STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

K132121 · Nova Biomedical Corporation · PZI · Sep 24, 2014 · Clinical Chemistry

Device Facts

• Record ID: K132121
• Device Name: STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
• Applicant: Nova Biomedical Corporation
• Product Code: PZI · Clinical Chemistry
• Decision Date: Sep 24, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens. The StatStrip Glucose Hospital Meter System is also intended for use in the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal heel stick and neonatal arterial whole blood samples throughout all hospital and all professional healthcare settings. The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick. It is not intended for use with neonate cord blood specimens. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia.

Device Story

Point-of-care glucose monitoring system for hospital use; utilizes electrochemical biosensor technology with glucose oxidase enzyme. Input: fresh whole blood (capillary, venous, arterial, neonate arterial, neonate heel stick) applied to test strip via capillary action. Operation: glucose oxidase reaction generates electrons; current magnitude proportional to glucose concentration. Output: quantitative glucose readout on meter display. Used by healthcare professionals in diverse hospital settings (ICU, OR, ER, etc.). Data management: stores 1000 patient tests, 200 QC tests, 4000 operators; bi-directional data transfer via docking station to management systems. Benefits: rapid bedside glucose assessment for dysglycemia management in hospitalized patients. Cleaning: validated for multiple-patient use with specific germicidal wipes.

Clinical Evidence

Clinical study of 1698 patients (ages 1 month–94 years) across 5 hospitals. Compared StatStrip results to Roche COBAS Modular P800 or Beckman Coulter Synchron UniCel DxC 800. Arterial (n=1468) and venous (n=347) samples analyzed. Accuracy: 98.2% of arterial results within ±15% (≥75 mg/dL) and 99.6% of venous results within ±15% (≥75 mg/dL). Study included diverse patient conditions (cardiac, oncology, sepsis, trauma, etc.) and medication regimens. CLIA waiver status extended based on reanalysis of previous data against new Allowable Total Error (ATE) standards.

Technological Characteristics

Electrochemical biosensor; glucose oxidase (Aspergillus sp.) chemistry. Measures current proportional to glucose concentration. Reportable range: 10–600 mg/dL. Sample volume: 1.2 μL. Measuring time: 6 seconds. Connectivity: bi-directional data transfer via docking station. Sterilization: N/A (single-use strips). Materials: validated for 10,950 cleaning cycles with Clorox Germicidal Wipes. Standards: IEC 61010-1, IEC 61010-2-101, EN55011.

Indications for Use

Indicated for quantitative glucose determination in capillary finger stick, venous, arterial, neonate arterial, and neonate heel stick whole blood samples in all hospitalized patients and professional healthcare settings. Contraindicated for neonate cord blood, serum, or plasma. Not for diabetes screening or diagnosis.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Nova StatStrip Glucose Hospital Meter System (k063821)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE

A. 510(k) Number:
k132121

B. Purpose for Submission:
Modified device to expand the indications for use of venous and arterial blood samples for use in all hospitalized patients.

C. Measurand:
Capillary whole blood glucose, venous, arterial, neonate arterial, and neonate heelstick samples.

D. Type of Test:
Quantitative amperometric assay, glucose oxidase

E. Applicant:
Nova Biomedical Corporation

F. Proprietary and Established Names:
StatStrip Glucose Hospital Meter System

G. Regulatory Information:
1. Regulation section:
21 CFR 862.1345, Glucose test system
2. Classification:
Class II
3. Product code:
CGA, Glucose Oxidase, Glucose
4. Panel:
Clinical Chemistry (75)

H. Intended Use:
1. Intended use(s):
See Indications for Use below.
2. Indications(s) for use:

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The StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens.

The StatStrip Glucose Hospital Meter System is also intended for use in the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal heel stick and neonatal arterial whole blood samples throughout all hospital and all professional healthcare settings.

The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick.

It is not intended for use with neonate cord blood specimens.

It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia.

3. Special conditions for use statement(s):

For prescription use only

For in vitro diagnostic use only

Capillary whole blood specimens (e.g. obtained by fingerstick) should not be used in patients receiving intensive medical intervention/therapy because of the potential for pre-analytical collection error and specifically in patients with decreased peripheral blood flow, as it may not reflect the true physiological state. Examples include, but are not limited to, severe hypotension, shock, hyperosmolar-hyperglycemia (with or without ketosis) and severe dehydration.

The system has not been evaluated for use with neonate venous blood.

Temperature and humidity extremes - Test results may be inaccurate when test strips are stored outside of the storage and handling conditions.

Altitudes above 15,000 feet (4500 meters) above sea level have not been evaluated.

Specimens - Only fresh whole blood or whole blood collected in lithium heparin collection devices should be used for arterial and venous specimens.

Fluoride, EDTA, Sodium, and Ammonium blood collection devices should not be used.

Use only whole blood. Do not use serum or plasma.

Should only be used with single-use, auto-disabling lancing devices

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4. Special instrument requirements: StatStrip Blood Glucose Hospital Meter

I. Device Description:

The StatStrip Glucose Hospital Meter System consists of a the StatStrip Glucose Hospital meter, StatStrip Test Strips (sold separately), Nova StatStrip Control Solutions (Levels 1, 2 and 3; sold separately), Nova StatStrip Linearity Test Kit solutions (5 levels; sold separately), docking station, Quick Reference Guide, and User Manual.

Each Nova StatStrip Glucose Test Strip contains glucose oxidase (Aspergillus sp.) >1.0 IU, mediator >20 µg, and other nonreactive substances.

Three levels of control solutions (Level 1, Level 2, Level 3) and five levels of linearity solutions (Level 1, Level 2, Level 3, Level 4, Level 5) are available for use with the StatStrip Glucose Hospital Meter System and were previously cleared in k060345.

