i-STAT Alinity System with i-STAT Sodium test

K153357 · Abbott Point of Care, Inc. · JGS · Jul 8, 2016 · Clinical Chemistry

Device Facts

• Record ID: K153357
• Device Name: i-STAT Alinity System with i-STAT Sodium test
• Applicant: Abbott Point of Care, Inc.
• Product Code: JGS · Clinical Chemistry
• Decision Date: Jul 8, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1665
• Device Class: Class 2

Intended Use

The i-STAT Alinity System with i-STAT Sodium test is intended for use in point of care or clinical laboratory settings. The i-STAT Alinity System with Sodium test is intended for the quantitative measurement of sodium in arterial and venous whole blood. Sodium measurements are used for monitoring electrolyte imbalances. For in vitro diagnostic use.

Device Story

Handheld in vitro diagnostic system for point-of-care or clinical laboratory use; operated by trained medical professionals. System components include instrument, rechargeable battery, base station, electronic simulator, control material, printer, and i-STAT test cartridges. Input: 2-3 drops of fresh arterial or venous whole blood applied to cartridge via syringe. Operation: Instrument interacts with cartridge to move fluid across biosensors; utilizes ion-selective electrode technology. Output: Quantitative sodium concentration displayed on color LCD touch screen within ~2 minutes. Data management: Wireless connectivity (802.11 a/b/g/n) and TCP/IP for record storage. Clinical utility: Enables rapid assessment of electrolyte status to guide clinical decision-making and patient management.

Clinical Evidence

Bench testing only. Precision evaluated via 20-day internal study and multi-day POC site studies using aqueous materials and whole blood (n=174). Linearity confirmed across 87-204 mmol/L range. Method comparison against predicate showed high correlation (r=0.999). Interference testing performed per CLSI EP07-A2; limitations identified for bromide and sodium thiosulfate.

Technological Characteristics

Ion-selective electrode (potentiometric) measurement. Thin-film microfabricated silicon biosensors. Lithium-ion rechargeable battery. Color LCD touchscreen. Wireless (802.11 a/b/g/n) and barcode scanner. Standalone handheld form factor. Calibration: 1-point on-board. Standards: CLSI EP05-A3, EP06-A, EP07-A2, EP09-A3, EP15-A3, EP17-A2, IEC 62366-1.

Indications for Use

Indicated for the quantitative measurement of sodium in arterial and venous whole blood for monitoring electrolyte imbalances in patients in point of care or clinical laboratory settings.

Regulatory Classification

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.

Predicate Devices

• i-STAT 1 Wireless Analyzer (k103195)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

ABBOTT POINT OF CARE INC. MELISSA ROBINSON ASSOCIATE DIRECTOR REGULATORY AFFAIRS 400 COLLEGE ROAD EAST PRINCETON NJ 08540

July 8, 2016

Re: k153357

Trade/Device Name: i-STAT Alinity System with i-STAT Sodium test Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium test system Regulatory Class: II Product Code: JGS Dated: June 27, 2016 Received: June 28, 2016

Dear Melissa Robinson:

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Katherine Serrano -S

For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) k153357

Device Name

i-STAT Alinity System with i-STAT Sodium test

Indications for Use (Describe)

The i-STAT Alinity System with i-STAT Sodium test is intended for use or clinical laboratory settings. The i-STAT Alinity System with Sodium test is intended for the quantitative measurement of sodium in arterial and venous whole blood.

Sodium measurements are used for monitoring electrolyte imbalances.

For in vitro diagnostic use.

| Type of Use (Select one or both, as applicable) | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <table border="0"><tr><td><div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div></td></tr><tr><td><div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div></td></tr></table> | <div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
| <div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | | |
| <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | | |

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# 510(k) Summary

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

| 1. | Submitter Information<br>Owner | Abbott Point of Care Inc.<br>400 College Road East<br>Princeton, NJ 08540 | | | | | |
|----|------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|
| | Contact | Primary: Melissa Robinson<br>Associate Director Regulatory Affairs<br>[e-mail]<br>Phone: [phone] | | | | | |
| | | Secondary: Susan Tibedo<br>Director Regulatory Affairs<br>[e-mail]<br>Phone: [phone] | | | | | |
| | Date Prepared | July 06, 2016 | | | | | |
| 2. | Device Information<br>Proprietary Name<br>Common Name<br>Regulation Number<br>Classification Code<br>Device Classification Name | i-STAT® Alinity System with i-STAT Sodium test<br>i-STAT Alinity Instrument, i-STAT Alinity and handheld<br>862.1665 (Class II)<br>JGS<br>Electrode, Ion Specific, Sodium | | | | | |
| 3. | Predicate Device<br>Proprietary Name<br>Common Name<br>510(k) Number<br>Regulation Number<br>Classification Code<br>Device Classification Name | i-STAT® 1 Wireless Analyzer<br>i-STAT 1 Analyzer, i-STAT Analyzer and handheld<br>k103195<br>862.1665 (Class II)<br>JGS<br>Electrode, Ion Specific, Sodium | | | | | |

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# 4. Device Description

The i-STAT Alinity System is a handheld, in vitro diagnostic analytical device designed to run i-STAT test cartridges. The system is designed for use at or near point of patient care, by trained medical professionals and is for prescription use only and is for use in point of care and laboratory settings.

The i-STAT Alinity System is comprised of the instrument, rechargeable battery, base station, electronic simulator, control material, printer and i-STAT test cartridges. The i-STAT Alinity Instrument features a barcode scanner, user interface with touch screen display and wireless capability. The instrument reports quantitative results within approximately 2 minutes.

The i-STAT cartridge contains test reagents which are located on the biosensors chips. The instrument interacts with the cartridge to move fluid across the biosensors and generate a quantitative result. Cartridges require two to three drops of whole blood which are typically applied to the cartridge using a syringe.

# 5. Intended Use Statement

The i-STAT Alinity System with i-STAT Sodium test is intended for use in point of care or clinical laboratory settings. The i-STAT Alinity System with Sodium test is intended for the quantitative measurement of sodium in arterial and venous whole blood. Sodium measurements are used for monitoring electrolyte imbalances. For in vitro diagnostic use.

| Characteristics | Predicate Device<br>(k103195) | Candidate Device<br>i-STAT Alinity system |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The i-STAT 1 Wireless<br>Analyzer is used by trained<br>medical professionals for<br>running a variety of<br>clinical chemistry tests and<br>test panels contained in<br>i-STAT test cartridges.<br>The test for sodium, as part<br>of the i-STAT System is | The i-STAT Alinity<br>Instrument is intended to be<br>used by trained medical<br>professionals for a variety of<br>in vitro diagnostic tests and<br>test panels using i-STAT test<br>cartridges.<br>The test for sodium, as part<br>of the i-STAT System is |
| Characteristics | Predicate Device<br>(k103195) | Candidate Device<br>i-STAT Alinity system |
| | intended for use in the in<br>vitro quantification of<br>sodium in arterial, venous<br>or capillary whole blood. | intended for use in the in<br>vitro quantification of<br>sodium in arterial or venous<br>whole blood. |
| | Sodium measurements are<br>used for monitoring<br>electrolyte imbalances | Sodium measurements are<br>used for monitoring<br>electrolyte imbalances |
| Sample Type | Fresh arterial, venous or<br>capillary whole blood. | Fresh arterial or venous<br>whole blood. |
| Power | Two 9-volt lithium<br>batteries, or rechargeable<br>battery. | Lithium-Ion rechargeable<br>battery |
| Principle of<br>Measurement | Sodium: Ion selective<br>electrode | Same |
| Reagent Format | Cartridge | Same |
| Reagent Storage and<br>Stability | Storage: 2°C to 8°C (35-<br>46°F) | Same |
| Quality Checks | A series of quality checks<br>are automatically run each<br>test cycle prior to the<br>system generating a result.<br>Quality checks verify the<br>analyzer motor, electrical,<br>pressure and temperature<br>systems and cartridge<br>elements. | Same |
| Data Storage | 1,000 patient records | 500 patient records |
| Connectivity | TCP/IP<br>802.11 (WiFi) b/g | TCP/IP<br>802.11 a/b/g/n |
| Barcode Technology | Class II laser bar code<br>scanner | Imager that reads 1-D and<br>2-D barcodes |
| User Interface | 19 keys for data entry | LCD touch screen |
| User Interface<br>Screen | A grey scale LCD (3.5 in.) | A color LCD screen (5 in.) |

