(135 days)
The i-STAT CHEM8+ cartridge with the i-STAT 1 System is in the in vitro quantification of sodium, potassium, chloride, ionized calcium, glucose, blood urea nitrogen, creatinine, hematocrit, and total carbon dioxide in arterial or venous whole blood in point of care or clinical laboratory settings.
Sodium measurements are used for monitoring electrolyte imbalances.
Potassium measurements are used in the diagnosis and clinical conditions that manifest high and low potassium levels.
Chloride measurements are primarily used in the diagnosis, monitoring, and treatment of electrolyte and metabolic disorders including, but not limited to, cystic fibrosis, diabetic acidosis, and hydration disorders.
Ionized calcium measurements are used in the diagnosis and treatment of parathyroid disease, chronic renal disease and tetany.
Glucose measurements are used in the diagnosis, monitoring, and treatment of carbohydrate metabolism disorders including, but not limited to, diabetes mellitus, neonatal hypoglycemia, and pancreatic islet cell carcinoma.
Blood urea nitrogen measurements are used for the diagnosis, and treatment of certain renal and metabolic diseases.
Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
Hematoorit measurements can aid in the determination and monitoring of normal total red cell volume status that can be associated with conditions including anemia and erythrocytosis. The i-STAT Hematocrit test has not been evaluated in neonates.
Carbon dioxide measurements are used in the diagnosis, monitoring, and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
The i-STAT CHEM8+ test cartridge contains test reagents to analyze whole blood at the point of care or in the clinical laboratory for sodium (Na), potassium (K), chloride (CI), ionized calcium (iCa), glucose (Glu), blood urea nitrogen (BUN), creatinine (Crea), hematocrit (Hct), and total carbon dioxide (TCO2). 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.
The provided text describes a 510(k) premarket notification for the i-STAT CHEM8+ cartridge with the i-STAT 1 System, specifically addressing the addition of an anticoagulant-free whole blood matrix. The document references several previous 510(k) clearances for various analytical performance characteristics and presents a new "Matrix Equivalence" study for the anticoagulant-free whole blood.
Here's an analysis of the acceptance criteria and study information provided, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria for the "Matrix Equivalence" study in a tabulated format. However, it implicitly uses a Passing-Bablok linear regression analysis to demonstrate equivalence. The reported device performance is presented as the results of this regression analysis. We can infer the expected performance from general expectations for method comparisons in analytical chemistry, where a slope close to 1, an intercept close to 0, and a high correlation coefficient (r) indicate good agreement.
| Analyte | Units | Candidate Range | Primary Sample Range | r (Correlation Coefficient) | Slope | Intercept |
|---|---|---|---|---|---|---|
| Na | mmol/L | 110 - 174 | 111 - 173 | 0.99 | 1.00 | 0.50 |
| K | mmol/L | 2.2 - 7.7 | 2.2 - 7.5 | 0.96 | 1.00 | 0.00 |
| Cl | mmol/L | 76 - 136 | 79 - 137 | 0.98 | 1.00 | -0.50 |
| iCa | mmol/L | 0.41 - 2.48 | 0.71 - 2.28 | 0.85 | 1.04 | -0.04 |
| Glu | mg/dL | 29 - 663 | 35 - 660 | 1.00 | 1.01 | -0.63 |
| BUN | mg/dL | 4 - 120 | 4 - 118 | 1.00 | 1.00 | 0.00 |
| Crea | mg/dL | 0.2 - 19.4 | 0.2 - 19.4 | 1.00 | 1.00 | 0.00 |
| Hct | %PCV | 16 - 75 | 16 - 73 | 0.99 | 1.00 | 0.46 |
| TCO2 | mmol/L | 9 - 42 | 11 - 41 | 0.95 | 1.00 | 0.00 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set for Matrix Equivalence): The sample sizes vary slightly per analyte:
- Na, Cl, iCa: 314
- K, Glu: 313
- BUN: 310
- Crea: 312
- Hct: 311
- TCO2: 273
- Data Provenance: The study was conducted at "three (3) point of care sites." The document does not specify the country of origin, but given the FDA submission, it is likely the US or a region with equivalent regulatory standards. The data is prospective in nature, as it involved collecting samples (both anticoagulant-free and anticoagulated) for direct comparison.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study (matrix equivalence for IVD devices) does not typically involve human experts establishing "ground truth" in the way a diagnostic imaging study would. The ground truth (or reference method) for comparison is the measurement obtained from the previously cleared device using anticoagulated samples. The expertise lies in the calibration of the reference method and the design and execution of the analytical study, not in human interpretation of results.
