510(k) · Cleared
ClearedTina-Quant HBA1C Gen.2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · LCP Assay, Glycosylated Hemoglobin
Cleared on Dec 23, 2011 as substantially equivalent to K072714 (Roche Diagnostics Corp., 2008) after a 324-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Dec 23, 2011
- Review
- 324 days
- Class
- Class II
- Product code
- LCP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K934070 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK934070 Tina-Quant Hemoglobin A1CBoehringer Mannheim Corp. · 1994
- 2 generations backK052464 Tina-Quant Hemoglobin A1C Gen.2 TestRoche Diagnostics Corp. · 2005
- 1 generation backK072714 Tina-Quant Hemoglobin A1C Gen.2 Test SystemRoche Diagnostics Corp. · 2008 · Recalled
- This deviceK110313 Tina-Quant HBA1C Gen.2Roche Diagnostics · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K934070 | Tina-Quant Hemoglobin A1C | Boehringer Mannheim Corp. | 1994 | — |
| −2 | K052464 | Tina-Quant Hemoglobin A1C Gen.2 Test | Roche Diagnostics Corp. | 2005 | — |
| −1 | K072714 | Tina-Quant Hemoglobin A1C Gen.2 Test System | Roche Diagnostics Corp. | 2008 | 1 |
| 0 (this device) | K110313 | Tina-Quant HBA1C Gen.2 | Roche Diagnostics | 2011 | — |
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 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? (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 |
|---|---|---|---|
| * | K072714 | Tina-Quant Hemoglobin A1C Gen.2 Test SystemSummary page 2…tes mellitus. Predicate We claim substantial equivalence to the currently marketed device device Tina-quant Hemoglobin Aic Gen.2 cleared in K0727 14. Page 2 of 6 510(k) Summary - Tina-quant HbAlc Gen. 2 Assay, continued Su… | 2008 |
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?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K072714.
How does its category compare?
All LCP devicesLCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Tina-Quant Hemoglobin Ale Gen. 2 assay is an in vitro diagnostic reagent system intended for
quantitative determination of mmol/mol hemoglobin Alec (IFCC) and %hemoglobin Alc
(DCCT/NGSP) in hemolysate or whole blood on Roche clinical chemistry analyzers. HbAlc
determinations are useful for monitoring of long-term blood glucose control in individuals with
diabetes mellitus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110313 · printed Nov 3, 2026
Cite this page
510(k) Report. “K110313: Tina-Quant HBA1C Gen.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K110313
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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