# 6. Summary Comparision 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 Sodium Test on the i-STAT Alinity Instrument was evaluated using 5 levels of aqueous materials. This 20-day multi-day precision testing was was based on CLSI document EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline-Third Edition. The study was conducted using 10 instruments and one cartridge lot over 20 days at one site. The results of the 20-day precision study using the initial runs (including any outlying runs) are shown in Table 1.

| Calibration<br>Verification<br>Material Level | N | Mean<br>(mmol/L) | ST<br>(mmol/L) | CVT<br>(%) | Sr<br>(mmol/L) | CVr<br>(%) | Srr<br>(mmol/L) | CVrr<br>(%) | Sdd<br>(mmol/L) | CVdd<br>(%) |
|-----------------------------------------------|----|------------------|----------------|------------|----------------|------------|-----------------|-------------|-----------------|-------------|
| CV L1 | 80 | 99.6 | 0.43 | 0.43 | 0.36 | 0.36 | 0.22 | 0.22 | 0.00 | 0.00 |
| CV L2 | 80 | 121.2 | 0.32 | 0.27 | 0.31 | 0.26 | 0.02 | 0.017 | 0.09 | 0.074 |
| CV L3 | 80 | 133.7 | 0.34 | 0.26 | 0.29 | 0.22 | 0.17 | 0.13 | 0.00 | 0.00 |
| CV L4 | 80 | 160.9 | 0.96 | 0.60 | 0.96 | 0.60 | 0.00 | 0.00 | 0.00 | 0.00 |
| CV L5 | 80 | 180.2 | 0.56 | 0.31 | 0.38 | 0.21 | 0.42 | 0.23 | 0.00 | 0.00 |

#### Table 1: 20-day Precision Study Results (including outlying runs)

# Precision (whole blood)

The whole blood precision of the i-STAT Sodium Test on the i-STAT Alinity Instrument was evaluated using venous whole blood (native or altered) samples targeted to be within a low abnormal, normal and high abnormal sodium levels.

One 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 Alinity Instruments (total of 21 test results per sample). The largest estimate of precision was 0.50 mmol/L as shown in Table 2.

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| Concentration<br>Level | Site | N | Mean<br>(mmol/L) | Within-<br>Instrument | | Total | |
|--------------------------------|------|----|------------------|-----------------------|------|-------|------|
| | | | | SD | %CV | SD | %CV |
| <138 mmol/L<br>(abnormal low) | 1 | 21 | 114.6 | 0.50 | 0.43 | 0.50 | 0.43 |
| <138 mmol/L<br>(abnormal low) | 2 | 21 | 115.0 | 0.38 | 0.33 | 0.38 | 0.33 |
| <138 mmol/L<br>(abnormal low) | 3 | 21 | 114.2 | 0.44 | 0.38 | 0.44 | 0.38 |
| 138 to 146 mmol/L<br>(normal) | 1 | 21 | 140.0 | 0.00 | 0.00 | 0.00 | 0.00 |
| 138 to 146 mmol/L<br>(normal) | 2 | 21 | 139.8 | 0.31 | 0.22 | 0.45 | 0.32 |
| 138 to 146 mmol/L<br>(normal) | 3 | 21 | 141.6 | 0.49 | 0.34 | 0.51 | 0.36 |
| >146 mmol/L<br>(abnormal high) | 1 | 21 | 156.0 | 0.38 | 0.24 | 0.38 | 0.25 |
| >146 mmol/L<br>(abnormal high) | 2 | 21 | 155.1 | 0.36 | 0.23 | 0.36 | 0.23 |
| >146 mmol/L<br>(abnormal high) | 3 | 21 | 165.9 | 0.30 | 0.18 | 0.30 | 0.18 |

Table 2: Whole Blood Precision Results

# 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 Test was evaluated on the i-STAT Alinity Instruments by preparing a series of sodium concentration levels in whole blood that spanned the reportable range of the test. The best fitting regression model was a second order model, and the non-linearity ranged from -0.40 to 0.66 mmol/L. The linearity of the i-STAT Sodium Testused with the i-STAT Alinity Instruments was demonstrated over the reportable range (100 - 180 mmol/L).

