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

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. 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)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k092849

B. Purpose for Submission:
Add capillary blood samples to epoc Blood Analysis System (k061597 and k090109). Remove limitations in the labeling that state “The EPOC glucose sensor has not been evaluated in neonates”.

C. Measurand:
pH, pCO₂, pO₂, Na, K, iCa, Hct, Glu

D. Type of Test:
Electrode technology

E. Applicant:
Epocal, Inc.

F. Proprietary and Established Names:
epoc Capillary Blood Samples for use with epoc Blood Analysis System

G. Regulatory Information:

1. Regulation section:
21 CFR§-862.1120-Blood gases (PCO₂, PO₂) and blood pH test system
21 CFR§-862.1665-Sodium test system
21 CFR§-862.1600-Potassium test system
21 CFR§-862.1145-Calcium test system
21 CFR§-864.6400-Hematocrit measuring device
21 CFR§-862.1345-Glucose test system
21 CFR§-864.6150 - Capillary blood collection tube
21 CFR§-864.9 (c)(9) – near patient testing

2. Classification:
Class II, Class I - meets limitations of exemptions 21 CFR§-864.9 (c)(9)

3. Product code:
CHL - Electrode Measurement, Blood-Gases (PCO₂, PO₂) And Blood pH
JGS - Electrode, Ion Specific, Sodium
CEM - Electrode, Ion Specific, Potassium
JFP - Electrode, Ion Specific, Calcium
JPI - Device, Hematocrit Measuring
CGA - Glucose Oxidase, Glucose
GIO – Tube, collection, capillary blood

4. Panel:
Chemistry (75) Hematology (81)

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H. Intended Use:

1. Intended use(s):
See indications for use below

2. Indication(s) 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 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.

Measurement of pH, pCO2, pO2 (blood gases) is used in the diagnosis and treatment of life-threatening 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.

3. Special conditions for use statement(s):
For prescription use

4. Special instrument requirements:
epoc Card Reader, epoc Host, epoc BGE and epoc BGEM

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I. Device Description:

The epoc Care-Fill Capillary Tubes are finished components that are packaged and labeled for use and general sale as an accessory to the epoc Blood Analysis System. The Care-Fill Capillary Tube adds a new sample type to the epoc Blood Analysis System, which is reflected in the changes to the epoc System indications for use.

The epoc Blood Analysis System was originally cleared on 510k number k061597 with the Blood Gases (pCO2, pO2) and blood pH test system panel incorporated into the BGE (Blood Gas &amp; Electrolyte) Test Card. A Glucose test was subsequently added to the epoc System on k090109. The addition of Glucose to the epoc System also introduced the BGEM (Blood Gas, Electrolyte and Metabolite) test card, which is currently comprised of all tests on the BGE Test Card plus Glucose.

J. Substantial Equivalence Information:

1. Predicate device name(s): i-STAT Model 300
2. Predicate 510(k) number(s): k001387
3. Comparison with predicate:

| | epoc Blood Analysis System | i-STAT Model 300 | |
| --- | --- | --- | --- |
| Item | Device | Predicate (k001387) | 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 Metabolite), 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, point-of-care settings | same | 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 6.5 - 8.0 pH units | pH 6.5 - 8.2 pH units | different |
| | pCO2 5 - 250 mm Hg | pCO2 5 - 130 mm Hg | different |
| | pO2 5 - 750 mm Hg | pO2 5 - 800 mm Hg | different |
| | Na 85 - 180 mmol/L | Na 100 - 180 mmol/L | different |
| | K 1.5 - 12 mmol/L | K 2.0 - 9.0 mmol/L | different |
| | iCa 0.25 - 4 mmol/L | iCa 0.25 - 2.5 mmol/L | different |
| | Glu 20 - 700 mg/dL | Glu 20 - 700 mg/dL | same |
| | Hct 10 - 75 %PCV | Hct 10 - 75 %PCV | same |
| | TCO2 1 - 85 mmol/L | TCO2 5 - 50 mmol/L | different |
| | HCO3 1 - 85 mmol/L | HCO3 1 - 85 mmol/L | same |
| | BEref -30 - +30 mmol/L | BEref -30 - +30 mmol/L | same |

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| | BEh -30 - +30 mmol/L sO2 0 - 100 % Hb 3.3 - 25 g/dL | BEh -30 - +30 mmol/L sO2 0 - 100 % Hb 3 - 26 g/dL | same same different |
| --- | --- | --- | --- |
| Sample volume | Non volumetric over 90 μL | 100μL | different |
| 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 |
| Analyzer components | Two housings; 1 - The reader comprising - Orifice for test card introduction - electrical connector to card - heater for 37°C operation - 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 - op-amp sensor signal detectors - iQC monitoring devices - Thermal controllers - MUX - A/D - Bluetooth stack for wireless transmission of digitized raw | A single housing comprising - Orifice for test card introduction - electrical connector to card - heater for 37°C operation - 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 - op-amp sensor signal detectors - iQC monitoring devices - Thermal controllers - MUX - A/D - wire transmission of digitized raw | different same same same same same same same same same same same same same 4 of 9 |

