510(k) · Cleared
ClearedAccu-Base Hemoglobin A1C Sample Collection Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diabetes Technologies, Inc. · LCP Assay, Glycosylated Hemoglobin
Cleared on Jan 22, 2002 after a 96-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jan 22, 2002
- Review
- 96 days
- Class
- Class II
- Product code
- LCP
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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 intended use of the AccuBase A, Test Kit is for the determinatioa of the relative percent (%) A,, (glyochemozlabin) in human whole blood (capillary) samples, using high performance liquid chromatography (HPLC) as the analytical method. The AccuBase A, Test Kit will be available to diabetes paticats through physicians, pharmacies, diabetes supply and/or OTC distribution companies for the purpose of monitaring the average glucose concentration in the…
Read the full statement (235 words)
The intended use of the AccuBase A, Test Kit is for the determinatioa of the relative percent (%) A,, (glyochemozlabin) in human whole blood (capillary) samples, using high performance liquid chromatography (HPLC) as the analytical method.
The AccuBase A, Test Kit will be available to diabetes paticats through physicians, pharmacies, diabetes supply and/or OTC distribution companies for the purpose of monitaring the average glucose concentration in the body over the past 30, 60 or 90 days including; 2 calculated Mean Blood Glucose (MBG) determination based on the DCCT MBG equatica (31.7 X Ay % - 66.1) = MBG mg/d! as part of an comprehensive individual diabetes cutcomes managemeat, glycemic status assessment and reatrment program.
The AccuBasc A, Test Kit does nat replace daily blood glucose monitoring.
While there are no known contraindications, it is well known that the existence of disturbed erythrocyte kinetics conditions (such as anemia) many result in a non-reportable test result duc to too few Red Blood cells per volume of sample. A list of poteatial canfounding factors are reparted on the test result at time of reporting. Keep out of reach of children and pets.
The intended reporting path of the AccuBase A test Kit test resuls include direct reporting to patients and/or a healthcare professional. Test results must be provided to a physician and/ar healthcare professional for interpretation of specific A, values and setting of specific target A . goals.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013465 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013465: Accu-Base Hemoglobin A1C Sample Collection Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013465
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026