(264 days)
No
The document describes a standard in vitro diagnostic device for blood analysis and does not mention any AI or ML components. The performance studies focus on traditional analytical and clinical validation methods.
No
The device is an in vitro diagnostic device used for quantitative testing of blood samples to diagnose and monitor certain medical conditions, not to treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended for use by trained medical professionals as an in vitro diagnostic device" and describes its use for quantitative testing to aid in the "diagnosis and treatment of certain renal and metabolic diseases" and "disorders associated with changes in body acid-base balance." The "Device Description" also refers to it as "an in vitro diagnostic device system."
No
The device description clearly states the system is comprised of three major subsystems: epoc Host, epoc Reader, and epoc BGEM Test Card, indicating hardware components are integral to the device's function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states the device 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". It also describes the diagnostic purpose of the measurements (diagnosis and treatment of certain renal and metabolic diseases for BUN, and disorders associated with changes in body acid-base balance for TCO2).
- Device Description: The description clearly identifies the epoc Blood Analysis System as an "in vitro diagnostic device system for the quantitative testing of blood gases, electrolytes, and metabolites in venous, arterial, and capillary whole blood samples."
- Performance Studies: The document details various performance studies (Analytical Sensitivity, Linearity, Precision, Interference, Clinical Field Precision, Method Comparison, Matrix Comparison) which are standard evaluations for IVD devices to demonstrate their analytical and clinical performance.
- Predicate Device: The mention of a "Predicate Device" (K053110; i-STAT CHEM8+ Cartridge) is a strong indicator that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for comparison in the regulatory review process for new IVDs.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Blood Urea Nitrogen and Total Carbon Dioxide tests, as part of 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.
Blood Urea Nitrogen measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of certain renal and metabolic diseases.
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.
Product codes
CDS, JFL
Device Description
The epoc Blood Analysis System is an in vitro diagnostic device system for the quantitative testing of blood gases, electrolytes, and metabolites in venous, arterial, and capillary whole blood samples. The epoc System is comprised of 3 major subsystems: epoc Host, epoc Reader and epoc BGEM Test Card. The main accessory used with the epoc System includes the epoc Care-Fill Capillary Tubes used to collect and introduce capillary blood samples into the epoc Test Card.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Trained medical professionals in the laboratory or at the point of care.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
- Analytical Sensitivity: Evaluated Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ) for BUN and TCO2 using dialyzed whole blood samples per CLSI EP17-A2.
- Linearity: Performed in-house using multiple whole blood samples with BUN or TCO2 values spanning the reportable range. Conducted per CLSI EP06-A.
- Precision (Aqueous Controls): Analytical precision for BUN and TCO2 measurements conducted with four card lots using at least 25 epoc Readers, with replicate measurements run in-house twice a day for twenty days for each fluid per CLSI EP05-A3.
- Interference: Tested common interfering substances for BUN and TCO2 measurements per CLSI guideline EP07-A2, comparing spiked samples to control samples.
- Clinical Field Precision: External precision study to evaluate precision of BUN and TCO2 quantitation on the epoc System by intended users at three clinical sites using different epoc test card lots. Study included aqueous control precision (syringes), whole blood precision (syringes), and whole blood precision (capillary tubes). Additionally, precision was assessed on duplicate epoc test results during Method Comparison Studies (over 430 patient tests).
- Method Comparison:
- BUN: Conducted at three clinical sites per CLSI EP09-A3. Compared venous, arterial, and capillary blood samples (over 140 results for each blood type) to an IDMS-traceable plasma/serum-based laboratory system (Roche Cobas 8000).
- TCO2: Conducted at three clinical sites. Compared venous, arterial, and capillary patient samples (over 150 results for each blood type) with a whole blood point-of-care system (i-STAT-CHEM8+).
- Matrix Comparison: Anticoagulant: Compared epoc BUN and TCO2 results in venous blood samples (over 60 volunteer donors) collected into no additive, Li-heparin, and Na-heparin vacutainers.
