i-STAT CG4+ Cartridge with the i-STAT 1 System

K200492 · Abbott Point of Care, Inc. · CHL · Apr 9, 2020 · Clinical Chemistry

Device Facts

• Record ID: K200492
• Device Name: i-STAT CG4+ Cartridge with the i-STAT 1 System
• Applicant: Abbott Point of Care, Inc.
• Product Code: CHL · Clinical Chemistry
• Decision Date: Apr 9, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1120
• Device Class: Class 2

Intended Use

The i-STAT CG4+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of pH, PO2, PCO2, and lactate in arterial or venous whole blood in point of care or clinical laboratory settings. pH, PO2, and PCO2 measurements are used in the diagnosis, monitoring, and treatment of respiratory disturbances and metabolic and respiratory-based acid-base disturbances. Lactate measurements are used in (1) the diagnosis and treatment of lactic acidosis in conjunction with measurements of blood acid/base status, (2) monitoring tissue hypoxia and strenuous physical exertion, and (3) diagnosis of hyperlactatemia.

Device Story

i-STAT CG4+ cartridge is a single-use, disposable, in vitro diagnostic test used with the i-STAT 1 handheld analyzer. The system processes 2-3 drops of lithium heparinized arterial or venous whole blood. The cartridge contains potentiometric and amperometric sensors to measure pH, PO2, PCO2, and lactate. The analyzer moves the sample across sensors, performs on-board calibration, and calculates results. It also provides calculated parameters (HCO3, TCO2, BE, sO2) using standard equations. The device is used by trained medical professionals in point-of-care or clinical laboratory settings. Results are displayed on the analyzer screen to assist clinicians in diagnosing and monitoring acid-base status, respiratory disturbances, and tissue hypoxia. The system provides rapid, quantitative results, enabling timely clinical decision-making at the patient's side.

Clinical Evidence

Bench testing only. Precision evaluated over 20 days using aqueous materials (CLSI EP05-A3) and whole blood specimens. Linearity confirmed across reportable ranges (CLSI EP06-A). LoQ, LoB, and LoD determined per CLSI EP17-A2. Interference testing performed per CLSI EP07/EP37. Method comparison study (CLSI EP09c-ED3) against predicate devices (ABL800 FLEX and epoc) showed high correlation (r=0.97-1.00) across 246-327 samples.

Technological Characteristics

Single-use disposable cartridge containing potentiometric and amperometric sensors. Analyte measurement via ion-selective electrodes (pH, PCO2) and Clark-type/enzyme-based amperometric sensors (PO2, lactate). Handheld analyzer interface. On-board calibration with each use. Lithium heparinized whole blood sample. Software performs temperature correction and standard acid-base calculations.

Indications for Use

Indicated for patients requiring in vitro quantification of pH, PO2, PCO2, and lactate in arterial or venous whole blood. Used for diagnosis/monitoring of respiratory/metabolic acid-base disturbances, lactic acidosis, tissue hypoxia, and hyperlactatemia. For prescription use only in point-of-care or clinical laboratory settings.

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

• epoc Lactate test, epoc Blood Analysis System (K093297)
• ABL800 FLEX blood gas, oximetry, electrolyte and metabolite analyzer (K041874)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 9, 2020

Abbott Point of Care Inc. Susan Tibedo Director, Regulatory Affairs 400 College Road East Princeton, NJ 08540

Re: K200492

Trade/Device Name: i-STAT CG4+ Cartridge with the i-STAT 1 System Regulation Number: 21 CFR 862.1120 Regulation Name: Blood Gases (PCO2, PO2) and Blood pH Test System Regulatory Class: Class II Product Code: CHL, KHP Dated: February 27, 2020 Received: February 28, 2020

Dear Susan Tibedo:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Marianela Perez-Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K200492

#### Device Name

i-STAT CG4+ cartridge with the i-STAT 1 System

#### Indications for Use (Describe)

The i-STAT CG4+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of pH, PO2, PCO2, and lactate in arterial or venous whole blood in point of care or clinical laboratory settings.

pH, PO2, and PCO2 measurements are used in the diagnosis, monitoring, and treatment of respiratory disturbances and metabolic and respiratory-based acid-base disturbances.

