(41 days)
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No
The summary describes a standard in vitro diagnostic device using electrochemical sensors and a handheld analyzer to measure specific analytes in blood. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No.
This device is an in vitro diagnostic device used for quantifying substances in blood for diagnostic purposes, not for providing therapy or treatment.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device's measurements are "used in the diagnosis, monitoring, and treatment of respiratory disturbances and metabolic and respiratory-based acid-base disturbances" and "the diagnosis and treatment of lactic acidosis". The 'Device Description' also refers to the i-STAT 1 Analyzer as a "handheld, in vitro diagnostic analytical device".
No
The device description clearly states the system is comprised of a handheld analyzer, disposable cartridges, and accessories, indicating significant hardware components are integral to its function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states the device is intended for "in vitro quantification of pH, PO2, PCO2, and lactate in arterial or venous whole blood". "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Device Description: The description details a "handheld, in vitro diagnostic analytical device designed to run only i-STAT test cartridges." This directly labels the device as an IVD.
- Sample Type: The device analyzes "whole blood," which is a biological specimen taken from the body and analyzed outside the body.
- Purpose: The measurements are used in the "diagnosis, monitoring, and treatment" of various medical conditions, which is the core function of IVDs.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
CHL, KHP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
"trained medical professionals at the patient point of care or in the clinical laboratory"
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision (Aqueous Materials):
The precision of the i-STAT pH, PO2, PCO2, and Lactate tests in the i-STAT CG4+ blue cartridge with the i-STAT 1 System was evaluated using 5 levels of aqueous materials. This 20-day multi-day precision testing was based on CLSI document EP05-A3. The study was conducted using multiple instruments and one test cartridge lot over 20 days at one site. Total precision ( 'within-laboratory'), within-run, between-run, and between-day were estimated for each level. Results table shows mean, SD, and %CV for each precision component across 5 levels for pH, PO2, PCO2, and Lactate.
Precision (Whole Blood):
Whole blood precision was evaluated using whole blood venous and arterial specimens collected with lithium heparin. The repeatability analysis was conducted using the data collected across multiple point of care sites. The mean values for each sample were divided into subintervals for each sample type. Results table shows N, Mean, SD, and CV (%) across different ranges for pH, PO2, PCO2, and Lactate in both venous and arterial whole blood.
Linearity:
The study was designed based on CLSI EP06-A. The linearity of the i-STAT pH, PO2, PCO2, and Lactate tests in the i-STAT CG4+ blue cartridge with the i-STAT 1 System was evaluated by preparing whole blood samples of varying analyte levels for each i-STAT test. The i-STAT pH, PO2, PCO2, and Lactate tests demonstrated linearity over the reportable range for each i-STAT test. Regression summary table provides Reportable Range, Range Tested, Slope, Intercept, and r2 for pH, PO2, PCO2, and Lactate.
Limit of Quantitation (LoQ):
The study was based on CLSI EP17-A2. The LoQ of the i-STAT pH, PO2, PCO2, and Lactate tests in the i-STAT CG4+ blue cartridge were evaluated on the i-STAT 1 analyzer using whole blood that was altered to low pH (500 mmHg.
Interference:
The interference performance of the i-STAT pH, PO2, PCO2, and Lactate tests in the i-STAT CG4+ blue cartridge on the i-STAT 1 analyzer was evaluated using whole blood samples based on CLSI EP07 ED3. A substance was identified as an interferent if the difference between the control and test samples was outside of the allowed error (Ea). Most substances tested (Acetaminophen, Atracurium, Calcium, Ethanol, Ibuprofen, Morphine, Potassium, Sodium, Bilirubin, Hemoglobin, Triglyceride, Intralipid, Thiopental for pH/PO2/PCO2; Acetaldehyde, Acetaminophen, N-Acetyl-Cysteine, Ascorbic Acid, β-Hydroxybutyric Acid, Bilirubin, Dopamine, Formaldehyde, Hemoglobin, Hydroxyurea, Pyruvate, Salicylate, Thiocyanate, Triglyceride, Intralipid, Uric Acid for Lactate) showed no interference. Bromide showed interference (decreased results ≥ 40.7 mmol/L) and Glycolic Acid showed interference (increased results ≥ 1.18 mmol/L) for the Lactate test.
