510(k) · Cleared
Recalled · Class II · 2016Tina-Quant Hemoglobin A1C Gen.2 Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · LCP Assay, Glycosylated Hemoglobin
Cleared on Apr 18, 2008 as substantially equivalent to K052464 (Roche Diagnostics Corp., 2005) after a 206-day review. Its family tree reaches back 2 generations to 1994. 2 later devices descend from it. It has been recalled once.
- Decided
- Apr 18, 2008
- Review
- 206 days
- Class
- Class II
- Product code
- LCP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K934070 (1994). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK934070 Tina-Quant Hemoglobin A1CBoehringer Mannheim Corp. · 1994
- 1 generation backK052464 Tina-Quant Hemoglobin A1C Gen.2 TestRoche Diagnostics Corp. · 2005
- This deviceK072714 Tina-Quant Hemoglobin A1C Gen.2 Test SystemRoche Diagnostics Corp. · 2008
- Descendant · cites it directly · 0 of its ownK110313 Tina-Quant HBA1C Gen.2Roche Diagnostics · 2011
- Descendant · cites it directly · 0 of its ownK102914 TQ HBA1C GEN3Roche · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K934070 | Tina-Quant Hemoglobin A1C | Boehringer Mannheim Corp. | 1994 | — |
| −1 | K052464 | Tina-Quant Hemoglobin A1C Gen.2 Test | Roche Diagnostics Corp. | 2005 | — |
| 0 (this device) | K072714 | Tina-Quant Hemoglobin A1C Gen.2 Test System | Roche Diagnostics Corp. | 2008 | — |
| +1 | K110313 | Tina-Quant HBA1C Gen.2 | Roche Diagnostics | 2011 | — |
| +1 | K102914 | TQ HBA1C GEN3 | Roche | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 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 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 |
|---|---|---|---|
| * | K052464 | Tina-Quant Hemoglobin A1C Gen.2 TestSummary page 1…acy Bush Date prepared: Oct 15, 2007 Submission The Tina-Quant Hemoglobin Alc Gen.2 assay was originally cleared for use Purpose and as K052464. The purpose of this submission is to modify the device by History extending the labeled measuring range for the HbA I c… | 2005 |
What descends from it? (2)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 4, 2016 | Class II | Z-0395-2017 | Storage | Roche Diagnostics has confirmed elevated QC and patient sample recovery for individual Tina-quant Hemoglobin A1c Gen.2 and Tina-quant Hemoglobin A1cDx Gen.2 cassettes/bottles. This issue occurred over multiple lots. Single… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 11.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K110313 (Roche Diagnostics, 2011) has gone furthest, with 0 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. 2008, 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?
For the quantitative determination of percent hemoglobin A1c in whole blood (or hemolysate derived from whole blood) on Roche clinical chemistry analyzers.
HbA1c 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/K072714 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072714: Tina-Quant Hemoglobin A1C Gen.2 Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072714
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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