J. Substantial Equivalence Information:

1. Predicate device name(s): Nova StatStrip Glucose Hospital Meter System
2. Predicate 510(k) number(s): k063821
3. Comparison with predicate:

| Similarities and Differences | | |
| --- | --- | --- |
| Item | Predicate (k063821) | Candidate Device |
| Brand Name | Nova StatStrip Glucose Hospital Meter System | Nova StatStrip Glucose Hospital Meter System |
| Indications for Use/Intended Use | For the quantitative measurement of glucose in capillary, venous, arterial, and neonate whole blood as an aid in monitoring the effectiveness of glucose control. | For the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens. Also for the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal heel stick, and neonatal arterial whole blood throughout all hospital and all professional healthcare settings. |
| Enzyme | Glucose Oxidase | Same |
| Test Principle | Coulometeric electro- | Same |

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| Similarities and Differences | | |
| --- | --- | --- |
| Item | Predicate (k063821) | Candidate Device |
| | chemical sensor | |
| Sample type | Capillary finger stick, venous and arterial whole blood, and neonatal arterial and heelstick | Capillary finger stick, venous and arterial whole blood, neonatal arterial and heelstick.
Venous, arterial, neonatal arterial, and heelstick in all hospitalized patients |
| Measuring time | 6 sec | Same |
| Sample volume | 1.2 μL | Same |
| Control solutions | 3 liquid levels | Same |
| Linearity solutions | 5 liquid levels | Same |
| Data Storage | 1000 Patient Test
200 QC Tests
4000 Operators | Same |

K. Standard/Guidance Document Referenced (if applicable):
- IEC 61010-1:2001; Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements.
- IEC 61010-2-101:2002; Safety Requirements for electrical equipment for measurement, control and laboratory use. Particular requirements for In Vitro Diagnostic (IVD) Medical Equipment.
- EN55011: Industrial, scientific and medical equipment - Radio frequency disturbance characteristics - Limits and Methods of Measurement

L. Test Principle:
The Nova StatStrip Hospital Meter System is based on electrochemical biosensor technology and the principle of capillary action. The system quantitatively measure blood glucose levels using glucose oxidase enzyme chemistry. The electrons generated during this reaction are transferred from the blood to the electrodes. The magnitude of the resultant current is proportional to the concentration of glucose in the specimen and the signal is converted into a readout displayed on the meter.

M. Performance Characteristics (if/when applicable):
This submission was for the expansion of the indications for use to add the use of venous and arterial blood samples (lithium heparin) in hospitalized patients. The expanded indications for use is supported by a clinical study (see section M below). The meter, test strips, and software were not modified from the predicate.

1. Analytical performance:
a. Precision/Reproducibility:
As established in k060345

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b. Linearity/assay reportable range: As established in k063821.

c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability established in k060345.

Control Solutions: Value Assignment and Stability protocols for the 3 levels of control solutions were evaluated in k060345. The ranges for each control solution are provided on the test strip vial label.

Linearity Solutions: Value Assignment and Stability protocols for the 5 levels of linearity solutions were evaluated in k060345.

Test Strips: Stability protocols for the test strips were evaluated in k060345. The claimed closed-vial stability is 24 months at $33 - 86^{\circ}\mathrm{F}$ and $10 - 90\%$ RH. The claimed open-vial stability is 180 days when stored at the recommended storage temperatures $33 - 86^{\circ}\mathrm{F}$ and $10 - 90\%$ RH or until the expiration date printed on the label, whichever comes first. The labeling instructs the users not to freeze the test strips.

c. Detection limit: The reportable range for the Nova StatStrip Blood Glucose Hospital Meter is 10 to $600\mathrm{mg / dL}$. This range was verified by the linearity established in k063821; section M.1.b.

d. Analytical specificity: Potential interference from some common endogenous and exogenous substances was established in k060345.

Additional interference testing was performed to support the additional intended use claims. To study the effects of commonly used drugs and endogenous substances on the StatStrip Glucose Hospital Meter System, one lot of strips and three levels of blood glucose concentrations (20 - 80 mg/dL, 100 - 200 mg/dL, and 250-400 mg/dL) were used. Blood samples at each glucose concentration were spiked with a toxic concentration of one of each of 80 potential interferents and tested on five Nova StatStrip Glucose Hospital Meters. The results were compared to results from unspiked, control samples and the concentrations at which no significant interference was observed are listed in the table below:

| Potential Interfering Substance | Concentration at which no significant interference is observed (mg/dL) | Potential Interfering Substance | Concentration at which no significant interference is observed (mg/dL) |
| --- | --- | --- | --- |
| Acetaminophen | 20 mg/dL | Lactose | 500 mg/dL |
| Acetoacetate | 51.0 mg/dL | L-dopa | 5 mg/dL |
| Acetone | 69.7 mg/dL | Lansoprizole | 20 mg/dL |

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| Potential Interfering Substance | Concentration at which no significant interference is observed (mg/dL) | Potential Interfering Substance | Concentration at which no significant interference is observed (mg/dL) |
| --- | --- | --- | --- |
| Acyclovir | 0.6 mg/dL | Levofloxacin | 1.8 mg/dL |
| Albuterol | 0.06 mg/dL | Lidocaine | 0.7 mg/dL |
| Amitriptyline | 0.06 mg/dL | Lisinopril | 0.5 mg/dL |
| Amoxicillin | 5 mg/dL | Maltose | 500 mg/dL |
| Ampicillin | 0.8 mg/dL | Mannitol | 6000 mg/dL |
| Atropine | 0.01 mg/dL | Mannose | 500 mg/dL |
| Ascorbic acid | 22.5 mg/dL | Methyl-dopa | 0.9 mg/dL |
| Beta-hydroxybutyrate | 166.6 mg/dL | Metoprolol tartrate salt | 1.8 mg/dL |
| Bilirubin | 297.3 mg/dL | N-acetylcysteine | 81.6 mg/dL |
| Captopril | 0.6 mg/dL | Naproxen | 40 mg/dL |
| Carbamazepine | 1 mg/dL | Nifedipine | 0.02 mg/dL |
| Cefaclor | 35 mg/dL | Nortriptyline hydrochloride | 0.02 mg/dL |
| Cholesterol | 1000 mg/dL | Norepinephrine | 10 mg/dL |
| Cimetidine | 5 mg/dL | Olanzapine | 0.2 mg/dL |
| Citric acid | 384.3 mg/dL | Pancuronium bromide | 0.4 mg/dL |
| Creatinine | 5 mg/dL | Penicillin | 72 mg/dL |
| Digoxin | 0.3 μg/dL | Phenytoin | 2.5 mg/dL |
| Diltiazem hydrochloride | 0.1 mg/dL | Prednisone | 1 mg/dL |
| Dopamine | 20 mg/dL | Propofol | 3.2 mg/dL |
| Enalapril | 0.5 mg/dL | Propranolol hydrochloride | 0.3 mg/dL |
| Ephedrine | 1 mg/dL | Ranitidine hydrochloride | 1 mg/dL |
| Erythromycin | 1.5 mg/dL | Salicylate | 120 mg/dL |
| Ethanol | 399.9 mg/dL | Sodium chloride | 23.8 mg/dL |
| Famotidine | 0.042 mg/dL | Sodium nitroprusside dehydrate | 0.05 mg/dL |
| Fluconazole | 2 mg/dL | Sorbitol | 500 mg/dL |
| Fluoxetine hydrochloride | 2 mg/dL | Sucrose | 500 mg/dL |
| Fructose | 500 mg/dL | Sulfamethoxazole | 1.5 mg/dL |
| Furosemide | 3 mg/dL | Tetracycline | 30 mg/dL |
| Galactose | 500 mg/dL | Theophyline | 2 mg/dL |
| Galactose-1- | 500 mg/dL | Tolazamide | 45 mg/dL |