Key Metrics
- Analytical Sensitivity:
- BUN: LoB = 2 mg/dL, LoD = 3 mg/dL, LoQ = 3 mg/dL
- TCO2: LoB = 4.0 mM, LoD = 4.3 mM, LoQ = 4.3 mM
- Linearity:
- BUN (4-119 mg/dL): Slope = 1.020, Intercept = 0.4, R = 0.9989
- TCO2 (4-49 mmol/L): Slope = 0.903, Intercept = 3.32, R = 0.9997
- Precision (Aqueous Controls):
- High Level (BUN 51.7 mg/dL): %CVWR = 2.0%, %CVT = 2.3%
- Low Level (BUN 7.1 mg/dL): %CVWR = 4.2%, %CVT = 4.5%
- High Level (TCO2 30.7 mmol/L): %CVWR = 2.7%, %CVT = 3.0%
- Low Level (TCO2 16.2 mmol/L): %CVWR = 5.4%, %CVT = 6.3%
- Clinical Field Precision with Aqueous Controls:
- BUN (Level 1, 52.1 mg/dL): Repeatability (SWR %CV) = 2.0%, Total Reproducibility (ST %CV) = 3.0%
- BUN (Level 2, 17.7 mg/dL): Repeatability (SWR %CV) = 2.5%, Total Reproducibility (ST %CV) = 6.3%
- BUN (Level 3, 7.1 mg/dL): Repeatability (SWR %CV) = 3.4%, Total Reproducibility (ST %CV) = 3.7%
- TCO2 (Level 1, 15.9 mM): Repeatability (SWR %CV) = 2.8%, Total Reproducibility (ST %CV) = 3.1%
- TCO2 (Level 2, 19.7 mM): Repeatability (SWR %CV) = 3.4%, Total Reproducibility (ST %CV) = 3.9%
- TCO2 (Level 3, 30.4 mM): Repeatability (SWR %CV) = 1.9%, Total Reproducibility (ST %CV) = 3.4%
- Clinical Field Precision with Whole Blood (N = 134-139 samples per group):
- Hi-Syringe BUN: Avg = 57.4 mg/dL, %CV = 2.3%
- Hi-Cap Tube BUN: Avg = 55.5 mg/dL, %CV = 2.9%
- NB-Syringe BUN: Avg = 17.3 mg/dL, %CV = 4.1%
- NB-Cap Tube BUN: Avg = 15.6 mg/dL, %CV = 3.9%
- Lo-Syringe BUN: Avg = 7.0 mg/dL, %CV = 7.2%
- Lo-Cap Tube BUN: Avg = 7.6 mg/dL, %CV = 7.0%
- Hi-Syringe TCO2: Avg = 36.5 mM, %CV = 1.5%
- Hi-Cap Tube TCO2: Avg = 34.1 mM, %CV = 2.1%
- NB-Syringe TCO2: Avg = 27.5 mM, %CV = 1.4%
- NB-Cap Tube TCO2: Avg = 25.6 mM, %CV = 2.9%
- Lo-Syringe TCO2: Avg = 10.5 mM, %CV = 3.7%
- Lo-Cap Tube TCO2: Avg = 13.5 mM, %CV = 3.5%
- Precision with duplicate epoc test results during Method Comparison Studies:
- BUN (100 mg/dL, N=12): Average Reading = 111.1, Pair Precision (SD) = 1.6, %CV = 1.4%
- TCO2 (40 mM, N=23): Average Reading = 44.8, Pair Precision (SD) = 1.0, %CV = 2.2%
- Method Comparison (BUN vs. Roche Cobas 8000, N=433):
- Intercept = 0.3, Slope = 0.985, R = 0.998, Mean Bias at 26 mg/dL = -0.1+0.2
- Method Comparison (TCO2 vs. i-STAT-CHEM8+, N=574):
- Intercept = -0.8, Slope = 1.039, R = 0.974, Mean Bias at 20 mM = 0.0 + 0.2
Predicate Device(s)
Reference Device(s)
K061597, K090109, K092849, K093297, and K113726
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1770 Urea nitrogen test system.
(a)
Identification. A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
January 17, 2018
Epocal Inc. Jennifer Armstrong Regulatory Affairs Manager 2060 Walkley Road Ottawa, ON K1G 3P5 Canada
Re: K171247
Trade/Device Name: epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test Regulation Number: 21 CFR 862.1770 Regulation Name: Urea nitrogen test system Regulatory Class: II Product Code: CDS. JFL Dated: December 11, 2017 Received: December 13, 2017
Dear Jennifer Armstrong:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR
1
Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kellie B. K
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171247
Device Name epoc® Blood Urea Nitrogen Test epoc® Total Carbon Dioxide Test
Indications for Use (Describe)
The Blood Urea Nitrogen and Total Carbon Dioxide tests, as part of 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.
Blood Urea Nitrogen measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of certain renal and metabolic diseases.
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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY K171247
GENERAL INFORMATION
| Applicant Name: | Epocal Inc.
