510(k) · Cleared
ClearedISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · JGS Electrode, Ion Specific, Sodium
Cleared on Dec 16, 2016 as substantially equivalent to K003721 (Olympus America, Inc., 2000) and 2 other predicates after a 164-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it.
- Decided
- Dec 16, 2016
- Review
- 164 days
- Class
- Class II
- Product code
- JGS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K002982 (2000). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK002982 Olympus AU2700 Clinical Chemistry AnalyzerOlympus America, Inc. · 2000
- 1 generation backK112412 AU5800(R) Chemistry AnalyzerBeckman Coulter, Inc. · 2011 · Recalled
- This deviceK161837 ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry…Beckman Coulter, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK220977 ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry…Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. · 2023 · Recalled
- Descendant · cites it directly · 0 of its ownK183375 Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium…Horiba, Ltd. · 2019
Most influential descendants
Showing 2 of 2 · See all- K220977ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerBeckman Coulter Laboratory Systems (Suzhou) Co., Ltd. · 2023 · cites it directly0descendants
- K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride…Horiba, Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002982 | Olympus AU2700 Clinical Chemistry Analyzer | Olympus America, Inc. | 2000 | — |
| −1 | K112412 | AU5800(R) Chemistry Analyzer | Beckman Coulter, Inc. | 2011 | 7 |
| 0 (this device) | K161837 | ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer | Beckman Coulter, Inc. | 2016 | — |
| +1 | K220977 | ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer | Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | 2023 | 7 |
| +1 | K183375 | Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium… | Horiba, Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2023 | 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 JGS? 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 JGS device
- #1 K252475 ABL90 FLEX PLUS Systemscore 12.2 · 4 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 |
|---|---|---|---|
| * | K003721 | Modification to Olympus AU2700 Clinical Chemistry AnalyzerSummary page 6…Sodium and Chloride Chloride Inc. (K003721) ISE Reagents : Potassium Beckman Coulter, ISE Reagents : Potassium… | 2000 |
| * | K112412 | AU5800(R) Chemistry AnalyzerSummary page 6…ISE Reagents : Potassium Beckman Coulter, ISE Reagents : Potassium (K112412) Inc. Glucose Beckman Coulter,… | 2011 |
| * | K051564 | Olympus CRP Latex Reagent, OSR6199; Olympus CRP Latex Calibrator Normal Set, ODC0026…Summary page 6…x Immunoturbidimetric Reagent Inc. (K051564) AU5800 Clinical Chemistry DxC 700 AU Clinical… | 2005 |
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)
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 16 years and passes through 2 companies; a new generation was cleared every 11.2 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K220977 (Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JGS devicesJGS Electrode, Ion Specific, Sodium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · JGS
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JGS
347in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JGS
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JGS
64in 2025
MAUDE reports naming product code JGS, 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 | 0 | — | 7 | 33 |
| 2008 | 2 | — | 1 | 3 |
| 2009 | 2 | — | 0 | 57 |
| 2010 | 1 | — | 1 | 361 |
| 2011 | 3 | 191 | 1 | 912 |
| 2012 | 1 | — | 2 | 412 |
| 2013 | 2 | — | 5 | 510 |
| 2014 | 1 | — | 0 | 251 |
| 2015 | 1 | — | 1 | 158 |
| 2016 | 4 | 198 | 0 | 84 |
| 2017 | 1 | — | 0 | 292 |
| 2018 | 3 | 180 | 0 | 158 |
| 2019 | 3 | 58 | 5 | 105 |
| 2020 | 2 | — | 1 | 89 |
| 2021 | 0 | — | 1 | 91 |
| 2022 | 1 | — | 0 | 60 |
| 2023 | 3 | 347 | 4 | 98 |
| 2024 | 0 | — | 0 | 96 |
| 2025 | 0 | — | 0 | 64 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Applications include colorimetric, latex agglutination, and ion selective electrode. The Glucose test system is for the quantitative measurement of glucose in human serum…
Read the full statement (378 words)
The Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Applications include colorimetric, latex agglutination, and ion selective electrode.
The Glucose test system is for the quantitative measurement of glucose in human serum, plasma, urine and cerebrospinal fluid on Beckman Coulter AU analyzers. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemnia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
System reagent for the quantitative determination of C-Reactive Protein in human serum and plasma on Beckman Coulter AU Analyzers. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. Measurements may also be useful as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes.
Reagents for the quantitative determination of Sodium, Potassium and Chloride concentrations in human serum, plasma and urine on the Beckman Coulter ISE modules.
The sodium test system is intended for the quantitative measurement sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
The potassium test system is intended for the quantitative measurement of potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.
The chloride test system is intended for the quantitative measurement of the level of chloride in plasma, serum, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161837 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161837: ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161837
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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