510(k) · Cleared
ClearedInfinity Hba Kit, Models 537-a, 537-B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sigma Diagnostics, Inc. · LCP Assay, Glycosylated Hemoglobin
Cleared on Oct 26, 2001 as substantially equivalent to K940082 (Pacific Hemostasis, 1995) and 1 other predicate after an 88-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Oct 26, 2001
- Review
- 88 days
- Class
- Class II
- Product code
- LCP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K926469 (1993). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K926469 | Variant (TM) Hemoglobin a 1C Program | Bio-Rad | 1993 | — |
| −1 | K984268 | Variant II Hemoglobin A1C Program | Bio-Rad | 1998 | 2 |
| 0 (this device) | K012410 | Infinity Hba Kit, Models 537-a, 537-B | Sigma Diagnostics, Inc. | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 |
|---|---|---|---|
| * | K940082 | Thromboscreen Thromboplastin-DSSummary page 1…e: INFINITY™ HbA,, Common name: Hemoglobin A, Classification name: Assay, Glycosylated Hemoglobin, 81 LCP, 21 CFR 864.7470 Predicate device Roche Diagnostics HbA1c Il K940082 Bio-Rad VARIANT™ || K984268 Device description The INFINITY HbA,. assay is a microparticle enhanced turbidimetric i'mmunoassay.… | 1995 |
| * | K984268 | Variant II Hemoglobin A1C ProgramSummary page 1…ame: Hemoglobin A, Classification name: Assay, Glycosylated Hemoglobin, 81 LCP, 21 CFR 864.7470 Predicate device Roche Diagnostics HbA1c Il K940082 Bio-Rad VARIANT™ || K984268 Device description The INFINITY HbA,. assay is a microparticle enhanced turbidimetric i'mmunoassay. Intended Use Sigma Diagnost… | 1998 |
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 8 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 2 other devices also cite its predicate K940082.
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?
Sigma Diagnostics INFINITY™ HbA, is a device to measure the percent hemoglobin
A,. in anticoagulated whole blood. Hemoglobin A, is indicated for the monitoring of
long-term glucose control in individuals with diabetes mellitus.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012410 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012410: Infinity Hba Kit, Models 537-a, 537-B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012410
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026