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| Potential Interfering Substance | Concentration at which no significant interference is observed (mg/dL) | Potential Interfering Substance | Concentration at which no significant interference is observed (mg/dL) |
| --- | --- | --- | --- |
| phosphate | | | |
| Gentamicin sulfate | 12 mg/dL | Tolbutamide | 50 mg/dL |
| Glycerol | 500 mg/dL | Triglyceride | 1500 mg/dL |
| Heparin | 1.2 mg/dL | Uric acid | 23.5 mg/dL |
| Hydrochlorothiazide | 2 mg/dL | Vancomycin hydrochloride hydrate | 3 mg/dL |
| Hydrocortisone | 20 mg/dL | Verapamil hydrochloride | 0.1 mg/dL |
| Ibuprofen | 20 mg/dL | Warfarin | 1.2 mg/dL |
| Ketoprofen | 6 mg/dL | Xylose | 500 mg/dL |

The sponsor also evaluated in vivo interference during the clinical performance evaluation in the new intended use population. See Clinical Studies (section M.3.c) below.

e. Assay cut-off:
Not Applicable.

2. Comparison studies:
a. Method comparison with predicate device:
Performance for capillary finger stick samples was established in k060345.
Performance for neonatal heelsticks and neonatal arterial samples was established in k063821.
b. Matrix comparison:
Not applicable

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):
The performance of the Nova StatStrip Glucose Hospital Meter System in hospitalized patients was established in this submission using venous (lithium

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heparin) and arterial samples (lithium heparin) obtained from 1698 patients at 5 different hospitals.

The study was comprised of patients throughout the hospital which included emergency rooms, operating rooms, oncology departments, intensive care units, medical intensive care units, surgical intensive care units, cardiovascular surgical intensive care units, pediatric intensive care units, transplant departments, cardiac departments, nursing, and surgical departments.

Samples from patients, ages 1 month – 94 years of age, were analyzed using 4 test strip lots at each study site. Results obtained by a point of care user on the StatStrip Glucose Hospital Meter were compared to results obtained on the comparator method (Roche COBAS Modular P800 Chemistry System at sites 1, 2, 4 and 5, and the Beckman Coulter Synchron UniCel DxC 800 at site 3). Glucose results, patient conditions (see Patient Conditions table below for details), physiological status (e.g., pH, pO2, pCO2, sO2, albumin, protein, red blood cell count, hematocrit, hemoglobin, platelets, white blood cell count, mean corpuscular volume (MCV), mean corpuscular hemoglobin concentration (MCHC), major histocompatibility complex (MHC), sodium, potassium, calcium, lactate, chloride, creatinine, blood urea nitrogen (BUN), triglycerides, Multiple Organ Dysfunction (MOD) score), and medication information (see the Medications table below for details) were collected during the study. The glucose ranges, according to the reference method, and the number of samples obtained at each study site are summarized in the table below:

| Site | Specimen type | Glucose Range (mg/dL) | Number of Samples |
| --- | --- | --- | --- |
| 1 | Arterial | 16-571 | 620 |
| | Venous | 22-600 | 132 |
| 2 | Arterial | 16-550 | 307 |
| | Venous | 20-582 | 186 |
| 3 | Arterial | 63-223 | 123 |
| | Venous | 0 | 0 |
| 4 | Arterial | 34-526 | 374 |
| | Venous | 0 | 0 |
| 5 | Arterial | 80-428 | 44 |
| | Venous | 90-362 | 29 |
| Combined Sites | Arterial | 16-571 | 1,468 |
| | Venous | 20-600 | 347 |

The results of the StatStrip Hospital Meter compared with the comparator method can be found in the tables below for each specimen type (arterial and venous) and at each of the study sites:

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# Arterial Specimens:

Analytical and System Accuracy Comparison: Glucose concentrations < 75 mg/dL

| Site | Within ± 5 mg/dL | Within ± 10 mg/dL | Within ± 12 mg/dL | Within ± 15 mg/dL | Exceeds ± 15 mg/dL |
| --- | --- | --- | --- | --- | --- |
| 1 | 64/82 (78.0%) | 75/82 (91.5%) | 78/82 (95.1%) | 79/82 (96.3%) | 3/82 (3.7%) |
| 2 | 79/93 (84.9%) | 89/93 (95.7%) | 91/93 (97.9%) | 92/93 (98.9%) | 1/93 (1.1%) |
| 3 | 1/1 (100%) | 1/1 (100%) | 1/1 (100%) | 1/1 (100%) | 0/1 (0.0%) |
| 4 | 19/25 (76.0%) | 24/25 (96.0%) | 25/25 (100%) | 25/25 (100%) | 0/25 (0.0%) |
| 5 | 0/0 (Not Applicable) | 0/0 (Not Applicable) | 0/0 (Not Applicable) | 0/0 (Not Applicable) | 0/0 (Not Applicable) |
| All sites combined | 163/201 (81.1%) | 189/201 (94.0%) | 195/201 (97.0%) | 197/201 (98.0%) | 4/201 (2.0%) |

