510(k) · Cleared
ClearedPoly-Chem 90 Albumin, Bun, Calcium, Carbon Dioxide, Creatinine, and Total Protein Tests
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polymedco, Inc. · CIX Bromcresol Green Dye-Binding, Albumin
Cleared on Sep 8, 2011 after a 168-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 8, 2011
- Review
- 168 days
- Class
- Class II
- Product code
- CIX
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 CIX devicesCIX Bromcresol Green Dye-Binding, Albumin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 Poly-Chem 90 Albumin test system is an in vitro diagnostic procedure intended to measure the albumin concentration in human serum on the Poly-Chem 90 analyzer. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. The Poly-Chem 90 BUN test system is an in vitro diagnostic procedure intended to measure urea nitrogen (an end-product of nitrogen metabolism) in human serum on the…
Read the full statement (245 words)
The Poly-Chem 90 Albumin test system is an in vitro diagnostic procedure intended to
measure the albumin concentration in human serum on the Poly-Chem 90 analyzer.
Albumin measurements are used in the diagnosis and treatment of numerous diseases
involving primarily the liver or kidneys.
The Poly-Chem 90 BUN test system is an in vitro diagnostic procedure intended to
measure urea nitrogen (an end-product of nitrogen metabolism) in human serum on the
Poly-Chem 90 analyzer. Measurements obtained by this device are used in the
diagnosis and treatment of certain renal and metabolic diseases.
The Poly-Chem 90 Calcium test system is an in vitro diagnostic procedure intended to
measure the total calcium level in human serum on the Poly-Chem 90 analyzer.
Calcium measurements are used in the diagnosis and treatment of parathyroid disease,
a variety of bone diseases, chronic renal disease and tetany (intermittent muscular
contractions or spasms).
The Poly-Chem 90 Carbon Dioxide test system is an in vitro diagnostic procedure
intended to measure bicarbonate/carbon dioxide in human serum on the Poly-Chem 90
analyzer. Bicarbonate/carbon dioxide measurements are used in the diagnosis and
treatment of numerous potentially serious disorders associated with changes in body
acid-base balance.
The Poly-Chem 90 Creatinine test system is an in vitro diagnostic procedure intended to
measure creatinine levels in human serum on the Poly-Chem 90 analyzer. Creatinine
measurements are used in the diagnosis and treatment of renal diseases, in monitoring
renal dialysis, and as a calculation basis for measuring other urine analytes.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K110818 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110818: Poly-Chem 90 Albumin, Bun, Calcium, Carbon Dioxide, Creatinine, and Total Protein Tests.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110818
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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