510(k) · Cleared
ClearedLyphochek Maternal Serum Control, Model 220
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 Feb 2, 1999 as substantially equivalent to K981532 (Bio-Rad, 1998) after a 36-day review. Its family tree reaches back 2 generations to 1989. 1 later device descends from it.
- Decided
- Feb 2, 1999
- Review
- 36 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K891475 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK891475 Lyphochek (R) Immunoassay Contr Serum (Human) 1,2,3Bio-Rad · 1989
- 1 generation backK981532 Lyphochek Immunoassay Plus ControlBio-Rad · 1998
- This deviceK984594 Lyphochek Maternal Serum Control, Model 220Bio-Rad · 1999
- Descendant · cites it directly · 0 of its ownK143379 Liquichek Maternal Serum II ControlBio-Rad Laboratories · 2015
Most influential descendants
Showing 1 of 1 · See all- K143379Liquichek Maternal Serum II ControlBio-Rad Laboratories · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K891475 | Lyphochek (R) Immunoassay Contr Serum (Human) 1,2,3 | Bio-Rad | 1989 | — |
| −1 | K981532 | Lyphochek Immunoassay Plus Control | Bio-Rad | 1998 | — |
| 0 (this device) | K984594 | Lyphochek Maternal Serum Control, Model 220 | Bio-Rad | 1999 | — |
| +1 | K143379 | Liquichek Maternal Serum II Control | Bio-Rad Laboratories | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | K981532 | Lyphochek Immunoassay Plus ControlSummary page 1…Control (Assayed and Unassayed) 75JJY Devices to Which Substantial Equivalence is Claimed Lyphochek Immunoassay Plus Control Bio-Rad Laboratories, Irvine, California K981532 Statement of Intended Use Lyphochek Maternal Serum Control is intended for use as an assayed quality control to monitor the pre… | 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 |
|---|---|---|---|
| K143379 | Liquichek Maternal Serum II Control | 2015 | 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?
- The line of descent spans 10 years and passes through 1 company; a new generation was cleared every 8.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K143379 (Bio-Rad Laboratories, 2015) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K981532.
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 Maternal Serum Control is intended for use as an assayed quality control
serum 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/K984594 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984594: Lyphochek Maternal Serum Control, Model 220.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984594
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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