# K200107: epoc Blood Analysis System

- Pathway: 510(k) (Special)
- Applicant: Epocal, Inc.
- Decided: Jun 5, 2020 after 140 days
- Product code: CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph)
- Device class: 2
- Regulation: 21 CFR 862.1120
- Recalls of this device: 19 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K003261 (2000). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061597: Epoc Blood Analysis System, Epocal, Inc. (2006) Summary page 6.
- K092849: Blood Collection Tube Samples for Use with Point of Care Blood Analyzer, Epocal, Inc. (2010) Summary page 6.
- K093297: Epoc Bgem, Epoc Reader, Epoc Host, Epoc Care-Fill Capillary Tube, Epocal, Inc. (2010) Summary page 6.
- K113726: Epoc Chloride Test and Epoc Creatinine Test, Epocal, Inc. (2012) Summary page 6.
- K171247: epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test, Epocal, Inc. (2018) Summary page 6.

## Recalls of this device
- Apr 2, 2026 · Class II · Z-2005-2026: Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary patient samples. An
- Jul 7, 2025 · Class II · Z-2272-2025: Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test card lots. All other analytes are performing as intended. The observed average bias for sodium
- Mar 19, 2025 · Class II · Z-1684-2025: The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.
- Mar 19, 2025 · Class II · Z-1685-2025: The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.
- Nov 22, 2024 · Class II · Z-0741-2025: Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name 
- Nov 22, 2024 · Class II · Z-0734-2025: Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name 
- Nov 22, 2024 · Class II · Z-0736-2025: Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name 
- Nov 22, 2024 · Class II · Z-0735-2025: Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name 
- Nov 22, 2024 · Class II · Z-0737-2025: Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name 
- Nov 22, 2024 · Class II · Z-0740-2025: Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name 
- Nov 22, 2024 · Class II · Z-0738-2025: Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name 
- Nov 22, 2024 · Class II · Z-0739-2025: Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name 
- Sep 24, 2024 · Class II · Z-0286-2025: Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in one lot of epoc BGEM BUN Test Cards approximately 2 months prior to expiration. The observed maximum negative
- Oct 19, 2023 · Class II · Z-0601-2024: Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certain conditions, a software problem is causing erroneous results to be printed. When the results are run o
- Jun 1, 2023 · Class II · Z-2476-2023: There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
- Jun 1, 2023 · Class II · Z-2477-2023: There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
- Jun 1, 2023 · Class II · Z-2478-2023: There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
- Dec 12, 2022 · Class II · Z-1215-2023: pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure
- Aug 28, 2020 · Class II · Z-2970-2020: Sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. Potential exists for a delay in diagnosis of hyperglycemia or unnecessary treatment for hypoglycemia.

## Indications for use
The epoc Blood Analysis System is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous, or capillary whole blood in the laboratory or at the point of care. The Blood Gas Electrolyte and Metabolite (BGEM) Test Card panel configuration includes sensors that quantitate pH, pCO2, pO2, Sodium, Potassium, Ionized Calcium, Chloride, Total Carbon Dioxide, Glucose, Lactate, Blood Urea Nitrogen, Creatinine, and Hematocrit. pH, pCO2, pO2 (blood gases) measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of life-threatening acid-base disturbances. Sodium and Potassium measurements from the epoc Blood Analysis System are used in diagnosis and treatment of diseases involving electrolyte imbalance. Ionized Calcium measurements from the epoc Blood Analysis System are used in diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. Chloride measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of electrolyte and metabolic disorders. Total Carbon Dioxide measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of disorders associated with changes in body acid-base balance. Glucose measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic islet cell tumors. Lactate measurements from the epoc Blood Analysis System are used to evaluate the acid-base status and are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood). Blood Urea Nitrogen measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of certain renal and metabolic diseases. Creatinine measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of certain renal diseases and in monitoring renal dialysis. Hematocrit measurements from the epoc Blood Analysis System are used to distinguish normal from abnormal states of blood volume, such as anemia and erythrocytosis.

Source page: https://510kreport.com/device/K200107
Methodology: https://510kreport.com/methodology