K Number
K183688
Device Name
i-STAT CHEM8+ cartridge with the i-STAT 1 System
Date Cleared
2020-02-07

(406 days)

Product Code
Regulation Number
862.1665
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
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.
More Information

Not Found

No
The summary describes a point-of-care in vitro diagnostic system that uses electrochemical sensors to measure analytes. There is no mention of AI or ML in the intended use, device description, or performance studies. The performance studies focus on standard analytical validation metrics like precision, linearity, and method comparison, not AI/ML specific metrics or training/test data descriptions.

No
The device is an in vitro diagnostic device used for quantifying analytes in blood to aid in diagnosis and monitoring, not for direct therapy.

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is used for the "diagnosis and monitoring of diseases and clinical conditions" related to potassium levels, and for the "diagnosis, monitoring, and treatment" of electrolyte and metabolic disorders related to chloride and BUN measurements. Additionally, the "Device Description" calls the i-STAT 1 Analyzer an "in vitro diagnostic analytical device."

No

The device description clearly states that the system is comprised of a handheld analyzer (hardware), test cartridges (hardware/consumable), and accessories (hardware). While software is undoubtedly involved in the analyzer's function, the device is not solely software.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is intended for "in vitro quantification" of various analytes in whole blood. This is a key characteristic of an IVD.
  • Device Description: The description refers to the device as an "in vitro diagnostic analytical device."
  • Function: The device analyzes biological samples (whole blood) outside of the body to provide diagnostic information (quantification of electrolytes and BUN).

Therefore, based on the provided information, the i-STAT CHEM8+ cartridge with the i-STAT 1 System clearly fits the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

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.

Product codes

JGS, CDS, CEM, CGZ

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.

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

Not Found

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

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Analytical Performance

  • Precision (Aqueous Materials): Evaluated using 5 levels of aqueous materials based on CLSI document EP05-A3.
    • Sample Size: 80 or 81 measurements per fluid level per test.
    • Key Results: Detailed Coefficient of Variation (CV) for Sodium, Potassium, Chloride, and BUN tests across various fluid levels.
  • Precision (Whole Blood): Evaluated using venous whole blood samples (native or altered) targeted to three levels within the test reportable range.
    • Sample Size: Varies by Site and Level, N=14, 20, or 21 measurements.
    • Key Results: Detailed Within-Analyzer SD and %CV, and Total SD and %CV with 95% CI for Sodium, Potassium, Chloride, and BUN tests across multiple sites and levels.
  • Linearity: Evaluated by preparing whole blood samples of varying analyte levels that spanned the reportable range of the tests, based on CLSI EP06-A.
    • Key Results: Sodium, Potassium, Chloride, and BUN tests demonstrated linearity over their reportable ranges. Regression analysis provided Slope, Intercept, and R squared values.
  • Limit of Quantitation (LoQ): Evaluated based on CLSI EP17-A2.
    • Key Results: LoQs determined for Sodium (91 mmol/L), Potassium (1.5 mmol/L), Chloride (56 mmol/L), and BUN (1 mg/dL).
  • Interference: Evaluated using whole blood samples based on CLSI EP07 ED3. Potentially interfering substances were tested at toxic/pathological concentrations.
    • Key Results: Identified Sodium Thiosulfate as an interferent for Sodium (Increased results >= 3.1 mmol/L) and Chloride (Increased results >= 4.19 mmol/L). Identified Lithium Bromide as an interferent for Chloride (Increased results >= 2.4 mmol/L). Identified Triglyceride as an interferent for BUN (Increased results >= 10.2 mmol/L). All other tested substances showed no interference.

Comparison Study

  • Method Comparison with Predicate Device: Compared i-STAT Sodium, Potassium, Chloride, and BUN tests performance on the i-STAT 1 System to the Beckman DxC. Based on CLSI guideline EP09c-ED3.
    • Sample Size: Sodium (187), Potassium (189), Chloride (176), BUN (184).
    • Key Results: Passing-Bablok linear regression analysis showed high correlation (r values: Sodium 0.96, Potassium 0.99, Chloride 0.96, BUN 0.99).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

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.

