510(k) · Cleared
ClearedLyphochek Whole Blood Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · DIF Drug Mixture Control Materials
Cleared on Apr 6, 1998 as substantially equivalent to K895905 (Bio-Rad, 1990) after a 46-day review. Its family tree reaches back 1 generation to 1990. 9 later devices descend from it.
- Decided
- Apr 6, 1998
- Review
- 46 days
- Class
- Class I
- Product code
- DIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K895905 (1990). 9 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK895905 Lyphochek Whole Blood Control (Human) Levels 1,2,3Bio-Rad · 1990
- This deviceK980871 Lyphochek Whole Blood ControlBio-Rad · 1998
- Descendant · cites it directly · 6 of its ownK022041 Lyphochek Whole Blood Control, Models 561, 562, 563Bio-Rad Laboratories, Inc. · 2002
- Descendant · 2 generations on · 2 of its ownK072721 Lyphochek Whole Blood Immunosuppressant Control , Abbott…Bio-Rad, Diagnostics Grp. · 2007
- Descendant · cites it directly · 1 of its ownK984477 Lyphochek Whole Blood Metals Control Levels 1,2,3, Models 527, 528…Bio-Rad · 1999
- Descendant · 3 generations on · 0 of its ownK132174 Multichem WBTTechno-Path Manufacturing, Ltd. · 2013
- Descendant · 3 generations on · 0 of its ownK080459 Chromesytems Toxicology Calibrators and ControlsChromsystems Instruments & Chemicals GmbH · 2009
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K022041Lyphochek Whole Blood Control, Models 561, 562, 563Bio-Rad Laboratories, Inc. · 2002 · cites it directly6descendants
- K072721Lyphochek Whole Blood Immunosuppressant Control , Abbott Immunosuppressant MCCBio-Rad, Diagnostics Grp. · 2007 · 2 generations on2descendants
- K984477Lyphochek Whole Blood Metals Control Levels 1,2,3, Models 527, 528, 529Bio-Rad · 1999 · cites it directly1descendant
- K132174Multichem WBTTechno-Path Manufacturing, Ltd. · 2013 · 3 generations on0descendants
- K080459Chromesytems Toxicology Calibrators and ControlsChromsystems Instruments & Chemicals GmbH · 2009 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K895905 | Lyphochek Whole Blood Control (Human) Levels 1,2,3 | Bio-Rad | 1990 | — |
| 0 (this device) | K980871 | Lyphochek Whole Blood Control | Bio-Rad | 1998 | — |
| +1 | K022041 | Lyphochek Whole Blood Control, Models 561, 562, 563 | Bio-Rad Laboratories, Inc. | 2002 | — |
| +2 | K072721 | Lyphochek Whole Blood Immunosuppressant Control , Abbott Immunosuppressant MCC | Bio-Rad, Diagnostics Grp. | 2007 | — |
| +1 | K984477 | Lyphochek Whole Blood Metals Control Levels 1,2,3, Models 527, 528, 529 | Bio-Rad | 1999 | — |
| +3 | K132174 | Multichem WBT | Techno-Path Manufacturing, Ltd. | 2013 | — |
| +3 | K080459 | Chromesytems Toxicology Calibrators and Controls | Chromsystems Instruments & Chemicals GmbH | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 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 DIF? 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 |
|---|---|---|---|
| * | K895905 | Lyphochek Whole Blood Control (Human) Levels 1,2,3Summary page 1…ntrol Material (Assayed and Unassayed) APR -6 1998 Devices to Which Substantial Equivalence is Claimed Lyphochek Whole Blood Control Bio-Rad Laboratories, Irvine, CA K895905 Statement of intended Use Lyphochek Whole Blood Control is intended for use as an assayed quality control material to monitor t… | 1990 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K022041 (Bio-Rad Laboratories, Inc., 2002) has gone furthest, with 6 descendants of its own.
How does its category compare?
All DIF devicesDIF Drug Mixture Control Materials: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DIF
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · DIF
35in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIF
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIF
1in 2016
MAUDE reports naming product code DIF, 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 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 1 |
| 2012 | 3 | 35 | 0 | 3 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 5 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 1 | 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?
Lyphochek Whole Blood Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in this 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/K980871 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980871: Lyphochek Whole Blood Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980871
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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