510(k) · Cleared
Recalled · 2010G5 I HBA1C Test, G5 II HBA1C Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Provalis Diagnostics, Ltd. · LCP Assay, Glycosylated Hemoglobin
Cleared on Aug 16, 2004 as substantially equivalent to K952720 (Aalto Scientific, Ltd., 1995) after a 61-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it. It has been recalled 4 times.
- Decided
- Aug 16, 2004
- Review
- 61 days
- Class
- Class II
- Product code
- LCP
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952720 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK952720 Aalto Scientific LTD. Glycated Hemoglobin Control Levels I & IIAalto Scientific, Ltd. · 1995 · Recalled
- This deviceK041635 G5 I HBA1C Test, G5 II HBA1C TestProvalis Diagnostics, Ltd. · 2004
- Descendant · cites it directly · 0 of its ownK081269 Avie A1C Test SystemMec Dynamics Corp · 2009
Most influential descendants
Showing 1 of 1 · See all- K081269Avie A1C Test SystemMec Dynamics Corp · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952720 | Aalto Scientific LTD. Glycated Hemoglobin Control Levels I & II | Aalto Scientific, Ltd. | 1995 | 3 |
| 0 (this device) | K041635 | G5 I HBA1C Test, G5 II HBA1C Test | Provalis Diagnostics, Ltd. | 2004 | — |
| +1 | K081269 | Avie A1C Test System | Mec Dynamics Corp | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 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? (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 |
|---|---|---|---|
| * | K952720 | Aalto Scientific LTD. Glycated Hemoglobin Control Levels I & II Our reading of the summary gave “K952720.” beside “510(k)”; FDA’s K952720 is the only number that fits it and carries the summary’s name for the device. Summary page 8…ple addition G5 HbAl, Quality Control Kit Provalis use commercially available controls from Aalto scientific Ltd; Glycohemoglobin controls normal and abnormal. 510(k) K952720. 7) Conclusion: These performance characteristics clearly indicate substantial equivalence of… | 1995 |
| * | — | Glycosal II HbA1c Test Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081269 | Avie A1C Test System | 2009 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 7, 2010 | Not classified | Z-0109-2011 | Component design/selection | Test Cartridges may leak and have the potential to generate error messages and biased inaccurate results. |
| Jul 26, 2010 | Not classified | Z-0122-2011 | Device Design | Inaccurate results with high bias-- Inaccurate results may be read by the machine, creating the risk for untreated hypoglycemia at elevated altitudes. |
| Aug 3, 2006 | Not classified | Z-2460-2008 | Nonconforming Material/Component | Cholestech Corp. was notified by the foreign manufacturer of the A1C test cartridge that stability data indicated that the product would not meet performance claims through the end of its shelf life. |
| May 20, 2005 | Not classified | Z-0171-06 | Other | Provalis Diagnostics discovered, following its internal stability testing program (mid-point batch testing), that occasional low values were being found across multiple lots of in2it HbA1C Test Cartridges. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K081269 (Mec Dynamics Corp, 2009) 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.
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 G5 II HbAlc Test System is intended for testing blood taken from a fingerprick. G5 II HbAl c Test System shows how good glucose control has been over a two to three month period. The G5 II HbAlc Test System consists of the HbAlc test cartridge, the G5 Instrument, the G5 System Check Cartridge and the 05 HbAlc Quality Controls. The G5 II HbAlc Test System is intended for prescription home use. The G5 I HbAlc Test System is an affinity chromatography…
Read the full statement (178 words)
The G5 II HbAlc Test System is intended for testing blood taken from a fingerprick.
G5 II HbAl c Test System shows how good glucose control has been over a two to three month period.
The G5 II HbAlc Test System consists of the HbAlc test cartridge, the G5 Instrument, the G5 System Check Cartridge and the 05 HbAlc Quality Controls.
The G5 II HbAlc Test System is intended for prescription home use.
The G5 I HbAlc Test System is an affinity chromatography method and is intended for the in vitro quantitative determination of HbAl c in capillary blood taken from a fingerprick or whole blood in EDTA.
G5 I HbAl c Test System is indicated for monitoring the time averaged blood glucose levels of known diabetics, for professional use as an indicator of overall Glycaemic control.
The G5 I HbAlc Test System consists of the HbAlc test cartridge, the G5 Instrument, the G5 System Check Cartridge and the G5 HbAlc Quality Controls.
The 05 I HbAlc Test System is intended for use in a physicians/ doctors office.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041635 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041635: G5 I HBA1C Test, G5 II HBA1C Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041635
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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