Lactate measurements are used in (1) the diagnosis and treatment of lactic acidosis in conjunction with measurements of blood acid/base status, (2) monitoring tissue hypoxia and strenuous physical exertion, and (3) diagnosis of hyperlactatemia.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

× Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

The information in this 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

| 1. | Submitter Information | |
|----|-----------------------|---------------------------------------------------------------------------------------------------------------|
| | Owner | Abbott Point of Care Inc.<br>400 College Road East<br>Princeton, NJ 08540 |
| | Contact | Primary: Susan Tibedo<br>Director Regulatory Affairs<br>[e-mail]<br>Phone: [phone] |
| | | Secondary: Maria Figueroa<br>Manager Regulatory Affairs<br>[e-mail]<br>Phone: [phone] |
| | Date Prepared | April 7, 2020 |

#### 2. Device Information

| Proprietary Name | i-STAT CG4+ cartridge with the i-STAT 1 System |
|------------------|------------------------------------------------|
| Common Name | Blood gas test, analyzer, handheld |
| 510(k) Number | K200492 |

| Product<br>code | Device Classification<br>name | Regulation<br>Number | Class | Panel |
|-----------------|----------------------------------|----------------------|-------|--------------------|
| CHL | Electrode, Ion Specific, pH | 862.1120 | II | Clinical Chemistry |
| CHL | Electrode, Ion Specific, pCO2 | 862.1120 | II | Clinical Chemistry |
| CHL | Electrode, Ion Specific pO2 | 862.1120 | II | Clinical Chemistry |
| KHP | Electrode, Ion Specific, Lactate | 862.1450 | I | Clinical Chemistry |

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## 3. Predicate Device

Proprietary Name epoc Lactate test, epoc Blood Analysis System

510(k) Number K093297

| Product<br>code | Device Classification<br>name | Regulation<br>Number | Class | Panel |
|-----------------|-------------------------------------|----------------------|-------|--------------------|
| KHP | Electrode, Ion Specific,<br>Lactate | 862.1450 | I | Clinical Chemistry |

Proprietary Name ABL800 FLEX blood gas, oximetry, electrolyte and metabolite analyzer

#### 510(k) Number K041874

| Product<br>code | Device Classification<br>name | Regulation<br>Number | Class | Panel |
|-----------------|----------------------------------|----------------------|-------|--------------------|
| CHL | Electrode, Ion Specific, pH | 862.1120 | II | Clinical Chemistry |
| CHL | Electrode, Ion Specific,<br>PCO2 | 862.1120 | II | Clinical Chemistry |
| CHL | Electrode, Ion Specific<br>PO2 | 862.1120 | II | Clinical Chemistry |

## 4. Device Description

The i-STAT CG4+ test cartridge contains test reagents to analyze whole blood at the point of care or in the clinical laboratory for pH. PO2 (partial pressure of oxygen), PCO2 (partial pressure of carbon dioxide), and lactate. The test is contained in a single-use, disposable cartridge. Cartridges require two to three drops of whole blood which are typically applied to the cartridge using a transfer device.

The i-STAT 1 Analyzer is a handheld, in vitro diagnostic analytical device designed to run only i-STAT test cartridges. The instrument interacts with the cartridge to move fluid across the sensors and generate a quantitative result (within approximately 2 minutes).

The i-STAT 1 System is comprised of the i-STAT 1 analyzer, the i-STAT test cartridges and accessories (i-STAT 1 Downloader/Recharger, electronic simulator and portable printer). The system is designed for use by trained medical professionals at the patient point of care or in the clinical laboratory and is for prescription use only.

