(269 days)
Not Found
No
The summary describes a standard in vitro diagnostic device using electrochemical sensors to measure ionized calcium. There is no mention of AI, ML, or any computational methods beyond basic signal processing and regression analysis for calibration and performance evaluation.
No.
The device is an in vitro diagnostic device used to quantify ionized calcium in blood, which aids in diagnosis and treatment, but it does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section states that "Ionized calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany," indicating that the device provides information for diagnostic purposes. Additionally, the "Device Description" explicitly calls the i-STAT 1 Analyzer an "in vitro diagnostic analytical device."
No
The device description clearly outlines hardware components including a test cartridge, a handheld analyzer, and accessories like a downloader/recharger, electronic simulator, and portable printer. The software is part of a larger system that includes physical components for sample analysis.
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 use in the in vitro quantification of ionized calcium in arterial or venous whole blood in point of care or clinical laboratory settings." The term "in vitro" is a key indicator of an IVD, meaning it's used to test samples outside of the living body.
- Device Description: The "Device Description" further clarifies that the system analyzes "whole blood at the point of care or in the clinical laboratory." This reinforces the use of biological samples for diagnostic purposes.
- System Components: The description of the "i-STAT 1 System" explicitly calls the i-STAT 1 Analyzer a "handheld, in vitro diagnostic analytical device."
These points clearly align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
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 ionized calcium in arterial or venous whole blood in point of care or clinical laboratory settings.
Ionized calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
Product codes
JFP
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 ionized calcium (iCa). 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
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
a. Precision
- Precision 20 days (Aqueous Materials): The precision of the i-STAT iCa test on the i-STAT 1 Wireless Analyzer was evaluated using 5 levels of aqueous materials. This 20-day multi-day precision testing was based on CLSI document EP05-A3. The study was conducted using multiple instruments and one test cartridge lot over 20 days at one site. Total precision ('within-laboratory', ST), within-run, (Sr), between-run, (Sr) and between-day, (Sad) were estimated for each level.
- Precision (Whole Blood): A whole blood repeatability analysis was conducted using the data collected across three point of care sites. Two hundred and forty-one samples (132 venous and 109 arterial) were measured in duplicate. The mean values for each sample were divided into four subintervals for each sample type.
b. Linearity
The linearity of the i-STAT iCa test on the i-STAT 1 Analyzer was evaluated by preparing whole blood samples of varying analyte levels that spanned the reportable range of the test. The study was designed based on CLSI EP06-A. The best fitting regression model was a second order model. The absolute degree of nonlinearity results met the acceptance criteria for each of the levels tested. The i-STAT iCa demonstrated linearity over the reportable range 0.25 - 2.50 mmol/L.
c. Limit of Quantitation (LoQ)
The LoQ of the i-STAT iCa test was evaluated on the i-STAT 1 Analyzer using whole blood that was altered to low iCa (
§ 862.1145 Calcium test system.
(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(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 includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The logos are placed side by side.
February 14, 2020
Abbott Point of Care, Inc. Susan Tibedo Director, Regulatory Affairs 400 College Road East Princeton, NJ 08540
Re: K191360
Trade/Device Name: i-STAT CHEM8+ cartridge with the i-STAT 1 System Regulation Number: 21 CFR 862.1145 Regulation Name: Calcium Test System Regulatory Class: Class II Product Code: JFP Dated: January 15, 2020 Received: January 16, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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. Acting 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) K191360
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 ionized calcium in arterial or venous whole blood in point of care or clinical laboratory settings.
Ionized calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 | ||
|---|---|---|---|
| Owner | Abbott Point of Care Inc. | ||
| 400 College Road East | |||
| Princeton, NJ 08540 | |||
| Contact | Primary: 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 14, 2020 | ||
| 510(k) Number | K191360 |
2. Device Information
Proprietary Name i-STAT CHEM8+ cartridge with i-STAT 1 System
Common Name Chemistry test, analyzer, handheld
| Product
code | Device Classification
name | Regulation
Number | Class | Panel |
|-----------------|-------------------------------------|----------------------|-------|--------------------|
| JFP | Electrode, Ion Specific,
Calcium | 862.1145 | II | Clinical Chemistry |
3. Predicate Device
Proprietary Name Ionized Calcium test with the Epocal EPOC Blood Analysis System
510(k) Number K061597
| Product
code | Device Classification
name | Regulation
Number | Class | Panel |
|-----------------|-------------------------------------|----------------------|-------|--------------------|
| JFP | Electrode, Ion Specific,
Calcium | 862.1145 | II | Clinical Chemistry |
4
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 ionized calcium (iCa). 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.