Analytical and System Accuracy Comparison: Glucose concentrations ≥75 mg/dL

| Site | Within ± 5 % | Within ± 10 % | Within ± 12.5 % | Within ± 15 % | Within ± 20 % | Exceeds ± 20 % |
| --- | --- | --- | --- | --- | --- | --- |
| 1 | 362/538 (67.3%) | 497/538 (92.4%) | 515/538 (95.7%) | 523/538 (97.2%) | 532/538 (98.9%) | 6/538 (1.1%) |
| 2 | 120/214 (56.1%) | 195/214 (91.1%) | 208/214 (97.2%) | 214/214 (100%) | 214/214 (100%) | 0/214 (0.0%) |
| 3 | 83/122 (68.0%) | 112/122 (91.8%) | 115/122 (94.3%) | 117/122 (95.9%) | 120/122 (98.4%) | 2/122 (1.6%) |
| 4 | 257/349 (73.6%) | 330/349 (94.6%) | 340/349 (97.4%) | 346/349 (99.1%) | 348/349 (99.7%) | 1/349 (0.3%) |
| 5 | 22/44 (50.0%) | 41/44 (93.2%) | 42/44 (95.5%) | 44/44 (100%) | 44/44 (100%) | 0/44 (0.0%) |
| All sites combined | 844/1267 (66.6%) | 1175/1267 (92.7%) | 1220/1267 (96.3%) | 1244/1267 (98.2%) | 1258/1267 (99.3%) | 9/1267 (0.7%) |

# Venous Specimens:

Analytical and System Accuracy Comparison: Glucose concentrations < 75 mg/dL

| Site | Within ± 5 mg/dL | Within ± 10 mg/dL | Within ± 12 mg/dL | Within ± 15 mg/dL | Exceeds ± 15 mg/dL |
| --- | --- | --- | --- | --- | --- |
| 1 | 17/20 (85.0%) | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 0/20 (0.0%) |

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| 2 | 51/59 (86.4%) | 51/59 (96.6%) | 58/59 (98.3%) | 59/59 (100%) | 0/59 (0.0%) |
| --- | --- | --- | --- | --- | --- |
| 5 | 0/0 (Not Applicable) | 0/0 (Not Applicable) | 0/0 (Not Applicable) | 0/0 (Not Applicable) | 0/0 (Not Applicable) |
| All sites combined | 68/79 (86.1%) | 77/79 (97.5%) | 78/79 (98.7%) | 79/79 (100%) | 0/79 (0.0%) |

Analytical and System Accuracy Comparison: Glucose concentrations $\geq 75\mathrm{mg / dL}$

| Site | Within ± 5 % | Within ± 10 % | Within ± 12.5 % | Within ± 15 % | Within ± 20 % | Exceeds ± 20 % |
| --- | --- | --- | --- | --- | --- | --- |
| 1 | 77/112 (68.8%) | 108/112 (96.4%) | 111/112 (99.1%) | 111/112 (99.1%) | 112/112 (100%) | 0/112 (0.0%) |
| 2 | 84/127 (66.1%) | 116/127 (91.3%) | 123/127 (96.9%) | 127/127 (100%) | 127/127 (100%) | 0/127 (0.0%) |
| 5 | 10/29 (34.5%) | 22/29 (75.9%) | 26/29 (89.7%) | 29/29 (100%) | 29/29 (100%) | 0/29 (0.0%) |
| All sites combined | 171/268 (63.8%) | 246/268 (91.8%) | 260/268 (97.0%) | 267/268 (99.6%) | 268/268 (100%) | 0/268 (0.0%) |

The following table includes the patient condition, StatStrip Glucose Hospital Meter result, comparator result and bias (mg/dL an d%) for the 13 arterial results that exceeded +/- 15 mg/dL (<75 mg/dL glucose) or +/- 20% (≥75 mg/dL glucose) of the comparator method:

| Sample type | Patient condition | Comparator Result (mg/dL) | StatStrip Result (mg/dL) | mg/dL bias | % bias |
| --- | --- | --- | --- | --- | --- |
| Arterial | Pneumonia | 72 | 52 | -20 | -27.5 |
| Arterial | COPD Exacerbation | 58 | 83 | 25 | 42.2 |
| Arterial | Sepsis | 50 | 31 | -19 | -39.3 |
| Arterial | Cardio Thoracic | 59 | 96 | 37 | 39.5 |
| Arterial | Cardio Thoracic | 112 | 139 | 27 | 24.2 |
| Arterial | Cardio Thoracic | 83 | 130 | 47 | 56.5 |
| Arterial | Cardio Thoracic | 83 | 130 | 47 | 56.6 |
| Arterial | Pre-Op Coronary Arterial Angiography | 88 | 106 | 18 | 20.4 |
| Arterial | Cardio Thoracic | 132 | 101 | -31 | -23.3 |
| Arterial | Pacemaker Surgical Implant | 141 | 106 | -35 | -24.4 |
| Arterial | Cardio Thoracic | 135 | 94 | -41 | -30.7 |
| Arterial | Post Thoracic Surgery | 90 | 67 | -23 | -26.0 |
| Arterial | 27% Total Body Surface Area burns | 122 | 122 | -41 | -34.0 |

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# Patient Conditions:

The study participants fell in to the following medical condition categories (bolded in left hand column) that included over 250 medical condition subclasses describing the reason for hospitalization. The number of patients that fell into each of the subclasses can be found in the table below:

| Medical Condition Category | Medical Condition Sub-category/ Reason for Hospitalization | # of Patients |
| --- | --- | --- |
| Burn Trauma | Burns | 6 |
| Cardiac | Observation: Thoracic Surgery | 3 |
| | Post thoracic surgery | 141 |
| | Pre-Operative Coronary Arterial Angiography | 7 |
| | Acute coronary syndrome | 1 |
| | Heart failure | 14 |
| | Acute Myocardial Infarction | 46 |
| | Ventricular Rhythm Disorders | 9 |
| | Arterial Vascular Disease | 3 |
| | Artery Disease | 3 |
| | Bradycardia | 2 |
| | Cardiac arrest | 5 |
| | Cardiogenic shock | 2 |
| | Cardiomyopathy | 1 |
| | Chronic heart failure | 1 |
| | Coronary Angiography | 4 |
| | Endocarditis | 6 |
| | Cardiac Gangrene | 1 |
| | Hypertension | 2 |
| | Myocardial Infarction/Ventricular-Fib | 1 |
| | Resuscitation | 21 |
| | Stable Angina | 11 |
| | Transient Ischemic Attack | 1 |
| | Angiography | 1 |
| | Endarterectomy | 5 |
| | Cardio Thoracic (Aortic Bypass Surgery) | 12 |
| | Cardio Thoracic (Aortic Rupture) | 4 |
| | Endarterectomy | 7 |
| | Femoral aneurism rupture | 2 |
| | Fibrosing mediastinitis | 1 |
| | Obstructive arteriopathy | 1 |
| | Pacemaker Surgical Implant | 47 |
| | Percutaneous Transluminal Ablation (PCTA Stent) | 3 |
| | Pericardial Surgery (Pericardial Patch) | 1 |
| | Aortic Aneurism | 12 |
| | Thoracic Surgery (Robotic Assisted) | 1 |