Method Comparison with Predicate Device:
Method comparison data was demonstrated in a study based on CLSI guideline EP09c-ED3. Lithium heparin venous and arterial blood specimens were evaluated and analyzed on the i-STAT 1 analyzer against whole blood specimens tested on the comparative method. For pH, PO2, and PCO2, a Passing Bablok linear regression analysis was performed using the first replicate result from the i-STAT CG4+ cartridge with the i-STAT 1 System versus the singlicate result of Radiometer ABL800 FLEX. For lactate, the first replicate result from the i-STAT CG4+ cartridge with the i-STAT 1 System was compared to the mean result of epoc® Blood Analysis System. The results of the method comparison for pH, PO2, PCO2, and Lactate are displayed in a table showing N, Slope, Intercept, and r.
Key Result: The results of these studies demonstrate that performance of the i-STAT pH, PO2, PCO2, and Lactate tests in the i-STAT CG4+ blue cartridge with the i-STAT 1 System are substantially equivalent to the comparative method.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics provided are precision (SD, %CV), linearity (slope, intercept, r2), and limit of quantitation/detection. Sensitivity, Specificity, PPV, NPV are not explicitly stated.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1120 Blood gases (P
CO2 , PO2 ) and blood pH test system.(a)
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.(b)
Classification. Class II.
0
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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3
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. | |
| 400 College Road East | ||
| Princeton, NJ 08540 | ||
| Contact | Primary: Susan Tibedo | |
| Director Regulatory Affairs | ||
| susan.tibedo@abbott.com | ||
| Phone: 609-454-9360 | ||
| Secondary: Maria Figueroa | ||
| Manager Regulatory Affairs | ||
| maria.l.figueroa@abbott.com | ||
| Phone: 609-454-9271 | ||
| 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
code | Device Classification
name | Regulation
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 |
4
3. Predicate Device
Proprietary Name epoc Lactate test, epoc Blood Analysis System
510(k) Number K093297
| Product
code | Device Classification
name | Regulation
Number | Class | Panel |
|-----------------|-------------------------------------|----------------------|-------|--------------------|
| KHP | Electrode, Ion Specific,
Lactate | 862.1450 | I | Clinical Chemistry |
Proprietary Name ABL800 FLEX blood gas, oximetry, electrolyte and metabolite analyzer
510(k) Number K041874
| Product
code | Device Classification
name | Regulation
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 |
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.
5
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 | ||
| Characteristic | Predicate: | |
| ABL800 FLEX pH Test | ||
| (K041874) | Candidate: pH test in the | |
| i-STAT CG4+ cartridge with | ||
| the i-STAT 1 System | ||
| Intended Use | The ABL800 FLEX is intended for in vitro | |
| testing of samples of whole blood for the | ||
| parameters pH, pO2, pCO2, potassium, | ||
| sodium, calcium, chloride, glucose, lactate, | ||
| total bilirubin, and co-oximetry parameters | ||
| (total hemoglobin, oxygen saturation, and the | ||
| hemoglobin fractions FO2Hb, FCOHb, | ||
| FMetHb, FHHb, and FHbF). In addition the | ||
| ABL800 FLEX is intended for in vitro testing of | ||
| samples of expired air for the parameters pO2 | ||
| and pCO2. The ABL800 FLEX includes an | ||
| AutoCheck Module to perform automated | ||
| analysis of quality control fluids. |
pH is the indispensable measure of acidemia
or alkalemia and is therefore an essential part
of the pH/blood gas measurement. The
normal function of many metabolic
processes requires a pH to be within a
relatively narrow range. | The i-STAT CG4+ cartridge with
the i-STAT 1 System is intended
for use in the in vitro quantification
of pH in arterial or venous whole
blood in point of care or clinical
laboratory settings.
pH measurements are used in the
diagnosis, monitoring, and
treatment of respiratory
disturbances and metabolic and
respiratory-based acid-base
disturbances. |
| Reportable
Range | Test Range:1 7.0 – 7.7
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).
