510(k) · Cleared
ClearedBayer Advia Ims System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Corp. · CIG Diazo Colorimetry, Bilirubin
Cleared on Apr 10, 2000 after a 147-day review. The FDA summary names its predicate without a number.
- Decided
- Apr 10, 2000
- Review
- 147 days
- Class
- Class II
- Product code
- CIG
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 CIG? 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 CIG device
- #1 K251998 Atellica CH Diazo Total Bilirubin (D_TBil)score 11.8 · 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? (7)
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® D. Bilirubin Named without a submission number | |
| * | — | Bayer RA-1000 HbA1c Named without a submission number | |
| * | — | Bayer Immuno 1 Gentamicin Named without a submission number | |
| * | — | Technicon CHEM 1 Named without a submission number | |
| * | — | Bayer RA-1000 Theophylline Named without a submission number | |
| * | — | Bayer Immuno 1 Tobramycin Named without a submission number | |
| * | — | Technicon CHEM 1® Uric Acid Named without a submission number |
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.
How does its category compare?
All CIG devicesCIG Diazo Colorimetry, Bilirubin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CIG
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · CIG
64in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CIG
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CIG
52in 2025
MAUDE reports naming product code CIG, 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 | 2 |
| 2008 | 3 | 199 | 0 | 8 |
| 2009 | 2 | — | 3 | 3 |
| 2010 | 1 | — | 0 | 6 |
| 2011 | 2 | — | 0 | 38 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 5 | 64 | 3 | 8 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 23 |
| 2019 | 1 | — | 1 | 25 |
| 2020 | 0 | — | 0 | 31 |
| 2021 | 0 | — | 0 | 22 |
| 2022 | 1 | — | 0 | 26 |
| 2023 | 2 | — | 0 | 34 |
| 2024 | 0 | — | 0 | 39 |
| 2025 | 0 | — | 0 | 52 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Bayer Advia IMS Direct Bilirubin assay is an in vitro diagnostic device intended to measure conjugated 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…
Read the full statement (382 words)
The Bayer Advia IMS Direct Bilirubin assay is an in vitro diagnostic device intended to measure conjugated 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 Hemoglobin Alc (HbAlc) method is an in vitro diagnostic device intended to measure Hemoglobin A lc, a diabetes marker, in human blood. Measurements of HbA ¢ can be used for monitoring the long term care of persons with diabetes. The HbAl¢ and total hemoglobin (1Hb) values generated as part of the HbA 1 ¢ assay are intended for use in the calculation of the HbA 1¢/THb ratio, and must not be used individually for diagnostic purposes.
The Bayer Advia IMS Gentamicin assay is an in vitro diagnostic device intended to measure gentamicin, an antibiotic drug, in human serum. Measurements of gentamicin are used as an aid in the diagnosis and treatment of gentamicin overdose and in monitoring therapeutic levels of gentamicin to ensure appropriate therapy.
The Bayer Advia IMS Magnesium method is an in vitro diagnostic device intended to measure magnesium in human serum, plasma or urine. Measurements of magnesium are used in the diagnosis and treatment of hypomagnesemia, hypermagnesemia and monitoring of paticnts receiving prolonged magnesium-free intravenous therapv.
The Bayer Advia IMS Theophyiline assay is an in vitro diagnostic device intended to measure theophylline in human serum. Measurements of theophyllinc arc used as an aid in the diaguosis and treatment theophylline overdose and in monitoring therapeutic levels of theophylline to ensure appropriate therapy.
The Bayer Advia IMS Tobramycin assay is an in virro diagnostic device intended to quantitatively measure tobramycin, an antibiotic drug, human serum. Measurements of tobramycin are used in the diagnosis and treatment of tobramycin overdose and in monitoring therapeutic levels of tobramycin to ensure appropriate therapy.
The Bayer Advia IMS Uric Acid (UA) method is an in vitre diagnostic device intended to measure uric acid in human serum, plasma, and urine. Such measurements are used as an aid in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, and of patients receiving cytotoxic drugs.
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/K993867 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993867: Bayer Advia Ims System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993867
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026