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| Medical Condition Category | Medical Condition Sub-category/ Reason for Hospitalization | # of Patients |
| --- | --- | --- |
| | Ventricular Septal Rupture | 7 |
| | Aortic stenosis | 4 |
| | Aortic valve replacement | 17 |
| | Cardio Thoracic (Arterial Valve Replacement (↑Aorta)) | 11 |
| | Cardio Thoracic (Atrial Fibrillation (Maze + MVP)) | 8 |
| | Cardio Thoracic (aortic valve replacement (AVR) + mitral valve replacement (MVR)) | 7 |
| | Mitral Valve Replacement | 34 |
| | Cardio Thoracic (AVR + Mitral Valve Plasty(MPL)) | 3 |
| | Coronary artery bypass graft (CABG) surgery | 29 |
| | Cardio Thoracic (CABG (1 art) + AVR) | 9 |
| | Cardio Thoracic (CABG (2 art) + AVR) | 16 |
| | Cardio Thoracic (CABG + AVR + Maze) | 4 |
| | Cardio Thoracic (CABG + MPL+ Maze) | 9 |
| | Cardio Thoracic (CABG > = 3 art. grafts (incl ven gr) | 46 |
| | Cardio Thoracic (CABG banned venous grafts) | 7 |
| | Cardio Thoracic (CABG robot Inc. ven 3art. > = graft) | 4 |
| | Cardio Thoracic (CABG robot vene Max. 1 art.) | 2 |
| | Cardio Thoracic (CABG ven gr or max. 1 art. Gra) | 7 |
| | Cardio Thoracic (Re-CABG) | 14 |
| | Coronary artery disease | 6 |
| | Cardio Thoracic (Maze Procedure) | 5 |
| | Total All Cardiac | 670 |
| Endocrinology | Acute Kidney Injury | 2 |
| | Addison's Disease | 6 |
| | Anemia | 3 |
| | Diabetes | 1 |
| | Diabetes mellitus | 3 |
| | Diabetes Mellitus (Uncontrolled) | 10 |
| | Diabetic ketoacidosis | 1 |
| | Hyperkalemia | 1 |
| | Hypocalcemic crisis | 1 |
| | Hypoxemia | 1 |
| | Inaugural diabetes | 1 |
| | Total Endocrinology | 30 |
| Gastroenterological | Acute on chronic liver failure | 2 |
| | Gastrointestinal | 1 |
| | Gastrointestinal | 1 |
| | Gastrointestinal | 1 |
| | Gastrointestinal | 1 |
| | Gastrointestinal | 1 |

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| Medical Condition Category | Medical Condition Sub-category/ Reason for Hospitalization | # of Patients |
| --- | --- | --- |
| | Adhesive bowel obstruction | 2 |
| | Bleeding bulbar ulcer | 4 |
| | Bleeding oesophageal varices | 1 |
| | Constipation | 8 |
| | Diaphragmatic hernia | 1 |
| | Diarrhea | 17 |
| | Digestive obstruction | 1 |
| | Diverticular peritonitis | 1 |
| | Gastric ulcer perforated | 1 |
| | Hepatitis | 1 |
| | Observation: Abdominal Discomfort | 3 |
| | Pancreatitis | 10 |
| | Peritonitis | 7 |
| | Small bowel obstruction | 1 |
| | Umbilical Hernia | 1 |
| | Total Gastroenterological | 61 |
| Miscellaneous | Blood Transfusion | 1 |
| | Hospitalization by Intensivist (Disease Status Not Given) | 4 |
| | Hospitalization for internal medicine (other reasons) | 15 |
| | Hospitalization for internal medicine (other surgical reasons) | 1 |
| | Nausea/vomiting | 2 |
| | Observation: Pediatrics | 1 |
| | Total Miscellaneous | 24 |
| Neuro-Trauma | Acute Brain Injury (Aneurysm) | 6 |
| | Acute Brain Injury (Hematoma-Drilling) | 1 |
| | Brain hemorrhage | 36 |
| | Brain trauma | 3 |
| | Chronic subdural hematoma | 1 |
| | Fractured Vertebrae | 1 |
| | Neuro-trauma | 33 |
| | Seizures | 3 |
| | Stroke | 10 |
| | Subarachnoidal hemorrhage | 1 |
| | Subdural hematoma | 1 |
| | Total Neuro-Trauma | 96 |
| Neurological | Altered consciousness | 1 |
| | Confusion | 1 |
| | Hypercapnic encephalopathy | 2 |
| | Muscular dystrophy (Pompe disease) | 1 |
| | Myopathy ( Pompe disease) | 1 |

