510(k) · Cleared
ClearedTina-Quant Hemoglobin A1C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · LCP Assay, Glycosylated Hemoglobin
Cleared on Oct 11, 1994 after a 417-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 17 later devices descend from it.
- Decided
- Oct 11, 1994
- Review
- 417 days
- Class
- Class II
- Product code
- LCP
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 6 citing it directly.
- This deviceK934070 Tina-Quant Hemoglobin A1CBoehringer Mannheim Corp. · 1994
- Descendant · cites it directly · 6 of its ownK052101 C.F.a.S. (Calibrator for Automated Systems) HBA1CRoche Diagnostics · 2005
- Descendant · 2 generations on · 4 of its ownK130255 Hemoglobin A1C, Hemoglobin A1C Calibrators, Hemoglobin A1C ControlsAbbott Laboratories · 2014 · Recalled
- Descendant · cites it directly · 3 of its ownK052464 Tina-Quant Hemoglobin A1C Gen.2 TestRoche Diagnostics Corp. · 2005
- Descendant · 2 generations on · 2 of its ownK072714 Tina-Quant Hemoglobin A1C Gen.2 Test SystemRoche Diagnostics Corp. · 2008 · Recalled
- Descendant · 3 generations on · 1 of its ownK171771 ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) AssaySiemens Healthcare Diagnostics, Inc. · 2017 · Recalled
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K052101C.F.a.S. (Calibrator for Automated Systems) HBA1CRoche Diagnostics · 2005 · cites it directly6descendants
- K130255Hemoglobin A1C, Hemoglobin A1C Calibrators, Hemoglobin A1C ControlsAbbott Laboratories · 2014 · 2 generations on4descendants
- K052464Tina-Quant Hemoglobin A1C Gen.2 TestRoche Diagnostics Corp. · 2005 · cites it directly3descendants
- K072714Tina-Quant Hemoglobin A1C Gen.2 Test SystemRoche Diagnostics Corp. · 2008 · 2 generations on2descendants
- K171771ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) AssaySiemens Healthcare Diagnostics, Inc. · 2017 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K934070 | Tina-Quant Hemoglobin A1C | Boehringer Mannheim Corp. | 1994 | — |
| +1 | K052101 | C.F.a.S. (Calibrator for Automated Systems) HBA1C | Roche Diagnostics | 2005 | — |
| +2 | K130255 | Hemoglobin A1C, Hemoglobin A1C Calibrators, Hemoglobin A1C Controls | Abbott Laboratories | 2014 | 3 |
| +1 | K052464 | Tina-Quant Hemoglobin A1C Gen.2 Test | Roche Diagnostics Corp. | 2005 | — |
| +2 | K072714 | Tina-Quant Hemoglobin A1C Gen.2 Test System | Roche Diagnostics Corp. | 2008 | 1 |
| +3 | K171771 | ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay | Siemens Healthcare Diagnostics, Inc. | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2021 | 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? (17)
See all 176 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, K052101 (Roche Diagnostics, 2005) has gone furthest, with 6 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/K934070 · printed Nov 5, 2026
Cite this page
510(k) Report. “K934070: Tina-Quant Hemoglobin A1C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K934070
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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