Who is the manufacturer of BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER?

Epocal, Inc. filed the 510(k) submission for BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER (K092849).

What is the FDA product code for BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER?

CEM. It is classified under 21 CFR 862.1600 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER?

510(k) clearance (submission type: Traditional).

What are the predicate devices for BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER?

i-STAT Model 300 Portable Clinical Analyzer (K001387).

Who can help prepare an FDA 510(k) submission like BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER

K092849 · Epocal, Inc. · CEM · Mar 30, 2010 · Clinical Chemistry

Device Facts

Record ID	K092849
Device Name	BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER
Applicant	Epocal, Inc.
Product Code	CEM · Clinical Chemistry
Decision Date	Mar 30, 2010
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1600
Device Class	Class 2
Attributes	Pediatric

Intended 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 unanticoagulated arterial, venous, or capillary whole blood in the laboratory or at the point of care in hospitals, nursing homes or other clinical care institutions. The BGEM test card panel configuration includes sensors for sodium (Na), potassium (K), ionized calcium (iCa), pH, pCO2, pO2, glucose (Gluc) and hematocrit (Hct). Care-Fill Capillary Tubes are intended for use with the epoc Blood Analysis System and are used for the collection and dispensing of capillary blood samples with epoc Test Cards.

Device Story

System comprises epoc Blood Analysis System (reader/host) and Care-Fill Capillary Tubes. Tubes collect capillary blood via skin puncture; heparin-coated Mylar-wrapped glass tube preserves sample. Tubes act as delivery mechanism, mating with epoc test cards; manual plunger pressure injects blood over electrochemical sensor array. Reader performs automated calibration, sample analysis, and data processing. Used at point-of-care by trained professionals (RNs, technicians). Output displayed on PDA-based host; aids clinical decision-making for acid-base, electrolyte, and metabolic status. Benefits include rapid, bedside diagnostic results from small-volume capillary samples.

Clinical Evidence

Method comparison study conducted at four POC locations (NICU, nursery, outpatient) using 48 patient capillary samples (12 adult, 36 neonatal). Compared epoc/Care-Fill against i-STAT/Clinitube. Bias results showed high correlation across all analytes (pH, pCO2, pO2, Na, K, iCa, Glu, Hct). Additional in-house study compared Care-Fill capillary delivery to syringe delivery (n=42), demonstrating R² values >0.99 for all analytes. Precision studies (n=10 replicates per study) across six sites/operators showed %CVs generally <5%.

Technological Characteristics

System uses electrochemical multi-sensor array (PVC ion-selective electrodes for pH, Na, K, iCa; enzymatic amperometric for glucose; conductivity for Hct). Reader includes thermal subsystem (37°C), bar code scanner, and Bluetooth connectivity. Software performs signal processing and calculation. Powered by rechargeable batteries. Sterilization not specified; unit-use cards.

Indications for Use

Indicated for trained medical professionals to perform quantitative testing of heparinized or unanticoagulated arterial, venous, or capillary whole blood for electrolytes (Na, K, iCa), blood gases (pH, pCO2, pO2), glucose, and hematocrit in clinical settings. Used for diagnosing/treating electrolyte imbalances, acid-base disturbances, parathyroid/bone/renal diseases, anemia, erythrocytosis, and carbohydrate metabolism disorders (e.g., diabetes, hypoglycemia).

Regulatory Classification

Identification

A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

Predicate Devices

i-STAT Model 300 Portable Clinical Analyzer (K001387)

Related Devices

K061597 — EPOC BLOOD ANALYSIS SYSTEM · Epocal, Inc. · Sep 27, 2006
K200107 — epoc Blood Analysis System · Epocal, Inc. · Jun 5, 2020
K090109 — BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD · Epocal, Inc. · Jun 24, 2009

Submission Summary (Full Text)

