(406 days)
The i-STAT CHEM8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of sodium, potassium, chloride and blood urea nitrogen 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.
Blood urea nitrogen measurements are used for the diagnosis, monitoring, and treatment of certain renal and metabolic diseases.
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, potassium, chloride and blood urea nitrogen. The test is contained in a single-use, disposable 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 i-STAT CHEM8+ cartridge with the i-STAT 1 System is intended for in vitro quantification of sodium, potassium, chloride, and blood urea nitrogen (BUN) in arterial or venous whole blood in point-of-care or clinical laboratory settings.
Here's an analysis of the acceptance criteria and the study results:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the precision and method comparison studies aiming to demonstrate substantial equivalence to a predicate device (Beckman DxC). While explicit "acceptance criteria" are not listed in terms of specific thresholds for precision or correlation, the studies aim to show that the i-STAT CHEM8+ performs comparably to the predicate. The "Reportable Range" serves as one aspect of the acceptance criteria for each analyte.
| Analyte | Acceptance Criteria (Reportable Range) | Reported Device Performance (Precision) - Aqueous Materials (Total CV) | Reported Device Performance (Precision) - Whole Blood (Total %CV) (Range) | Reported Device Performance (Method Comparison - Correlation (r)) |
|---|---|---|---|---|
| Sodium | 100 - 180 mmol/L | 0.2% - 0.3% | 0.2% - 0.5% | 0.96 |
| Potassium | 2.0 - 9.0 mmol/L | 0.3% - 0.4% | 0.0% - 1.9% | 0.99 |
| Chloride | 65 - 140 mmol/L | 0.4% - 0.7% | 0.2% - 1.2% | 0.96 |
| BUN | 3 - 140 mg/dL | 0.8% - 3.7% | 0.0% - 9.4% | 0.99 |
Interference:
- Sodium: Increased results ≥ 3.1 mmol/L with Sodium Thiosulfate.
- Potassium: No identified interferents from the tested substances.
- Chloride: Increased results ≥ 2.4 mmol/L with Lithium Bromide, Increased results ≥ 4.19 mmol/L with Sodium Thiosulfate.
- BUN: Increased results ≥ 10.2 mmol/L with Triglyceride.
Limit of Quantitation (LoQ):
- Sodium: 91 mmol/L
- Potassium: 1.5 mmol/L
- Chloride: 56 mmol/L
- BUN: 1 mg/dL
2. Sample Sizes and Data Provenance
-
Precision (Aqueous Materials):
- Sample Size: 80 or 81 data points for each of 5 levels per analyte (e.g., 81 for Sodium CV L1, 80 for Sodium CV L4). This study was conducted using multiple instruments and one test cartridge lot (implied prospective, in-house laboratory study).
- Data Provenance: Not explicitly stated as country of origin, but implies an in-house or specialized laboratory setting. It is a prospective analytical study.
-
Precision (Whole Blood):
- Sample Size: 21 test results per sample per instrument (total of 21 test results per sample). This study involved at least 3 levels per analyte, 3 point of care sites, and 7 i-STAT 1 Analyzers. The number of unique whole blood samples is not specified, but the total number of measurements is significant (e.g., for Sodium, there are 19 rows of data, each representing a mean derived from 20 or 21 measurements).
- Data Provenance: Not explicitly stated as country of origin, but indicates multiple point-of-care sites. This is a prospective analytical study.
-
Linearity:
- Sample Size: Not explicitly stated as a number of individual samples, but involves preparing "whole blood samples of varying analyte levels that spanned the reportable range of the tests."
- Data Provenance: Implied laboratory-based prospective analytical study.
-
Limit of Quantitation (LoQ):
- Sample Size: Not explicitly stated, but involved whole blood samples (and plasma for Chloride) altered to low concentrations and two test cartridge lots.
- Data Provenance: Implied laboratory-based prospective analytical study.
-
Interference:
- Sample Size: Not explicitly stated ("whole blood samples").
- Data Provenance: Implied laboratory-based prospective analytical study.
-
Method Comparison:
- Sample Size:
- Sodium: N=187
- Potassium: N=189
- Chloride: N=176
- BUN: N=184
- Data Provenance: Venous and arterial blood specimens were evaluated. Not explicitly stated as country of origin, but indicates clinical laboratory settings. This is a prospective analytical study comparing the i-STAT 1 System to the Beckman DxC.
- Sample Size:
3. Number of Experts and Qualifications for Ground Truth
This type of device (in vitro diagnostic for laboratory analytes) does not typically involve human expert adjudication for ground truth. The "ground truth" for analytical performance studies is established by:
- The reference method (Beckman DxC in the method comparison study).
- Precisely prepared calibrators or control materials with known concentrations (for precision, linearity, LoQ, and interference studies).
- NIST Standard Reference Materials (SRM) were used for traceability and calibration (NIST SRM 918, 919, 956, 912, 909).
4. Adjudication Method for the Test Set
Not applicable, as this is an analytical device for quantitative measurements, not an imaging device requiring expert clinical interpretation. The ground truth is established by reference measurement systems and documented analytical methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done. This type of study is typically for evaluating the performance of diagnostic imaging devices that rely on human interpretation, often with and without AI assistance. This device is an in vitro diagnostic (IVD) analyzer that provides quantitative results.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
Yes, the studies presented (precision, linearity, LoQ, interference, and method comparison) represent the standalone performance of the i-STAT CHEM8+ cartridge with the i-STAT 1 System. The device provides a direct quantitative measurement without human interpretation of its internal algorithm's output in the manner implied by "human-in-the-loop performance" for AI/ML devices.
7. The Type of Ground Truth Used
The ground truth for the analytical performance studies was established using:
- Reference instrumentation run by trained laboratory personnel: For the method comparison, the Beckman DxC clinical analyzer served as the comparative method.