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| Medical Condition Category | Medical Condition Sub-category/ Reason for Hospitalization | # of Patients |
| --- | --- | --- |
| | Observation: Neurological | 16 |
| | Observation: Psychiatrics | 1 |
| | Sacral meningocele dural fistula | 1 |
| | Tetraplegia ankylosing spondylitis | 1 |
| | **Total Neurological** | **25** |
| **Obstetrics/ Gynecological** | Cesarean Section | 26 |
| | Dilatation & Curettage | 1 |
| | Gemellary pregnancy | 1 |
| | Gemellary Pregnancy Delivery | 1 |
| | Observation: Primary Cesarean Section | 3 |
| | Obstetric hemorrhage Atonic uterus | 1 |
| | Obstetrics (pre-term labor) | 17 |
| | Ovarian hyperstimulation syndrome | 1 |
| | Postpartum hemorrhage Placental retention | 2 |
| | Pre Eclampsia | 2 |
| | Pregnancy associated vomiting | 4 |
| | Refractory vomiting in pregnancy | 1 |
| | Stall Wife After Parturition | 44 |
| | Fistula Revision | 1 |
| | **Total Obstetrics/Gynecological** | **105** |
| **Oncology** | Acute Lymphocytic Leukemia w/ Tumor Lysis Syndrome | 2 |
| | Acute Myeloid Leukemia | 16 |
| | AIDS Cerebral lymphoma | 1 |
| | Ampullary Adenocarcinoma | 1 |
| | Ampullary tubular Pancreatic Adenoma | 1 |
| | Bile Duct and Gallbladder Adenocarcinoma | 1 |
| | Bladder Cancer | 3 |
| | Brain metastasis | 1 |
| | Brain metastasis from mammary cancer | 1 |
| | Carcinoma of the mouth | 1 |
| | Carcinomatous peritonitis from ovarian sarcoma resection | 1 |
| | Central Nervous System Lymphoma | 1 |
| | Chemotherapy | 22 |
| | Cholangiocarcinoma | 3 |
| | Chronic Lymphocytic Leukemia | 1 |
| | Chronic lymphoid leukemia | 1 |
| | Chronic Myelomonocytic Leukemia (CMML) Type 2 | 1 |
| | Colorectal cancer | 1 |
| | Distal Esophageal Adenocarcinoma | 3 |

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| Medical Condition Category | Medical Condition Sub-category/ Reason for Hospitalization | # of Patients |
| --- | --- | --- |
| | Laryngeal cancer | 2 |
| | Lung Cancer w/pleural | 1 |
| | Lung carcinoma | 4 |
| | Mantle Cell Lymphoma | 2 |
| | Meningioma | 1 |
| | Metastatic Non-Small Cell Lung Cancer (NSCLC) 3 | 3 |
| | Mucinous Adenocarcinoma | 2 |
| | Multiple Myeloma | 3 |
| | Neuroendocrine (pancreas) | 2 |
| | Obstructive laryngeal cancer | 1 |
| | Oesophageal leiomyoma | 1 |
| | Ovarian Cancer | 1 |
| | Pancreatic cancer | 1 |
| | Pancreatic Ductal Adenocarcinoma | 1 |
| | Peritoneal carcinomatosis | 2 |
| | Thyroid Cancer | 1 |
| | Prostate stromal sarcoma | 1 |
| | Pulmonary cancer | 2 |
| | Pulmonary metastasis from colic adenocarcinoma | 1 |
| | Rectal Cancer | 3 |
| | Relapsed T cell prolymphocytic leukemia | 1 |
| | Small cell lung carcinoma | 1 |
| | T Cell Lymphoma | 1 |
| | Brain tumor resection | 1 |
| | Total Oncology | 101 |
| Oncology Surgical | Cerebral metastasis resection | 1 |
| | Colon cancer surgery | 11 |
| | Gastrectomy for gastric cancer | 1 |
| | Glossectomy for cancer | 1 |
| | Lipoma surgical removal | 1 |
| | Neoplastic colonic obstruction | 1 |
| | Pulmonary bilobectomy for lung cancer | 1 |
| | Lung lobectomy | 6 |
| | Pneumonectomy for cancer | 2 |
| | Supra cellar meningioma surgery | 1 |
| | Temporal meningioma removal surgery | 1 |
| | Total Oncology Surgical | 27 |
| Pulmonary | Acute lung edema | 4 |
| | Acute Respiratory Distress Syndrome | 1 |
| | Asthmatic crisis | 2 |
| | Hemoptysis | 1 |

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| Medical Condition Category | Medical Condition Sub-category/ Reason for Hospitalization | # of Patients |
| --- | --- | --- |
| | Chronic Obstructive Pulmonary Disease (COPD) exacerbation | 28 |
| | Dyspnea (respiratory distress) | 32 |
| | Hyperventilation | 1 |
| | Idiopathic pulmonary fibrosis | 3 |
| | Observation: Pulmonologist | 2 |
| | Pneumocystis jiroveci pneumonia | 3 |
| | Pneumonia | 62 |
| | Pneumothorax | 4 |
| | Pseudomonas aeruginosa bilateral pneumonia | 1 |
| | Pulmonary Embolism | 11 |
| | pulmonary hypertension | 2 |
| | Respiratory failure | 4 |
| | **Total Pulmonary** | **161** |
| **Renal** | Acute on chronic renal failure | 2 |
| | Chronic Kidney Disease | 6 |
| | End Stage Renal Disease | 3 |
| | Hematuria | 10 |
| | Renal failure | 1 |
| | Renal Insufficiency | 5 |
| | **Total Renal** | **27** |
| **Sepsis and Infection** | Acquired Immune Deficiency Syndrome (AIDS) | 10 |
| | Cirrhosis | 6 |
| | Erysipelas (Acute Infection) | 7 |
| | Fever of unknown origin | 1 |
| | General Malaise | 3 |
| | Hemorrhagic shock | 2 |
| | Liver cirrhosis | 1 |
| | Meningitis | 3 |
| | Meningoencephalitis | 1 |
| | Osteitis | 1 |
| | Sepsis | 17 |
| | Sepsis (Urological Origin) | 6 |
| | Septicemia | 2 |
| | Severe Malaria (falciparum ) | 1 |
| | Toxic coma | 1 |
| | Tuberculous meningitis | 2 |
| | Tuberculous pneumonia | 1 |
| | Urinary Tract Infection | 5 |
| | Urological Catheter and AWES (Ambulatory Wireless ECG Sensor) | 1 |
| | Urosepsis | 2 |

