510(k) · Cleared
ClearedAbx Pentra HBA1C WB, Calibrator, Control and Hemolysis Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Horiba Abx · LCP Assay, Glycosylated Hemoglobin
Cleared on Oct 17, 2008 as substantially equivalent to K031380 (Olympus America, Inc., 2003) and 2 other predicates after a 329-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Oct 17, 2008
- Review
- 329 days
- Class
- Class II
- Product code
- LCP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K951361 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK951361 Dca 2000 System for Hemoglobin A1CHeraeus Kulzer, Inc. · 1995 · Recalled
- This deviceK073309 Abx Pentra HBA1C WB, Calibrator, Control and Hemolysis ReagentHoriba Abx · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951361 | Dca 2000 System for Hemoglobin A1C | Heraeus Kulzer, Inc. | 1995 | 1 |
| 0 (this device) | K073309 | Abx Pentra HBA1C WB, Calibrator, Control and Hemolysis Reagent | Horiba Abx | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2003 | 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? (3)
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 |
|---|---|---|---|
| * | K031380 | Olympus HBA1C Reagent, (Catalog Number OSR6192), Olympus HBA1C Calibrator, (Catolog…Summary page 2…Substantially equivalent Submission device Predicate device ABX PENTRA HbA Ic WB K03 1380 (Olympus) K955087 (Bayer) ABX PENTRAHb~lc CalK031380… | 2003 |
| * | K955087 | Hemoglobin Alc (HBA1C) & Total Assays for the Technicon RA/Opera Systems in-Vitro…Summary page 2…ion device Predicate device ABX PENTRA HbA Ic WB K03 1380 (Olympus) K955087 (Bayer) ABX PENTRAHb~lc CalK031380 (Olympus)… | 1996 |
| * | K951361 | Dca 2000 System for Hemoglobin A1CSummary page 2…K955087 (Bayer) ABX PENTRA HbAlc Control K03 1380 (Olympus) K951361 (Bayer) Description: All the reagents, controls and calibrators included in this submission are for use on the ABX PENTRA 400… | 1995 |
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?
- 2 of the 3 ancestors have a recall of any class.
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?
ABX PENTRA HBAlc WB reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of Hemoglobin Alc percentage (%HbAlc) in human whole blood based on a colorimetric and turbidimetric assay. It is intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer Percent HbAlc measurements are used in the clinical management of diabetes to assess the long-term efficacy of diabetic control. The ABX PENTRA HbAlc WB Cal…
Read the full statement (140 words)
ABX PENTRA HBAlc WB reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of Hemoglobin Alc percentage (%HbAlc) in human whole blood based on a colorimetric and turbidimetric assay. It is intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer
Percent HbAlc measurements are used in the clinical management of diabetes to assess the long-term efficacy of diabetic control.
The ABX PENTRA HbAlc WB Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA HbAlc WB method on Horiba ABX clinical chemistry analyzers.
The ABX PENTRA HbAlc WE Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA HbAlc WB method.
The ABX PENTRA HbAlc WB Hemolysis Reagent is an additional reagent for use in combination for the quantitative ABX PENTRA HbAlc WB method.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073309 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073309: Abx Pentra HBA1C WB, Calibrator, Control and Hemolysis Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073309
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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