Who is the manufacturer of NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM?

Nova Biomedical Corporation filed the 510(k) submission for NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM (K110648).

What is the FDA product code for NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM?

CHL. It is classified under 21 CFR 862.1120 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM?

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

Who can help prepare an FDA 510(k) submission like NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM?

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.

NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM

K110648 · Nova Biomedical Corporation · CHL · Aug 29, 2011 · Clinical Chemistry

Device Facts

Record ID	K110648
Device Name	NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM
Applicant	Nova Biomedical Corporation
Product Code	CHL · Clinical Chemistry
Decision Date	Aug 29, 2011
Decision	SESE
Submission Type	Special
Regulation	21 CFR 862.1120
Device Class	Class 2
Attributes	Pediatric

Intended Use

The Nova Stat Profile pHOx Ultra Analyzer with CO-Oximeter is intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), total Hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), Deoxyhemoglobin (HHb), and total bilirubin (tBil) in heparinized whole blood; Na+, Cl-, Ca++, Mg++, Glucose (Glu), Lactate (Lac), BUN (Urea), and Creatinine (Creat) in heparinized whole blood, serum, or plasma. Total Bilirubin (tBil) was not evaluated on neonatal samples. The Nova Stat Profile pHOx Ultra Analyzer without CO-Oximeter is intended for in vitro diagnostic use by health care professionals and/or point-of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), Hemoglobin (Hb) in heparinized whole blood; Na+, K+, Cl-, Ca++, Mg++, Glucose (Glu), Lactate (Lac), BUN (Urea), and Creatinine (Creat) in heparinized whole blood, serum, or plasma. The intended use of the Nova STP pHOx Ultra Calibrator Cartridge is for the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), Hemoglobin (Hb) in heparinized whole blood; Na+, K+, Cl-, Ca++, Mg++, Glucose (Glu), Lactate (Lac), BUN (Urea), and Creatinine (Creat) in heparinized whole blood, serum, or plasma. The intended use of the Nova Stat Profile pHOx Ultra Analyzer CO-Oximeter Calibrator Cartridge with Bilirubin and Deproteinizing Solution is for the quantitative determination of total Hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), Deoxyhemoglobin (HHb), and total bilirubin (tBil) in human blood using the Nova Stat Profile pHOx Ultra Analyzer System with CO-Oximeter. Nova Stat Profile pHOx Ultra Analyzer CO-Oximeter Controls and Autocartridge QC are intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Nova Stat Profile pHOx Ultra Analyzer.

Device Story

Microprocessor-based point-of-care analyzer; measures blood pH, gases, electrolytes, metabolites, hematocrit, and CO-oximetry parameters. Inputs: heparinized whole blood, serum, or plasma samples. Technology: electrode-based (pH, pCO2, pO2, ion-selective), optical reflectance (SO2), enzyme/amperometric (glucose, urea, lactate, creatinine), and spectrophotometric (CO-oximetry). Automated sampling, calibration, and quality control via internal cartridges. Output: quantitative analyte concentrations displayed on a 12.1" touch screen; used by clinicians for rapid diagnostic decision-making in critical care. Benefits: rapid, point-of-care testing reduces turnaround time for critical patient management.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by software validation and performance verification testing confirming that hardware/software modifications did not affect system safety, efficacy, or performance.

Technological Characteristics

Analyte-configurable point-of-care analyzer. Materials: aluminum frame/cover, sapphire cuvette. Sensing: potentiometric (pH, Na+, K+, Cl-, Ca++, Mg++), polarographic (pO2), Severinghaus (pCO2), enzymatic (Glu, Lac, Creat, BUN), spectrophotometric (CO-oximetry), impedance (Hct, Hb). Connectivity: SATA hard drive, Windows 7 Embedded OS. Automated calibration/QC via internal cartridges.

Indications for Use

Indicated for healthcare professionals in point-of-care or clinical settings for quantitative analysis of blood gases, electrolytes, metabolites, and CO-oximetry parameters in heparinized whole blood, serum, or plasma. Total bilirubin not evaluated for neonatal samples.