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| Medical Condition Category | Medical Condition Sub-category/ Reason for Hospitalization | # of Patients |
| --- | --- | --- |
| | Variceal bleeding cirrhosis | 2 |
| | Wound Infection | 4 |
| | **Total Sepsis and Infection** | **90** |
| **Suicide** | Tentative Suicide/Suicide | 7 |
| **Surgical General** | Acoustic schwannoma resection | 1 |
| | Bariatric surgery body mass index (BMI) | 3 |
| | Cervical schwannoma | 2 |
| | Decortication Surgery | 7 |
| | Hip Dislocation | 1 |
| | Hip Replacement | 1 |
| | Morbid obesity | 1 |
| | Nephrectomy transabdominal | 1 |
| | Observation: Surgery | 12 |
| | Percutaneous Endoscopic Gastronomy Catheter Placement | 1 |
| | Abdominal Surgery | 15 |
| | Craniotomy | 7 |
| | Pharyngolaryngectomy | 1 |
| | Lung Surgery | 6 |
| | Pulmonary nodule resection | 1 |
| | Meningeal leak closure | 1 |
| | Pontocerebellar arachnoidal cyst removal | 1 |
| | Subdural hematoma removal surgery | 1 |
| | Surgical removal of a schwannoma of the VIII | 1 |
| | Postoperative gastric by-pass for obesity peritonitis | 2 |
| | Multinodulary thyroid goiter | 1 |
| | Kidney Transplant | 2 |
| | **Total Surgical General** | **71** |
| **Trauma** | Abdominal stab wound | 1 |
| | Carbamazepine overdose | 1 |
| | Coma | 1 |
| | Drug overdose | 1 |
| | Drug overdose coma | 1 |
| | Femoral fracture | 1 |
| | Head trauma | 13 |
| | Leg trauma | 1 |
| | Methadone alcohol overdose | 2 |
| | Multiple trauma | 13 |
| | Observation (Emergency Dept | 1 |
| | Pelvic fracture | 1 |
| | Polytrauma | 5 |

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| Medical Condition Category | Medical Condition Sub-category/ Reason for Hospitalization | # of Patients |
| --- | --- | --- |
| | Thoracic trauma | 1 |
| | Trauma | 18 |
| | Traumatic coma | 1 |
| | Total Trauma | 62 |

# Medications:

During the study, participants received approximately 8000 medications representing over 30 parent drug classes and over 140 drug subclasses (with as many as 68 different drugs administered to each patient). The parent drug classes (bolded) and the subclass distribution in the clinical study can be found in the table below along with the number of patients that received each sub-class of drugs:

| Parent Drug Classes | Drug Sub-Classes | # of Patients |
| --- | --- | --- |
| Alcohol | Alcohol | 1 |
| Anti-Infective | Quinolones | 6 |
| | Anthelminthics | 5 |
| | Antibiotic | 970 |
| | Anti-fungal | 515 |
| | Anti-malarial | 10 |
| | Anti-tuberculosis | 2 |
| | Anti-Viral | 99 |
| | Anti-Viral Protease Inhibitors | 78 |
| Antidote | Antidote | 32 |
| Anti-Neoplastic | Alkylating Agent | 2 |
| | Anti-metabolites | 5 |
| | Monoclonal Antibodies | 8 |
| | VEGF (Vascular endothelial growth factor) Inhibitors | 1 |
| Anti-Psoriatics | Vitamin A Retinoid | 3 |
| Disease Modifying Anti-Rheumatic | Anti-Rheumatic | 1 |
| Anti-Vertigo | Anti-Vertigo | 3 |
| Biologicals | Recombinant Human Eyrhropoietins | 27 |
| Blood Products | Plasma | 11 |
| | Platelets | 6 |
| | Red Blood Cells | 29 |
| Calcimimetic | Calcium Receptor | 11 |
| Cardiovascular Agents | ACE (angiotensin-converting-enzyme) Inhibitor / Diuretic | 1 |
| | ACE Inhibitors | 364 |
| | ACE Inhibitors | 1 |
| | ACE Inhibitors | 1 |

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| | Alpha-adrenergic Blockers | 21 |
| --- | --- | --- |
| | Angiotensin II Inhibitors | 93 |
| | Antiadrenergic | 197 |
| | Antidysrhythmic | 380 |
| | Antihypertensive | 22 |
| | Beta Blocker | 556 |
| | Calcium Channel Blocker | 328 |
| | Diuretic | 741 |
| | Inotropes | 300 |
| | Vasodilator | 376 |
| | Vasopressors | 68 |
| | Vasopressors or Inotropics | 367 |
| Cholinergic Muscle Stimulant Agents | Choline Thick Stimulant | 1 |
| Central Nervous System Agents | 5HT3 Antagonist Antiemetic | 185 |
| | Anaesthetic | 465 |
| | Analgesic – NSAID (non-steroidal anti-inflammatory drug) | 947 |
| | Analgesics - narcotic | 840 |
| | Anticholinergic | 40 |
| | Anticonvulsant | 140 |
| | Antiemetic | 71 |
| | Anti-Parkinson | 10 |
| | Benzodiazepines | 719 |
| | Muscle Relaxer | 138 |
| | Sedative | 7 |
| | Stimulants | 2 |
| Coagulation Modifiers | Anticoagulants | 957 |
| | Anti-platelet | 30 |
| | Thrombolytics | 142 |
| Radiologic Agent | Contrast Agents | 4 |
| Gastrointestinal | Antacid | 91 |
| | Antacid and Electrolyte | 2 |
| | Antidiarrheals | 13 |
| | Antispasmodic | 4 |
| | Digestive enzymes | 11 |
| | Gallstone Solubilizing Agents | 12 |
| | Gastrointestinal Deamination | 400 |
| | Gastrointestinal Stimulant (also used as antiemetic) | 376 |

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| | H-2 Antagonist | 229 |
| --- | --- | --- |
| | Laxative | 611 |
| | Laxative / Antacid | 61 |
| | Protectant | 8 |
| | Proton-pump Inhibitor | 754 |
| Genitourinary | Antispasmodic | 15 |
| | PDE5 (phosphodiesterase type 5 inhibitor) Inhibitor | 10 |
| Hemodialysis | Hemodialysis | 6 |
| Hormonal | Glucocorticoids | 467 |
| | Hormone - Sex | 175 |
| | Hormone | 3 |
| | Hormone - growth | 6 |
| | Hormone - peptide | 99 |
| | Hormone - Pituitary | 1 |
| | Hormone - Polypeptide | 3 |
| | Hormone - Thyroid | 60 |
| | Hormone- Antidiuretic | 71 |
| | Insulin – Injectable and Oral | 705 |
| | Somatostatine Analog | 15 |
| Hyperkalemia Agent | Uncategorized Agent used to treat Hyperkalemia (High Potassium) | 40 |
| Immunologic Agent | Immunoglobulins | 3 |
| | Immunostimulants | 4 |
| | Immunostimulants –Vaccine | 3 |
| | Immunosuppressant | 32 |
| Metabolic/Nutritional | Glucose Elevating / Electrolyte | 58 |
| | Anti-diabetic | 100 |
| | Anti-hyperlipidemic | 16 |
| | Anti-hyperuricemic | 19 |
| | Bisphosphonates | 55 |
| | Glucose Elevating Agent | 177 |
| | Statin | 433 |
| Nutritional Product | Amino Acid | 100 |
| | Electrolyte | 81 |
| | Herbal Supplement | 7 |
| | Iron | 52 |
| | Mineral / Electrolyte | 685 |
| | Multivitamin | 94 |
| | Vitamin | 15 |

