510(k) · Cleared
Recalled · Class II · 2016Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine Control L/H
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Horiba Abx · CFR Hexokinase, Glucose
Cleared on Sep 12, 2008 as substantially equivalent to K944406 (Olympus America, Inc., 1995) and 2 other predicates after a 130-day review. Its family tree reaches back 4 generations to 1997. 2 later devices descend from it. It has been recalled once.
- Decided
- Sep 12, 2008
- Review
- 130 days
- Class
- Class II
- Product code
- CFR
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 4 generations to K971954 (1997). 11 ancestors in all, the oldest K883962 (1988). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK971954 Liquichek Urine Chemistry Control (Cat.NO. 397,398)Bio-Rad · 1997
- 3 generations backK020817 Liquichek Urine Chemistry ControlBio-Rad Laboratories, Inc. · 2002
- 2 generations backK070249 Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase…Horiba Abx · 2007 · Recalled
- 1 generation backK070146 Abx Pentra Glucose HK CP, Urea CP, Uric Acid CPHoriba Abx · 2007
- This deviceK081276 Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine…Horiba Abx · 2008
- Descendant · cites it directly · 0 of its ownK183375 Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium…Horiba, Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK100263 Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV…Seppim S.A.S. · 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 |
|---|---|---|---|---|---|
| −4 | K971954 | Liquichek Urine Chemistry Control (Cat.NO. 397,398) | Bio-Rad | 1997 | — |
| −3 | K020817 | Liquichek Urine Chemistry Control | Bio-Rad Laboratories, Inc. | 2002 | — |
| −2 | K070249 | Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase CP, Urine… | Horiba Abx | 2007 | 1 |
| −1 | K070146 | Abx Pentra Glucose HK CP, Urea CP, Uric Acid CP | Horiba Abx | 2007 | — |
| 0 (this device) | K081276 | Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine Control L/H | Horiba Abx | 2008 | — |
| +1 | K183375 | Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium… | Horiba, Ltd. | 2019 | — |
| +1 | K100263 | Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL Reagents | Seppim S.A.S. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2019 | 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 CFR? 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 CFR device
- #1 K253490 Glucose HK Gen.3; ONLINE DAT Methadone II…score 11.4 · 3 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 |
|---|---|---|---|
| * | K944406 | Olympus Glucose ReagentSummary page 2…Substantially equivalent Submission device Predicate device ABX PENTRA Glucose HK CP K944406 ABX PENTRA Uric Acid CP K971485 ABX PENTRA Urine Control L/H I K070146… | 1995 |
| * | K971485 | Uric Acid - Incorporating Dynamic Stabilization Technology - (DST)Summary page 2…ssion device Predicate device ABX PENTRA Glucose HK CP K944406 ABX PENTRA Uric Acid CP K971485 ABX PENTRA Urine Control L/H I K070146 HORIBA ABXSAS, FRANCE… | 1997 |
| * | K070146 | Abx Pentra Glucose HK CP, Urea CP, Uric Acid CPSummary page 2…NTRA Glucose HK CP K944406 ABX PENTRA Uric Acid CP K971485 ABX PENTRA Urine Control L/H I K070146 HORIBA ABXSAS, FRANCE Section 5-2 Description: Al… | 2007 |
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 |
|---|---|---|---|---|
| Jan 11, 2016 | Class II | Z-0743-2016 | Under Investigation by firm | N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K183375 (Horiba, Ltd., 2019) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K944406.
How does its category compare?
All CFR devicesCFR Hexokinase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · CFR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CFR
115in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CFR
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CFR
16in 2025
MAUDE reports naming product code CFR, 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 | 1 | — | 0 | 1 |
| 2008 | 5 | 182 | 7 | 2 |
| 2009 | 3 | 101 | 1 | 7 |
| 2010 | 0 | — | 0 | 11 |
| 2011 | 3 | 316 | 0 | 43 |
| 2012 | 4 | 115 | 1 | 49 |
| 2013 | 1 | — | 0 | 36 |
| 2014 | 1 | — | 1 | 2 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 2 | — | 1 | 1 |
| 2017 | 1 | — | 0 | 13 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 1 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 29 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 1 | — | 0 | 16 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
ABX PENTRA Glucose HK CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 for quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using glucose hexokinase method by colorimetry. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet…
Read the full statement (172 words)
ABX PENTRA Glucose HK CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 for quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using glucose hexokinase method by colorimetry. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
ABX PENTRA Uric Acid CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 for quantitative in vitro diagnostic determination of uric acid in human serum, plasma and urine based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method). Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs..
ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081276 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081276: Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine Control L/H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081276
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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