- Prepared aqueous and whole blood materials with known analyte concentrations: Used for precision, linearity, LoQ, and interference studies.
- NIST Standard Reference Materials (SRM): Used for traceability and calibration.
8. The Sample Size for the Training Set
Not applicable. This device is a traditional in vitro diagnostic device, not an AI/ML device that requires a "training set" in the machine learning sense. The "training" for such devices typically refers to the development and optimization of the electrochemical sensors and algorithms during the R&D phase, which is not described in terms of a quantifiable "training set size" in a regulatory submission for a traditional IVD.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" in the AI/ML context for this traditional IVD device. The accuracy of the device's measurement principles is established through rigorous analytical verification and validation using reference materials and comparative methods, as detailed in the performance characteristics section.
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February 7, 2020
Abbott Point of Care Inc. Susan Tibedo Director, Regulatory Affairs 400 College Road East Princeton, NJ 08540
Re: K183688
Trade/Device Name: i-STAT CHEM8+ cartridge with the i-STAT 1 System Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium Test System Regulatory Class: Class II Product Code: JGS, CDS, CEM, CGZ Dated: January 9, 2020 Received: January 10, 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
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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 (OS) 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 mediation-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,
Kellie Kelm, Ph.D. Acting 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) K183688
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 intended for use in the in vitro quantification of sodium, potassium, chloride and blood urea nitrogen 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.
Blood urea nitrogen measurements are used for the diagnosis, monitoring, and treatment of certain renal and metabolic diseases.
| 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.400 College Road EastPrinceton, NJ 08540 |
| Contact | Primary: Susan TibedoDirector Regulatory Affairssusan.tibedo@abbott.comPhone: 609-454-9360Secondary: Maria FigueroaManager Regulatory Affairsmaria.l.figueroa@abbott.comPhone: 609-454-9271 |
| Date Prepared | February 5, 2020 |
| 510(k) Number | K183688 |
2. Device Information
| Proprietary Name | i-STAT CHEM8+ cartridge with i-STAT 1 System |
|---|---|
| Common Name | Chemistry test, analyzer, handheld |
| Productcode | Device Classificationname | RegulationNumber | Class | Panel |
|---|---|---|---|---|
| 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 |
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3. Predicate Device
Proprietary Name SYNCHRON Systems Sodium Reagent on UniCel DxC 600/800 SYNCHRON Clinical System
SYNCHRON Systems Potassium Reagent on UniCel DxC 600/800 SYNCHRON Clinical System
SYNCHRON Systems Chloride Reagent on UniCel DxC 600/800 SYNCHRON Clinical System
SYNCHRON Systems BUN Reagent on UniCel DxC 600/800 SYNCHRON Clinical System
510(k) Number K042291
| Productcode | Device Classificationname | RegulationNumber | Class | Panel |
|---|---|---|---|---|
| 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 |
| LFP | Conductivity Rate, UreaNitrogen | 862.1770 | II | Clinical Chemistry |
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, potassium, chloride and blood urea nitrogen. The test is contained in a single-use, disposable 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 CHEM8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of sodium, potassium, chloride and blood urea nitrogen 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.
Blood urea nitrogen measurements are used for the diagnosis, monitoring, and treatment of certain renal and metabolic diseases.
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| Similarities and Differences: System (Test and Instrument) for Sodium | ||
|---|---|---|
| Feature orCharacteristic | PredicateSYNCHRON Systems SodiumReagent on UniCel DxC 600/800SYNCHRON Clinical System(K042291) | CandidateSodium Test with i-STAT 1System |
| Intended Use | The sodium test systems are intendedfor the quantitative determination ofsodium concentration in humanserum, plasma or urine.Sodium measurements are used in thediagnosis and treatment ofaldosteronism (excessive secretion ofhormone aldosterone), diabetesinsipidus, adrenal hypertension,Addison's disease, dehydration,inappropriate antidiuretic hormonesecretion, or other diseases involvingelectrolyte imbalance. | The i-STAT CHEM8+ cartridge withthe i-STAT 1 System is intended foruse in the in vitro quantification ofsodium, potassium, chloride and bloodurea nitrogen in arterial or venouswhole blood in point of care or clinicallaboratory settings.Sodium measurements are used formonitoring electrolyte imbalances. |
| Reportable Range | 100-200 mmol/L (Serum or Plasma)10-300 mmol/L (Urine) | Sodium: 100-180 mmol/L (mEq/L) |
| Sample Type | Serum, plasma, urine | Arterial or venous whole blood |
| Sample Volume | 0.5 mL (500 $ μ $ L) | 95 $ μ $ L |
| Preparation | Sample tubes prepared and thenprocessed within analyzer | Ready to Use |
| TraceabilityCalibration | NIST SRM 919Must be conducted every 24 hours andwith each new reagent | NIST SRM 9561-point on-board contained within thecartridge |
| Time to Test(Sample Stability) | Serum or plasma: Within 8 hours atroom temperature, or up to 48 hours ifstored at +2°C to +8°CUrine: Within 2 hours of collection | Heparinized samples: within 30minutes of collection |
| Principle ofMeasurement | Ion selective electrode | Ion selective electrode |
| Reagent Format | Reagent handling system, storedwithin analyzer | Cartridge |
| Reagent Storageand Stability | Room temperature | 2°C to 8°C (35-46°F) |
| Similarities and Differences: System (Test and Instrument) for Potassium | ||
| Feature orCharacteristic | PredicateSYNCHRON Systems PotassiumReagent on UniCel DxC 600/800SYNCHRON Clinical System(K042291) | CandidatePotassium Test with i-STAT 1System |
