510(k) · Cleared
ClearedMedicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicon Hellas S.A · CIX Bromcresol Green Dye-Binding, Albumin
Cleared on Sep 21, 2021 as substantially equivalent to K924368 (Olympus Corp., 1993) and 6 other predicates after a 536-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it.
- Decided
- Sep 21, 2021
- Review
- 536 days
- Class
- Class II
- Product code
- CIX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 1 generation to K924964 (1992). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K251157Core MetabolicTruvian Health · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924964 | Olympus Total Bilirubin Reagent | Olympus Corp. | 1992 | — |
| 0 (this device) | K200898 | Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine… | Medicon Hellas S.A | 2021 | — |
| +1 | K251157 | Core Metabolic | Truvian Health | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1995 | 2 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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
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 |
|---|---|---|---|
| * | K924368 | Olympus Albumin ReagentSummary page 5…age 5 === 807.92 (a)(3): Identification of the legally marketed predicate devices 21 CFR § 862.1035 - Albumin Test system - Class II- Beckman Coulter Albumin (k924368) 21 CFR § 862.1145 - Calcium Test system - Class II- Beckman Coulter Calcium (k061575) 21 CFR § 862.1225 - Creatin… | 1993 |
| * | K061575 | Olympus Calcium Arsenazo Reagent, OSR60117, OSR61117, OSR65117Summary page 5…2.1035 - Albumin Test system - Class II- Beckman Coulter Albumin (k924368) 21 CFR § 862.1145 - Calcium Test system - Class II- Beckman Coulter Calcium (k061575) 21 CFR § 862.1225 - Creatinine Test system- Class II- Beckman Coulter Creatinine (k934361) 21 CFR § 862.1345 - Gl… | 2006 |
| * | K934361 | Olympus Creatinine ReagentSummary page 5…5 - Calcium Test system - Class II- Beckman Coulter Calcium (k061575) 21 CFR § 862.1225 - Creatinine Test system- Class II- Beckman Coulter Creatinine (k934361) 21 CFR § 862.1345 - Glucose Test system - Class II- Beckman Coulter Glucose (k944406) 21 CFR § 862.1110 - Direct… | 1993 |
| * | K944406 | Olympus Glucose ReagentSummary page 5…5 - Creatinine Test system- Class II- Beckman Coulter Creatinine (k934361) 21 CFR § 862.1345 - Glucose Test system - Class II- Beckman Coulter Glucose (k944406) 21 CFR § 862.1110 - Direct Bilirubin Test system - Class II- Abbott Architect Direct Bilirubin (K022180) 21 CFR §… | 1995 |
| * | K022180 | Direct BilirubinSummary page 5…st system - Class II- Beckman Coulter Glucose (k944406) 21 CFR § 862.1110 - Direct Bilirubin Test system - Class II- Abbott Architect Direct Bilirubin (K022180) 21 CFR § 862.1110 - Total Bilirubin Test system - Class II- Beckman Coulter Total Bilirubin (k924964) 21 CFR § 86… | 2002 |
| * | K924964 | Olympus Total Bilirubin ReagentSummary page 5…em - Class II- Abbott Architect Direct Bilirubin (K022180) 21 CFR § 862.1110 - Total Bilirubin Test system - Class II- Beckman Coulter Total Bilirubin (k924964) 21 CFR § 862.1770 – Urea Nitrogen Test system - Class II- Beckman Coulter Urea Nitrogen (BUN) (k944250) 807.92 (a)(… | 1992 |
| * | K944250 | Urea Nitrogen ReagentSummary page 5…em - Class II- Beckman Coulter Total Bilirubin (k924964) 21 CFR § 862.1770 – Urea Nitrogen Test system - Class II- Beckman Coulter Urea Nitrogen (BUN) (k944250) 807.92 (a)(4): Device Description Medicon Hellas Albumin: The BCG method is applied on serum samples, without serum blank. Th… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251157 | Core Metabolic | 2026 | 0 |
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?
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K251157 (Truvian Health, 2026) has gone furthest, with 0 descendants 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. 2021, 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?
Medicon Hellas Albumin: Reagent for the quantitative measurement of albumin in serum. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. Medicon Hellas Calcium: Reagent for the quantitative measurement of calcium in serum or urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany…
Read the full statement (256 words)
Medicon Hellas Albumin: Reagent for the quantitative measurement of albumin in serum. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
Medicon Hellas Calcium: Reagent for the quantitative measurement of calcium in serum or urine. 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).
Medicon Hellas Creatinine: Reagent for the quantitative measurement of creatinine in serum and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.
Medicon Hellas Glucose: Reagent for the quantitative measurement of glucose in serum and urine. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Medicon Hellas Direct Bilirubin; Reagent for the quantitative measurement of direct bilirubin (conjugated) in serum. Measurements of the level of direct bilirubin is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall blader block.
Medicon Hellas Total Bilirubin; Reagent for the quantitative measurements of total bilirubin in serum. Measurements of the levels of total bilirubin is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
Medicon Hellas Urea Nitrogen: Reagent for the quantitative measurement of urea nitrogen in serum and urine. Measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200898 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200898: Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200898
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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