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## 5. Intended Use Statement

The i-STAT CG4+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of pH, PO2, PCO2, and lactate in arterial or venous whole blood in point of care or clinical laboratory settings.

pH, PO2, and PCO2 measurements are used in the diagnosis, monitoring, and treatment of respiratory disturbances and metabolic and respiratory-based acid-base disturbances.

Lactate measurements are used in (1) the diagnosis and treatment of lactic acidosis in conjunction with measurements of blood acid/base status, (2) monitoring tissue hypoxia and strenuous physical exertion, and (3) diagnosis of hyperlactatemia.

| Similarities and Differences: System (Test and Instrument) for pH | | |
|-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature or<br>Characteristic | Predicate:<br>ABL800 FLEX pH Test<br>(K041874) | Candidate: pH test in the<br>i-STAT CG4+ cartridge with<br>the i-STAT 1 System |
| Intended Use | The ABL800 FLEX is intended for <i>in vitro</i><br>testing of samples of whole blood for the<br>parameters pH, pO2, pCO2, potassium,<br>sodium, calcium, chloride, glucose, lactate,<br>total bilirubin, and co-oximetry parameters<br>(total hemoglobin, oxygen saturation, and the<br>hemoglobin fractions FO2Hb, FCOHb,<br>FMetHb, FHHb, and FHbF). In addition the<br>ABL800 FLEX is intended for <i>in vitro</i> testing of<br>samples of expired air for the parameters pO2<br>and pCO2. The ABL800 FLEX includes an<br>AutoCheck Module to perform automated<br>analysis of quality control fluids.<br><br>pH is the indispensable measure of acidemia<br>or alkalemia and is therefore an essential part<br>of the pH/blood gas measurement. The<br>normal function of many metabolic<br>processes requires a pH to be within a<br>relatively narrow range. | The i-STAT CG4+ cartridge with<br>the i-STAT 1 System is intended<br>for use in the <i>in vitro</i> quantification<br>of pH in arterial or venous whole<br>blood in point of care or clinical<br>laboratory settings.<br><br>pH measurements are used in the<br>diagnosis, monitoring, and<br>treatment of respiratory<br>disturbances and metabolic and<br>respiratory-based acid-base<br>disturbances. |
| Reportable<br>Range | Test Range:1 7.0 – 7.7<br><br>Measuring Range:2 6.300 - 8.000 | Reportable Range: 7.000 - 7.700 |
| Sample Type | Arterial, venous or capillary whole blood | Arterial or venous whole blood |
| Sample Volume | At least 50 – 70 μL | 95 μL |

## 6. Summary Comparison of Technological Characteristics

¹ The measuring range for a parameter is the range within which the analyzer is physically capable of measuring. The measuring range corresponds to the "range of indication" as defined in the International vocabulary of basic and general terms in metrology" (VIM).

^? The test range for a parameter is the range within which accuracy and precision of a measured parameter has been specified and intended to lie within specified limits. The test range corresponds to the "measuring range" as defined in the "International vocabulary of basic and general terms in metrology" (VIM).

