510(k) · Cleared
ClearedCore Metabolic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Truvian Health · CIX Bromcresol Green Dye-Binding, Albumin
Cleared on Jan 9, 2026 as substantially equivalent to K200898 (Medicon Hellas S.A, 2021) and 1 other predicate after a 269-day review. Its family tree reaches back 2 generations to 1992.
- Decided
- Jan 9, 2026
- Review
- 269 days
- Class
- Class II
- Product code
- CIX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K924964 (1992). 9 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K924964 | Olympus Total Bilirubin Reagent | Olympus Corp. | 1992 | — |
| −1 | K200898 | Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine… | Medicon Hellas S.A | 2021 | — |
| 0 (this device) | K251157 | Core Metabolic | Truvian Health | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1995 | 3 | 0 |
| 2002 | 1 | 0 |
| 2006 | 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 K200898 Medicon Hellas Albumin, Medicon Hellas…score 5.0 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K200898 | Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon…Summary page 6…1 Hellas Direct Bilirubin and Medicon Hellas Urea Nitrogen (K200898) Secondary Predicate Device: Abaxis Piccolo Primary Health Panel (K950164) 4 Device Description The TruSy… | 2021 |
| * | K950164 | Piccolo (TM) Primary Health Panel Reagent RotorSummary page 6…Medicon Hellas Urea Nitrogen (K200898) Secondary Predicate Device: Abaxis Piccolo Primary Health Panel (K950164) 4 Device Description The TruSystem is an automated, integrated in vitro diagnostic platform consisting of the TruVerus™ and… | 1995 |
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.
What does this lineage say?
- The line of descent spans 34 years and passes through 3 companies; a new generation was cleared every 28.8 years on median.
- 2 of the 9 ancestors have a recall of any class.
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. 2026, 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 Core Metabolic panel is part of the TruWellness Panel™ and is intended for use on the TruVerus™. The Core Metabolic panel (part of the TruWellness Panel™) is an in vitro diagnostic device and intended to be used for the quantitative determination of Glucose (GLU), Total Protein (TP), and Albumin (ALB) in lithium-heparinized venous whole blood in clinical laboratory or point-of-care settings. The Core Metabolic panel (part of the TruWellness Panel™)…
Read the full statement (150 words)
The Core Metabolic panel is part of the TruWellness Panel™ and is intended for use on the TruVerus™. The Core Metabolic panel (part of the TruWellness Panel™) is an in vitro diagnostic device and intended to be used for the quantitative determination of Glucose (GLU), Total Protein (TP), and Albumin (ALB) in lithium-heparinized venous whole blood in clinical laboratory or point-of-care settings.
The Core Metabolic panel (part of the TruWellness Panel™) is an in vitro diagnostic test system that aids the physician in the diagnosis and treatment of the following disorders in adults 18 years of age or older:
- Glucose (GLU): Carbohydrate metabolism disorders, including diabetes mellitus, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
- Total Protein (TP): Variety of diseases involving the liver, kidney, or bone marrow, as well as other metabolic and nutritional disorders.
- Albumin (ALB): Numerous diseases involving primarily the liver and kidneys.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251157 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251157: Core Metabolic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251157
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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