K042291

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

§ 862.1665 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.

0

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

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

1

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

2

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)

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
OwnerAbbott Point of Care Inc.
400 College Road East
Princeton, NJ 08540
ContactPrimary: 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 | February 5, 2020 |
| 510(k) Number | K183688 |

2. Device Information

Proprietary Namei-STAT CHEM8+ cartridge with i-STAT 1 System
Common NameChemistry test, analyzer, handheld

| Product
code | Device Classification
name | Regulation
Number | 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 Specific
Chloride | 862.1170 | II | Clinical Chemistry |
| CDS | Electrode, Ion Specific,
Urea Nitrogen | 862.1770 | II | Clinical Chemistry |

4

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

| Product
code | Device Classification
name | Regulation
Number | 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 Specific
Chloride | 862.1170 | II | Clinical Chemistry |
| LFP | Conductivity Rate, Urea
Nitrogen | 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.

5

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.

6

Similarities and Differences: System (Test and Instrument) for Sodium
Feature or
CharacteristicPredicate
SYNCHRON Systems Sodium
Reagent on UniCel DxC 600/800
SYNCHRON Clinical System
(K042291)Candidate
Sodium Test with i-STAT 1
System
Intended UseThe sodium test systems are intended
for the quantitative determination of
sodium concentration in human
serum, plasma or urine.

Sodium measurements are used in the
diagnosis and treatment of
aldosteronism (excessive secretion of
hormone aldosterone), diabetes
insipidus, adrenal hypertension,
Addison's disease, dehydration,
inappropriate antidiuretic hormone
secretion, or other diseases involving
electrolyte imbalance. | 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. |
| 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 then
processed within analyzer | Ready to Use |
| Traceability
Calibration | NIST SRM 919
Must be conducted every 24 hours and
with each new reagent | NIST SRM 956
1-point on-board contained within the
cartridge |
| Time to Test
(Sample Stability) | Serum or plasma: Within 8 hours at
room temperature, or up to 48 hours if
stored at +2°C to +8°C

Urine: Within 2 hours of collection | Heparinized samples: within 30
minutes of collection |
| Principle of
Measurement | Ion selective electrode | Ion selective electrode |
| Reagent Format | Reagent handling system, stored
within analyzer | Cartridge |
| Reagent Storage
and Stability | Room temperature | 2°C to 8°C (35-46°F) |
| Similarities and Differences: System (Test and Instrument) for Potassium | | |
| Feature or
Characteristic | Predicate
SYNCHRON Systems Potassium
Reagent on UniCel DxC 600/800
SYNCHRON Clinical System
(K042291) | Candidate
Potassium Test with i-STAT 1
System |
| Intended Use | The potassium test systems are
intended the quantitative
determination of potassium
concentration in human serum, plasma
or urine.

Potassium measurements are used in
the diagnosis and treatment of
hypokalemia (metabolic alkalosis,
metabolic acidosis or the absence of
acid-base disturbances), hyperkalemia
(over administration of potassium,
acidosis, or crush injuries), renal
failure, Addison's disease or other
diseases involving electrolyte
imbalance. | 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

Potassium measurements are used in
the diagnosis and monitoring of
diseases and clinical conditions that
manifest high and low potassium
levels. |
| 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 |
| Sample
Preparation | Sample tubes prepared and then
processed within analyzer | Ready to Use |
| Traceability | NIST SRM 918 | NIST SRM 956 |
| Calibration | Must be conducted every 24 hours and
with each new reagent | 1-point on-board contained within the
cartridge |
| Time to Test
(Sample Stability) | Serum or plasma: Within 8 hours at
room temperature, or up to 48 hours if
stored at +2°C to +8°C

Urine: Within 2 hours of collection | Non-anticoagulated samples: within 3
minutes of collection