6
| Similarities and Differences: System (Test and Instrument) for pH | ||
|---|---|---|
| Feature or | ||
| Characteristic | Predicate: | |
| ABL800 FLEX pH Test | ||
| (K041874) | Candidate: pH test in the | |
| i-STAT CG4+ cartridge with | ||
| the i-STAT 1 System | ||
| Sample | ||
| Preparation | Ready to Use | Ready to Use |
| Traceability | BMS™ Mk2 | NIST SRM 186-I, 186-II, 185, and |
| 187 | ||
| Calibration | 1-point intervals 30 min, 1 hour, 2 hours | 1-point on-board contained within |
| the cartridge | ||
| Time to Test | ||
| (Sample | ||
| Stability) | Analyze heparinized samples within 30 | |
| minutes after collection | Heparinized samples: within 10 | |
| minutes of collection | ||
| Principle of | ||
| Measurement | Ion selective electrode | Ion selective electrode |
| Reagent Format | Reagent handling system, stored within | |
| analyzer | Cartridge | |
| Analyzer Type | Floor Model | Handheld |
| Similarities and Differences: System (Test and Instrument) for PO2 | ||
| Feature or | ||
| Characteristic | Predicate: | |
| ABL800 FLEX pO2 Test | ||
| (K041874) | Candidate: PO2 test in the | |
| i-STAT CG4+ cartridge with | ||
| the i-STAT 1 System | ||
| Intended Use | The ABL800 FLEX is intended for in vitro | |
| testing of samples of whole blood for the | ||
| parameters pH, pO2, pCO2, potassium, | ||
| sodium, calcium, chloride, glucose, lactate, | ||
| total bilirubin, and co-oximetry parameters | ||
| (total hemoglobin, oxygen saturation, and the | ||
| hemoglobin fractions FO2Hb, FCOHb, | ||
| FMetHb, FHHb, and FHbF). In addition the | ||
| ABL800 FLEX is intended for in vitro testing | ||
| of samples of expired air for the parameters | ||
| pO2 and pCO2. The ABL800 FLEX includes | ||
| an AutoCheck Module to perform automated | ||
| analysis of quality control fluids. | ||
| The arterial oxygen tension is an indicator of | ||
| the oxygen uptake in the lungs. | The i-STAT CG4+ cartridge with | |
| the i-STAT 1 System is intended | ||
| for use in the in vitro quantification | ||
| of PO2 in arterial or venous whole | ||
| blood in point of care or clinical | ||
| laboratory settings. | ||
| PO2 measurements are used in the | ||
| diagnosis, monitoring, and | ||
| treatment of respiratory | ||
| disturbances and metabolic and | ||
| respiratory-based acid-base | ||
| disturbances. | ||
| Reportable | ||
| Range | Test Range:1 | |
| 15 - 530 mmHg | ||
| Measuring Range:2 | ||
| 0.0 - 800 mmHg | ||
| 0.00 – 107 kPa | Reportable Range: | |
| 15 – 530 mmHg | ||
| 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 | ||
| Preparation | Ready to Use | Ready to Use |
| Traceability | NIST certified Standard Reference Materials | NIST standard reference materials |
| via commercially available certified | ||
| specialty medical gas standards | ||
| Calibration | 1-point intervals 30 min, 1 hour, 2 hours | 1-point on-board contained within |
| the cartridge | ||
| Time to Test | ||
| (Sample Stability) | Analyze heparinized samples within 30 | |
| minutes after collection | Heparinized samples: within 10 | |
| minutes of collection | ||
| Principle of | ||
| Measurement | Amperometric measurement of oxygen | |
| reduction current | Amperometric measurement of | |
| oxygen reduction current | ||
| Reagent Format | Reagent handling system, stored within | |
| analyzer | Cartridge | |
| Analyzer Type | Floor Model | Handheld |
| Similarities and Differences: System (Test and Instrument) for PCO2 | ||
| Feature or | ||
| Characteristic | Predicate: | |
| ABL800 FLEX pCO2 Test | ||
| (K041874) | Candidate: PCO2 test in the | |
| i-STAT CG4+ cartridge with | ||
| the i-STAT 1 System | ||
| Intended Use | The ABL800 FLEX is intended for in vitro | |
| testing of samples of whole blood for the | ||
| parameters pH, pO2, pCO2, potassium, | ||
| sodium, calcium, chloride, glucose, lactate, | ||
| total bilirubin, and co-oximetry parameters | ||
| (total hemoglobin, oxygen saturation, and the | ||
| hemoglobin fractions FO2Hb, FCOHb, | ||
| FMetHb, FHHb, and FHbF). In addition the | ||
| ABL800 FLEX is intended for in vitro testing | ||
| of samples of expired air for the parameters | ||
| pO2 and pCO2. The ABL800 FLEX includes | ||
| an AutoCheck Module to perform automated | ||
| analysis of quality control fluids. |
pCO2 is a direct reflection of the adequacy of
alveolar ventilation in relation to the
metabolic rate. | The i-STAT CG4+ cartridge with
the i-STAT 1 System is intended
for use in the in vitro quantification
of PCO2 in arterial or venous whole
blood in point of care or clinical
laboratory settings.