4. Adjudication Method for the Test Set
Not applicable for this type of analytical method comparison study. Adjudication is relevant for subjective assessments, typically in diagnostic imaging or clinical outcomes, to resolve discrepancies among human readers or between AI and human readers. Here, the comparison is between two quantitative measurement methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is an analytical performance study for an in vitro diagnostic device, not a diagnostic imaging or clinical decision support AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the analytical performance (precision, linearity, LoQ, LoB/LoD, interference, and method comparison) of the i-STAT CHEM8+ cartridge with the i-STAT 1 System, and its equivalence between different sample matrices, primarily represents standalone performance of the device without human intervention beyond sample collection and device operation. The "Matrix Equivalence" study directly compares the results of the device using two different sample types.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the "Matrix Equivalence" study was established by the mean result from the primary sample, which refers to measurements obtained from whole blood samples collected with balanced heparin or lithium heparin anticoagulant using the previously cleared i-STAT CHEM8+ system. This acts as the "reference method" for comparison to the anticoagulant-free samples.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" for the purpose of the Matrix Equivalence study. This study is a validation study demonstrating that a new sample matrix (anticoagulant-free whole blood) yields equivalent results to the established (anticoagulated) sample matrix. The device itself (i-STAT CHEM8+ with i-STAT 1 System) would have undergone extensive development and internal testing (which could be considered a form of "training") prior to its initial clearances (K183678, K183680, K183688, K191298, K191360). The current submission focuses on extending the indications for use.
9. How the Ground Truth for the Training Set was Established
As no explicit "training set" is mentioned for this specific submission's study, this question is not directly answerable from the provided text. The "ground truth" for the reference method within the Matrix Equivalence study, as stated above, derives from the previously cleared performance of the i-STAT CHEM8+ system using anticoagulated samples, which would have been established through robust analytical validation studies (e.g., comparison to laboratory reference methods).
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
August 13, 2021
Abbott Point of Care Inc. Maria Figueroa Associate Director, Regulatory Affairs 400 College Road East Princeton, New Jersey 08540
Re: K210958
Trade/Device Name: i-STAT CHEM8+ cartridge with the i-STAT 1 System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: CGA, CGL, JGS, CEM, CGZ, JFP, CDS, JFL, JPI Dated: March 30, 2021 Received: March 31, 2021
Dear Maria Figueroa:
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.
{1}------------------------------------------------
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 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. 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) K210958
Device Name
i-STAT CHEM8+ cartridge with the i-STAT 1 System
Indications for Use (Describe)
The i-STAT CHEM8+ cartridge with the i-STAT 1 System is in the in vitro quantification of sodium, potassium, chloride, ionized calcium, glucose, blood urea nitrogen, creatinine, hematocrit, and total carbon dioxide in arterial or venous whole blood in point of care or clinical laboratory settings.
Sodium measurements are used for monitoring electrolyte imbalances.
Potassium measurements are used in the diagnosis and clinical conditions that manifest high and low potassium levels.
Chloride measurements are primarily used in the diagnosis, monitoring, and treatment of electrolyte and metabolic disorders including, but not limited to, cystic fibrosis, diabetic acidosis, and hydration disorders.
Ionized calcium measurements are used in the diagnosis and treatment of parathyroid disease, chronic renal disease and tetany.
