Its family tree reaches back 2 generations to 1990. 1 later device descends from it.
- Decided
- Jan 29, 1999
- Review
- 44 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K895905 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK895905 Lyphochek Whole Blood Control (Human) Levels 1,2,3Bio-Rad · 1990
- 1 generation backK980871 Lyphochek Whole Blood ControlBio-Rad · 1998
- This deviceK984477 Lyphochek Whole Blood Metals Control Levels 1,2,3, Models 527, 528…Bio-Rad · 1999
- Descendant · cites it directly · 0 of its ownK020610 Lyphochek Whole Blood Metals Control Model # 527, 528, 529Bio-Rad · 2002
Most influential descendants
Showing 1 of 1 · See all- K020610Lyphochek Whole Blood Metals Control Model # 527, 528, 529Bio-Rad · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K895905 | Lyphochek Whole Blood Control (Human) Levels 1,2,3 | Bio-Rad | 1990 | — |
| −1 | K980871 | Lyphochek Whole Blood Control | Bio-Rad | 1998 | — |
| 0 (this device) | K984477 | Lyphochek Whole Blood Metals Control Levels 1,2,3, Models 527, 528, 529 | Bio-Rad | 1999 | — |
| +1 | K020610 | Lyphochek Whole Blood Metals Control Model # 527, 528, 529 | Bio-Rad | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 JJY? 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 |
|---|---|---|---|
| * | K980871 | Lyphochek Whole Blood Control Our OCR of the scanned summary read K380871, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Lyphochek Whole Blood Control”. | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020610 | Lyphochek Whole Blood Metals Control Model # 527, 528, 529 | 2002 | 0 |
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?
How does its category compare?
All JJY devicesJJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJY
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJY
78in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJY
13in 2025
MAUDE reports naming product code JJY, 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 | 11 | 49 | 5 | 2 |
| 2008 | 7 | 54 | 0 | 1 |
| 2009 | 8 | 80 | 2 | 3 |
| 2010 | 10 | 109 | 6 | 3 |
| 2011 | 14 | 120 | 1 | 6 |
| 2012 | 13 | 40 | 3 | 20 |
| 2013 | 16 | 82 | 2 | 5 |
| 2014 | 10 | 49 | 2 | 4 |
| 2015 | 4 | 153 | 1 | 4 |
| 2016 | 1 | — | 3 | 13 |
| 2017 | 3 | 78 | 4 | 12 |
| 2018 | 0 | — | 3 | 7 |
| 2019 | 0 | — | 4 | 1 |
| 2020 | 0 | — | 6 | 7 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 3 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 13 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Lyphochek Whole Blood Metals Control is intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
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/K984477 · printed Nov 5, 2026
Cite this page
510(k) Report. “K984477: Lyphochek Whole Blood Metals Control Levels 1,2,3, Models 527, 528, 529.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K984477
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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