510(k) · Cleared
ClearedBayer Advia Ims System (in Vitro Diagnostic System)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Corp. · CJO Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes
Cleared on Jan 29, 1999 after a 211-day review. The FDA summary names its predicate without a number.
- Decided
- Jan 29, 1999
- Review
- 211 days
- Class
- Class II
- Product code
- CJO
- 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 CJO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | Bayer Chem 1 ALP (AMP) method Named without a submission number | |
| * | — | Technicon CHEM 1 Calcium method Named without a submission number | |
| * | — | Bayer Technicon Chem 1 Glucose method Named without a submission number | |
| * | — | Immuno 1 Ferritin assay Named without a submission number | |
| * | — | Bayer Immuno 1 hCG Assay Named without a submission number | |
| * | — | Bayer Immuno 1 TSH Assay 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 CJO devicesCJO Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CJO
2in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · CJO
Too few CJO 510(k)s in any year since 2007 to give a median.
Recalls per year · CJO
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CJO
1in 2010
MAUDE reports naming product code CJO, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 1 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Bayer ADVIA IMS alkaline phosphatase (ALP) assay is an in vitro diagnostic device intended to measure ALP in human serum or plasma. Such measurements are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. This diagnostic method is not intended for use on any other diagnostic system. The Bayer ADVIA IMS Calcium assay is an in vitro diagnostic device intended to measure calcium in human serum or plasma.…
Read the full statement (359 words)
The Bayer ADVIA IMS alkaline phosphatase (ALP) assay is an in vitro diagnostic device intended to measure ALP in human serum or plasma. Such measurements are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. This diagnostic method is not intended for use on any other diagnostic system.
The Bayer ADVIA IMS Calcium assay is an in vitro diagnostic device intended to measure calcium in human serum or plasma. Measurements of calcium are used in the diagnosis, monitoring and treatment of a variety of diseases including parathyroid disease, a variety of bone diseases, chronic renal disease, and tetany. This diagnostic method is not intended for use on any other diagnostic system.
The Bayer ADVIA IMS Glucose assay is an in vitro diagnostic device intended to measure glucose in human serum or plasma. Such measurements are used in the diagnosis, monitoring and treatment of carbohydrate metabolism disorders, including diabetes mellitus and neonatal hypoglycemia. This diagnostic method is not intended for use on any other diagnostic system.
The Bayer ADVIA IMS Ferritin assay is an in vitro diagnostic device intended to quantitatively measure ferritin (an iron-storage protein) in human serum. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency. This diagnostic method is not intended for use on any other diagnostic system.
The Bayer ADVIA IMS hCG assay is an in vitro diagnostic device intended to quantitatively measure total beta (B) in human chorionic gonadotropin (hcG) in human serum. Measurements of human chorionic gonadotropin are used in the detection of pregnancy. This diagnostic method is not intended for use on any other diagnostic system.
The Bayer ADVIA IMS TSH assay is an in vitro diagnostic device intended to quantitatively measure thyroid stimulating hormone (TSH)in human serum. This assay allows the determination of TSH with 3™ generation sensitivity of less than 20% total coefficient variation (CV) at 0.01 to 0.02 mIU/L or piU/mL, as defined by the American Thyroid Association. Measurements thyroid stimulating hormone are used in the diagnosis of thyroid or pituitary disorders. This diagnostic method is not intended for use on any other diagnostic system.
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/K982328 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982328: Bayer Advia Ims System (in Vitro Diagnostic System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982328
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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