2060 Walkley Road
Ottawa, ON K1G 3P5 Canada |
|------------------|-------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Jennifer Armstrong
Manager, Regulatory Affairs
Phone: (613) 688-3982 x2227
Email: jennifer.armstrong@alere.com |
| Date Prepared: | January 15, 2018 |
DEVICE IDENTIFICATION
Trade or Proprietary Names: epoc® Blood Urea Nitrogen Test epoc® Total Carbon Dioxide Test
REGULATORY INFORMATION
| Classification Regulation: | 21 CFR 862.1770 | Urea nitrogen test system |
|---|---|---|
| 21 CFR 862.1160 | Bicarbonate/carbon dioxide test system | |
| Regulatory Class: | Class II | |
| Product Codes: | CDS | Electrode, Ion Specific, Urea Nitrogen |
| JFL | pH Rate Measurement, Carbon-Dioxide | |
| Predicate Device: | i-STAT CHEM8+ Cartridge (K053110; cleared by i-STAT Corporation) |
DEVICE DESCRIPTION
The epoc Blood Analysis System is an in vitro diagnostic device system for the quantitative testing of blood gases, electrolytes, and metabolites in venous, arterial, and capillary whole blood samples. The epoc System is comprised of 3 major subsystems: epoc Host, epoc Reader and epoc BGEM Test Card. The main accessory used with the epoc System includes the epoc Care-Fill Capillary Tubes used to collect and introduce capillary blood samples into the epoc Test Card.
4
The epoc Blood Analysis System was previously cleared for prescription use to quantitate pH, pCO2, pO2, Na, K, iCa, Cl, Glu, Lact, Crea, and Hct in arterial, venous, and capillary blood samples per K061597, K090109, K092849, K093297, and K113726. This premarket notification submission adds blood urea nitrogen (BUN) and total carbon dioxide (TCO2) quantitation to the epoc BGEM Test Card and Blood Analysis System.
INTENDED USE
The Blood Urea Nitrogen and Total Carbon Dioxide tests, as part of 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 unanticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.
Blood Urea Nitrogen measurements from the epoc Blood Analysis System are used in the diagnosis and treatment of certain renal and metabolic diseases.
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.
| Attribute | Predicate Device
i-STAT CHEM8+ Cartridge
(with i-STAT Portable Clinical
Analyzer) [K053110] | Candidate Device
epoc BGEM Test Card with epoc Blood
Analysis System |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Intended use | Portable, prescription use test system | Prescription, point-of-care test system |
| Measured
Parameter | Urea Nitrogen (BUN);
Total CO2 (TCO2) | Blood Urea Nitrogen (BUN);
Total CO2 (TCO2) |
| Calculated
Parameter | Anion Gap (AnGap); | Anion Gap (AGap, AGapK);
BUN/Creatinine ratio (BUN/Crea) |
| Where used | hospital, point of care | Same |
| Sample type | Venous, arterial and capillary whole
blood | Same |
| Technology | An electrochemical multi-sensor array
integrated into a single-use test that is
interpreted by a handheld reader and
associated software | Same |
| Reportable ranges
(BUN and TCO2) | BUN 3-140 mg/dL
TCO2 5-50 mmol/L | BUN 3-120 mg/dL
TCO2 same |
| Sample volume | 95 µL | At least 92 µL |
COMPARISON WITH PREDICATE
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PERFORMANCE CHARACTERISTICS
1. Analytical Sensitivity
This study evaluated and verified the performance of the epoc Blood Analysis System for BUN and TCO2 quantitation at the low end of their respective concentration ranges by determining the Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ) according to CLSI EP17-A2. Test samples were prepared from dialyzed whole blood. Results from this study are shown below:
| Analyte | LoB | LoD | LoQ |
|---|---|---|---|
| BUN | 2 mg/dL | 3 mg/dL | 3 mg/dL |
| TCO2 | 4.0 mM | 4.3 mM | 4.3 mM |
2. Linearity
Linearity was performed in-house on multiple whole blood samples with BUN or TCO2 values spanning the reportable range. Linearity is reported versus theoretical BUN values based on gravimetric mixtures of high and low BUN samples (as measured using an in-house standard whole blood BUN method). Three card lots were used in this study. The study was conducted per CLSI EP06-A.
| BUN | |||
|---|---|---|---|
| Test Range | Slope | Intercept | R |
| 4-119 mg/dL | 1.020 | 0.4 | 0.9989 |
| TCO2 | |||
| Test Range | Slope | Intercept | R |
| 4-49 mmol/L | 0.903 | 3.32 | 0.9997 |
3. Precision (Aqueous Controls)
Analytical precision for BUN and TCO2 measurements was conducted with four card lots using at least 25 epoc Readers where replicate measurements were run in-house twice a day for twenty days for each fluid per CLSI EP05-A3. In the precision data tables below, Swx denotes within-run standard deviation, %CVwr denotes within-run coefficient of variation, Sr denotes total standard deviation, and %CVr denotes total coefficient of variation.