| Intended Use | The potassium test systems areintended the quantitativedetermination of potassiumconcentration in human serum, plasmaor urine.Potassium measurements are used inthe diagnosis and treatment ofhypokalemia (metabolic alkalosis,metabolic acidosis or the absence ofacid-base disturbances), hyperkalemia(over administration of potassium,acidosis, or crush injuries), renalfailure, Addison's disease or otherdiseases involving electrolyteimbalance. | The i-STAT CHEM8+ cartridge withthe i-STAT 1 System is intended foruse in the in vitro quantification ofsodium, potassium, chloride and bloodurea nitrogen in arterial or venouswhole blood in point of care or clinicallaboratory settingsPotassium measurements are used inthe diagnosis and monitoring ofdiseases and clinical conditions thatmanifest high and low potassiumlevels. |
| Reportable Range | 1-15.0 mmol/L (Serum or Plasma) | 2.0 - 9.0 mmol/L (mEq/L) |
| Sample Type | Serum, plasma, urine | Arterial or venous whole blood |
| Sample Volume | 0.5 mL (500 µL) | 95 µL |
| SamplePreparation | Sample tubes prepared and thenprocessed within analyzer | Ready to Use |
| Traceability | NIST SRM 918 | NIST SRM 956 |
| Calibration | Must be conducted every 24 hours andwith each new reagent | 1-point on-board contained within thecartridge |
| Time to Test(Sample Stability) | Serum or plasma: Within 8 hours atroom temperature, or up to 48 hours ifstored at +2°C to +8°CUrine: Within 2 hours of collection | Non-anticoagulated samples: within 3minutes of collectionHeparinized samples: within 30minutes of collection |
| Principle ofMeasurement | Ion selective electrode | Ion selective electrode |
| Reagent Format | Reagent handling system, storedwithin analyzer | Cartridge |
| Reagent Storageand Stability | Room temperature | 2°C to 8°C (35-46°F) |
| Analyzer Type | Floor Model | Handheld |
| Similarities and Differences: System (Test and Instrument) for Chloride | ||
| Feature orCharacteristic | PredicateSYNCHRON Systems ChlorideReagent on UniCel DxC 600/800SYNCHRON Clinical System(K042291) | CandidateChloride Test with i-STAT 1System |
| Intended Use | The chloride test systems are intendedfor the quantitative determination ofchloride concentration in human serum,plasma, urine or cerebrospinal fluid(CSF).Chloride measurements are used in thediagnosis and treatment of electrolyteand metabolic disorders such as cysticfibrosis and diabetic acidosis. | The i-STAT CHEM8+ cartridgewith the i-STAT 1 System isintended for use in the in vitroquantification of sodium, potassium,chloride and blood urea nitrogen inarterial or venous whole blood inpoint of care or clinical laboratorysettings.Chloride measurements are primarilyused in the diagnosis, monitoring,and treatment of electrolyte andmetabolic disorders including, butnot limited to, cystic fibrosis,diabetic acidosis, and hydrationdisorders. |
| Reportable Range | 50-200 mmol/L (Serum or Plasma) | 65-140 mmol/L (mEq/L) |
| Sample Type | Serum, plasma, urine | Arterial or, venous whole blood |
| Sample Volume | 0.5 mL (500 µL) | 95 µL |
| Sample | Sample tubes prepared and then | Ready to Use |
| Preparation | processed within analyzer | |
| Traceability | NIST SRM 918/919 | NIST SRM 956 |
| Calibration | Must be conducted every 24 hours andwith each new reagent | 1-point on-board contained withinthe cartridge |
| Time to Test(Sample Stability) | Serum or plasma: Within 8 hours atroom temperature, or up to 48 hours ifstored at +2°C to +8°CUrine: Within 2 hours of collection | Non-anticoagulated samples: within3 minutes of collectionHeparinized samples: within 30minutes of collection |
| Principle ofMeasurement | Ion selective electrode | Ion selective electrode |
| Reagent Format | Reagent handling system, stored withinanalyzer | Cartridge |
| Reagent Storageand Stability | Room temperature | 2°C to 8°C (35-46°F) |
| Analyzer Type | Floor Model | Handheld |
| Feature orCharacteristic | PredicateSYNCHRON Systems BUNReagent on UniCel DxC 600/800SYNCHRON Clinical System(K042291) | CandidateBUN Test with i-STAT 1System |
| Intended Use | The blood urea nitrogen (BUN) testsystems are intended for thequantitative determination of ureanitrogen or urea concentration inhuman serum, plasma or urine.Urea nitrogen or urea measurements areused in the diagnosis and treatment ofcertain renal and metabolic diseases. | The i-STAT CHEM8+ cartridge withthe i-STAT 1 System is intended foruse in the in vitro quantification ofsodium, potassium, chloride andblood urea nitrogen in arterial orvenous whole blood in point of careor clinical laboratory settingsBlood urea nitrogen measurementsare used for the diagnosis,monitoring, and treatment of certainrenal and metabolic diseases. |
| Reportable Range | 1-150 mg/dL (Serum or Plasma)10-1500 mg/dL (Urine) | 3-140 mg/dL |
| Sample Type | Serum, plasma, urine | Arterial or venous whole blood |
| Sample Volume | 0.5 mL (500 μL) | 95 µL |
| Sample Preparation | Sample tubes prepared and thenprocessed within analyzer | Ready to Use |
| Traceability | NIST SRM 912 | NIST SRM 909 |
| Calibration | Must be conducted every 24 hours andwith each new reagent | 1-point on-board contained withinthe cartridge |
| Time to Test(Sample Stability) | Serum or plasma: Within 8 hours atroom temperature, or up to 48 hours at+2°C to +8°CUrine: Within 2 hours of collection | Non-anticoagulated samples: within3 minutes of collectionHeparinized samples: within 30minutes of collection |
| Principle ofMeasurement | Conductivity | Ion selective electrode |
| Reagent Format | Reagent handling system, stored withinanalyzer | Cartridge |
| Reagent Storageand Stability | 2°C to 8°C (35-46°F) | 2°C to 8°C (35-46°F) |
| Analyzer Type | Floor Model | Handheld |
-
- Summary Comparison of Technological Characteristics
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7. Performance Characteristics
Analytical Performance
- a. Precision
Precision 20 days (Aqueous Materials)
The precision of the i-STAT Potassium, Chloride, and BUN Tests on the i-STAT 1 Analyzer were 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
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was conducted using multiple instruments and one test cartridge lot over 20 days at one site. Total precision ('within-laboratory', Sr), within-run, (Sr), between-run, (Sm) and between-day, (Saa) were estimated for each level. The results of the 20-day precision study are shown in Table 1.