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| | Vitamin / Mineral | 351 |
| --- | --- | --- |
| | Vitamin B | 54 |
| | Vitamin B-12 | 20 |
| | Vitamin B-6 | 2 |
| | Vitamin C | 113 |
| | Vitamin D | 38 |
| Phosphate Binder | Phosphate Binder | 41 |
| Plasma Expander | Blood Products | 36 |
| | Gelatin | 1 |
| | Globular Proteins | 104 |
| | Plasma Replacement | 3 |
| | Starch | 46 |
| Psychotherapeutic Agent | Antidelirium | 12 |
| | Antidepressants | 79 |
| | Antipsychotic - Atypical | 68 |
| | Antipsychotic - Non-phenothiazine | 221 |
| | Antipsychotic - Phenothiazines | 5 |
| | Bipolar Agent | 40 |
| Respiratory | Antihistamine | 175 |
| | Bronchodilator | 636 |
| | Decongestant | 22 |
| | Expectorant | 12 |
| | Leukotriene modifier | 1 |
| | PDE4 Inhibitors | 1 |
| Smoking Cessation Agents | Smoking Cessation Agents | 45 |
| Topical Agents | Anti-hemorrhagic | 54 |
| | Antimicrobial Irrigation | 66 |
| | Dental and Oral Agents | 118 |
| | Dermatological Crèam | 10 |
| | Dermatological Powder | 78 |
| | Emollients | 95 |
| | Hydrating Eye Ointment | 179 |
| | Medicated Ointment | 248 |
| | Medicated Ophthalmic Drops | 40 |
| | Medicated Ophthalmic Drops and Steroid | 11 |
| | Nasal Antibiotic | 116 |
| | Nasal Decongestant | 2 |
| | Nasal Steroid | 10 |

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| | Ophthalmic Diagnostic Agent | 1 |
| --- | --- | --- |
| | Ophthalmic Glaucoma Agent | 20 |
| | Ophthalmic Medicated Steroid | 6 |
| | Ophthalmic Preparation | 5 |
| | Topical Photochemotherapeutics | 4 |
| Topical Anti-Infective | Antibiotic Crème | 3 |
| | Dermatological Antibacterial | 90 |

CLIA WAIVER

The Nova StatStrip Glucose Hospital Meter System previously obtained CLIA WAIVER by application on February 28, 2008. The study performed to support CLIA waiver for this device was reanalyzed to evaluate whether the arterial and venous data would meet new and clinically appropriate Limits of Erroneous Results (LER) and Allowable Total Error (ATE) for the sponsor's new intended use population (all hospitalized patients). The analysis demonstrates that the previous CLIA Waived studies in venous and arterial whole blood meet appropriate waiver standards for hospitalized patients. The percentage of arterial and venous data over the entire measurement range that falls within the ATE zone is 98.4% (363/369). None of the results were in the LER zone.

Therefore, the sponsor's CLIA waived status is extended to cover the new intended use claims cleared in this current submission.

4. Clinical cut-off:
Not Applicable

5. Expected values/Reference range:

Normal (non-diabetic) adult fasting: Less than 100 mg/dL (5.55 mmol/L) and less than 140 mg/dL (7.77 mmol/L) 1-2 hours after meals

American Diabetes Association. Diabetes Care (2013), Volume 36, Supplement 1.

N. Instrument Name:
Nova StatStrip Glucose Hospital Meter

O. System Description:

1. Modes of Operation:

Each test strip is single use and must be replaced with a new strip for additional readings.

Does the applicant's device contain the ability to transmit data to a computer, webserver, or mobile device?:
Yes ☐ X or No ☐

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Does the applicant's device transmit data to a computer, webserver, or mobile device using wireless transmission?:
Yes ______ or No ☐

2. Software:
As established in k060345 and k063821. No changes were made to the software in this submission.

3. Specimen Identification:
The Nova StatStrip Glucose Hospital Meter memory will store 1000 patient tests, 200 QC tests, and 4000 operators.

4. Specimen Sampling and Handling:
The glucose test is intended to be used with capillary fingerstick whole blood, arterial, venous, neonatal heel stick and neonatal arterial. The blood sample is applied directly to the test strip by capillary action.

The meter stores patient test data, quality control test data, and other information relating to the patient, patient sample, operator, reagents, and meter. Meter setup options relating to authorized operators, reagent lots, QC preferences, and other operational settings are customizable. Data is transferred bi-directionally between the meter, data docking station, and separate data management system each time a meter is placed in to a data docking station.

5. Calibration:
As established in k060345, the meter does not require the user to input a test strip code.

6. Quality Control:
Three levels of aqueous ready to use glucose control solutions are available with this system (Level 1, Level 2, and Level 3). Control solution testing can be performed by pushing the QC key, entering (or scanning) the test strip lot number. Recommendations on when to test the control materials are provided in the labeling. An acceptable range for each control level is printed on the vial label of the control being used.

P. Other Supportive Instrument Performance Characteristics Data Not Covered In the "Performance Characteristics" Section above:

1) Hematocrit study:
As established in k060345 and k063821 to support the claimed hematocrit range of 20-65%.

2) Altitude study:
As established in k060345 to support the use of the device up to 15,000 ft.

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3) Temperature and humidity studies:
As established in k060345 to support the claimed operating condition range of 59°F - 104°F and 10-90% relative humidity.

4) Infection Control Studies: The device is intended for multiple-patient use. Clorox Germicidal Wipes, EPA registration # 67619-12 was validated demonstrating complete inactivation of live virus for use with the meter. The sponsor also demonstrated that there was no change in performance or in the external materials of the meter after 10,950 cleaning and disinfection cycles (one cycle includes one cleaning wipe plus one disinfecting wipe) to simulate 3 years of device use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.

5) Certificates of Electromagnetic Compatibility (EMC) as established in k060345.

6) Customer Care Service Center is available by calling 800-345-6682.

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

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

24