PCO2 measurements are used in
the diagnosis, monitoring, and
treatment of respiratory
disturbances and metabolic and
respiratory-based acid-base
disturbances. |
| Reportable
Range | Test Range:1
15 – 150 mmHg
Measuring Range:2
5.0 – 250 mmHg
0.67 – 33.3 kPa | Reportable Range:
15.0 – 130.0 mmHg
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
Preparation | Ready to Use | Ready to Use |
| Traceability | NIST certified Standard Reference Materials | NIST standard reference materials
via commercially available certified
specialty medical gas standards |
| Calibration | 1-point intervals 30 min, 1 hour, 2 hours | 1-point on-board contained within
the cartridge |
| Time to Test
(Sample Stability) | Analyze heparinized samples within 30
minutes after collection | Heparinized samples: within 10
minutes of collection |
| Principle of
Measurement | Ion selective electrode | Ion selective electrode |
| Reagent Format | Reagent handling system, stored within
analyzer | Cartridge |
| Analyzer Type | Floor Model | Handheld |
| Similarities and Differences: System (Test and Instrument) for Lactate | | |
| Feature or
Characteristic | Predicate:
epoc Lactate Test with epoc Blood
Analysis System
(K093297) | Candidate: Lactate test in the
i-STAT CG4+ cartridge with
the i-STAT 1 System |
| Intended Use | The Lactate test, as part of the epoc Blood
Analysis System, is intended for use by
trained medical professionals as an in vitro
diagnostic device for the quantitative testing
of samples of heparinized or un-
anticoagulated arterial, venous or capillary
whole blood in the laboratory or at the point
of care in hospitals, nursing homes or other
clinical institutions.
Lactate measurements from the epoc Blood
Analysis System are used to evaluate the
acid-base status and are used in the
diagnosis and treatment of lactic acidosis
(abnormally high acidity of the blood.) | The i-STAT CG4+ cartridge with
the i-STAT 1 System is intended
for use in the in vitro quantification
of lactate in arterial or venous
whole blood in point of care or
clinical laboratory settings.
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. |
| Reportable
Range | Reportable Range:
0.30 – 20.00 mmol/L
2.7 – 180.2 mg/dL
0.03 – 1.80 g/L | Reportable Range:
0.30 – 20.00 mmol/L
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
Preparation | Ready to Use | Ready to Use |
| Traceability | Certified standard reference material not
available at present | Certified standard reference
material not available at present |
| Calibration | 1-point on-board contained within the card | 1-point on-board contained within
the cartridge |
| Time to Test
(Sample Stability) | Immediately after collection or in less than 5
minutes | Immediately after collection |
| Principle of
Measurement | Amperometric measurement of oxidized
hydrogen peroxide produced by lactate
oxidase activity | Amperometric measurement of
oxidized hydrogen peroxide
produced by lactate oxidase
activity |
| Reagent Format | Test card | Cartridge |
| Analyzer Type | Handheld | Handheld |
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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).
² 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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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).
² 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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10
7. Performance Characteristics Analytical Performance
a. Precision
Precision 20 days (Aqueous Materials)
The precision of the i-STAT pH, PO2, PCO2, and Lactate tests in the i-STAT CG4+ blue cartridge with the i-STAT 1 System was evaluated using 5 levels of aqueous materials. This 20-day multi-day precision testing was based on CLSI document EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline-Third Edition. The study was conducted using multiple instruments and one test cartridge lot over 20 days at one site. Total precision ( 'within-laboratory'), withinrun, between-run, and between-day were estimated for each level. The results of the 20day precision study are shown in Table 1.