| Table 1: 20-day Precision Study Results (i-STAT 1 Analyzer) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| i-STATTest | FluidLevel | N | Mean | ST | Total | Within-run | Between-run | Between-day | ||||
| CVT(%) | Sr | CVr(%) | Srr | CVrr(%) | Sdd | CVdd(%) | ||||||
| Sodium(mmol/L) | CV L1 | 81 | 100.0 | 0.27 | 0.3 | 0.25 | 0.3 | 0.07 | 0.1 | 0.07 | 0.1 | |
| CV L2 | 81 | 121.6 | 0.35 | 0.3 | 0.33 | 0.3 | 0.09 | 0.1 | 0.10 | 0.1 | ||
| CV L3 | 81 | 134.8 | 0.31 | 0.2 | 0.28 | 0.2 | 0.09 | 0.1 | 0.10 | 0.1 | ||
| CV L4 | 80 | 160.4 | 0.41 | 0.3 | 0.39 | 0.2 | 0.10 | 0.1 | 0.10 | 0.1 | ||
| CV L5 | 80 | 178 | 0.42 | 0.2 | 0.40 | 0.2 | 0.10 | 0.1 | 0.11 | 0.1 | ||
| Potassium(mmol/L) | CV L1 | 81 | 2.07 | 0.006 | 0.3 | 0.006 | 0.3 | 0.001 | 0.05 | 0.002 | 0.1 | |
| CV L2 | 81 | 2.83 | 0.011 | 0.4 | 0.011 | 0.4 | 0.003 | 0.1 | 0.002 | 0.1 | ||
| CV L3 | 81 | 3.69 | 0.010 | 0.3 | 0.008 | 0.2 | 0.004 | 0.1 | 0.003 | 0.1 | ||
| CV L4 | 80 | 6.17 | 0.018 | 0.3 | 0.017 | 0.3 | 0.002 | 0.03 | 0.007 | 0.1 | ||
| CV L5 | 80 | 7.75 | 0.033 | 0.4 | 0.027 | 0.3 | 0.017 | 0.2 | 0.009 | 0.1 | ||
| Chloride(mmol/L) | CV L1 | 81 | 70.9 | 0.47 | 0.7 | 0.43 | 0.6 | 0.12 | 0.2 | 0.12 | 0.2 | |
| CV L2 | 81 | 76.2 | 0.53 | 0.7 | 0.50 | 0.7 | 0.13 | 0.2 | 0.13 | 0.2 | ||
| CV L3 | 81 | 89.2 | 0.33 | 0.4 | 0.29 | 0.3 | 0.08 | 0.1 | 0.12 | 0.1 | ||
| CV L4 | 80 | 107.9 | 0.43 | 0.4 | 0.40 | 0.4 | 0.11 | 0.1 | 0.12 | 0.1 | ||
| CV L5 | 80 | 122.3 | 0.48 | 0.4 | 0.44 | 0.4 | 0.15 | 0.1 | 0.12 | 0.1 | ||
| BUN(mg/dL) | CV L1 | 81 | 107.3 | 0.91 | 0.8 | 0.81 | 0.8 | 0.41 | 0.4 | 0.04 | 0.04 | |
| CV L2 | 81 | 59.7 | 0.92 | 1.5 | 0.86 | 1.4 | 0.23 | 0.4 | 0.20 | 0.3 | ||
| CV L3 | 81 | 10.5 | 0.12 | 1.1 | 0.11 | 1.0 | 0.05 | 0.5 | 0.03 | 0.3 | ||
| CV L4 | 80 | 8.1 | 0.18 | 2.2 | 0.17 | 2.1 | 0.03 | 0.4 | 0.05 | 0.6 | ||
| CV L5 | 80 | 4.1 | 0.15 | 3.7 | 0.14 | 3.4 | 0.04 | 1.0 | 0.03 | 0.7 |
Precision (Whole Blood)
The whole blood precision of the i-STAT Sodium, Potassium, Chloride, and BUN Tests on i-STAT 1 Analyzer were evaluated using venous whole blood (native or altered) samples targeted to three levels within the test reportable range.
One test cartridge lot was used across 3 point of care sites. At each site, each sample was tested 3 times on each of 7 i-STAT 1 Analyzers (total of 21 test results per sample per instrument). The results of the whole blood precision using the i-STAT 1 Analyzer are shown in Table 2.