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 ionized calcium in arterial or venous whole blood in point of care or clinical laboratory settings.
Ionized calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
| Feature or
Characteristic | Predicate
lonized Calcium Test with
EPOC Blood Analysis System
(K061597) | Candidate
lonized Calcium Test with i-STAT 1
System |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Measurement of Ionized Calcium
is used in diagnosis and
treatment of parathyroid disease,
a variety of bone diseases,
chronic renal disease and
tetany. | The i-STAT CHEM8+ cartridge with
the i-STAT 1 System is intended for
use in the in vitro quantification of
ionized calcium in arterial or venous
whole blood in point of care or clinical
laboratory settings. |
| | | lonized calcium measurements are
used in the diagnosis and treatment
of parathyroid disease, a variety of
bone diseases, chronic renal disease |
6. Summary Comparison of Technological Characteristics
5
| Feature or
Characteristic | Predicate
lonized Calcium Test with
EPOC Blood Analysis System
(K061597) | Candidate
lonized Calcium Test with i-STAT 1
System |
|------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------|
| | | and tetany. |
| Reportable | 0.25 - 4.00 mmol/L | 0.25 - 2.50 mmol/L (mEq/L) |
| Range | | |
| Sample Type | Arterial or venous whole blood | Arterial or venous whole blood |
| Sample Volume | At least 92 µL | 95 µL |
| Sample | Ready to Use | Ready to Use |
| Preparation | | |
| Traceability | NIST SRM 956 | NIST SRM 956 |
| Calibration | On board the instrument initiated | 1-point on-board contained within the |
| | once test card is inserted | cartridge |
| Time to Test | Immediately after drawing | Heparinized samples: within 10 |
| (Sample | sample | minutes of collection |
| Stability) | | |
| Principle of | lon selective electrode | lon selective electrode |
| Measurement | | |
| Reagent Format | Test Card | Cartridge |
| Reagent Storage | 15 to 30°C (59 to 86°F) | 2°C to 8°C (35-46°F) |
| and Stability | | |
| Analyzer Type | Handheld | Handheld |
7. Performance Characteristics
Analytical Performance
a. Precision
Precision 20 days (Aqueous Materials)
The precision of the i-STAT iCa test on the i-STAT 1 Wireless Analyzer was 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 was conducted using multiple instruments and one test cartridge lot over 20 days at one site. Total precision ('within-laboratory', ST), within-run, (Sr), between-run, (Sr) and between-day, (Sad) were estimated for each level. The results of the 20-day precision study are shown in Table 1.
| i-STAT
Test | Calibration
Verification
Level | N | Mean /
Median | Total | | Within-run | | Between-run | | Between-day | |
|-----------------|--------------------------------------|----|------------------|--------|------------|------------|------------|-------------|-------------|-------------|-------------|
| | | | | ST | CVT
(%) | Sr | CVr
(%) | Srr | CVrr
(%) | Sdd | CVdd
(%) |
| iCa
(mmol/L) | CV L1 | 81 | 2.328 | 0.0132 | 0.6 | 0.0121 | 0.5 | 0.0037 | 0.2 | 0.0038 | 0.2 |
| iCa
(mmol/L) | CV L2 /
Control L1*,a | 81 | 1.484 | 0.0103 | 0.7 | 0.0096 | 0.6 | 0.0025 | 0.2 | 0.0026 | 0.2 |
6
| i-STAT
Test | Calibration
Verification
Level | N | Mean /
Median | Total | | Within-run | | Between-run | | Between-day | |
|----------------|--------------------------------------|----|------------------|--------|------------|------------|------------|-------------|-------------|-------------|-------------|
| | | | | ST | CVT
(%) | Sr | CVr
(%) | Srr | CVrr
(%) | Sdd | CVdd
(%) |
| | CV L3 /
Control L2* | 81 | 1.299 | 0.0067 | 0.5 | 0.0062 | 0.5 | 0.0020 | 0.2 | 0.0018 | 0.1 |
| | CV L4 /
Control L3*,a | 80 | 0.724 | 0.0038 | 0.5 | 0.0036 | 0.5 | 0.0009 | 0.1 | 0.0008 | 0.1 |
| | CV L5 | 80 | 0.262 | 0.0040 | 1.5 | 0.0035 | 1.3 | 0.0015 | 0.6 | 0.0010 | 0.4 |
- The aqueous control materials (Control L1, L2, L3) are also used as the middle levels of the calibration verification set (CV L2, CV L3, CV L4). The aqueous fluids are the same.
a Non-normal distribution (p-value