epoc Blood Analysis System

K200107 · Epocal, Inc. · CHL · Jun 5, 2020 · Clinical Chemistry

Device Facts

• Record ID: K200107
• Device Name: epoc Blood Analysis System
• Applicant: Epocal, Inc.
• Product Code: CHL · Clinical Chemistry
• Decision Date: Jun 5, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1120
• Device Class: Class 2

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.

Device Story

The epoc® Blood Analysis System is a point-of-care diagnostic platform for whole blood analysis. The system consists of a host device (the epoc® NXS Host) and a test card (not detailed here). The NXS Host is a tablet-based mobile platform running Android 9.0 OS, replacing the previous Windows Mobile-based PDA. The host processes data from the test card, manages the user interface, and provides results to the clinician. The system includes hardware components such as a touchscreen, barcode scanner, Bluetooth/Wi-Fi modules, and a cradle. The modification involves a transition to the Android-based NXS Host, which includes updated electronics, processors, and software. The device is used by healthcare professionals in clinical settings to obtain rapid diagnostic results, facilitating immediate clinical decision-making for patient management.

Clinical Evidence

No clinical data required. Substantial equivalence supported by software, hardware, and usability verification and validation testing.

Technological Characteristics

The system is a point-of-care blood analysis platform. The NXS Host is a tablet-based mobile computer running Android 9.0 OS. Hardware includes a touchscreen, barcode scanner, Bluetooth/Wi-Fi connectivity, and a cradle. The system utilizes electrochemical sensing principles (implied by the analyte list). The modification includes updated processors, electronics, battery, power circuits, and case materials. The system is designed for clinical use.

Indications for Use

Indicated for trained medical professionals to quantitate blood gases, electrolytes, and metabolites in heparinized or un-anticoagulated arterial, venous, or capillary whole blood. Used for diagnosis and treatment of acid-base disturbances, electrolyte imbalances, parathyroid/bone/renal diseases, tetany, metabolic disorders, carbohydrate metabolism disorders (diabetes, hypoglycemia), pancreatic islet cell tumors, lactic acidosis, and monitoring renal dialysis or blood volume states (anemia, erythrocytosis).

Regulatory Classification

Identification

A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

Predicate Devices

• epoc® Blood Analysis System (K092849, K093297, K113726, K171247)

Submission Summary (Full Text)

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SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY

I Background Information:

A 510(k) Number
K200107

B Applicant
Epocal Inc.

C Proprietary and Established Names
epoc® Blood Analysis System

D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| CHL | Class II | 21 CFR 862.1120 - Blood Gases (PCO2, PO2) and Blood pH Test System | CH - Clinical Chemistry |
| CEM | Class II | 21 CFR 862.1600 - Potassium test system | CH - Clinical Chemistry |
| JGS | Class II | 21 CFR 862.1665 - Sodium test system | CH - Clinical Chemistry |
| JFP | Class II | 21 CFR 862.1145 - Calcium test system | CH - Clinical Chemistry |
| JPI | Class II | 21 CFR 864.6400 - Hematocrit measuring device | HE - Hematology |
| CGA | Class II | 21 CFR 862.1345 - Glucose test system | CH - Clinical Chemistry |
| KHP | Class I | 21 CFR 862.1450 - Lactic acid test system | CH - Clinical Chemistry |
| CGL | Class II | 21 CFR 862.1225 - Creatinine test system | CH - Clinical Chemistry |
| CGZ | Class II | 21 CFR 862.1170 - Chloride test system | CH - Clinical Chemistry |
| CDS | Class II | 21 CFR 862.1770 - Urea nitrogen test system | CH - Clinical Chemistry |

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| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JFL | Class II | 21 CFR 862.1160 - Bicarbonate/carbon dioxide test system | CH - Clinical Chemistry |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) numbers of the SUBMITTER'S previously cleared device, the epoc® Blood Analysis System, k092849, k093297, k113726, and k171247.

2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. A description of the device MODIFICATIONS, including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for:

- Change from the previously cleared epoc® Host (a dedicated-use Personal Digital Assistant (PDA) computer-based platform that operators on Microsoft® Windows Mobile 6.5 Operating System (OS)) to the new epoc® NXS Host (a tablet-based mobile platform running on Android 9.0 OS). These changes include the following:

- Changes to the epoc® System user manual and Quick Start Guide to add instructions specific for the NXS Host.
- Change to the epoc® Host Software application (from a Windows-based OS to Android 9 OS), including a new user interface
- Hardware changes
- Change in form factor for Cradle (device component that holds the epoc® NXS Host)
- New mobile computer assembly (change in processors and electronics, battery, and power circuits)
- Bluetooth and Wi-Fi module
- New barcode scanner
- New touchscreen
- New case surface materials and structural design
- New MicroSD card
- New audio component

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4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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