Glucose measurements are used in the diagnosis, monitoring, and treatment of carbohydrate metabolism disorders including, but not limited to, diabetes mellitus, neonatal hypoglycemia, and pancreatic islet cell carcinoma.
Blood urea nitrogen measurements are used for the diagnosis, and treatment of certain renal and metabolic diseases.
Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
Hematoorit measurements can aid in the determination and monitoring of normal total red cell volume status that can be associated with conditions including anemia and erythrocytosis. The i-STAT Hematocrit test has not been evaluated in neonates.
Carbon dioxide measurements are used in the diagnosis, monitoring, and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{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 EastPrinceton, NJ 08540 |
|---|---|
| Contact | Primary: Maria FigueroaAssociate Director Regulatory AffairsPhone: 609-454-9271Secondary contact person for all communications:Secondary: Jaquelyn GesumariaSenior Specialist Regulatory AffairsPhone: 609-454-9384 |
Date Prepared August 12, 2021
Device Information 2.
Proprietary Name i-STAT CHEM8+ cartridge with the i-STAT 1 System
Chemistry test, analyzer, handheld Common Name
| Productcode | Device Classificationname | RegulationNumber | Class | Panel |
|---|---|---|---|---|
| CGA | Glucose Oxidase,Glucose | 862.1345 | II | Clinical Chemistry |
| CGL | Electrode, Ion BasedEnzymatic, Creatinine | 862.1225 | II | Clinical Chemistry |
| JGS | Electrode, Ion Specific,Sodium | 862.1665 | II | Clinical Chemistry |
| CEM | Electrode, Ion Specific,Potassium | 862.1600 | II | Clinical Chemistry |
| CGZ | Electrode, Ion SpecificChloride | 862.1170 | II | Clinical Chemistry |
| CDS | Electrode, Ion Specific,Urea Nitrogen | 862.1770 | II | Clinical Chemistry |
{4}------------------------------------------------
| Productcode | Device Classificationname | RegulationNumber | Class | Panel |
|---|---|---|---|---|
| JFL | Bicarbonate, CarbonDioxide Test System | 862.1160 | II | Clinical Chemistry |
| JFP | Electrode, Ion Specific,Calcium | 862.1145 | II | Clinical Chemistry |
| JPI | Device, HematocritMeasuring | 862.6400 | II | Hematology |
Predicate Device 3.
Proprietary Name i-STAT CHEM8+ cartridge with the i-STAT 1 System
| 510(k) Numbers | K183678 | |
|---|---|---|
| K183688 | ||
| K191298 | ||
| K191360 | ||
| K183680 |
| 510(k) Number | Product code | Device Classification name | Regulation Number | Class | Panel |
|---|---|---|---|---|---|
| K183678 | CGA | Glucose Oxidase, Glucose | 862.1345 | II | Clinical Chemistry |
| CGL | Electrode, Ion Based Enzymatic, Creatinine | 862.1225 | II | Clinical Chemistry | |
| K183688 | JGS | Electrode, Ion Specific, Sodium | 862.1665 | II | Clinical Chemistry |
| CEM | Electrode, Ion Specific, Potassium | 862.1600 | II | Clinical Chemistry | |
| CGZ | Electrode, Ion Specific Chloride | 862.1170 | II | Clinical Chemistry | |
| CDS | Electrode, Ion Specific, Urea Nitrogen | 862.1770 | II | Clinical Chemistry | |
| K191298 | JFL | Bicarbonate, Carbon Dioxide Test System | 862.1160 | II | Clinical Chemistry |
| K191360 | JFP | Electrode, Ion Specific, Calcium | 862.1145 | II | Clinical Chemistry |
| K183680 | JPI | Device, Hematocrit Measuring | 862.6400 | II | Hematology |
4. Device Description
The i-STAT CHEM8+ test cartridge contains test reagents to analyze whole blood at the point of care or in the clinical laboratory for sodium (Na), potassium (K), chloride (CI), ionized calcium (iCa), glucose (Glu), blood urea nitrogen (BUN), creatinine (Crea), hematocrit (Hct), and total carbon dioxide (TCO2). 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.