| Table 1: 20-Day Precision of i-STAT pH, PO2, PCO2, and Lactate tests on the i-STAT 1
| Analyzer | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| i-STAT | |||||||||||
| Test | Fluid | ||||||||||
| Level | N | Mean | Total | Within-run | Between-run | Between-day | |||||
| SD | %CV | SD | %CV | SD | %CV | SD | %CV | ||||
| pH | CV L1 | 80 | 6.5215 | 0.00435 | 0.07 | 0.00347 | 0.05 | 0.00228 | 0.03 | 0.00129 | 0.02 |
| CV L2 | 81 | 7.0199 | 0.00287 | 0.04 | 0.00252 | 0.04 | 0.00040 | 0.01 | 0.00132 | 0.02 | |
| CV L3 | 80 | 7.4758 | 0.00279 | 0.04 | 0.00250 | 0.03 | 0.00098 | 0.01 | 0.00075 | 0.01 | |
| CV L4 | 80 | 7.7551 | 0.00241 | 0.03 | 0.00209 | 0.03 | 0.00071 | 0.01 | 0.00097 | 0.01 | |
| CV L5 | 80 | 7.9862 | 0.00369 | 0.05 | 0.00322 | 0.04 | 0.00118 | 0.01 | 0.00135 | 0.02 | |
| PO2 | |||||||||||
| (mmHg) | CV L1 | 80 | 70.2 | 2.45 | 3.5 | 2.08 | 3.0 | 0.70 | 1.0 | 1.08 | 1.5 |
| CV L2 | 81 | 85.7 | 2.69 | 3.1 | 2.40 | 2.8 | 0.76 | 0.9 | 0.93 | 1.1 | |
| CV L3 | 80 | 120.4 | 2.66 | 2.2 | 2.25 | 1.9 | 1.18 | 1.0 | 0.81 | 0.7 | |
| CV L4 | 80 | 152.9 | 3.02 | 2.0 | 1.88 | 1.2 | 1.78 | 1.2 | 1.55 | 1.0 | |
| CV L5 | 80 | 363.4 | 6.98 | 1.9 | 4.15 | 1.1 | 5.07 | 1.4 | 2.40 | 0.7 | |
| PCO2 | |||||||||||
| (mmHg) | CV L1 | 80 | 87.08 | 1.349 | 1.5 | 0.916 | 1.1 | 0.872 | 1.0 | 0.470 | 0.5 |
| CV L2 | 81 | 59.48 | 0.921 | 1.5 | 0.872 | 1.5 | 0.228 | 0.4 | 0.190 | 0.3 | |
| CV L3 | 80 | 29.24 | 0.675 | 2.3 | 0.617 | 2.1 | 0.227 | 0.8 | 0.151 | 0.5 | |
| CV L4 | 80 | 21.14 | 0.552 | 2.6 | 0.521 | 2.5 | 0.141 | 0.7 | 0.118 | 0.6 | |
| CV L5 | 80 | 15.05 | 0.506 | 3.4 | 0.473 | 3.1 | 0.138 | 0.9 | 0.114 | 0.8 | |
| Lactate | |||||||||||
| (mmol/L) | CV L1 | 80 | 18.448 | 0.1655 | 0.9 | 0.1505 | 0.8 | 0.0266 | 0.1 | 0.0634 | 0.3 |
| CV L2 | 80 | 7.967 | 0.0495 | 0.6 | 0.0459 | 0.6 | 0.0132 | 0.2 | 0.0128 | 0.2 | |
| CV L3 | 79 | 2.251 | 0.0082 | 0.4 | 0.0073 | 0.3 | 0.0030 | 0.1 | 0.0021 | 0.1 | |
| CV L4 | 80 | 0.924 | 0.0122 | 1.3 | 0.0108 | 1.2 | 0.0038 | 0.4 | 0.0041 | 0.4 | |
| CV L5 | 80 | 0.497 | 0.0133 | 2.7 | 0.0123 | 2.5 | 0.0033 | 0.7 | 0.0037 | 0.7 |
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Precision (Whole Blood)
Whole blood precision was evaluated using whole blood venous and arterial specimens collected with lithium heparin. The repeatability analysis was conducted using the data collected across multiple point of care sites. The mean values for each sample were divided into subintervals for each sample type. The results are provided in Table 2 below:
| Table 2: Precision for venous and arterial whole blood | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| i-STAT | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Test | Units | Sample Type | Sample | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Range | N | Mean | SD | CV (%) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| pH | pH units | Venous | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Whole Blood | 7.45 | 7 | 7.585 | 0.0030 | 0.04 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| pH | pH units | Arterial | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Whole Blood | 7.45 | 36 | 7.494 | 0.0047 | 0.06 | PO2 | mmHg | Venous | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Whole Blood | 250 | 6 | 450.0 | 12.4 | 2.8 | PO2 | mmHg | Arterial | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Whole Blood | 250 | 33 | 355.6 | 8.5 | 2.4 | PCO2 | mmHg | Venous | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Whole Blood | 62.5 | 26 | 91.61 | 0.73 | 0.8 | PCO2 | mmHg | Arterial | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Whole Blood | 62.5 | 4 | 74.36 | 0.37 | 0.5 | Lactate | mmol/L | Venous | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Whole