#### c. Recovery

The recovery of the i-STAT Sodium test was evaluated on the i-STAT Alinity Instrument by creating a series of sodium concentration levels in whole blood, measuring their expected value on the predicate and determining the recovery bias and % recovery. The % recovery ranged from 99.9% to 100.6%.

# d. Limit of Quantitation (LoQ)

The study was based on the CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures. The LoQ of the i-STAT Sodium Test was evaluated on the i-STAT Alinity Instruments using whole blood that was altered to low sodium concentrations (< 100 mmol/L) and two cartridge lots. The LoQ for the i-STAT Sodium Test on the i-STAT Alinity Instrument was determined to be 80 mmol/L.

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#### e. Interference

The interference performance of the i-STAT Sodium Test on the i-STAT Alinity Instrument was evaluated using whole blood and plasma test samples based on CLSI EP07-A2: Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition. The effect of each potentially interfering compound was evaluated by comparing the performance of a test sample spiked to a high concentration of the compound and a control test sample spiked with an equal volume of solvent. A compound was identified as an interferent if the difference between the spiked test sample and the control was > 4 mmol/L. Compounds that do not interfere with the i-STAT Sodium Test are shown in Table 3; those compounds that do interfere are shown in Table 4.

| | Test Concentration | |
|------------------------|------------------------------|----------|
| Substance | mmol/L<br>(unless specified) | (mg/dL)* |
| Acetaminophen | 1.33 | 20.10 |
| Acetyl Cysteine | 10.2 | 166.45 |
| Ascorbic Acid | 0.342 | 6.02 |
| Bromide (therapeutic) | 2.5 | 19.98 |
| β-Hydroxybutyric Acid | 6.0 | 62.47 |
| Calcium (Total) | 5.0 | 20.04 |
| Lactate | 6.6 | 58.79 |
| Magnesium | 15 | 36.46 |
| Salicylic Acid | 4.34 | 59.94 |
| Ibuprofen | 2.425 | 50.03 |
| Heparin | 3 U/mL | n/a |
| Ammonium | 2.0 | 10.70 |
| Lithium | 3.2 | 2.22 |
| Acetyl Salicyclic Acid | 3.62 | 65.22 |
| Bilirubin | 0.342 | 20.01 |
| Hemoglobin | 2 g/L | 200.00 |
| Triglyceride | 37 | 3233.80 |
| Uric Acid | 1.4 | 23.54 |

#### Table 3: Non-Interfering Compounds and Test Concentrations

* 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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| Compound | Test Concentration<br>(mmol/L) | (mg/dL) |
|---------------------------------|--------------------------------|---------|
| Bromide | 37.5 | 299.64 |
| Nithiodote (sodium thiosulfate) | 16.7 | 264.04 |

#### Table 4: Interfering Compounds and Interfering Concentrations

A bromide concentration above 16.65 mmol/L may give a falsely decreased i-STAT Sodium Test result of more than 4 mmol/L.

A sodium thiosulfate concentration above 3.57 mmol/L mav give a falsely increased i-STAT Sodium Test result of more than 4 mmol/L.

# f. Anticoagulant Study

The sample type comparison study was performed using the i-STAT Sodium Test on the i-STAT Alinity Instrument and 40 blood samples ranging from 100 to 180 mmol/L. The comparator condition for this study was heparinized whole blood and the test condition was non-anticoagulated whole blood. The Deming regression result was a slope of 1.00 and a correlation coefficient of 1.00.

# g. Method Comparison with Predicate Device

The method comparison study compared the clinical results of the i-STAT Sodium Test on the i-STAT Alinity Instrument to the i-STAT Sodium Test performance on the i-STAT 1 Wireless Analyzer (predicate). This study was conducted across 4 point of care sites. The study included 174 subjects using whole blood (venous or arterial) samples covering the measuring range 100 to 180 mmol/L. The Weighted Deming regression for all 4 sites combined had a regression slope of 1.0 and correlation coefficient of 0.999.

# 8. Conclusion

Analytical and clinical studies have shown the i-STAT Alinity System to be safe and effective for its intended use. The results of these studies demonstrate that performance of the i-STAT Alinity System is substantially equivalent to the predicate device.