Heparinized samples: within 30
minutes of collection |
| Principle of
Measurement | Ion selective electrode | Ion selective electrode |
| Reagent Format | Reagent handling system, stored
within analyzer | Cartridge |
| Reagent Storage
and 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 or
Characteristic | Predicate
SYNCHRON Systems Chloride
Reagent on UniCel DxC 600/800
SYNCHRON Clinical System
(K042291) | Candidate
Chloride Test with i-STAT 1
System |
| Intended Use | The chloride test systems are intended
for the quantitative determination of
chloride concentration in human serum,
plasma, urine or cerebrospinal fluid
(CSF).
Chloride measurements are used in the
diagnosis and treatment of electrolyte
and metabolic disorders such as cystic
fibrosis and diabetic acidosis. | 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.
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. |
| 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 and
with each new reagent | 1-point on-board contained within
the cartridge |
| Time to Test
(Sample Stability) | Serum or plasma: Within 8 hours at
room temperature, or up to 48 hours if
stored at +2°C to +8°C
Urine: Within 2 hours of collection | Non-anticoagulated samples: within
3 minutes of collection
Heparinized samples: within 30
minutes of collection |
| Principle of
Measurement | Ion selective electrode | Ion selective electrode |
| Reagent Format | Reagent handling system, stored within
analyzer | Cartridge |
| Reagent Storage
and Stability | Room temperature | 2°C to 8°C (35-46°F) |
| Analyzer Type | Floor Model | Handheld |
| Feature or
Characteristic | Predicate
SYNCHRON Systems BUN
Reagent on UniCel DxC 600/800
SYNCHRON Clinical System
(K042291) | Candidate
BUN Test with i-STAT 1
System |
| Intended Use | The blood urea nitrogen (BUN) test
systems are intended for the
quantitative determination of urea
nitrogen or urea concentration in
human serum, plasma or urine.

Urea nitrogen or urea measurements are
used in the diagnosis and treatment of
certain renal and metabolic diseases. | 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

Blood urea nitrogen measurements
are used for the diagnosis,
monitoring, and treatment of certain
renal 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 then
processed within analyzer | Ready to Use |
| Traceability | NIST SRM 912 | NIST SRM 909 |
| Calibration | Must be conducted every 24 hours and
with each new reagent | 1-point on-board contained within
the cartridge |
| Time to Test
(Sample Stability) | Serum or plasma: Within 8 hours at
room temperature, or up to 48 hours at
+2°C to +8°C
Urine: Within 2 hours of collection | Non-anticoagulated samples: within
3 minutes of collection
Heparinized samples: within 30
minutes of collection |
| Principle of
Measurement | Conductivity | Ion selective electrode |
| Reagent Format | Reagent handling system, stored within
analyzer | Cartridge |
| Reagent Storage
and Stability | 2°C to 8°C (35-46°F) | 2°C to 8°C (35-46°F) |
| Analyzer Type | Floor Model | Handheld |

    1. Summary Comparison of Technological Characteristics

7

8

9

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

10

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-STAT
TestFluid
LevelNMeanSTTotalWithin-runBetween-runBetween-day
CVT
(%)SrCVr
(%)SrrCVrr
(%)SddCVdd
(%)
Sodium
(mmol/L)CV L181100.00.270.30.250.30.070.10.070.1
CV L281121.60.350.30.330.30.090.10.100.1
CV L381134.80.310.20.280.20.090.10.100.1
CV L480160.40.410.30.390.20.100.10.100.1
CV L5801780.420.20.400.20.100.10.110.1
Potassium
(mmol/L)CV L1812.070.0060.30.0060.30.0010.050.0020.1
CV L2812.830.0110.40.0110.40.0030.10.0020.1
CV L3813.690.0100.30.0080.20.0040.10.0030.1
CV L4806.170.0180.30.0170.30.0020.030.0070.1
CV L5807.750.0330.40.0270.30.0170.20.0090.1
Chloride
(mmol/L)CV L18170.90.470.70.430.60.120.20.120.2
CV L28176.20.530.70.500.70.130.20.130.2
CV L38189.20.330.40.290.30.080.10.120.1
CV L480107.90.430.40.400.40.110.10.120.1
CV L580122.30.480.40.440.40.150.10.120.1
BUN
(mg/dL)CV L181107.30.910.80.810.80.410.40.040.04
CV L28159.70.921.50.861.40.230.40.200.3
CV L38110.50.121.10.111.00.050.50.030.3
CV L4808.10.182.20.172.10.030.40.050.6
CV L5804.10.153.70.143.40.041.00.030.7

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.