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| Table 2: Whole Blood Precision Results - i-STAT 1 Wireless Analyzer | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| i-STATTest | Level | Site | N | Mean | Within-Analyzer | Total | ||||
| SD | %CV | SD | SD 95% CI | %CV | %CV 95% CI | |||||
| ≤ 134 | 01 | 21 | 110.3 | 0.49 | 0.4 | 0.49 | 0.39 to 0.78 | 0.4 | 0.4 to 0.7 | |
| 02 | 21 | 123.9 | 0.38 | 0.3 | 0.38 | 0.31 to 0.57 | 0.3 | 0.3 to 0.5 | ||
| 03 | 21 | 108.3 | 0.44 | 0.4 | 0.49 | 0.39 to 0.84 | 0.5 | 0.4 to 0.8 | ||
| Sodium(mmol/L) | 01 | 21 | 139.2 | 0.58 | 0.4 | 0.58 | 0.48 to 0.83 | 0.4 | 0.3 to 0.6 | |
| 01 | 21 | 138.0 | 0.22 | 0.2 | 0.22 | 0.17 to 0.35 | 0.2 | 0.1 to 0.3 | ||
| 01 | 21 | 136.5 | 0.65 | 0.5 | 0.68 | 0.54 to 1.13 | 0.5 | 0.4 to 0.8 | ||
| 02 | 20 | 138.3 | 0.45 | 0.3 | 0.45 | 0.36 to 0.73 | 0.3 | 0.3 to 0.5 | ||
| 02 | 14 | 141.8 | 0.46 | 0.3 | 0.46 | 0.38 to 0.81 | 0.3 | 0.3 to 0.6 | ||
| 02 | 21 | 141.9 | 0.31 | 0.2 | 0.31 | 0.25 to 0.48 | 0.2 | 0.2 to 0.3 | ||
| 02 | 21 | 140.0 | 0.38 | 0.3 | 0.38 | 0.31 to 0.63 | 0.3 | 0.2 to 0.5 | ||
| 135-145 | 02 | 21 | 138.9 | 0.44 | 0.3 | 0.48 | 0.38 to 0.83 | 0.3 | 0.3 to 0.6 | |
| 02 | 21 | 138.3 | 0.53 | 0.4 | 0.53 | 0.44 to 0.76 | 0.4 | 0.3 to 0.5 | ||
| 03 | 21 | 140.9 | 0.31 | 0.2 | 0.36 | 0.29 to 0.64 | 0.3 | 0.2 to 0.5 | ||
| 03 | 21 | 141.0 | 0.22 | 0.2 | 0.22 | 0.17 to 0.35 | 0.2 | 0.1 to 0.2 | ||
| 03 | 21 | 142.1 | 0.31 | 0.2 | 0.31 | 0.25 to 0.48 | 0.2 | 0.2 to 0.3 | ||
| 03 | 21 | 143.0 | 0.22 | 0.2 | 0.22 | 0.17 to 0.35 | 0.2 | 0.1 to 0.2 | ||
| 03 | 21 | 139.8 | 0.44 | 0.3 | 0.44 | 0.35 to 0.71 | 0.3 | 0.3 to 0.5 | ||
| ≥ 146 | 01 | 21 | 150.1 | 0.62 | 0.4 | 0.62 | 0.51 to 0.88 | 0.4 | 0.3 to 0.6 | |
| 02 | 21 | 163.2 | 0.49 | 0.3 | 0.49 | 0.40 to 0.70 | 0.3 | 0.2 to 0.4 | ||
| 03 | 21 | 150.1 | 0.38 | 0.3 | 0.38 | 0.31 to 0.57 | 0.3 | 0.2 to 0.4 | ||
| Potassium(mmol/L) | 2.75-3.25 | 1 | 21 | 2.80 | 0.022 | 0.8 | 0.022 | 0.017 to 0.035 | 0.8 | 0.6 to 1.3 |
| 2 | 21 | 2.80 | 0.000 | 0.0 | 0.000 | 0.000 to 0.000 | 0.0 | 0.0 to 0.0 | ||
| 3 | 21 | 3.05 | 0.058 | 1.9 | 0.058 | 0.048 to 0.083 | 1.9 | 1.6 to 2.7 | ||
| 1 | 21 | 4.30 | 0.000 | 0.0 | 0.000 | 0.000 to 0.000 | 0.0 | 0.0 to 0.0 | ||
| 1 | 21 | 4.00 | 0.022 | 0.6 | 0.022 | 0.017 to 0.035 | 0.6 | 0.4 to 0.9 | ||
| 1 | 21 | 3.98 | 0.049 | 1.2 | 0.049 | 0.040 0.070 | 1.2 | 1.0 to 1.8 | ||
| 2 | 20 | 4.95 | 0.059 | 1.2 | 0.059 | 0.049 to 0.085 | 1.2 | 1.0 to 1.7 | ||
| 2 | 14 | 4.20 | 0.000 | 0.0 | 0.000 | 0.000 to 0.000 | 0.0 | 0.0 to 0.0 | ||
| 2 | 21 | 4.13 | 0.053 | 1.3 | 0.053 | 0.044 to 0.076 | 1.3 | 1.1 to 1.8 | ||
| >3.25 -<5.55 | 2 | 21 | 4.24 | 0.058 | 1.4 | 0.058 | 0.048 to 0.082 | 1.4 | 1.1 to 1.9 | |
| 2 | 21 | 4.29 | 0.038 | 0.9 | 0.038 | 0.031 to 0.057 | 0.9 | 0.7 to 1.3 | ||
| 2 | 21 | 4.10 | 0.000 | 0.0 | 0.000 | 0.000 to 0.000 | 0.0 | 0.0 to 0.0 | ||
| 3 | 21 | 4.80 | 0.031 | 0.6 | 0.032 | 0.025 to 0.052 | 0.7 | 0.5 to 1.1 | ||
| 3 | 21 | 3.97 | 0.053 | 1.3 | 0.053 | 0.044 to 0.078 | 1.3 | 1.1 to 2.0 | ||
| 3 | 21 | 4.00 | 0.000 | 0.0 | 0.000 | 0.000 to 0.000 | 0.0 | 0.0 to 0.0 | ||
| 3 | 21 | 3.40 | 0.000 | 0.0 | 0.000 | 0.000 to 0.000 | 0.0 | 0.0 to 0.0 | ||
| 1 | 21 | 5.80 | 0.022 | 0.4 | 0.022 | 0.017 to 0.035 | 0.4 | 0.3 to 0.6 | ||
| 5.55 -6.05 | 2 | 21 | 5.85 | 0.058 | 1.0 | 0.058 | 0.048 to 0.083 | 1.0 | 0.8 to 1.4 | |
| 3 | 21 | 5.71 | 0.038 | 0.7 | 0.038 | 0.031 to 0.057 | 0.7 | 0.5 to 1.0 | ||
| 1 | 21 | 7.60 | 0.000 | 0.0 | 0.000 | 0.000 to 0.000 | 0.0 | 0.0 to 0.0 | ||
| 7.25 -7.75 | 2 | 21 | 7.64 | 0.053 | 0.7 | 0.053 | 0.044 to 0.081 | 0.7 | 0.6 to 1.1 | |
| 3 | 21 | 7.73 | 0.053 | 0.7 | 0.053 | 0.044 to 0.078 | 0.7 | 0.6 to 1.0 | ||
| Table 2: Whole Blood Precision Results - i-STAT 1 Wireless Analyzer | ||||||||||