{0}------------------------------------------------ # e pocal 2060 Walkley Road Ottawa Ontario, Canada K1G 3P5 MAR 3 0 2010 # 510(k) SUMMARY This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. | The assigned 510(k) number is: | K092849 | |--------------------------------|---------| |--------------------------------|---------| Summary Prepared: Sept 11, 2009 Submitted by: Epocal Inc. 2060 Walkley Road, Ottawa, Ontario, Canada K1G 3P5 Telephone: (613) 738-6192 Fax: (613) 738-6195 Contact: Roy Layer Director of Quality Assurance and Regulatory Affairs. #### Identification of the Device 5.1 | Device Name: | epoc® Blood Analysis System | |---------------------------|-----------------------------| | Proprietary / Trade Name: | epoc Blood Analysis System | | Common Name: | Portable Blood Analyzer | | Classification Name: | See Table 5.1 Below | | Device Classification: | See Table 5.1 Below | | Regulation Number: | See Table 5.1 Below | | Panel: | See Table 5.1 Below | | Product Code: | See Table 5.1 Below | | Name | Class | Regulation Number | Panel | Product Code | |-----------------------------------------------------------------|-------|----------------------|-----------------------|-----------------| | Electrode Measurement, Blood- Gases (PCO2, PO2) and Blood pH | II | 862.1120 | Clinical Chemistry | CHL | | Electrode, Ion Specific, Sodium | II | 862.1665 | Clinical Chemistry | JGS | | Electrode, Ion Specific, Potassium | II | 862.1600 | Clinical Chemistry | CEM | | Electrode, Ion Specific, Calcium | II | 862.1145 | Clinical Chemistry | JFP | | Glucose | II | 862.1345 | Clinical Chemistry | CGA | | Hematocrit | II | 864.6400 | Hematology | JPI | Figure 5.1 - Table - epoc™ Blood Analysis System with Blood Gas, Electrolytes and Metabolytes (BGEM) Test Card {1}------------------------------------------------ #### 5.2 Identification of the Predicate Device i-STAT® Model 300 Portable Clinical Analyzer #### 5.3 Description of the New Device The epoc System is a point-of-care device currently in use in hospitals. The epoc System was previously cleared for use with arterial and venous blood in 510(k) submissions K061597 and K090109. In this submission we are seeking clearance to use capillary blood specimens on the epoc System and to remove the limiting labeling regarding the glucose test using neonatal samples. The epoc Blood Analysis System consists of three (3) components: - 1. epoc Test Card The single use blood test card comprises a port for introduction of a blood sample to an array of sensors on a sensor module. The sensor module is mounted proximal to a fluidic channel contained in a credit-card sized housing. The card has an on-board calibrator contained in a sealed reservoir fluidically connected to the senor array through a valve. - 2. epoc Card Reader The reader is a minimally featured raw-signal acquisition peripheral. The reader comprises a card orifice for accepting a test card, and a mechanical actuation assembly for engaging the test card after it is inserted into the card orifice. Within the reader's card orifice there is a bar code scanner, an electrical contact array for contacting the card's sensor module, and a thermal subsystem for heating the card's measurement region to 37℃ during the test. The reader also comprises circuits for amplifying, digitizing and converting the raw sensor signals to a wireless transmittable Bluetooth™ format, - 3. epoc Host The host is a dedicated-use Personal Digital Assistant (PDA) computing device with custom software that displays the test results. The reader and host computer together constitute all of the subsystems generally found in a traditional analyzer that operates on unit-use sensors and reagents ## 5.3.1 epoc Care-Fill Capillary Tube The epoc Care-Fill Capillary Tube has been developed to introduce capillary