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| Similarities and Differences: System (Test and Instrument) for pH | | |
|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature or<br>Characteristic | Predicate:<br>ABL800 FLEX pH Test<br>(K041874) | Candidate: pH test in the<br>i-STAT CG4+ cartridge with<br>the i-STAT 1 System |
| Sample<br>Preparation | Ready to Use | Ready to Use |
| Traceability | BMS™ Mk2 | NIST SRM 186-I, 186-II, 185, and<br>187 |
| Calibration | 1-point intervals 30 min, 1 hour, 2 hours | 1-point on-board contained within<br>the cartridge |
| Time to Test<br>(Sample<br>Stability) | Analyze heparinized samples within 30<br>minutes after collection | Heparinized samples: within 10<br>minutes of collection |
| Principle of<br>Measurement | Ion selective electrode | Ion selective electrode |
| Reagent Format | Reagent handling system, stored within<br>analyzer | Cartridge |
| Analyzer Type | Floor Model | Handheld |
| Similarities and Differences: System (Test and Instrument) for PO2 | | |
| Feature or<br>Characteristic | Predicate:<br>ABL800 FLEX pO2 Test<br>(K041874) | Candidate: PO2 test in the<br>i-STAT CG4+ cartridge with<br>the i-STAT 1 System |
| Intended Use | The ABL800 FLEX is intended for in vitro<br>testing of samples of whole blood for the<br>parameters pH, pO2, pCO2, potassium,<br>sodium, calcium, chloride, glucose, lactate,<br>total bilirubin, and co-oximetry parameters<br>(total hemoglobin, oxygen saturation, and the<br>hemoglobin fractions FO2Hb, FCOHb,<br>FMetHb, FHHb, and FHbF). In addition the<br>ABL800 FLEX is intended for in vitro testing<br>of samples of expired air for the parameters<br>pO2 and pCO2. The ABL800 FLEX includes<br>an AutoCheck Module to perform automated<br>analysis of quality control fluids.<br>The arterial oxygen tension is an indicator of<br>the oxygen uptake in the lungs. | The i-STAT CG4+ cartridge with<br>the i-STAT 1 System is intended<br>for use in the <i>in vitro</i> quantification<br>of PO2 in arterial or venous whole<br>blood in point of care or clinical<br>laboratory settings.<br>PO2 measurements are used in the<br>diagnosis, monitoring, and<br>treatment of respiratory<br>disturbances and metabolic and<br>respiratory-based acid-base<br>disturbances. |
| Reportable<br>Range | Test Range:1<br>15 - 530 mmHg<br>Measuring Range:2<br>0.0 - 800 mmHg<br>0.00 – 107 kPa | Reportable Range:<br>15 – 530 mmHg<br>2.00 - 70.49 kPa |
| Sample Type | Arterial, venous or capillary whole blood | Arterial or venous whole blood |
| Sample Volume | At least 50 - 70 μL | 95 μL |
| Sample<br>Preparation | Ready to Use | Ready to Use |
| Traceability | NIST certified Standard Reference Materials | NIST standard reference materials<br>via commercially available certified<br>specialty medical gas standards |
| Calibration | 1-point intervals 30 min, 1 hour, 2 hours | 1-point on-board contained within<br>the cartridge |
| Time to Test<br>(Sample Stability) | Analyze heparinized samples within 30<br>minutes after collection | Heparinized samples: within 10<br>minutes of collection |
| Principle of<br>Measurement | Amperometric measurement of oxygen<br>reduction current | Amperometric measurement of<br>oxygen reduction current |
| Reagent Format | Reagent handling system, stored within<br>analyzer | Cartridge |
| Analyzer Type | Floor Model | Handheld |
| Similarities and Differences: System (Test and Instrument) for PCO2 | | |
| Feature or<br>Characteristic | Predicate:<br>ABL800 FLEX pCO2 Test<br>(K041874) | Candidate: PCO2 test in the<br>i-STAT CG4+ cartridge with<br>the i-STAT 1 System |