| i-STATTest | Level | Site | N | Mean | Within-Analyzer | Total | ||||
| SD | %CV | SD | SD 95% CI | %CV | %CV 95% CI | |||||
| <80 | 01 | 21 | 77.0 | 0.53 | 0.7 | 0.53 | 0.44 to 0.80 | 0.7 | 0.6 to 1.0 | |
| 02 | 21 | 77.4 | 0.95 | 1.2 | 0.95 | 0.78 to 1.40 | 1.2 | 1.0 to 1.8 | ||
| 03 | 21 | 76.9 | 0.62 | 0.8 | 0.66 | 0.53 to 1.11 | 0.9 | 0.7 to 1.4 | ||
| 01 | 21 | 102.0 | 0.62 | 0.6 | 0.62 | 0.51 to 0.89 | 0.6 | 0.5 to 0.9 | ||
| 01 | 21 | 97.0 | 0.31 | 0.3 | 0.32 | 0.25 to 0.52 | 0.3 | 0.3 to 0.5 | ||
| 01 | 21 | 102.3 | 0.53 | 0.5 | 0.53 | 0.44 to 0.78 | 0.5 | 0.4 to 0.8 | ||
| 02 | 21 | 100.2 | 0.32 | 0.3 | 0.37 | 0.29 to 0.66 | 0.4 | 0.3 to 0.7 | ||
| 02 | 21 | 101.3 | 0.53 | 0.5 | 0.53 | 0.44 to 0.90 | 0.5 | 0.4 to 0.9 | ||
| 02 | 21 | 103.5 | 0.38 | 0.4 | 0.52 | 0.40 to 0.99 | 0.5 | 0.4 to 1.0 | ||
| Chloride(mmol/L) | 90-112 | 02 | 21 | 102.1 | 0.31 | 0.3 | 0.31 | 0.25 to 0.48 | 0.3 | 0.2 to 0.5 |
| 02 | 21 | 101.4 | 0.44 | 0.4 | 0.51 | 0.41 to 0.91 | 0.5 | 0.4 to 0.9 | ||
| 02 | 21 | 101.0 | 0.22 | 0.2 | 0.22 | 0.17 to 0.35 | 0.2 | 0.2 to 0.3 | ||
| 03 | 21 | 104.0 | 0.49 | 0.5 | 0.50 | 0.40 to 0.82 | 0.5 | 0.4 to 0.8 | ||
| 03 | 21 | 104.0 | 0.62 | 0.6 | 0.62 | 0.50 to 0.95 | 0.6 | 0.5 to 0.9 | ||
| 03 | 21 | 103.1 | 0.49 | 0.5 | 0.54 | 0.43 to 0.94 | 0.5 | 0.4 to 0.9 | ||
| 03 | 21 | 101.0 | 0.31 | 0.3 | 0.32 | 0.25 to 0.52 | 0.3 | 0.2 to 0.5 | ||
| 03 | 21 | 99.8 | 0.44 | 0.4 | 0.44 | 0.36 to 0.64 | 0.4 | 0.4 to 0.6 | ||
| 01 | 21 | 126.1 | 0.58 | 0.5 | 0.58 | 0.47 to 0.86 | 0.5 | 0.4 to 0.7 | ||
| >120 | 02 | 21 | 123.8 | 0.69 | 0.6 | 0.69 | 0.57 to 0.98 | 0.6 | 0.5 to 0.8 | |
| 03 | 21 | 123.2 | 0.44 | 0.4 | 0.55 | 0.43 to 1.00 | 0.4 | 0.3 to 0.8 | ||
| 01 | 21 | 5.0 | 0.00 | 0.0 | 0.00 | 0.00 to 0.00 | 0.0 | 0.0 to 0.0 | ||
| < 10 | 01 | 21 | 5.5 | 0.49 | 8.9 | 0.51 | 0.41 to 0.86 | 9.4 | 7.5 to 15.6 | |
| 02 | 21 | 7.0 | 0.00 | 0.0 | 0.00 | 0.00 to 0.00 | 0.0 | 0.0 to 0.0 | ||
| 03 | 21 | 6.9 | 0.31 | 4.5 | 0.36 | 0.29 to 0.64 | 5.3 | 4.2 to 9.3 | ||
| BUN(mg/dL) | 01 | 21 | 14.0 | 0.00 | 0.0 | 0.00 | 0.00 to 0.00 | 0.0 | 0.0 to 0.0 | |
| 02 | 20 | 18.0 | 0.23 | 1.3 | 0.23 | 0.18 to 0.37 | 1.3 | 1.0 to 2.1 | ||
| 10-25 | 02 | 14 | 23.5 | 0.60 | 2.5 | 0.60 | 0.50 to 1.00 | 2.5 | 2.1 to 4.3 | |
| 02 | 21 | 20.9 | 0.38 | 1.8 | 0.38 | 0.31 to 0.57 | 1.8 | 1.5 to 2.7 | ||
| 02 | 21 | 10.0 | 0.00 | 0.0 | 0.00 | 0.00 to 0.00 | 0.0 | 0.0 to 0.0 | ||
| 03 | 21 | 11.0 | 0.22 | 2.0 | 0.22 | 0.17 to 0.35 | 2.0 | 1.5 to 3.2 | ||
| 03 | 21 | 14.0 | 0.00 | 0.0 | 0.00 | 0.00 to 0.00 | 0.0 | 0.0 to 0.0 | ||
| 03 | 21 | 13.9 | 0.31 | 2.2 | 0.31 | 0.25 to 0.48 | 2.2 | 1.8 to 3.5 | ||
| 01 | 21 | 38.0 | 0.44 | 1.1 | 0.50 | 0.40 to 0.88 | 1.3 | 1.1 to 2.3 | ||
| 25-50 | 02 | 21 | 46.0 | 1.11 | 2.4 | 1.12 | 0.89 to 1.81 | 2.4 | 1.9 to 3.9 | |
| 03 | 21 | 27.8 | 0.62 | 2.2 | 0.71 | 0.56 to 1.24 | 2.6 | 2.0 to 4.5 | ||
| 01 | 21 | 111.8 | 2.82 | 2.5 | 2.82 | 2.31 to 4.20 | 2.5 | 2.1 to 3.8 | ||
| > 110 | 02 | 21 | 125.0 | 1.72 | 1.4 | 1.97 | 1.56 to 3.44 | 1.6 | 1.2 to 2.8 | |
| 03 | 21 | 118.6 | 1.83 | 1.5 | 1.83 | 1.50 to 2.71 | 1.5 | 1.3 to 2.3 |
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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 Sodium, Potassium, Chloride, and BUN tests on the i-STAT 1 Analyzer was evaluated by preparing whole blood samples of varying analyte levels that spanned the reportable range of the tests. The i-STAT Sodium, Potassium, Chloride, and BUN tests demonstrated linearity over the reportable range as shown in Table 3. Regression summary of the Sodium, Potassium, Chloride, and BUN response
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| Table 3: Regression Summary for the i-STAT tests on the i-STAT 1 Analyzer | |||||
|---|---|---|---|---|---|