samples into the epoc Test card. The epoc Care-Fill Capillary Tube is intended for use only with epoc Blood Analysis System and is the only method, other than using a syringe, to introduce samples into the epoc test cards. #### Intended Use of the Device 5.4 The epoc 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 in hospitals, nursing homes or other clinical care institutions. The BGEM test card panel configuration includes sensors for sodium (Na), potassium (K), ionized calcium (iCa), pH, pCO2, pO2, glucose (Gluc) and hematocrit (Hct). Care-Fill Capillary Tubes are intended for use with the epoc Blood Analysis System and are used for the collection and dispensing of capillary blood samples with epoc Test Cards. {2}------------------------------------------------ | 510(k) # Item | epoc Blood Analysis System K061597 and K090109 Device | | I-STAT Model 300 K001387 Predicate | | Same / Different | | |----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------| | Intended 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 whole blood using the BGEM (Blood Gas Electrolyte Metabolyte), BGE (Blood Gas Electrolyte) and ABG (Arterial Blood Gas) test card panels. | | The i-STAT Model 300 Portable Clinical Analyzer is intended to be used by trained medical professionals for use with i-STAT test cartridges and MediSense blood glucose test strips. i-STAT cartridges comprise a variety of clinical chemistry tests and test panels. | | same | | | Where used | hospital | | hospital | | same | | | Measured parameters | pH, pCO2, pO2, Na, K, iCa, Gluc, Hct | | pH, pCO2, pO2, Na, K, iCa, Gluc, Hct | | same | | | Calculated parameters | TCO2, HCO3, BE, SO2, Hgb | | TCO2, HCO3, BE, SO2, Hgb | | same | | | Sample type | Venous, arterial and capillary whole blood | | Venous, arterial and capillary whole blood | | same | | | Reportable ranges | pH pCO2 pO2 Na K iCa Glu Hct | 6.5 - 8.0 5 - 250 5 - 750 85 - 180 1.5 - 12 0.25 - 4 20 - 700 10 - 75 | pH pCO2 pO2 Na K iCa Glu Hct | 6.5 - 8.2 5 - 130 5 - 800 100 - 180 2.0 - 9.0 0.25 - 2.5 20 - 700 10 - 75 | pH units mm Hg mm Hg mmol/L mmol/L mmol/L mg/dL %PCV mmol/L mmol/L mmol/L mmol/L % g/dL | different different same different different different same same | | | TCO2 HCO3 BEecf BEb SO2 Hb | 1 - 85 1 - 85 -30 - +30 -30 - +30 0 - 100 3.3 - 25 | TCO2 HCO3 BEect BEb SO2 Hb | 5 - 50 1 - 85 -30 - +30 -30 - +30 0 - 100 3 - 26 | mmol/L mmol/L mmol/L mmol/L % g/dL | different same same same same same | | Sample volume | Non volumetric over 90 μL | | 100μL | | same | | | Test card | Unit-use card with - on-board calibrator in sealed reservoir - an electrochemical multi-sensor array - port for sample introduction - fluid waste chamber | | Unit-use cartridge with - on-board calibrator in sealed reservoir - an electrochemical multi-sensor array - port for sample introduction - fluid waste chamber | | same | | | Test card storage | Room temperature until expiry date | | Storage at 2-8°C until expiry date including max 2 weeks at room temperature | | different | | | Sensor array | A laminated foil sensor module | | A micro-fabricated chip-set | | different | | | Tests/sensor components | pH - PVC ion selective electrode pCO2 - QH modified Severinghaus type pO2 - membrane coated gold cathode Na - PVC ion selective electrode K - PVC ion selective electrode iCa - PVC ion selective electrode Glu - Enzymatic (glucose oxidase based), amperometric peroxide detection Hct - conductivity, gold electrodes | | pH - PVC ion selective electrode pCO2 - QH modified Severinghaus type pO2 - membrane coated gold cathode Na - PVC ion selective electrode K - PVC ion selective electrode iCa - PVC ion selective electrode Glu - Enzymatic (glucose oxidase based), amperometric peroxide detection Hct - conductivity, gold electrodes | | same same same same same same same