510(k) · Cleared
ClearedLyphocheck Urine Metals Control, Item NO.400, 405
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 16, 1999 as substantially equivalent to K891691 (Bio-Rad, 1989) after a 28-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Apr 16, 1999
- Review
- 28 days
- Class
- Class I
- Product code
- DIE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K891691 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK891691 Lyphochek Urine Metals Control, Levels I and IIBio-Rad · 1989
- This deviceK990928 Lyphocheck Urine Metals Control, Item NO.400, 405Bio-Rad · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891691 | Lyphochek Urine Metals Control, Levels I and II | Bio-Rad | 1989 | — |
| 0 (this device) | K990928 | Lyphocheck Urine Metals Control, Item NO.400, 405 | Bio-Rad | 1999 | — |
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 |
|---|---|---|---|
| * | K891691 | Lyphochek Urine Metals Control, Levels I and IISummary page 1…862.3280: Materials, Heavy Metals Control Devices to Which Substantial Equivalence is Claimed Lyphochek Urine Metals Control Bio-Rad Laboratories irvine, California K891691/A Statement of Intended Use Lyphochek Urine Metals Control is intended for use as an assayed quality control urine to monitor t… | 1989 |
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?
- Its one ancestor has no 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?
Lyphochek Urine Metals Control is intended for use as an assayed quality control urine 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/K990928 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990928: Lyphocheck Urine Metals Control, Item NO.400, 405.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990928
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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