| i-STAT Test | ReportableRange | Range Tested | Slope | Intercept | R2 |
| Sodium (mmol/L) | 100 - 180 | 89 – 205 | 1.077 | -5.244 | 0.9994 |
| Potassium (mmol/L) | 2.0 - 9.0 | 1.7 – 10.4 | 1.109 | -0.136 | 0.9999 |
| Chloride (mmol/L) | 65 - 140 | 76 – 158 WB54 – 157 Plasma | 0.8670.969 | 7.3532.130 | 0.99830.9987 |
| BUN (mg/dL) | 3 - 140 | 2 - 143 | 0.946 | 0.209 | 0.9950 |
versus the concentration of the whole blood samples of varying analyte levels is also provided in Table 3.
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 LoQs of the i-STAT Sodium, Potassium and BUN tests were evaluated on the i-STAT 1 Analyzer using whole blood that was altered to low sodium (<100 mmol/L), potassium (< 2.0 mmol/L), or BUN (<3 mg/dL) concentrations and two test cartridge lots. For Chloride, plasma samples that were altered to <65 mmol/L were evaluated as whole blood samples altered to achieve a chloride concentration <65 mmol/L have been found to hemolyze. The LoQs for the i-STAT Sodium Potassium, Chloride, and BUN tests on the i-STAT 1 Analyzer were determined to be 91 mmol/L, 1.5 mmol/L, 56 mmol/L, and 1 mg/dL, respectively.
d. Interference
The interference performance of the i-STAT Sodium, Potassium, Chloride, and BUN tests on the i-STAT 1 System 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.
Tables 4, 5, 6 and 7 contain the list of potentially interfering substances tested for the i-STAT Sodium, Potassium, Chloride, and BUN tests and the interference results.
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i-STAT Sodium Test
| Table 4: Summary of Substance Tested and Interference Results for the i-STATSodium test | |||||
|---|---|---|---|---|---|
| Substance | Test Concentration | Interference | Interference | ||
| mmol/L | mg/dL | (Yes/No) | Results | ||
| Acetaminophen | 1.03 | 15.6 | No | ||
| N-Acetyl-L-Cysteine | 0.92 | 15.0 | No | ||
| Acetylsalicylic Acid | 0.167 | 3.0 | No | ||
| Ammonium Chloride | 2.0a | 10.7 | No | ||
| Ascorbic Acid | 0.298 | 5.25 | No | ||
| Bilirubin | 0.684 | 40 | No | ||
| Lithium Bromide | 37.5a | 325.69 | No | ||
| β-Hydroxybutyric Acid | 6.0a | 62.47 | No | ||
| Calcium Chloride | 5 | 20 | No | ||
| Hemoglobin | 10 g/L | 1000 | No | ||
| Sodium Heparin | 3.30 U/mL | 330 U/dL | No | ||
| Ibuprofen | 1.06 | 21.9 | No | ||
| Lithium Lactate | 10 | 90 | No | ||
| Lithium Chloride | 3.2a | 13.6 | No | ||
| Lithium Salicylate | 0.207 | 2.86 | No | ||
| Magnesium Chloride | 4.1 | 10 | No | ||
| Sodium Thiosulfate | 16.7a | 264.04 | Yes | Increased results≥ 3.1 mmol/L | |
| Triglyceride | 16.94 | 1500 | No | ||
| Uric Acid | 1.4 | 23.5 | No | ||
| Cholesterol | 10.3 | 400 | No |
i-STAT Potassium Test
| Table 5: Summary of Substance Tested and Interference Results for the i-STATPotassium test | |||||
|---|---|---|---|---|---|
| Substance | Test Concentration | Interference | Interference | ||
| mmol/L | mg/dL | (Yes/No) | Results | ||
| Acetaminophen | 1.03 | 15.6 | No | ||
| N-Acetyl-L-Cysteine | 0.92 | 15.0 | No | ||
| Ammonium Chloride | 2.0a | 10.7 | No | ||
| Ascorbic Acid | 0.298 | 5.25 | No | ||
| Benzalkonium Chloride | 0.03 | 1.13 | No | ||
| β-Hydroxybutyric Acid | 6.0a | 62.47 | No | ||
| Bilirubin | 0.684 | 40 | No | ||
| Lithium Bromide | 37.5a | 325.69 | No | ||
| Calcium Chloride | 5.0 | 20 | No | ||
| Hemoglobin | 10 g/L | 1000 | No | ||
| Lithium Lactate | 10 | 90 | No | ||
| Lithium Chloride | 3.2a | 13.6 | No | ||
| Magnesium Chloride | 4.1 | 10 | No | ||
| Lithium Salicylate | 0.207 | 2.86 | No |
ª No CLSI EP37 test concentration available. The molecular weight of the substance tested was used to convert the test concentration from mmol/L to mg/dL. The molecular weight of each substance could vary depending on the form chosen.