same | | | Analyzer components | Two housings; 1 - The reader comprising - Orifice for test card introduction - electrical connector to card | | A single housing comprising - Orifice for test card introduction - electrical connector to card | | different same same | | ### Comparison of Technological Characteristics To Predicate 5.5 vice epoc Capillary Samples 510(k) Submission : {3}------------------------------------------------ | | mechanical card engagement device for making electrical contact to card's sensors for rupture of calibrator reservoir moving calibrator to sensors engaging heaters with card | mechanical card engagement device for making electrical contact to card's sensors for rupture of calibrator reservoir moving calibrator to sensors engaging heaters with card | same | |-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------| | | op-amp sensor signal detectors IQC monitoring devices Thermal controllers MUX A/D Bluetooth stack for wireless transmission of digitized raw | op-amp sensor signal detectors IQC monitoring devices Thermal controllers MUX A/D wire transmission of digitized raw sensor signals to computing subsystem in same housing | same same same same same different | | | sensor signals to computing device | | | | | bar code scanner for acquiring card info | n/a | different | | | internal electronic reader self-test circuit 2 - The computing device comprising a PDA | internal and external electronic self-test circuit | different | | | microprocessor memory color LCD display keyboard i/o for communicating test results to other devices software to control the test and calculate analytical values from raw sensor signals battery operated with rechargeable batteries via plug in plug-in power supply | microprocessor memory monochrome LCD display keyboard i/o for communicating test results to other devices software to control the test and calculate analytical values from raw sensor signals battery operated with rechargeable batteries via external power supply in downloader cradle | same same different same same same same | | Measurement | 37°C | 37°C | same | | temperature | | | | | Measurement sequence | Calibrate test card-introduce sample- measure | Introduce sample-calibrate test cartridge-measure | different | | Measurement time | 35sec from sample introduction | 130-200 sec from sample introduction | different | | Error detection | IQC system to detect user errors IQC system for reader self-check IQC system to detect card non- | IQC system to detect user errors IQC system for reader self-check IQC system to detect card non-conformance | same same same | ### Figure 5.2 – Table Comparing epoc Device Performance Characteristics With Predicate Device In this 510(k) submission we demonstrate that the epoc System is substantially equivalent to the predicate device when using capillary blood. This submission also includes glucose data on neonatal capillary whole blood and therefore offers ground to remove the current labeling limitation on the epoc glucose test. {4}------------------------------------------------ #### Summary of Non-Clinical Test Performance in Support of 5.6 Substantial Equivalence ### Equivalence of the epoc Test Results Between Samples 5.6.1 Delivered from a Syringe Versus Samples Delivered from Care-Fill Capillary Tubes Experiments were performed in house to demonstrate that the collection and delivery method using Care-Fill cap tubes yields test results equivalent with those where a syringe is used as a sample delivery method. This study was also used as the only opportunity to test the capillary delivery over extended ranges of the various analytes, as capillary samples are difficult to modify. The table in Figure 5.3. below shows the results of a method comparison between the two means of sample delivery: X-svringe and