Blood | 5.0 | 11 | 12.88 | 0.200 | 1.55 | Lactate | mmol/L | Arterial | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Whole Blood | 5.0 | 8 | 8.55 | 0.036 | 0.42 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| pH | pH units | Arterial | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Whole Blood | 7.45 | 36 | 7.494 | 0.0047 | 0.06 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PO2 | mmHg | Venous | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Whole Blood | 250 | 6 | 450.0 | 12.4 | 2.8 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PO2 | mmHg | Arterial | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Whole Blood | 250 | 33 | 355.6 | 8.5 | 2.4 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PCO2 | mmHg | Venous | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Whole Blood | 62.5 | 26 | 91.61 | 0.73 | 0.8 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PCO2 | mmHg | Arterial | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Whole Blood | 62.5 | 4 | 74.36 | 0.37 | 0.5 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Lactate | mmol/L | Venous | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Whole Blood | 5.0 | 11 | 12.88 | 0.200 | 1.55 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Lactate | mmol/L | Arterial | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Whole Blood | 5.0 | 8 | 8.55 | 0.036 | 0.42 |
b. Linearity
The study was designed based on CLSI EP06-A: Evaluation of the Linearity of Quantitative Measurement Procedures.
The linearity of the i-STAT pH, PO2, PCO2, and Lactate tests in the i-STAT CG4+ blue cartridge with the i-STAT 1 System was evaluated by preparing whole blood samples of varying analyte levels for each i-STAT test. The i-STAT pH, PO2, PCO2, and Lactate tests demonstrated linearity over the reportable range for each i-STAT test. Regression summary of the response for each i-STAT test versus the concentration of the whole blood samples of varying analyte levels is provided in Table 3.
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| Table 3: Regression Summary for the i-STAT PO2, PCO2, pH and Lactate tests on the
| i-STAT 1 Analyzer | ||||||
|---|---|---|---|---|---|---|
| i-STAT | ||||||
| Test | Units | Reportable | ||||
| Range | Range Tested | Slope | Intercept | r2 | ||
| pH | pH units | 7.0 - 7.7 | 6.889 - 7.979 | 0.966 | 0.246 | 0.9983 |
| PO2 | mmHg | 15 - 530 | 10.69 - 608.49 | 1.005 | -0.196 | 0.9988 |
| PCO2 | mmHg | 15 - 130 | 10.75 - 151.02 | 1.027 | -1.084 | 0.9978 |
| Lactate | mmol/L | 0.30 - 20.00 | 0.222 - 21.742 | 1.128 | 0.104 | 0.9966 |
c. Limit of Quantitation (LoQ)
The study was based on the CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline-Second Edition.
The LoQ of the i-STAT pH, PO2, PCO2, and Lactate tests in the i-STAT CG4+ blue cartridge were evaluated on the i-STAT 1 analyzer using whole blood that was altered to low pH (500 mmHg.
f. Interference
The interference performance of the i-STAT pH, PO2, PCO2, and Lactate tests in the i-STAT CG4+ blue cartridge on the i-STAT 1 analyzer was evaluated using whole blood samples based on CLSI EP07 ED3: Interference Testing in Clinical Chemistry, Third Edition. The effect of each substance was evaluated by comparing the performance of a control sample, spiked with blank solvent solution, with the test results from a sample spiked with the potentially interfering substance at the toxic/pathological concentration based on CLSI EP37 ED1: Supplemental Tables for Interference Testing in Clinical Chemistry, First Edition, as applicable. A substance was identified as an interferent if the difference between the control and test samples was outside of the allowed error (Ea) for the i-STAT test.