{15}------------------------------------------------
| Table 5: Summary of Substance Tested and Interference Results for the i-STATPotassium test | |||||
|---|---|---|---|---|---|
| Substance | Test Concentration | Interference | Interference | ||
| mmol/L | mg/dL | (Yes/No) | Results | ||
| Sodium Thiosulfate | 16.7aa | 264.04 | No | ||
| Triglyceride | 16.94 | 1500 | No | ||
| Cholesterol | 10.3 | 400 | No |
i-STAT Chloride Test
| Table 6: Summary of Substance Tested and Interference Results for the i-STATChloride test | ||||
|---|---|---|---|---|
| Substance | Test Concentration | Interference(Yes/No) | InterferenceResults | |
| Acetaminophen | 1.03 | 15.6 | No | |
| N-Acetyl-L-Cysteine | 0.92 | 15.0 | No | |
| L-Ascorbic Acid | 0.298 | 5.25 | No | |
| Bicarbonate | 35.0a | 294 | No | |
| Bilirubin | 0.684 | 40 | No | |
| Lithium Bromide | 37.5 | 325.69 | Yes | Increased results≥ 2.4 mmol/L |
| β-Hydroxybutyric Acid | 6.0a | 62.47 | No | |
| Hemoglobin | 10 g/L | 1000 | No | |
| Sodium lodide | 2.99a | 44.82 | No | |
| Lithium Lactate | 10 | 90 | No | |
| Sodium Oxalate | 0.09 | 1.206 | No | |
| Lithium Salicylate | 0.207 | 2.86 | No | |
| Lithium Thiocyanate | 0.898 | 5.22 | No | |
| Sodium Thiosulfate | 16.7a | 264.04 | Yes | Increased results≥ 4.19 mmol/L |
| Triglyceride | 16.94 | 1500 | No | |
| Cholesterol | 10.3 | 400 | No |
i-STAT BUN Test
| Table 7: Summary of Substance Tested and Interference Results for i-STAT BUNtest | |||||
|---|---|---|---|---|---|
| Substance | Test Concentration | Interference | Interference | ||
| mmol/L | mg/dL | (Yes/No) | Results | ||
| Acetaminophen | 1.03 | 15.6 | No | ||
| N-Acetyl-L-Cysteine | 0.92 | 15.0 | No | ||
| L-Ascorbic Acid | 0.298 | 5.25 | No | ||
| β-Hydroxybutyric Acid | 6.0a | 62.47 | No | ||
| Bilirubin | 0.684 | 40 | No | ||
| Lithium Bromide | 37.5a | 325.69 | No | ||
| Hemoglobin | 10 g/L | 1000 | No | ||
| Hydroxyurea | 0.405 | 3.08 | No | ||
| Lithium Lactate | 10 | 90 | No |
ª No CLSI EP37 test concentration available. The molecular weight of the substance tested was used to convert the test concentration from mmol/L to mg/dL. The molecular weight of each substance could vary depending on the form chosen.
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| Table 7: Summary of Substance Tested and Interference Results for i-STAT BUNtest | ||||
|---|---|---|---|---|
| Substance | Test Concentration | Interference(Yes/No) | InterferenceResults | |
| pH | 8.0 pHunits | N/A | No | |
| Lithium Salicylate | 0.207 | 2.86 | No | |
| Lithium Thiocyanate | 0.898 | 5.22 | No | |
| Sodium Thiosulfate | 16.7a | 264.04 | No | |
| Triglyceride | 16.94 | 1500 | Yes | Increased results≥ 10.2 mmol/L |
| Cholesterol | 10.3 | 400 | No |
Table 7: Summary of Substance Tested and Interference Results for i-STAT BUN
test
Comparison Study
e. Method Comparison with Predicate Device
Method comparison was demonstrated in a study comparing the i-STAT Sodium Potassium, Chloride, and BUN tests performance on the i-STAT 1 System to the Beckman DxC. The study was based on CLSI guideline EP09c-ED3. Venous and arterial blood specimens were evaluated and analyzed on the i-STAT 1 Analyzer against plasma specimens on the Beckman DxC. A Passing-Bablok linear regression analysis was performed using the first replicate result from the i-STAT 1 Analyzer versus the singlicate result of the comparative method.
| Table 8: Method Comparison Results | ||||
|---|---|---|---|---|
| i-STAT Test | N | Slope | Intercept | r |
| Sodium | 187 | 1.00 | 2.00 | 0.96 |
| Potassium | 189 | 1.00 | 0.00 | 0.99 |
| Chloride | 176 | 1.000 | 0.000 | 0.96 |
| Bun | 184 | 0.940 | 1.675 | 0.99 |
8. Conclusion
The results of these studies demonstrate that performance of the i-STAT CHEM8+ Sodium, Potassium, Chloride and BUN test with the i-STAT 1 System are substantially equivalent to the comparative method.
§ 862.1665 Sodium test system.
(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.(b)
Classification. Class II.