Y-Care-Fill capillary tube. | EPOC-CareFill vs EPOC-Syringe | | | | | | | | | |-------------------------------|--------|-------|-------|-------|-------|--------|-------|-------| | | pH | pCO2 | pO2 | Na | K | Ca | Glu | Hct | | N | 42 | 42 | 42 | 42 | 42 | 42 | 42 | 42 | | Sxx | 0.004 | 0.8 | 3.1 | 0.5 | 0.06 | 0.018 | 4.7 | 0.41 | | Syy | 0.005 | 1.4 | 2.5 | 0.7 | 0.10 | 0.019 | 4.0 | 0.60 | | intercept | 0.446 | 3.8 | 0.4 | 2.7 | 0.06 | -0.010 | -2.5 | 1.6 | | slope | 0.940 | 0.885 | 0.996 | 0.981 | 0.981 | 0.991 | 1.037 | 0.946 | | Syx | 0.008 | 1.1 | 2.2 | 1.0 | 0.07 | 0.037 | 4.07 | 0.7 | | X min | 6.721 | 14.0 | 22.7 | 102.5 | 1.2 | 0.389 | 16.0 | 10.5 | | X max | 7.555 | 143.6 | 383.0 | 176.0 | 12.0 | 2.868 | 530.5 | 76.7 | | R2 | 0.997 | 0.996 | 0.999 | 0.994 | 0.999 | 0.994 | 0.998 | 0.997 | | Decision Level 1 | 7.3 | 35 | 30 | 135 | 3 | 0.8 | 45 | 33 | | Bias | 0.005 | -0.3 | 0.3 | 0.1 | 0.01 | -0.018 | -0.8 | -0.18 | | Bias 95% Conf. Hi | 0.007 | 0.0 | 1.0 | 0.3 | 0.03 | -0.007 | 0.2 | 0.04 | | Bias 95% Conf. Lo | 0.003 | -0.5 | -0.4 | -0.2 | -0.01 | -0.029 | -1.8 | -0.39 | | Decision Level 2 | 7.5 | 50 | 80 | 150 | 5.8 | 1.4 | 180 | 55 | | Bias | -0.007 | -2.0 | 0.1 | -0.2 | -0.04 | -0.024 | 4.3 | -1.34 | | Bias 95% Conf. Hi | -0.004 | -1.7 | 0.6 | 0.1 | -0.03 | -0.015 | 5.4 | -1.13 | | Bias 95% Conf. Lo | -0.010 | -2.2 | -0.4 | -0.5 | -0.06 | -0.032 | 3.1 | -1.54 | Figure 5.3 - Table - Summary results of the Care-Fill vs. Syringe method comparison study #### 5.6.2 In-house Method Comparison study using capillary samples This study was performed in-house to establish analytical performance versus the predicate device when using capillary blood samples. The table in Figure 5.4. below shows the results of the study between the two testing methods: X-i-STAT-CG8 using CLINITUBES and Y-epoc-BGEM using Care-Fill. {5}------------------------------------------------ | | Y: EPOC/CareFill vs X:i-STAT/CliniTube | | | | | | | | |------------------|----------------------------------------|------|-------|-------|------|--------|-------|------| | | pH | pCO2 | pO2 | Na | K | Ca | Glu | Hct | | N | 51 | 51 | 52 | 52 | 52 | 52 | 52 | 52 | | Sxx | 0.015 | 1.3 | 6.7 | 0.8 | 0.13 | 0.020 | 2.6 | 0.85 | | Syy | 0.007 | 1.5 | 4.5 | 0.8 | 0.10 | 0.014 | 3.8 | 0.82 | | X min | 7.357 | 30.4 | 56.5 | 135.0 | 3.75 | 1.210 | 81 | 36.0 | | X max | 7.478 | 48.7 | 100.0 | 143.5 | 4.8 | 1.435 | 414 | 51.0 | | average X | 7.425 | 39.1 | 76.5 | 140.5 | 4.1 | 1.273 | 122.2 | 43.6 | | average Y | 7.403 | 39.1 | 82.3 | 139.2 | 4.1 | 1.197 | 122.4 | 40.2 | | average(Yij-Xij) | -0.023 | 0.5 | 6.0 | -1.0 | -0.1 | -0.075 | 0.8 | -2.3 | | | | | Table 5.4 - Table - Average readings and biases for epoc/Care-Fill vs. i- | | |--|----------------|--|---------------------------------------------------------------------------|--| | | STAT/CLINITUBE | | | | ### 5.7 Summary of Clinical Tests Submitted in Support of Substantial Equivalence ### Blood precision when using Care-Fill capillary tubes as 5.7.1 delivery method We performed six (6) precision studies in two (2) POC locations having six (6) different operators testing from three (3) different pools of blood with n=10 replicates per study. A summary of the results is presented in the table below in Figure 5.5. | Sample | Site | Operator | Param | pH | pCO2 | p02 | Na | K | iCa | Glu | Hct | |--------|---------|----------|-------|-------|------|-------|-------|------|-------|-------|------| | 1 | Nursery | RN | n | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | | 1 | Nursery | RN | avg | 7.292 | 55.2 | 75.0 | 132.1 | 3.2 | 0.873 | 52.7 | 22.1 | | 1 | Nursery | RN | SD | 0.009 | 1.2 | 3.1 | 1.2 | 0.05 | 0.013 | 1.7 | 0.6 | | 1 | Nursery | RN | %CV | 0.1% | 2.3% | 4.1% | 0.9% | 1.7% | 1.4% | 3.2% | 2.6% | | 1 | Nursery | POC Tech | n | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | | 1 | Nursery | POC Tech | avg | 7.289 | 54.8 | 72.2 | 131.4 | 3.1 | 0.860 | 52.3 | 21.9 | | 1 | Nursery | POC Tech | SD | 0.006 | 0.9 | 1.2 | 0.5 | 0.04 | 0.009 | 1.5 | 0.3 | | 1 | Nursery | POC Tech | %CV | 0.1% | 1.6% | 1.6% | 0.4% | 1.4% | 1.1% | 2.9% | 1.4% | | 2 | NICU | RN | n | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 9 | | 2 | NICU | RN | avg | 7.388 | 43.0 | 156.8 | 138.6 | 3.2 | 1.124 | 143.3 | 39.1 | | 2 | NICU | RN | SD | 0.012 | 1.0 | 7.1 | 0.7 | 0.07 | 0.028 | 2.8 | 0.8 | | 2 | NICU | RN | %CV | 0.2% | 2.3% | 4.5% | 0.5% | 2.2% | 2.5% | 2.0% | 2.0% | | 2 | NICU | RN | n | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | | 2 | NICU | RN | avg | 7.387 | 43.8 | 157.0 | 139.0 | 3.2 | 1.137 | 144.0 | 39.8 | | 2 | NICU | RN | SD | 0.008 | 0.8 | 9.1 | 0.7 | 0.06 | 0.025 | 5.1 | 1.0 | | 2 | NICU | RN | %CV | 0.1% | 1.8% | 5.8% | 0.5% | 2.0% | 2.2% | 3.5% | 2.6% | | 3 | NICU | RN | n | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | | 3 | NICU | RN | avg | 7.624 | 25.5 | 85.7 | 149.8 | 6.7 | 0.948 | 222.3 | 48.0 | | 3 | NICU | RN | SD | 0.013 | 0.7 | 6.3 | 1.5 | 0.24 | 0.012 | 8.6 | 1.4 | | 3 | NICU | RN | %CV | 0.2% | 2.8% | 7.4% | 1.0% | 3.5% | 1.3% | 3.9% | 2.9% | | 3 | NICU | RT | n | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | | 3 | NICU | RT | avg | 7.621 | 26.0 | 82.5 | 150.2 | 6.8 | 0.948 | 222.4 | 48.0 | | 3 | NICU | RT | SD | 0.009 | 0.5 | 5.4 | 0.6 | 0.12 | 0.008 | 7.1 | 0.7 | | 3 | NICU | RT | %CV | 0.1% | 2.0% | 6.6% | 0.4% | 1.8% | 0.8% | 3.2% | 1.4% | Figure 5.5 - Table - Field Trial: Precision Study Summary {6}------------------------------------------------ ## 5.7.2 Method comparison with predicate device The method comparison studies were performed in a field trial at a hospital on patient samples of whole blood at the point of care in four (4) locations: NICU, Wellbaby Nursery and two (2) different outpatient drawing areas. The testing was performed by five (5) phlebotomists in the outpatient drawing areas, three (3) registered nurses (RN) in the Well-baby Nursery and five (5) registered nurses in the NICU. Patient specimens were 12 adult capillary blood samples and 36 neonatal capillary blood samples. The comparative method was the predicate device. | | Y: EPOC/CareFill vs X:i-STAT/CliniTube | | | | | | | | |------------------|----------------------------------------|------|------|-------|------|--------|------|------| | | pH | pC02 | p02 | Na | K | Ca | Glu | Hct | | N | 47 | 48 | 48 | 48 | 48 | 47 | 48 | 47 | | Sxx | 0.011 | 1.2 | 2.9 | 0.5 | 0.15 | 0.024 | 1.1 | 0.89 | | Syy | 0.008 | 1.4 | 2.9 | 0.9 | 0.15 | 0.020 | 1.8 | 0.75 | | X min | 7.328 | 26.0 | 36.0 | 137.0 | 3.55 | 0.93 | 42.5 | 31.5 | | X max | 7.552 | 49.3 | 91.0 | 149.5 | 7.05 | 1.35 | 147 | 61.0 | | average X | 7.408 | 36.1 | 52.8 | 143.3 | 4.8 | 1.197 | 73.1 | 47.1 | | average Y | 7.387 | 38.2 | 54.1 | 140.8 | 4.6 | 1.151 | 73.6 | 42.7 | | average(Yii-Xii) | -0.02 | 1.5 | 2.3 | -2.5 | -0.2 | -0.041 | 0.53 | -4.5 | Figure 5.6 - Table - Average readings and biases for Epoc/Care-Fill vs. i-STAT/CLINITUBE In this study, the glucose results coming from neonatal blood specimens were analyzed separately. The summary of this analysis is given in the table in Figure 5.7. | Glucose [mg/dL] | Y: EPOC/CareFill vs X:i-STAT/CliniTube | |-------------------|----------------------------------------| | N | 36 | | Sxx | 1.3 | | Syy | 2.1 | | intercept | 4.2 | | slope | 0.948 | | Syx | 2.30 | | X min | 42.5 | | X max | 134 | | R2 | 0.982 | | Decision Level 1 | 45 | | Bias | 1.8 | | Bias 95% Conf. Hi | 2.8 | | Bias 95% Conf. Lo | 0.9 | | Decision Level 2 | 180 | | Bias | -5.2 | | Bias 95% Conf. Hi | -1.3 | | Bias 95% Conf. Lo | -9.2 | Figure 5.7 - Table - Method Comparison Summary for qlucose readings on neonatal capillary