Table 6 and Table 7 contain the lists of potentially interfering substances tested for the i-STAT pH, PO2, PCO2, and Lactate tests and the interference results.
| Table 6: Potentially Interfering Substances and Test Concentration for pH, PO2, and PCO2 | |||||
|---|---|---|---|---|---|
| i-STAT | |||||
| Test | Substance | Test Concentration | Interference | ||
| (Yes/No) | Interference | ||||
| Results | |||||
| mmol/L | mg/dL | ||||
| Acetaminophen | 1.03 | 15.6 | No | ||
| Atracurium1 | 0.0287 | 3.57 | No | ||
| Calcium | 5.0 | 20 | No | ||
| Ethanol | 130 | 600 | No | ||
| PO2 | |||||
| PCO2 | |||||
| pH | Ibuprofen | 1.06 | 21.9 | No | |
| Morphine | 0.0273 | 0.78 | No | ||
| Potassium | 8 | 59.6 | No | ||
| Sodium | 170 | 993.48 | No | ||
| Bilirubin | 0.684 | 40 | No | ||
| Hemoglobin | 10 g/L | 1000 | No | ||
| Triglyceride | 16.94 | 1500 | No | ||
| Intralipid | N/A | 2493 | No | ||
| Thiopental | 1660 | 40.2 | No |
1 The test concentration for this substance is not included in CLSI guideline EP37 1st edition.
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| Table 7: Potentially Interfering Substances and Test Concentration for Lactate | |||||
|---|---|---|---|---|---|
| i-STAT | |||||
| Test | Substance | Test Concentration | Interference | ||
| (Yes/No) | Interference | ||||
| Results | |||||
| Lactate | Acetaldehyde1 | 45 μmol/L | 0.20 | No | |
| Acetaminophen | 1.03 | 15.6 | No | ||
| N-Acetyl-Cysteine | 0.92 | 15.0 | No | ||
| Ascorbic Acid | 0.298 | 5.25 | No | ||
| β-Hydroxybutyric Acid1 | 6 | 62 | No | ||
| Bilirubin | 0.684 | 40 | No | ||
| Bromide1 | 40.7 | 325.7 | Yes | Decreased results | |
| ≥ 40.7 mmol/L | |||||
| Dopamine | 4.06 μmol/L | 0.0621 | No | ||
| Formaldehyde1 | 0.133 | 0.399 | No | ||
| Glycolic Acid1 | 10.0 | 76.1 | Yes | Increased results | |
| ≥ 1.18 mmol/L | |||||
| Hemoglobin | 10 g/L | 1000 | No | ||
| Hydroxyurea | 0.405 | 3.08 | No | ||
| Pyruvate | 0.570 | 5 | No | ||
| Salicylate | 0.207 | 2.86 | No | ||
| Thiocyanate | 0.898 | 5.22 | No | ||
| Triglyceride | 16.94 | 1500 | No | ||
| Intralipid | N/A | 3423 | No | ||
| Uric Acid | 1.4 | 23.5 | No |
Comparison Study
g. Method Comparison with Predicate Device
Method comparison data was demonstrated in a study based on CLSI guideline EP09c-ED3. Lithium heparin venous and arterial blood specimens were evaluated and analyzed on the i-STAT 1 analyzer against whole blood specimens tested on the comparative method. For pH, PO2, and PCO2, a Passing Bablok linear regression analysis was performed using the first replicate result from the i-STAT CG4+ cartridge with the i-STAT 1 System versus the singlicate result of Radiometer ABL800 FLEX. For lactate, the first replicate result from the i-STAT CG4+ cartridge with the i-STAT 1 System was compared to the mean result of epoc® Blood Analysis System.
The results of the method comparison of venous whole blood and arterial whole blood samples is presented in Table 8.
| Table 8: Method Comparison Results for venous and arterial whole blood | ||||
|---|---|---|---|---|
| i-STAT Test | N | Slope | Intercept | r |
| pH | 316 | 1.05 | -0.34 | 0.97 |
| PO 2 | 308 | 1.03 | -3.96 | 0.99 |
| PCO 2 | 327 | 1.01 | -1.29 | 0.99 |
| Lactate | 246 | 0.96 | 0.08 | 1.00 |
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8. Conclusion
The results of these studies demonstrate that performance of the i-STAT pH, PO2, PCO2, and Lactate tests in the i-STAT CG4+ blue cartridge with the i-STAT 1 System are substantially equivalent to the comparative method.