510(k) · Cleared
ClearedAbx Pentra Glucose HK CP, Urea CP, Uric Acid CP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Horiba Abx · CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
Cleared on Oct 12, 2007 as substantially equivalent to K971477 (Trace America, Inc., 1997) and 1 other predicate after a 269-day review. Its family tree reaches back 3 generations to 1997. 3 later devices descend from it.
- Decided
- Oct 12, 2007
- Review
- 269 days
- Class
- Class II
- Product code
- CDQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K971954 (1997). 8 ancestors in all, the oldest K883962 (1988). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK971954 Liquichek Urine Chemistry Control (Cat.NO. 397,398)Bio-Rad · 1997
- 2 generations backK020817 Liquichek Urine Chemistry ControlBio-Rad Laboratories, Inc. · 2002
- 1 generation backK070249 Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase…Horiba Abx · 2007 · Recalled
- This deviceK070146 Abx Pentra Glucose HK CP, Urea CP, Uric Acid CPHoriba Abx · 2007
- Descendant · cites it directly · 2 of its ownK081276 Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine…Horiba Abx · 2008 · Recalled
- Descendant · 2 generations on · 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 3 of 3 · See all- K081276Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine Control L/HHoriba Abx · 2008 · cites it directly2descendants
- K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride…Horiba, Ltd. · 2019 · 2 generations on0descendants
- K100263Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL ReagentsSeppim S.A.S. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971954 | Liquichek Urine Chemistry Control (Cat.NO. 397,398) | Bio-Rad | 1997 | — |
| −2 | K020817 | Liquichek Urine Chemistry Control | Bio-Rad Laboratories, Inc. | 2002 | — |
| −1 | K070249 | Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase CP, Urine… | Horiba Abx | 2007 | 1 |
| 0 (this device) | K070146 | Abx Pentra Glucose HK CP, Urea CP, Uric Acid CP | Horiba Abx | 2007 | — |
| +1 | K081276 | Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine Control L/H | Horiba Abx | 2008 | 1 |
| +2 | 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 |
| 1997 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 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 CDQ? 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 CDQ device
- #1 K203771 Urea Nitrogen2score 3.7 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K971477 | Urea (Urea Nitrogen) - Incorporating Dynamic Stabilization Technology (DST)Summary page 2…Substantially equivalent Submission device Predicate device ABX PENTRA Urea CP K971477 ABX PENTRA Urine Control L/H I 070249 Description: All the reagents, controls and calibrators inclu… | 1997 |
| * | K070249 | Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase CP, Urine Control L/H Cleared while this submission was under review Summary page 3…rine Control L/H: Analytes Already cleared Included in this submission Amylase ' (K070249) Calcium V (K070249) Creatinine - (K070249)… | 2007 |
What descends from it? (3)
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)
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 10 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K081276 (Horiba Abx, 2008) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K971477.
How does its category compare?
All CDQ devicesCDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · CDQ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · CDQ
Too few CDQ 510(k)s in any year since 2007 to give a median.
Recalls per year · CDQ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CDQ
6in 2025
MAUDE reports naming product code CDQ, 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 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 1 | — | 1 | 37 |
| 2012 | 0 | — | 0 | 44 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 231 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
ABX PENTRA Urea CP reagent with associated calibrators and controls are intended
for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro
diagnostic determination of urea / urea nitrogen (an end-product of nitrogen
metabolism) in human serum, plasma and urine based on an enzymatic UV test using
urease and glutamate dehydrogenase. Measurements obtained by this device are used
in the diagnosis and treatment of certain renal and metabolic diseases.
The 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/K070146 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070146: Abx Pentra Glucose HK CP, Urea CP, Uric Acid CP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070146
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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