510(k) · Cleared
ClearedLyphochek Whole Blood Metals Control Model # 527, 528, 529
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · DIE Heavy Metals Control Materials
Cleared on Apr 22, 2002 as substantially equivalent to K984477 (Bio-Rad, 1999) after a 56-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Apr 22, 2002
- Review
- 56 days
- Class
- Class I
- Product code
- DIE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K895905 (1990). No later device cites it as a predicate yet.
- Root · 3 generations backK895905 Lyphochek Whole Blood Control (Human) Levels 1,2,3Bio-Rad · 1990
- 2 generations backK980871 Lyphochek Whole Blood ControlBio-Rad · 1998
- 1 generation backK984477 Lyphochek Whole Blood Metals Control Levels 1,2,3, Models 527, 528…Bio-Rad · 1999
- This deviceK020610 Lyphochek Whole Blood Metals Control Model # 527, 528, 529Bio-Rad · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K895905 | Lyphochek Whole Blood Control (Human) Levels 1,2,3 | Bio-Rad | 1990 | — |
| −2 | K980871 | Lyphochek Whole Blood Control | Bio-Rad | 1998 | — |
| −1 | K984477 | Lyphochek Whole Blood Metals Control Levels 1,2,3, Models 527, 528, 529 | Bio-Rad | 1999 | — |
| 0 (this device) | K020610 | Lyphochek Whole Blood Metals Control Model # 527, 528, 529 | Bio-Rad | 2002 | — |
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 DIE? 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 |
|---|---|---|---|
| * | K984477 | Lyphochek Whole Blood Metals Control Levels 1,2,3, Models 527, 528, 529Summary page 1…assayed) Class | 75JJY CFR 862.1660 30 Device to Which Substantial Equivalence is Claimed Lyphochek® Whole Blood Metals Control Bio-Rad Laboratories 510 (k) Number: K984477 4.0 Description of Device The Lyphochek® Whole Blood Metals Control is a lyophilized control prepared from human whole blood wi… | 1999 |
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?
- The line of descent spans 12 years and passes through 1 company; a new generation was cleared every 3.2 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All DIE devicesDIE Heavy Metals Control Materials: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DIE
FDA has decided no DIE device since 2007.
Median 510(k) review, days · DIE
Too few DIE 510(k)s in any year since 2007 to give a median.
Recalls per year · DIE
No recall names DIE since 2007.
Adverse event reports per year · DIE
No MAUDE report names DIE since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
An assayed quality control serum to monitor the precision of laboratory
testing procedures for 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/K020610 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020610: Lyphochek Whole Blood Metals Control Model # 527, 528, 529.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020610
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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