Epocal Inc
Ottawa Ontario, CA
EPOCAL, INC. appears in FDA device records in Ottawa Ontario, CA. FDA records list 7 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Epocal Inc between 2006 and 2020. The busiest year on record is 2010, with 2. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2009 | 1 |
| 2010 | 2 |
| 2012 | 1 |
| 2018 | 1 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K200107 | epoc Blood Analysis System | CHL | Substantially Equivalent | |
| K171247 | epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test | CDS | Substantially Equivalent | |
| K113726 | EPOC CHLORIDE TEST AND EPOC CREATININE TEST | CGL | Substantially Equivalent | |
| K093297 | EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE | KHP | Substantially Equivalent | |
| K092849 | BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER | CEM | Substantially Equivalent | |
| K090109 | BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD | CGA | Substantially Equivalent | |
| K061597 | EPOC BLOOD ANALYSIS SYSTEM | JGS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004959793 | 3004959793 | EPOCAL, INC. | 2060 Walkley Road, Ottawa Ontario K1G-3P5 CA | 2026 | and 3 more, listed in full below |
| 3012817228 | 3012817228 | Epocal Inc | 855 Brookfield Road, Ottawa Ontario K1V 2S5 CA | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KHPAcid, Lactic, Enzymatic Method
- JQPCalculator/Data Processing Module, For Clinical Use
- JPIDevice, Hematocrit Measuring
- CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- CGLElectrode, Ion Based, Enzymatic, Creatinine
- JFPElectrode, Ion Specific, Calcium
- CEMElectrode, Ion Specific, Potassium
- JGSElectrode, Ion Specific, Sodium
- CDSElectrode, Ion Specific, Urea Nitrogen
- CGZElectrode, Ion-Specific, Chloride
- CGAGlucose Oxidase, Glucose
- JFLPh Rate Measurement, Carbon-Dioxide
- GIOTube, Collection, Capillary Blood
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1971-2013 | epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit. | This recall is being initiated because the affected lots of this product may yield results that are not consistent with stated precision performance criteria at concentration values at the high-end of the Glucose test sensor (>400 mg/dl). Specifically, after a period of storage of three (3) to four (4) months, the Glucose sensor may report low results at the high end of the measurement range. | Class II | Terminated | |
| Z-2034-2012 | epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System Product Usage: Usage: epoc Blood Analysis BGEM Test Cards are used with the epoc(R) Blood Analysis System which is a POC testing system | Customer reported problem while performing incoming QC of newly received lot of test cards. Liquid quality control results were found to be out of range. Further investigation by Epocal determined that a portion of the test card lot (approximately 3000 cards) could potentially report low glucose results. | Class II | Terminated | |
| Z-0952-2009 | EPOC BGE Test Card The EPOC Blood Analysis System is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of whole blood samples in the laboratory or at the point of care in hospitals, nursing homes, or other clinical care institutions. The Blood Gas Electrolyte (BGE) test card panel of this device includes sensors for testing Sodium, Potassium, ionized Calcium, pH, pCO2, pO2 and Hematocrit. | elevated range of potassium levels | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain