Predicate Devices

K183678, K183688, K191298, K191360, K183680

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a point-of-care diagnostic system that uses chemical reagents and electrochemical sensors to measure analytes in blood. There is no mention of AI, ML, or any computational analysis beyond generating quantitative results from sensor readings.

Therapeutic

No.
This device is an in vitro diagnostic (IVD) device used for the quantification of various analytes in whole blood to aid in diagnosis, monitoring, and treatment, but it does not directly provide therapy.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the measurements obtained from the device are "used in the diagnosis" of various conditions and "for monitoring electrolyte imbalances." Additionally, the "Device Description" states "The i-STAT 1 Analyzer is a handheld, in vitro diagnostic analytical device".

SaMD (Software as a Medical Device)

No

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

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use/Indications for Use: The description explicitly states "in the in vitro quantification of..." and lists various analytes measured in whole blood. This clearly indicates testing performed outside of the body.
Device Description: The description refers to the device as an "in vitro diagnostic analytical device."
Care Setting: It is intended for use in "point of care or clinical laboratory settings," which are typical environments for IVD testing.

The entire description aligns with the definition and characteristics of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The i-STAT CHEM8+ cartridge with the i-STAT 1 System is in the in vitro quantification of sodium, potassium, chloride, ionized calcium, glucose, blood urea nitrogen, creatinine, hematocrit, and total carbon dioxide in arterial or venous whole blood in point of care or clinical laboratory settings.

Sodium measurements are used for monitoring electrolyte imbalances.

Potassium measurements are used in the diagnosis and clinical conditions that manifest high and low potassium levels.

Chloride measurements are primarily used in the diagnosis, monitoring, and treatment of electrolyte and metabolic disorders including, but not limited to, cystic fibrosis, diabetic acidosis, and hydration disorders.

Ionized calcium measurements are used in the diagnosis and treatment of parathyroid disease, chronic renal disease and tetany.

Glucose measurements are used in the diagnosis, monitoring, and treatment of carbohydrate metabolism disorders including, but not limited to, diabetes mellitus, neonatal hypoglycemia, and pancreatic islet cell carcinoma.

Blood urea nitrogen measurements are used for the diagnosis, and treatment of certain renal and metabolic diseases.

Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Hematocrit measurements can aid in the determination and monitoring of normal total red cell volume status that can be associated with conditions including anemia and erythrocytosis. The i-STAT Hematocrit test has not been evaluated in neonates.

Carbon dioxide measurements are used in the diagnosis, monitoring, and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

Product codes

CGA, CGL, JGS, CEM, CGZ, JFP, CDS, JFL, JPI

Device Description

The i-STAT CHEM8+ test cartridge contains test reagents to analyze whole blood at the point of care or in the clinical laboratory for sodium (Na), potassium (K), chloride (CI), ionized calcium (iCa), glucose (Glu), blood urea nitrogen (BUN), creatinine (Crea), hematocrit (Hct), and total carbon dioxide (TCO2). The test is contained in a single-use, disposable cartridge. Cartridges require two to three drops of whole blood which are typically applied to the cartridge using a transfer device.

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

The i-STAT Hematocrit test has not been evaluated in neonates.

Intended User / Care Setting

point of care or clinical 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 matrix equivalence study was conducted at three (3) point of care sites to assess the performance of the i-STAT Sodium, Potassium, Chloride, Ionized Calcium, Glucose, Blood urea nitrogen, Creatinine, Hematocrit, and Total Carbon Dioxide tests in the i-STAT CHEM8+ cartridge on the i-STAT 1 System using non-anticoagulated venous and arterial whole blood samples. The matrix equivalence of each analyte in the i-STAT CHEM8+ cartridge was assessed by comparing samples collected without anticoagulant (candidate) to samples collected with balanced heparin or lithium heparin anticoagulant (primary sample). A Passing-Bablok linear regression analysis was performed using the first replicate result from the candidate (y-axis) versus the mean result from the primary sample (x-axis). The results of the study support the addition of whole blood samples collected without anticoagulant for use with the i-STAT CHEM8+ cartridge on the i-STAT 1 System.

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

Analyte	N	Units	Candidate Range	Primary Sample Range	r	Slope	Intercept
Na	314	mmol/L	110 - 174	111 - 173	0.99	1.00	0.50
K	313	mmol/L	2.2 - 7.7	2.2 - 7.5	0.96	1.00	0.00
Cl	314	mmol/L	76 - 136	79 - 137	0.98	1.00	-0.50
iCa	314	mmol/L	0.41 - 2.48	0.71 - 2.28	0.85	1.04	-0.04
Glu	313	mg/dL	29 - 663	35 - 660	1.00	1.01	-0.63
BUN	310	mg/dL	4 - 120	4 - 118	1.00	1.00	0.00
Crea	312	mg/dL	0.2 - 19.4	0.2 - 19.4	1.00	1.00	0.00
Hct	311	%PCV	16 - 75	16 - 73	0.99	1.00	0.46
TCO2	273	mmol/L	9 - 42	11 - 41	0.95	1.00	0.00

Predicate Device(s)

K183678, K183688, K191298, K191360, K183680

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.

August 13, 2021

Abbott Point of Care Inc. Maria Figueroa Associate Director, Regulatory Affairs 400 College Road East Princeton, New Jersey 08540

Re: K210958

Trade/Device Name: i-STAT CHEM8+ cartridge with the i-STAT 1 System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: CGA, CGL, JGS, CEM, CGZ, JFP, CDS, JFL, JPI Dated: March 30, 2021 Received: March 31, 2021

Dear Maria Figueroa:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

1

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K210958

Device Name

i-STAT CHEM8+ cartridge with the i-STAT 1 System

Indications for Use (Describe)