{5}------------------------------------------------
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. Intended Use Statement
The i-STAT CHEM8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of sodium, potassium, chloride, ionized calcium, glucose, blood urea nitrogen, creatinine, hematocrit, and total carbon dioxide in arterial or venous whole blood in point of care or clinical laboratory settings.
Sodium measurements are used for monitoring electrolyte imbalances.
Potassium measurements are used in the diagnosis and monitoring of diseases and clinical conditions that manifest high and low potassium levels.
Chloride measurements are primarily used in the diagnosis, monitoring, and treatment of electrolyte and metabolic disorders including, but not limited to, cystic fibrosis, diabetic acidosis, and hydration disorders.
Ionized calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
Glucose measurements are used in the diagnosis, monitoring, and treatment of carbohydrate metabolism disorders including, but not limited to, diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.
Blood urea nitrogen measurements are used for the diagnosis, monitoring, and treatment of certain renal and metabolic diseases.
Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
Hematocrit measurements can aid in the determination and monitoring of normal or abnormal total red cell volume status that can be associated with conditions including anemia and erythrocytosis. The i-STAT Hematocrit test has not been evaluated in neonates.
Carbon dioxide measurements are used in the diagnosis, monitoring, and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
{6}------------------------------------------------
6. Reason for Submission
Addition of anticoagulant free (non-anticoagulant) whole blood matrix to previously cleared i-STAT CHEM8+ cartridge with i-STAT 1 System under K183678, K183688, K191298, K191360 and K183680.
| Similarities and Differences | ||
|---|---|---|
| Feature orCharacteristic | Candidate Device: i-STAT CHEM8+cartridge with the i-STAT 1 System | Predicate Device: i-STAT CHEM8+cartridge with the i-STAT 1 System(K183678, K183680, K183688,K191298, K191360) |
| Intended Use | Same | The i-STAT CHEM8+ cartridge with the i-STAT 1 System is intended for use in the invitro quantification of sodium, potassium,chloride, ionized calcium, glucose, bloodurea nitrogen, creatinine, hematocrit, andtotal carbon dioxide in arterial or venouswhole blood in point of care or clinicallaboratory settings. |
| Sodium measurements are used formonitoring electrolyte imbalances. | ||
| Potassium measurements are used in thediagnosis and monitoring of diseases andclinical conditions that manifest high and lowpotassium levels. | ||
| Chloride measurements are primarily used inthe diagnosis, monitoring, and treatment ofelectrolyte and metabolic disordersincluding, but not limited to, cystic fibrosis,diabetic acidosis, and hydration disorders. | ||
| Ionized calcium measurements are used inthe diagnosis and treatment of parathyroiddisease, a variety of bone diseases,chronic renal disease and tetany. | ||
| Glucose measurements are used in thediagnosis, monitoring, and treatment ofcarbohydrate metabolism disordersincluding, but not limited to, diabetesmellitus, neonatal hypoglycemia, idiopathichypoglycemia, and pancreatic islet cellcarcinoma. | ||
| Blood urea nitrogen measurements areused for the diagnosis, monitoring, andtreatment of certain renal and metabolicdiseases. | ||
| Creatinine measurements are used in thediagnosis and treatment of renal diseases, | ||