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| | sensor signals to computing device | sensor signals to computing subsystem in same housing | different |
| --- | --- | --- | --- |
| | - bar code scanner for acquiring card info | - n/a | different |
| | - internal electronic reader self-test circuit | - internal and external electronic self-test circuit | different |
| | 2 - The computing device comprising a PDA | | |
| | - microprocessor | - microprocessor | same |
| | - memory | - memory | same |
| | - color LCD display | - monochrome LCD display | different |
| | - keyboard | - keyboard | same |
| | - i/o for communicating test results to other devices | - i/o for communicating test results to other devices | same |
| | - software to control the test and calculate analytical values from raw sensor signals | - software to control the test and calculate analytical values from raw sensor signals | same |
| | - battery operated with rechargeable batteries via plug in plug-in power supply | - battery operated with rechargeable batteries via external power supply in downloader cradle | same |
| Measurement temperature | 37°C | 37°C | same |
| 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-conformance | iQC system to detect user errors iQC system for reader self-check iQC system to detect card non-conformance | same same same |

The epoc System has the same intended use and utilizes the same test methodologies as the predicate device. Most of the system components are very similar to the predicate device. Differences between the epoc device and the predicate device have no significant effect on the safety or effectiveness of the system.

K. Standard/Guidance Document Referenced (if applicable):

| FDA Recognition No. | Standard | Title |
| --- | --- | --- |
| 5-4 | IEC 60601-1 | Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995. (General) |
| 5-28 | IEC 60601-1-2:2001 | Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral |

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| | | Standard: Electromagnetic Compatibility - Requirements and Tests |
| --- | --- | --- |
| 5-40 | ISO 14971 (2007) | Medical devices - Application of risk management to medical devices |
| 7-92 | CLSI EP09-A2 (2002) | Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline – Second Edition |

# L. Test Principle:

The Care-Fill Capillary Tube's first function is as a sample collection device. It is used to collect a blood sample from a skin puncture. The tube fills with a blood sample through a combination of capillary action and gravity flow. The tube fills readily when presented with sufficient blood and preserves the integrity of the blood sample until it can be tested, i.e. prevents clotting and post-collection alteration of analyte concentrations. To achieve its first function, the Care-Fill tube comprises a Mylar-wrapped glass tube coated internally with heparin.

A Care-Fill tube's second function is as a sample delivery device for the epoc test card. It mates with epoc test cards in a manner similar to a syringe and requires manual pressure to be applied to a plunger to inject blood into the test card. Just like a syringe, pressure is applied in order to push the calibration fluid, which is present within the card's sample channel over the working sensors, into the waste chamber of the card leaving the blood sample over the working sensors to be analyzed. To achieve its second function, Care-Fill tube also comprises a plastic adapter and a plastic air plunger and rubber seal.

# M. Performance Characteristics (if/when applicable):

# 1. Analytical performance:

# a. Precision/Reproducibility:

The applicant performed six (6) precision studies in two (2) POC locations having six (6) different operators testing from three (3) different pools of blood, using Care-Fill capillary tubes, with $n = 10$ replicates per study. A summary of the results is presented in the table below.

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| Sample | Site | Operator | Param | pH | pCO2 | pO2 | 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% |

b. Linearity/assay reportable range:

Refer to k090109, k061597

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Refer to k090109, k061597

d. Detection limit:

Refer to k090109, k061597

e. Analytical specificity:

Refer to k090109, k061597

f. Assay cut-off:

Not applicable

2. Comparison studies:

a. 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, Well-baby Nursery and two (2) different outpatients 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)

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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. Results of the study were summarized below:

Table 1: Bias results for Epoc/Care-Fill vs. i-STAT/Clinitube

| | pH | pCO2 | pO2 | 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 | 36 | 137 | 3.55 | 0.93 | 42.5 | 31.5 |
| X max | 7.552 | 49.3 | 91 | 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 (Yij-Xij) | -0.02 | 1.5 | 2.3 | -2.5 | -0.2 | -0.041 | 0.53 | -4.5 |
| Decision level 1 | 7.3 | 35 | 30 | 135 | 3.0 | 0.8 | 45 | 33 |
| Bias | 0.024 | 1.53 | 3.3 | -1.1 | 0.21 | 0.003 | 2.2 | -1.8 |
| Bias 95% CI | 0.011 to 0.036 | 1.11 to 1.95 | 0.5 to 6.2 | -2.1 to 0.0 | 0.05 to 0.37 | -0.025 to 0.031 | 1.3 to 3.2 | -2.7 to -1.0 |
| Decision level 2 | 7.5 | 50 | 80 | 150 | 5.8 | 1.4 | 180 | 54.5 |
| Bias | -0.055 | 0.31 | 0.0 | -3.6 | -0.45 | -0.061 | -6.5 | -5.8 |
| Bias 95% CI | -0.045 to -0.065 | -0.92 to 1.55 | -3.0 to 2.9 | -4.5 to -2.7 | -0.55 to -0.35 | -0.077 to -0.046 | -9.2 to -3.8 | -6.4 to -5.2 |

Additional studies 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 below shows the results of a method comparison between the two means of sample delivery: X-syringe and Y-Care-Fill capillary tube.

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| | 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 |
| Sy x | 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 |

b. Matrix comparison:
Refer to k090109, k061597

3. Clinical studies:
a. Clinical Sensitivity: Not applicable
b. Clinical specificity: Not applicable
c. Other clinical supportive data (when a. and b. are not applicable): Not applicable

4. Clinical cut-off: Not applicable

5. Expected values/Reference range: Refer to k090109, k061597

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.