Regulatory Classification

Identification

A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

Predicate Devices

Nova Stat Profile Critical Care Xpress (CCX), Model 1+ Analyzer System (K061830)

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Submission Summary (Full Text)

{0}------------------------------------------------ K110648 AUG 2 9 2011 ## 510(k) Summary | 510(K) Owner: | Nova Biomedical Corporation | |----------------------|---------------------------------------| | Registration Number: | 1219029 | | Address: | 200 Prospect St. Waltham, MA 02454 | | Phone: | 781-894-0800 | | Fax Number: | 784-891-4806 | | Contact Person: | Paul W. MacDonald | | Date Prepared: | 08/24/2011 | Proprietary Name: Nova Stat Profile pHOx Ultra Analyzer System Common or Usual Name: Blood Gas/Electrolyte/Metabolite/CO-Oximetry Analyzer ### Classification Name: Multiple | Classification Names: | Class No. | Reg. No. | Class | |-----------------------------------|-----------|----------|-------| | Blood Gases and Blood pH system | 75CHL | 862.1120 | II | | Sodium Test System | 75JGS | 862.1665 | II | | Potassium Test System | 75CEM | 862.1600 | II | | Calcium Test System | 75JFP | 862.1145 | II | | Chloride Test System | 75CGZ | 862.1170 | II | | Creatinine Test System | 75CGL | 862.1225 | II | | Magnesium Test System | 75CFA | 862.1495 | I | | Glucose Test System | 75CGA | 862.1345 | II | | Lactic Acid Test System | 75KHP | 862.1450 | I | | Urea Nitrogen System | 75CDS | 862.1770 | II | | Oxygen Saturation (SO2%) | 91JKS | 862.3220 | I | | Hematocrit Measuring Device | 81JPI | 864.6400 | II | | Hemoglobin System | 81GKR | 864.5620 | II | | Oxyhemoglobin | 91JKS | 862.3220 | I | | Carboxyhemoglobin | 81GHS | 864.7425 | II | | Methemoglobin | 81JBJ | 864.7360 | II | | Hemoglobin Standards and Controls | 81JPK | 864.8625 | II | | Hemoglobin Calibrator | 81KRZ | 864.8165 | II | | Calibrators | 75JIX | 862.1150 | II | | Quality Control Materials | 81JJS | 862.1660 | I | Product Codes: CHL, JGS, CEM, JFP, CGZ, CGL, CFA, CGA,KHP,CDS, JKS, GHS, JPI, GKR, JKS, JBJ, JPK,KRZ,JIX, JJS Predicate Device: Nova Stat Profile Critical Care Xpress (CCX), Model 1+ Analyzer System (K061830) {1}------------------------------------------------ #### Device Description: As in the Nova Stat Profile Critical Care Xpress (CCX), Model 1+ Analyzer System (K061830) predicate device, the Nova Stat Profile pHOx Ultra Analyzer System combines Blood Gas/pH, Chemistry, bilirubin and CO-Oximetry testing into one Point-of-Care Analyzer. This device is analyte configurable by the end user, based on tests needed. As with the predicate, this device is microprocessor-based and incorporates: - traditional electrode technology to measure blood pH, pCO2, pO2 . - Nova Biomedical proprietary optical reflectance technology for the measurement of oxygen . saturation - ion selective electrode technology to measure blood sodium, chloride, ionized . calcium, ionized magnesium - enzyme/amperometric technology for glucose, urea nitrogen, lactate and creatinine . measurements - conductivity/Na+ correction for hematocrit . - multi-wavelength reflectance/conductivity correction for hemoglobin. . Calibration standards with dissolved gases are provided in sealed pouches eliminating the need for users to calibrate the blood qas electrodes using external compressed gas cylinders. Quality control materials are available as external ampules and as internal auto-cartridge quality control packs. Sampling, calibration and quality control are fully automated. Nova will market the Nova Stat Profile pHOx Ultra Analyzer System in two configurations. The proposed Nova Stat Profile pHOx Ultra Analyzer System with CO-Ox module (Catalog #42013) will be offered with all the parameters listed above. A second configuration will be offered, called the Nova Stat Profile pHOx Ultra Analyzer System without the CO-Ox module (Catalog #42014). This configuration will not have the capability to measure Oxyhemoglobin (O₂Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), and Reduced Hemoglobin (HHb) or bilirubin. #### Summary of the Technological Characteristics: The Nova Stat Profile pHOx Ultra Analyzer System is identical to the previously cleared for market Nova Stat Profile Critical Care Xpress (CCX), Model 1+ Analyzer System in intended use. Modifications were made necessary due to the obsolescence and availability of certain components and hardware, which required minor modifications to the device software to support these changes. The software algorithms used in performing the analysis of samples are unchanged from the predicate device. Minor modifications have been made to simplify the User Interface. The same reagents, calibrators, and controls are used for all of the analytes. The comparison table below compares