| Similarities and Differences | ||
| Feature orCharacteristic | Candidate Device: i-STAT CHEM8+cartridge with the i-STAT 1 System | Predicate Device: i-STAT CHEM8+cartridge with the i-STAT 1 System(K183678, K183680, K183688,K191298, K191360) |
| calculation basis for measuring other urineanalytes. | ||
| Hematocrit measurements can aid in thedetermination and monitoring of normal orabnormal total red cell volume status thatcan be associated with conditions includinganemia and erythrocytosis. The i-STATHematocrit test has not been evaluated inneonates.Carbon dioxide measurements are used inthe diagnosis, monitoring, and treatment ofnumerous potentially serious disordersassociated with changes in body acid-basebalance. | ||
| Reportable Range | Same | Reportable Range:Sodium 100-180 mmol/LPotassium 2.0-9.0 mmol/LChloride 65-140 mmol/LIonized 0.25-2.50 mmol/LCalciumGlucose 20-700 mg/dLBUN/Urea 3-140 mg/dLCreatinine 0.2-20.0 mg/dLHematocrit 15-75 %PCVTCO2 5-50 mmol/L |
| Sample Type | Same | Arterial or venous whole blood |
| Sample Volume | Same | 95 μL |
| SamplePreparation | Same | Ready to Use |
| Sample Collection | With balanced heparin anticoagulant With lithium heparin anticoagulant Without anticoagulant | With balanced heparin anticoagulant With lithium heparin anticoagulant |
| TimeTesting/SampleStability(time fromcollection tosample fill) | With anticoagulant:TCO2, iCa within 10 minutesNa, K, Cl, Glu,BUN, Crea, Hct within 30 minutesWithout anticoagulant:TCO2, iCa, Na, K,Cl, Glu, BUN,Crea, Hct within 3 minutes | With anticoagulant:TCO2, iCa within 10 minutesNa, K, Cl, Glu,BUN, Crea, Hct within 30 minutes |
7. Summary Comparison of Technological Characteristics
{7}------------------------------------------------
{8}------------------------------------------------
8. Performance Characteristics
Analytical Performance
a. Precision
Precision 20 days (Aqueous Materials)
Precision of the i-STAT Sodium, Potassium, Chloride, Ionized Calcium, Glucose, Blood Urea Nitrogen, Creatinine, Hematocrit, and Total Carbon Dioxide tests in the i-STAT CHEM8+ cartridge with the i-STAT 1 System was previously reviewed under:
K183678 for Glucose and Creatinine K183680 for Hematocrit K186388 for Sodium, Potassium, Chloride and BUN K191298 for TCO2 K191360 for iCa
Precision (Whole Blood)
Whole blood precision of the i-STAT Sodium, Potassium, Chloride, Ionized Calcium, Glucose, Blood Urea Nitrogen, Creatinine, Hematocrit, and Total Carbon Dioxide tests in the i-STAT CHEM8+ cartridge with the i-STAT 1 System using whole blood venous and arterial specimens collected with lithium heparin was previously reviewed under:
K183678 for Glucose and Creatinine K183680 for Hematocrit K186388 for Sodium, Potassium, Chloride and BUN K191298 for TCO2 K191360 for iCa
b. Linearity
Linearity of the i-STAT Sodium, Potassium, Chloride, Ionized Calcium, Glucose, Blood Urea Nitrogen, Creatinine, Hematocrit, and Total Carbon Dioxide tests in the i-STAT CHEM8+ cartridge with the i-STAT 1 System was previously reviewed under:
K183678 for Glucose and Creatinine K183680 for Hematocrit K186388 for Sodium, Potassium, Chloride and BUN K191298 for TCO2 K191360 for iCa
c. Limit of Quantitation (LoO)
LoQ of the i-STAT Sodium, Potassium, Chloride, Ionized Calcium, Glucose, Blood Urea Nitrogen, Creatinine, Hematocrit, and Total Carbon Dioxide tests in the i-STAT CHEM8+ cartridge with the i-STAT 1 System was previously reviewed under:
{9}------------------------------------------------
K183678 for Glucose and Creatinine K183680 for Hematocrit K186388 for Sodium, Potassium, Chloride and BUN K191298 for TCO2 K191360 for iCa
