(231 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the device description focuses on standard electrochemical biosensor technology.
No.
The device is an in vitro diagnostic analytical device intended for the quantitative measurement of sodium to monitor electrolyte imbalances; it does not directly treat or prevent a disease or condition.
Yes
The device is described as an "in vitro diagnostic analytical device" and is intended for the quantitative measurement of sodium to monitor electrolyte imbalances, which is a diagnostic purpose.
No
The device description explicitly states that the system is comprised of an instrument, rechargeable battery, base station, electronic simulator, control material, printer, and test cartridges, in addition to software. This indicates significant hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use."
- Device Description: The "Device Description" section describes the i-STAT Alinity System as a "handheld, in vitro diagnostic analytical device."
- Function: The device is designed to measure sodium in whole blood, which is a biological sample taken from the body, and the analysis is performed outside of the body ("in vitro").
- Intended Use: The intended use is for "monitoring electrolyte imbalances," which is a diagnostic purpose.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JGS
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.
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 / point of care and laboratory settings
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)
a. Precision
- Precision 20 days (aqueous materials): Evaluated using 5 levels of aqueous materials with 10 instruments and one cartridge lot over 20 days at one site. Results shown in Table 1.
- Precision (whole blood): Evaluated using venous whole blood (native or altered) samples with one cartridge lot 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.
b. Linearity
Study based on CLSI EP06-A. Linearity of the i-STAT Sodium Test was evaluated on i-STAT Alinity Instruments by preparing a series of sodium concentrations in whole blood. The best fitting regression model was a second order model, and non-linearity ranged from -0.40 to 0.66 mmol/L. Linearity was demonstrated over the reportable range (100 - 180 mmol/L).
c. Recovery
Recovery 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 recovery bias and % recovery. The % recovery ranged from 99.9% to 100.6%.
d. Limit of Quantitation (LoQ)
Study based on CLSI EP17-A2. LoQ was evaluated using whole blood altered to low sodium concentrations ( 4 mmol/L. Non-interfering compounds are shown in Table 3. Interfering compounds (Bromide above 16.65 mmol/L and Sodium thiosulfate above 3.57 mmol/L) are shown in Table 4.
f. Anticoagulant Study
Sample type comparison study performed using 40 blood samples (100 to 180 mmol/L). Comparator was heparinized whole blood, and test condition was non-anticoagulated whole blood. Deming regression result was a slope of 1.00 and a correlation coefficient of 1.00.
g. Method Comparison with Predicate Device
Compared 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). Conducted across 4 point of care sites. Included 174 subjects using whole blood (venous or arterial) samples covering the measuring range 100 to 180 mmol/L. Weighted Deming regression for all 4 sites combined had a regression slope of 1.0 and correlation coefficient of 0.999.
Key results: Analytical and clinical studies have shown the i-STAT Alinity System to be safe and effective for its intended use, demonstrating performance substantially equivalent to the predicate device.
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.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines extending from the bottom of the profiles.
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.
1
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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) | ||
|---|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ 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 21CFR 807.92.
| 1. | Submitter Information
Owner | Abbott Point of Care Inc.
400 College Road East
Princeton, NJ 08540 | | | | | |
|----|------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|
| | Contact | Primary: Melissa Robinson
Associate Director Regulatory Affairs
melissa.robinson@abbott.com
Phone: 609-454-9371 | | | | | |
| | | Secondary: Susan Tibedo
Director Regulatory Affairs
susan.tibedo@abbott.com
Phone: 609-454-9360 | | | | | |
| | Date Prepared | July 06, 2016 | | | | | |
| 2. | Device Information
Proprietary Name
Common Name
Regulation Number
Classification Code
Device Classification Name | i-STAT® Alinity System with i-STAT Sodium test
i-STAT Alinity Instrument, i-STAT Alinity and handheld
862.1665 (Class II)
JGS
Electrode, Ion Specific, Sodium | | | | | |
| 3. | Predicate Device
Proprietary Name
Common Name
510(k) Number
Regulation Number
Classification Code
Device Classification Name | i-STAT® 1 Wireless Analyzer
i-STAT 1 Analyzer, i-STAT Analyzer and handheld
K103195
862.1665 (Class II)
JGS
Electrode, Ion Specific, Sodium | | | | | |
4
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
(K103195) | Candidate Device
i-STAT Alinity system |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The i-STAT 1 Wireless
Analyzer is used by trained
medical professionals for
running a variety of
clinical chemistry tests and
test panels contained in
i-STAT test cartridges.
The test for sodium, as part
of the i-STAT System is | The i-STAT Alinity
Instrument is intended to be
used by trained medical
professionals for a variety of
in vitro diagnostic tests and
test panels using i-STAT test
cartridges.
The test for sodium, as part
of the i-STAT System is |
| Characteristics | Predicate Device
(K103195) | Candidate Device
i-STAT Alinity system |
| | intended for use in the in
vitro quantification of
sodium in arterial, venous
or capillary whole blood. | intended for use in the in
vitro quantification of
sodium in arterial or venous
whole blood. |
| | Sodium measurements are
used for monitoring
electrolyte imbalances | Sodium measurements are
used for monitoring
electrolyte imbalances |
| Sample Type | Fresh arterial, venous or
capillary whole blood. | Fresh arterial or venous
whole blood. |
| Power | Two 9-volt lithium
batteries, or rechargeable
battery. | Lithium-Ion rechargeable
battery |
| Principle of
Measurement | Sodium: Ion selective
electrode | Same |
| Reagent Format | Cartridge | Same |
| Reagent Storage and
Stability | Storage: 2°C to 8°C (35-
46°F) | Same |
| Quality Checks | A series of quality checks
are automatically run each
test cycle prior to the
system generating a result.
Quality checks verify the
analyzer motor, electrical,
pressure and temperature
systems and cartridge
elements. | Same |
| Data Storage | 1,000 patient records | 500 patient records |
| Connectivity | TCP/IP
802.11 (WiFi) b/g | TCP/IP
802.11 a/b/g/n |
| Barcode Technology | Class II laser bar code
scanner | Imager that reads 1-D and
2-D barcodes |
| User Interface | 19 keys for data entry | LCD touch screen |
| User Interface
Screen | A grey scale LCD (3.5 in.) | A color LCD screen (5 in.) |
6. Summary Comparision of Technological Characteristics
5
6
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
Verification
Material Level | N | Mean
(mmol/L) | ST
(mmol/L) | CVT
(%) | Sr
(mmol/L) | CVr
(%) | Srr
(mmol/L) | CVrr
(%) | Sdd
(mmol/L) | CVdd
(%) |
|-----------------------------------------------|----|------------------|----------------|------------|----------------|------------|-----------------|-------------|-----------------|-------------|
| 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.
7
| Concentration
Level | Site | N | Mean
(mmol/L) | Within-
Instrument | | Total | |
|--------------------------------|------|----|------------------|-----------------------|------|-------|------|
| | | | | SD | %CV | SD | %CV |
| 146 mmol/L
(abnormal high) | 1 | 21 | 156.0 | 0.38 | 0.24 | 0.38 | 0.25 |
| >146 mmol/L
(abnormal high) | 2 | 21 | 155.1 | 0.36 | 0.23 | 0.36 | 0.23 |
| >146 mmol/L
(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 ( 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 | |
| (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.
9
| Compound | Test Concentration
(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.