| Intended Use | The ABL800 FLEX is intended for <i>in vitro</i><br>testing of samples of whole blood for the<br>parameters pH, pO2, pCO2, potassium,<br>sodium, calcium, chloride, glucose, lactate,<br>total bilirubin, and co-oximetry parameters<br>(total hemoglobin, oxygen saturation, and the<br>hemoglobin fractions FO2Hb, FCOHb,<br>FMetHb, FHHb, and FHbF). In addition the<br>ABL800 FLEX is intended for <i>in vitro</i> testing<br>of samples of expired air for the parameters<br>pO2 and pCO2. The ABL800 FLEX includes<br>an AutoCheck Module to perform automated<br>analysis of quality control fluids.<br><br>pCO2 is a direct reflection of the adequacy of<br>alveolar ventilation in relation to the<br>metabolic rate. | The i-STAT CG4+ cartridge with<br>the i-STAT 1 System is intended<br>for use in the <i>in vitro</i> quantification<br>of PCO2 in arterial or venous whole<br>blood in point of care or clinical<br>laboratory settings.<br><br>PCO2 measurements are used in<br>the diagnosis, monitoring, and<br>treatment of respiratory<br>disturbances and metabolic and<br>respiratory-based acid-base<br>disturbances. |
| Reportable<br>Range | Test Range:1<br>15 – 150 mmHg<br><br>Measuring Range:2<br>5.0 – 250 mmHg<br>0.67 – 33.3 kPa | Reportable Range:<br>15.0 – 130.0 mmHg<br>2.00 –17.29 kPa |
| Sample Type | Arterial, venous or capillary whole blood | Arterial or venous whole blood |
| Sample Volume | At least 50 – 70 μL | 95 μL |
| Sample<br>Preparation | Ready to Use | Ready to Use |
| Traceability | NIST certified Standard Reference Materials | NIST standard reference materials<br>via commercially available certified<br>specialty medical gas standards |
| Calibration | 1-point intervals 30 min, 1 hour, 2 hours | 1-point on-board contained within<br>the cartridge |
| Time to Test<br>(Sample Stability) | Analyze heparinized samples within 30<br>minutes after collection | Heparinized samples: within 10<br>minutes of collection |
| Principle of<br>Measurement | Ion selective electrode | Ion selective electrode |
| Reagent Format | Reagent handling system, stored within<br>analyzer | Cartridge |
| Analyzer Type | Floor Model | Handheld |
| Similarities and Differences: System (Test and Instrument) for Lactate | | |
| Feature or<br>Characteristic | Predicate:<br>epoc Lactate Test with epoc Blood<br>Analysis System<br>(K093297) | Candidate: Lactate test in the<br>i-STAT CG4+ cartridge with<br>the i-STAT 1 System |
| Intended Use | The Lactate test, as part of the epoc Blood<br>Analysis System, is intended for use by<br>trained medical professionals as an <i>in vitro</i><br>diagnostic device for the quantitative testing<br>of samples of heparinized or un-<br>anticoagulated arterial, venous or capillary<br>whole blood in the laboratory or at the point<br>of care in hospitals, nursing homes or other<br>clinical institutions.<br><br>Lactate measurements from the epoc Blood<br>Analysis System are used to evaluate the<br>acid-base status and are used in the<br>diagnosis and treatment of lactic acidosis<br>(abnormally high acidity of the blood.) | The i-STAT CG4+ cartridge with<br>the i-STAT 1 System is intended<br>for use in the <i>in vitro</i> quantification<br>of lactate in arterial or venous<br>whole blood in point of care or<br>clinical laboratory settings.<br><br>Lactate measurements are used in<br>(1) the diagnosis and treatment of<br>lactic acidosis in conjunction with<br>measurements of blood acid/base<br>status, (2) monitoring tissue<br>hypoxia and strenuous physical<br>exertion, and (3) diagnosis of<br>hyperlactatemia. |
| Reportable<br>Range | Reportable Range:<br>0.30 – 20.00 mmol/L<br>2.7 – 180.2 mg/dL<br>0.03 – 1.80 g/L | Reportable Range:<br>0.30 – 20.00 mmol/L<br>2.7 – 180.2 mg/dL |
| Sample Type | Arterial, venous or capillary whole blood | Arterial or venous whole blood |
| Sample Volume | At least 92 µL | 95 µL |
| Sample<br>Preparation | Ready to Use | Ready to Use |
| Traceability | Certified standard reference material not<br>available at present | Certified standard reference<br>material not available at present |
| Calibration | 1-point on-board contained within the card | 1-point on-board contained within<br>the cartridge |
| Time to Test<br>(Sample Stability) | Immediately after collection or in less than 5<br>minutes | Immediately after collection…