d. Limit of Blank and Detection (LoB/LoD)
LoB and LoD of the i-STAT Ionized Calcium, Glucose, Creatinine, and Hematocrit tests in the i-STAT CHEM8+ cartridge with the i-STAT 1 System was previously reviewed under:
K183678 for Glucose and Creatinine K183680 for Hematocrit K191360 for iCa
e. Interference
The performance of the i-STAT Sodium, Potassium, Chloride, Ionized Calcium, Glucose, Blood Urea Nitrogen, Creatinine, Hematocrit, and Total Carbon Dioxide tests in the i-STAT CHEM8+ cartridge with the i-STAT 1 System in the presence of potentially interfering substances was previously reviewed under:
K183678 for Glucose and Creatinine K183680 for Hematocrit K186388 for Sodium, Potassium, Chloride and BUN K191298 for TCO2 K191360 for iCa
Comparison Study
f. Method Comparison of Candidate versus Predicate Device
Method comparison of the i-STAT Sodium, Potassium, Chloride, Ionized Calcium, Glucose, Blood Urea Nitrogen, Creatinine, Hematocrit, and Total Carbon Dioxide tests in the i-STAT CHEM8+ cartridge with the i-STAT 1 System using whole blood venous and arterial specimens collected with lithium heparin was previously reviewed under:
K183678 for Glucose and Creatinine K183680 for Hematocrit K186388 for Sodium, Potassium, Chloride and BUN K191298 for TCO2 K191360 for iCa
{10}------------------------------------------------
g. Matrix Equivalence
A matrix equivalence study was conducted at three (3) point of care sites to assess the performance of the i-STAT Sodium, Potassium, Chloride, Ionized Calcium, Glucose, Blood urea nitrogen, Creatinine, Hematocrit, and Total Carbon Dioxide tests in the i-STAT CHEM8+ cartridge on the i-STAT 1 System using non-anticoagulated venous and arterial whole blood samples. The matrix equivalence of each analyte in the i-STAT CHEM8+ cartridge was assessed by comparing samples collected without anticoagulant (candidate) to samples collected with balanced heparin or lithium heparin anticoagulant (primary sample). A Passing-Bablok linear regression analysis was performed using the first replicate result from the candidate (y-axis) versus the mean result from the primary sample (x-axis). The regression analysis results are summarized in the table below.
| Analyte | N | Units | CandidateRange | Primary SampleRange | r | Slope | Intercept |
|---|---|---|---|---|---|---|---|
| Na | 314 | mmol/L | 110 - 174 | 111 - 173 | 0.99 | 1.00 | 0.50 |
| K | 313 | mmol/L | 2.2 - 7.7 | 2.2 - 7.5 | 0.96 | 1.00 | 0.00 |
| Cl | 314 | mmol/L | 76 - 136 | 79 - 137 | 0.98 | 1.00 | -0.50 |
| iCa | 314 | mmol/L | 0.41 - 2.48 | 0.71 - 2.28 | 0.85 | 1.04 | -0.04 |
| Glu | 313 | mg/dL | 29 - 663 | 35 - 660 | 1.00 | 1.01 | -0.63 |
| BUN | 310 | mg/dL | 4 - 120 | 4 - 118 | 1.00 | 1.00 | 0.00 |
| Crea | 312 | mg/dL | 0.2 - 19.4 | 0.2 - 19.4 | 1.00 | 1.00 | 0.00 |
| Hct | 311 | %PCV | 16 - 75 | 16 - 73 | 0.99 | 1.00 | 0.46 |
| TCO2 | 273 | mmol/L | 9 - 42 | 11 - 41 | 0.95 | 1.00 | 0.00 |
The results of the study support the addition of whole blood samples collected without anticoagulant for use with the i-STAT CHEM8+ cartridge on the i-STAT 1 System.
9. Conclusion
The results of the study demonstrate that performance of the i-STAT Sodium, Potassium, Chloride, Ionized Calcium, Glucose, Blood Urea Nitrogen, Creatinine, Hematocrit, and Total Carbon Dioxide tests in the i-STAT CHEM8+ cartridge with the i-STAT 1 System are substantially equivalent when tested using the anticoagulated and nonanticoagulated sample type.
§ 862.1345 Glucose test system.
(a)
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.(b)
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.