the Nova Stat Profile pHOx Ultra Analyzer System to the predicate Nova Stat Profile Critical Care Xpress (CCX), Model 1+ Analyzer System. The results of software validation and performance verification testing confirmed that the modifications made to the hardware and software of the Nova Stat Profile pHOx Ultra Analyzer System did not affect the safety, efficacy or performance of the system is substantially equivalent to the predicate device. {2}------------------------------------------------ ## Comparison Table | Characteristic | Predicate Stat Profile Critical Care Xpress with COOX Analyzer System | Proposed Stat Profile pHOx Ultra with COOX Analyzer System | |------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The Stat Profile Critical Care Xpress (STP CCX) Analyzer with CO-Oximeter is intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), total Hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), Deoxyhemoglobin (HHb), and total bilirubin (tBil) in heparinized whole blood; Na+, K+, Cl-, Ca++, Mg++, Glucose (Glu), Lactate (Lac), BUN (Urea), and Creatinine (Creat) in heparinized whole blood, serum, or plasma. Total Bilirubin (tBil) was not evaluated on neonatal The STP CCX Analyzer without CO-Oximeter is intended for in vitro diagnostic use by health care professionals and/or point-of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), Hemoglobin (Hb) in heparinized whole blood; Na+, K+, Cl-, Ca++, Mg++, Glucose (Glu), Lactate (Lac), BUN (Urea), and Creatinine (Creat) in heparinized whole blood, serum, or plasma samples. The intended use of the Nova STP CCX CO- Oximeter Calibrator Cartridge with Bilirubin and Deproteinizing Solution is for the quantitative determination of total Hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), Deoxyhemoglobin (HHb), and total bilirubin (tBil) in human blood using the STP CCX Analyzer with CO-Oximeter. Nova STP CCX CO-Oximeter Controls and Autocartridge QC are intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Nova STP CCX Analyzers. | The Stat Profile pHOx Ultra Analyzer with CO- Oximeter is intended for in vitro diagnostic use by health care professionals and for point-of- care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), total Hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), Deoxyhemoglobin (HHb), and total bilirubin (tBil) in heparinized whole blood; Na+, K+, Cl-, Ca++, Mg++, Glucose (Glu), Lactate (Lac), BUN (Urea), and Creatinine (Creat) in heparinized whole blood, serum, or plasma. Total Bilirubin (tBil) was not evaluated on neonatal samples. The Stat Profile pHOx Ultra Analyzer without CO-Oximeter is intended for in vitro diagnostic use by health care professionals and/or point- of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), Hemoglobin (Hb) in heparinized whole blood; Na+, K+, Cl-, Ca++, Mg++, Glucose (Glu), Lactate (Lac), BUN (Urea), and Creatinine (Creat) in heparinized whole blood, serum, or plasma. The intended use of the Nova STP pHOx Ultra Calibrator Cartridge is for the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), Hemoglobin (Hb) in heparinized whole blood; Na+, K+, Cl-, Ca++, Mg++, Glucose (Glu), Lactate (Lac), BUN (Urea), and Creatinine (Creat) in heparinized whole blood, serum, or plasma. The intended use of the Nova STP pHOx Ultra/CCX CO-Oximeter Calibrator Cartridge with Bilirubin and Deproteinizing Solution is for the quantitative determination of total Hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), Deoxyhemoglobin (HHb), and total bilirubin (tBil) in human blood using STP pHOx Ultra/CCX Analyzers with CO-Oximeter Nova STP pHOx Ultra/CCX ABG and CO- Oximeter Controls and Autocartridge QC are intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Nova STP pHOx Ultra/CCX Analyzers. | | Analyzer | Nova Stat Profile Critical Care Xpress (CCX), Model 1+ Analyzer System with CO-OX - 37413 Nova Stat Profile Critical Care Xpress (CCX), Model 1+ Analyzer System - 35942 | Nova Stat Profile pHOx Ultra Analyzer System with CO-OX - 42013 Nova Stat Profile pHOx Ultra Analyzer System - 42014 | | Consumables | | | | Calibrators | ABG, SO2, CO-Ox | Same | | Controls | ABG Gas, ABG Chem, CO-Ox, External Lin Standards | Same | | Sensors | PH, PCO2, PO2, SO2, Na+, K+, Cl-, Ca++, Mg++, Glu, Lac, Creat, BUN, REF | Same | | Membranes | Glu, Lac, Creat, BUN, PCO2, PO2 | Same | | Characteristic | Predicate Stat Profile Critical Care Xpress with COOX Analyzer System | Proposed Stat Profile pHOx Ultra with COOX Analyzer System | | Pump Tubing | ABG, CO-Ox | Same | | Acceptable Samples | Syringe, Capillary | Same | | Sample Volumes | | | | ABG Only | 150μL | Same | | CO-Ox Only | 100μL | Same | | Combined Analysis | 210µL | Same | | Micro Sample Volumes | | | | Full | 120µL | Same | | ABG | 60µL | Same | | ABG Plus | 70µL | Same…