510(k) · Cleared
ClearedDiamat Glycoslated Hemoglobin Analyzer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · LCP Assay, Glycosylated Hemoglobin
Cleared on Jul 30, 1985 after a 102-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jul 30, 1985
- Review
- 102 days
- Class
- Class II
- Product code
- LCP
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK851636 Diamat Glycoslated Hemoglobin Analyzer SystemBio-Rad · 1985
- Descendant · cites it directly · 2 of its ownK983172 Accu-Base Hemoglobin A1C Sample Collection KitDiabetes Technologies, Inc. (Dti) · 1998
- Descendant · 2 generations on · 1 of its ownK993787 Appraise-Cardio Sample Collection KitOsborn Group, Inc. · 2000 · Recalled
- Descendant · 3 generations on · 0 of its ownK021698 MY Allergy TestImmunetech Corporation · 2002 · Recalled
- Descendant · cites it directly · 0 of its ownK992085 Abbott Imx Glycated Hemoglobin IIAbbott Laboratories · 2000
- Descendant · cites it directly · 0 of its ownK991483 Abbott Architect Glycated HemoglobinAbbott Laboratories · 1999
Most influential descendants
Showing 5 of 5 · See all- K983172Accu-Base Hemoglobin A1C Sample Collection KitDiabetes Technologies, Inc. (Dti) · 1998 · cites it directly2descendants
- K993787Appraise-Cardio Sample Collection KitOsborn Group, Inc. · 2000 · 2 generations on1descendant
- K021698MY Allergy TestImmunetech Corporation · 2002 · 3 generations on0descendants
- K992085Abbott Imx Glycated Hemoglobin IIAbbott Laboratories · 2000 · cites it directly0descendants
- K991483Abbott Architect Glycated HemoglobinAbbott Laboratories · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K851636 | Diamat Glycoslated Hemoglobin Analyzer System | Bio-Rad | 1985 | — |
| +1 | K983172 | Accu-Base Hemoglobin A1C Sample Collection Kit | Diabetes Technologies, Inc. (Dti) | 1998 | — |
| +2 | K993787 | Appraise-Cardio Sample Collection Kit | Osborn Group, Inc. | 2000 | 3 |
| +3 | K021698 | MY Allergy Test | Immunetech Corporation | 2002 | 6 |
| +1 | K992085 | Abbott Imx Glycated Hemoglobin II | Abbott Laboratories | 2000 | — |
| +1 | K991483 | Abbott Architect Glycated Hemoglobin | Abbott Laboratories | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LCP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LCP device
- #1 K221326 Nova Allegro HbA1c Assay, Nova Allegro Analyzerscore 9.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
3 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?
- Of its descendants, K983172 (Diabetes Technologies, Inc. (Dti), 1998) has gone furthest, with 2 descendants of its own.
How does its category compare?
All LCP devicesLCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LCP
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LCP
269in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LCP
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LCP
22in 2025
MAUDE reports naming product code LCP, 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 | 7 | 133 | 1 | 5 |
| 2008 | 5 | 206 | 3 | 11 |
| 2009 | 6 | 158 | 6 | 15 |
| 2010 | 2 | — | 5 | 4 |
| 2011 | 10 | 176 | 51 | 27 |
| 2012 | 9 | 143 | 0 | 51 |
| 2013 | 2 | — | 4 | 193 |
| 2014 | 8 | 127 | 2 | 182 |
| 2015 | 3 | 239 | 2 | 64 |
| 2016 | 2 | — | 6 | 29 |
| 2017 | 5 | 218 | 1 | 149 |
| 2018 | 2 | — | 1 | 1,911 |
| 2019 | 4 | 269 | 0 | 114 |
| 2020 | 1 | — | 0 | 13 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 0 | — | 1 | 8 |
| 2023 | 2 | — | 0 | 27 |
| 2024 | 1 | — | 1 | 39 |
| 2025 | 0 | — | 1 | 22 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K851636 · printed Nov 4, 2026
Cite this page
510(k) Report. “K851636: Diamat Glycoslated Hemoglobin Analyzer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K851636
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026