510(k) · Cleared
ClearedAdditional Ims Assays for the Bayer Advia Ims System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Corp. · CIX Bromcresol Green Dye-Binding, Albumin
Cleared on Sep 15, 1999 after a 58-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Sep 15, 1999
- Review
- 58 days
- Class
- Class II
- Product code
- CIX
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK992399 Additional Ims Assays for the Bayer Advia Ims SystemBayer Corp. · 1999
- Descendant · cites it directly · 1 of its ownK063845 Advia Chemistry Total Bilirubin_2Bayer Healthcare, LLC · 2007
- Descendant · 2 generations on · 0 of its ownK152344 Total BilirubinRandox Laboratories Limited · 2016 · Recalled
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 |
|---|---|---|---|---|---|
| 0 (this device) | K992399 | Additional Ims Assays for the Bayer Advia Ims System | Bayer Corp. | 1999 | — |
| +1 | K063845 | Advia Chemistry Total Bilirubin_2 | Bayer Healthcare, LLC | 2007 | — |
| +2 | K152344 | Total Bilirubin | Randox Laboratories Limited | 2016 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2016 | 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 CIX? 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 CIX device
- #1 K251157 Core Metabolicscore 11.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | — | Technicon CHEM 1® Albumin Named without a submission number | |
| * | — | Technicon CHEM 1® T Bilirubin Named without a submission number | |
| * | — | Technicon CHEM 1 Carbon Dioxide, Enzymatic Named without a submission number | |
| * | — | Bayer Immuno 1 Digoxin Named without a submission number | |
| * | — | Bayer Technicon Chem 1 HDL cholesterol method Named without a submission number | |
| * | — | Technicon CHEM 1® Inorganic Phosphorus Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063845 | Advia Chemistry Total Bilirubin_2 | 2007 | 1 |
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?
- Of its descendants, K063845 (Bayer Healthcare, LLC, 2007) has gone furthest, with 1 descendant of its own.
How does its category compare?
All CIX devicesCIX Bromcresol Green Dye-Binding, Albumin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CIX
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · CIX
168in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CIX
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CIX
4in 2025
MAUDE reports naming product code CIX, 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 | 1 | — | 1 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 74 |
| 2011 | 3 | 168 | 0 | 8 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 1 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 1 | — | 1 | 0 |
| 2020 | 0 | — | 1 | 1 |
| 2021 | 2 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Bayer ADVIA IMS Albumin assay is an in vitro diagnostic device intended to measure Albumin in human serum or plasma. Measurements of albumin are used in the diagnosis, monitoring and treatment of a variety of diseases involving the liver and kidney. The Bayer ADVIA IMS Total Bilirubin assay is an in vitro diagnostic device intended to measure bilirubin in human serum or plasma. Measurements of direct or total bilirubin, organic compounds formed…
Read the full statement (424 words)
The Bayer ADVIA IMS Albumin assay is an in vitro diagnostic device intended to measure Albumin in human serum or plasma. Measurements of albumin are used in the diagnosis, monitoring and treatment of a variety of diseases involving the liver and kidney.
The Bayer ADVIA IMS Total Bilirubin assay is an in vitro diagnostic device intended to measure bilirubin in human serum or plasma. Measurements of direct or total bilirubin, organic compounds formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis, monitoring and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder disorders.
The Bayer ADVIA IMS Carbon Dioxide (CO2) assay is an in vitro diagnostic method intended to measure CO2 in human serum. Measurements of CO2 are used as an aid in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
The Bayer ADVIA IMS Digoxin assay is an in vitro diagnostic device intended to measure Digoxin, a cardioactive drug, in human serum. Measurements of Digoxin are used as an aid in the diagnosis of Digoxin overdose and in the monitoring therapeutic levels of Digoxin to ensure appropriate therapy.
The Bayer ADVIA IMS HDL Cholesterol assay is an in vitro diagnostic device intended to measure HDL Cholesterol (a lipoprotein) in human serum and plasma. Such measurements are used as an aid in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
The Bayer ADVIA IMS Inorganic Phosphorus assay is an in vitro diagnostic device intended to measure phosphorus in human serum, plasma or urine. Measurements of inorganic phosphorus are used in the diagnosis, monitoring and treatment of a variety of diseases involving the parathyroid gland and kidney, and vitamin D imbalance.
The Bayer ADVIA IMS Ion Selective Electrode assays for Sodium/Potassium,and Chloride are in vitro diagnostic devices intended to measure these analytes in human serum or plasma. Measurements of sodium are used as an aid in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison’s disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium are used as an aid in the diagnosis and treatment of renal tubular disease, hyperaldosteronism, metabolic alkolosis, adrenocortical disease and diabetic ketoacidosis. Measurements of chloride are used as an aid in the diagnosis and treatment of acid-base and water imbalance. It is especially important to measure chloride during the correction of hypokalemic alkalosis and also during severe, prolonged vomiting which lowers serum chloride levels.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992399 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992399: Additional Ims Assays for the Bayer Advia Ims System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992399
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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