510(k) · Cleared
ClearedVariant Express Glycohemoglobin Program
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · LCQ Fluorescent Immunoassay Gentamicin
Cleared on Aug 6, 1997 as substantially equivalent to K941616 (Bio-Rad, 1995) and 1 other predicate after a 26-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Aug 6, 1997
- Review
- 26 days
- Class
- Class II
- Product code
- LCQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K895661 (1989). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK895661 Glycotest II Glyhb Assay KitPierce Chemical Co. · 1989
- This deviceK972609 Variant Express Glycohemoglobin ProgramBio-Rad · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K895661 | Glycotest II Glyhb Assay Kit | Pierce Chemical Co. | 1989 | — |
| 0 (this device) | K972609 | Variant Express Glycohemoglobin Program | Bio-Rad | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 LCQ? 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? (2)
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 |
|---|---|---|---|
| * | K941616 | Variant Total GHB ProgramSummary page 1…xpress Glycohemoglobin Program Common Name: VARIANT Express Classification Name: Assay, Glycosylated Hemoglobin, 81LCP Predicate Devices 1. VARIANT Total GHb Program (K941616) 2. Pierce Glycotest Il GlyHb Assay Kit (K 895661) The Bio-Rad VARIANT Express Glycohemoglobin Program is designed for use on t… | 1995 |
| * | K895661 | Glycotest II Glyhb Assay KitSummary page 1…NT Express Classification Name: Assay, Glycosylated Hemoglobin, 81LCP Predicate Devices 1. VARIANT Total GHb Program (K941616) 2. Pierce Glycotest Il GlyHb Assay Kit (K 895661) The Bio-Rad VARIANT Express Glycohemoglobin Program is designed for use on the Bio-Rad VARIANT Express Instrument. The analytic… | 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?
- None of the 2 ancestors has a recall.
How does its category compare?
All LCQ devicesLCQ Fluorescent Immunoassay Gentamicin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LCQ
FDA has decided no LCQ device since 2007.
Median 510(k) review, days · LCQ
Too few LCQ 510(k)s in any year since 2007 to give a median.
Recalls per year · LCQ
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LCQ
2in 2008
MAUDE reports naming product code LCQ, 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 | 0 | — | 2 | 3 |
| 2008 | 0 | — | 0 | 2 |
| 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 | — | 1 | 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?
The VARIANT Express Glycohemoglobin Program is intended for the separation and area percent determination of glycohemoglobin (GHb) in whole blood using boronate affinity high performance liquid chromatography (HPLC).
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/K972609 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972609: Variant Express Glycohemoglobin Program.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972609
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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