510(k) · Cleared
ClearedLyphochek Diabetes Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories · GGM Control, Hemoglobin
Cleared on Apr 2, 2007 as substantially equivalent to K862186 (Bio-Rad, 1986) after a 35-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Apr 2, 2007
- Review
- 35 days
- Class
- Class II
- Product code
- GGM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K862186 (1986). No later device cites it as a predicate yet.
- Root · 1 generation backK862186 Lyphochek Glycated Hemoglobin/Whole Blood/Lev.I&IIBio-Rad · 1986
- This deviceK070546 Lyphochek Diabetes ControlBio-Rad Laboratories · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K862186 | Lyphochek Glycated Hemoglobin/Whole Blood/Lev.I&II | Bio-Rad | 1986 | — |
| 0 (this device) | K070546 | Lyphochek Diabetes Control | Bio-Rad Laboratories | 2007 | — |
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 GGM? 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 |
|---|---|---|---|
| * | K862186 | Lyphochek Glycated Hemoglobin/Whole Blood/Lev.I&IISummary page 1…Substantial Equivalence is Claimed Lyphochek Diabetes Control Bio-Rad Laboratories Irvine, California 92618 510 (k) Number: K862186 4.0 Description of Device This is a lyophilized product prepared from human whole blood containing preservati… | 1986 |
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.
- 1 other device also cites its predicate K862186.
How does its category compare?
All GGM devicesGGM Control, Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · GGM
2in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · GGM
Too few GGM 510(k)s in any year since 2007 to give a median.
Recalls per year · GGM
2in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GGM
1in 2018
MAUDE reports naming product code GGM, 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 | 2 | — | 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 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 2 | 1 |
| 2019 | 2 | — | 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 Diabetes Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070546 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070546: Lyphochek Diabetes Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070546
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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