| Aqueous Control | Units | N | Mean | SWR | %CVWR | ST | %CVT |
|---|---|---|---|---|---|---|---|
| High Level (BUN) | mg/dL | 320 | 51.7 | 1.01 | 2.0% | 1.16 | 2.3% |
| Low Level (BUN) | mg/dL | 320 | 7.1 | 0.30 | 4.2% | 0.32 | 4.5% |
| High Level (TCO2) | mmol/L | 320 | 30.7 | 0.82 | 2.7% | 0.92 | 3.0% |
| Low Level (TCO2) | mmol/L | 320 | 16.2 | 0.88 | 5.4% | 1.02 | 6.3% |
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4. Interference
Interferent testing of the BUN and TCO2 measurements on the epoc System was performed as recommended in the CLSI guideline EP07-A2. In each of these tests, human serum specimens were aliquoted into two (2) samples. The test sample was spiked by addition of interferent, while the control sample was spiked by the addition of the solvent of the interferent. The bias between the mean of six (6) replicates on both the control sample and the test sample with added interferent was calculated. Unacceptable interference bias was defined as producing a significant error more than 5% of the time.
Clinically significant interfering substances for BUN measurements are itemized below:
- . Samples contaminated with benzalkonium salts used as coatings for in-dwelling lines may cause elevated BUN results. For proper line-flushing procedures refer to CLSI H11-A4.
- Citrate will have no significant effect up to 6.0 mmol/L (176.5 mg/dL) after which it will decrease the BUN concentration by up to 0.26 mg/dL BUN per mmol/L citrate.
- EDTA will have no significant effect up to 4.5 mmol/L (167 mg/dL) after which it ● will decrease the BUN concentration by up to 0.43 mg/dL BUN per mmol/L EDTA.
- . Glutathione reduced will have no significant effect up to 1.7 mmol/L (52.2 mg/dL), after which it will increase the BUN concentration by up to 1.91 mg/dL BUN per mmol/L glutathione reduced. Blood glutathione (GSH) in human subjects is ~0.79-1.05 mmol/L. Long term oral glutathione reduced supplementation (250-1,000 mg/day administered for 6 months) increases glutathione plasma levels by ~0.2-8 µmol/L (~0.01-0.25 mg/dL). Short-term, oral intake of glutathione reduced does not affect plasma glutathione levels.
- ß-Hydroxybutyrate will have no significant effect up to 17.2 mmol/L (216.9 mg/dL), after which it will decrease the BUN concentration by up to 0.11 mg/dL BUN per mmol/L hydroxybutyrate. The reference range for ß-hydroxybutyrate in plasma is 100 | 40 |
| N | 253 | 143 | 12 | 524 | 23 |
| Average Reading | 13.1 | 44.2 | 111.1 | 24.5 | 44.8 |
| Pair Precision (SD) | 0.6 | 1.2 | 1.6 | 0.6 | 1.0 |
| %CV | 4.6% | 2.7% | 1.4% | 2.6% | 2.2% |
6. Method Comparison
Urea method comparison studies were performed at three clinical sites per CLSI EP09-A3. Venous, arterial and capillary blood samples for a total of over 140 results for each blood type were compared an IDMS-traceable plasma/serum-based laboratory system. Pooled results are shown below.
| BUN [mg/dL] | Roche Cobas 8000 | ||
|---|---|---|---|
| N | 433 | ||
| Sxx | 0.5 | ||
| Syy | 0.9 | ||
| Intercept | 0.3 | ||
| Slope | 0.985 | ||
| Syx | 1.8 | ||
| Xmin | 3 | ||
| Xmax | 118 | ||
| R | 0.998 | ||
| Mean Bias at 26 mg/dL | -0.1+0.2 |
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ероса I In с.
TCO2 method comparison studies were performed at three clinical sites. Venous, arterial and capillary patient samples for a total of over 150 results for each blood type were compared with a whole blood point-of-care system. Pooled results are shown below.
| TCO2 [mM] | i-STAT-CHEM8+ |
|---|---|
| N | 574 |
| Sxx | 0.68 |
| Syy | 0.64 |
| Intercept | -0.8 |
| Slope | 1.039 |
| Syx | 1.52 |
| Xmin | 7 |
| Xmax | 49 |
| R | 0.974 |
| Mean Bias at 20 mM | 0.0 + 0.2 |
7. Matrix Comparison: Anticoagulant
A method comparison approach was used to compare the epoc BUN and TCO2 results in venous blood samples, collected from over 60 volunteer donors into evacuated tubes containing no additive, and further aliquoted into three (3) vacutainers containing noadditive, Li-heparin and Na-heparin to create 3-way matched samples. It was concluded from the analysis that there was no significant difference between BUN and TCO2 results in Li-heparinized, Na-heparinized and non-anticoagulated blood samples on the epoc System.
CONCLUSION
The information provided in this pre-market notification demonstrates that the epoc BGEM Test Card and Blood Analysis System is substantially equivalent to the legally marketed predicate device for its intended use.