11

Table 2: Whole Blood Precision Results - i-STAT 1 Wireless Analyzer
i-STAT
TestLevelSiteNMeanWithin-AnalyzerTotal
SD%CVSDSD 95% CI%CV%CV 95% CI
≤ 1340121110.30.490.40.490.39 to 0.780.40.4 to 0.7
0221123.90.380.30.380.31 to 0.570.30.3 to 0.5
0321108.30.440.40.490.39 to 0.840.50.4 to 0.8
Sodium
(mmol/L)0121139.20.580.40.580.48 to 0.830.40.3 to 0.6
0121138.00.220.20.220.17 to 0.350.20.1 to 0.3
0121136.50.650.50.680.54 to 1.130.50.4 to 0.8
0220138.30.450.30.450.36 to 0.730.30.3 to 0.5
0214141.80.460.30.460.38 to 0.810.30.3 to 0.6
0221141.90.310.20.310.25 to 0.480.20.2 to 0.3
0221140.00.380.30.380.31 to 0.630.30.2 to 0.5
135-1450221138.90.440.30.480.38 to 0.830.30.3 to 0.6
0221138.30.530.40.530.44 to 0.760.40.3 to 0.5
0321140.90.310.20.360.29 to 0.640.30.2 to 0.5
0321141.00.220.20.220.17 to 0.350.20.1 to 0.2
0321142.10.310.20.310.25 to 0.480.20.2 to 0.3
0321143.00.220.20.220.17 to 0.350.20.1 to 0.2
0321139.80.440.30.440.35 to 0.710.30.3 to 0.5
≥ 1460121150.10.620.40.620.51 to 0.880.40.3 to 0.6
0221163.20.490.30.490.40 to 0.700.30.2 to 0.4
0321150.10.380.30.380.31 to 0.570.30.2 to 0.4
Potassium
(mmol/L)2.75-
3.251212.800.0220.80.0220.017 to 0.0350.80.6 to 1.3
2212.800.0000.00.0000.000 to 0.0000.00.0 to 0.0
3213.050.0581.90.0580.048 to 0.0831.91.6 to 2.7
1214.300.0000.00.0000.000 to 0.0000.00.0 to 0.0
1214.000.0220.60.0220.017 to 0.0350.60.4 to 0.9
1213.980.0491.20.0490.040 0.0701.21.0 to 1.8
2204.950.0591.20.0590.049 to 0.0851.21.0 to 1.7
2144.200.0000.00.0000.000 to 0.0000.00.0 to 0.0
2214.130.0531.30.0530.044 to 0.0761.31.1 to 1.8
>3.25 -
1200221123.80.690.60.690.57 to 0.980.60.5 to 0.8
0321123.20.440.40.550.43 to 1.000.40.3 to 0.8
01215.00.000.00.000.00 to 0.000.00.0 to 0.0
1100221125.01.721.41.971.56 to 3.441.61.2 to 2.8
0321118.61.831.51.831.50 to 2.711.51.3 to 2.3

12

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

13

Table 3: Regression Summary for the i-STAT tests on the i-STAT 1 Analyzer
i-STAT TestReportable
RangeRange TestedSlopeInterceptR2
Sodium (mmol/L)100 - 18089 – 2051.077-5.2440.9994
Potassium (mmol/L)2.0 - 9.01.7 – 10.41.109-0.1360.9999
Chloride (mmol/L)65 - 14076 – 158 WB
54 – 157 Plasma0.867
0.9697.353
2.1300.9983
0.9987
BUN (mg/dL)3 - 1402 - 1430.9460.2090.9950

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 (