whole blood specimens as tested on Y-Epoc/Care-Fill vs. X-i-STAT/CLINITUBE {7}------------------------------------------------ ### Summary of Conclusions Drawn from Non Clinical and 5.8 Clinical Tests We conclude from the data presented in section 5.7 that the device performs effectively. We conclude from the data presented in section 5.8 that the device performs effectively in the hands of the users. We conclude from the data presented in section 5.7 and 5.8 that the clinical performance of the device when using capillary samples is substantially equivalent to the predicate device: i-STAT Model 300 Portable Clinical Analyzer. We conclude from the data presented in section 5.8 that that the clinical performance of the epoc glucose test when using neonatal samples is substantially equivalent to the predicate device: i-STAT Model 300 Portable Clinical Analyzer. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, a symbol often associated with medicine and healthcare. Epocal, Inc. c/o Roy Layer 2060 Walkley Rd., Ottawa, Ontario CANADA K1G-3P5 Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002 HAR 3 0 2010 Re: k092849 Trade/Device Name: epoc Capillary Blood Samples for use with epoc Blood Analysis System Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases (PCO2, PO2) and blood pH test system Regulatory Class: II Product Code: CEM, CHL, JGS, JFP, JPI, CGA, GIO Dated: March 23, 2010 Received: March 24, 2010 Dear: Mr. Layer: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). {9}------------------------------------------------ Page 2 If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, CA Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {10}------------------------------------------------ ## Indications for Use 510(k) Number (if known): k092849 Device Name: epoc™ Capillary Blood Samples for use with epoc Blood Analysis System 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 unanticoagulated arterial, venous or capillary whole blood in the laboratory or at the point/of care in hospitals, nursing homes or other clinical care institutions. Care-Fill Capillary Tubes are intended for use with the epoc Blood Analysis system and are used for the collection and dispensing of capillary blood samples with epoc Test Cards. The Blood Gas Electrolyte (BGE) test card panel configuration includes sensors for Sodium -Na, Potassium - K, Calcium - iCa, pH, pCO2, pO2 and Hematocrit - Hct. The Blood Gas Electrolyte (BGEM) test card panel configuration includes sensors for Sodium - Na, Potassium - K, Calcium - iCa, pH, pCO2, pO2, Hematocrit - Hct and Glucose -Glu. Measurement of sodium is used in diagnosis and treatment of diseases involving electrolyte imbalance. Measurement of potassium is used in diagnosis and treatment of diseases involving electrolyte imbalance. Measurement of Ionized Calcium is used in diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. ### (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD) Signature Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K092849 {11}------------------------------------------------ ## Indications for Use 510(k) Number (if known): k092849 Device Name: epoc TM Capillary Blood Samples for use with epoc Blood Analysis System Indications For Use (continued): Measurement of pH, pCO2, pO2 (blood gases) is used in the diagnosis and treatment of lifethreatening acid-base disturbances. Measurement of Hct distinguishes normal from abnormal states of blood volume, such as anemia and erythrocytosis. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, idiopathic hypoglycemia, and of pancreatic islet cell tumors. Prescription Use X (21 CFR Part 801 Subpart D) And/Or Over the Counter Use (21 CFR Part 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K092849

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