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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the i-STAT CHEM8+ cartridge with the i-STAT 1 System, specifically for the ionized calcium (iCa) test. It details various performance characteristic studies to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text. Many elements cannot be fully answered as they are not explicitly stated in this specific document, which is a summary.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the successful outcomes of the performance studies. For a clearer table, we derive the 'acceptance criteria' from the observed 'performance' meeting regulatory expectations for substantial equivalence.

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Precision (Aqueous Materials)	Low %CV values, indicating reproducibility across various levels and within/between runs/days.	iCa (mmol/L): - CV L1: Total CV 0.6% - CV L2/Control L1: Total CV 0.7% - CV L3/Control L2: Total CV 0.5% - CV L4/Control L3: Total CV 0.5% - CV L5: Total CV 1.5%
Precision (Whole Blood - Venous)	Low %CV values across different sample ranges.	Venous Whole Blood: - 0.25-0.75 mmol/L: 2.2% CV - 0.75-1.2 mmol/L: 1.6% CV - 1.2-1.5 mmol/L: 1.0% CV - 1.5-2.5 mmol/L: 0.9% CV
Precision (Whole Blood - Arterial)	Low %CV values across different sample ranges.	Arterial Whole Blood: - 0.25-0.75 mmol/L: 0.9% CV - 0.75-1.2 mmol/L: 3.0% CV - 1.2-1.5 mmol/L: 0.8% CV - 1.5-2.5 mmol/L: 0.5% CV
Linearity	Demonstrate linearity over the specified reportable range with a good fit.	Linearity demonstrated over 0.25 - 2.50 mmol/L reportable range. Regression: Slope 0.9738, Intercept 0.360, R2 0.999. "Absolute degree of nonlinearity results met the acceptance criteria."
Limit of Quantitation (LoQ)	LoQ should be at or below the lower limit of the reportable range.	LoQ determined to be 0.21 mmol/L, which is below the lower limit of the reportable range (0.25 mmol/L).
Limit of Blank (LoB)	LoB should be very low, indicating minimal signal in the absence of analyte.	LoB determined to be 0.14 mmol/L.
Limit of Detection (LoD)	LoD should be very low, indicating the lowest detectable concentration.	LoD determined to be 0.15 mmol/L.
Interference	No significant interference from common substances or specified interfering substances below allowed error (Ea).	Several substances tested; Interference identified for: Leflunomide, Lithium Lactate, Lithium Thiocyanate, Sodium Thiosulfate, Teriflunomide. For these, details on the specific effect (e.g., "Decreased results ≥ 0.4 mmol/L") are provided. Other substances showed no interference at tested concentrations.
Method Comparison with Predicate Device	Strong correlation (r value close to 1) and a slope close to 1 with an intercept close to 0 when compared to the predicate device.	iCa: N=250, Slope 1.00, Intercept -0.02, r 0.99.

Study Details:

A table of acceptance criteria and the reported device performance: See table above.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Precision (Aqueous): 80-81 measurements per level (N values in Table 1). Data provenance is not specified regarding country, but it was conducted "at one site." The study design (20-day multi-day precision testing) implies a prospective collection of data for this specific study.
- Precision (Whole Blood): 241 samples (132 venous, 109 arterial). Data collected across "three point of care sites." Data provenance regarding country or retrospective/prospective nature is not explicitly mentioned, but the context of a validation study typically implies prospective collection for this analysis.
- Linearity: Not explicitly stated but implies multiple whole blood samples across the range (0.22 - 2.81 mmol/L).
- LoQ/LoB/LoD: Not explicitly stated how many individual sample measurements were involved, but mentions "whole blood that was altered" and conducted over "four (4) days using two (2) cartridge lots."
- Interference: Not explicitly stated, but each substance was evaluated by comparing a control sample to a spiked sample.
- Method Comparison: 250 samples (N value in Table 6). Venous and arterial blood specimens were evaluated. Data provenance regarding country or retrospective/prospective nature is not explicitly mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable for this type of device. This is an in vitro diagnostic (IVD) device for quantitative measurement. Ground truth is established by reference methods or direct measurement comparisons, not expert subjective interpretation (like radiologists for imaging). The predicate device (Epocal EPOC Blood Analysis System) served as the comparative method for the method comparison study.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. As an IVD device measuring a quantitative analyte, there is no subjective interpretation requiring adjudication methods.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI-assisted diagnostic imaging device that involves human reader interpretation. It's an automated quantitative IVD system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this is a standalone device. The performance characteristics (precision, linearity, LoQ, LoD, LoB, interference) and the method comparison against a predicate device evaluate the device itself without direct human interpretation influencing the measurement result for iCa. The system automatically performs quality checks and suppresses results if specifications are not met.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For precision studies, the 'ground truth' is the mean value derived from repeated measurements of stable materials or samples, reflecting the inherent variability.
- For linearity studies, ground truth is established by accurately prepared samples with known concentrations.
- For LoQ/LoB/LoD studies, ground truth is based on samples expertly prepared to very low or zero analyte concentrations.
- For interference studies, ground truth is the expected value of the sample without the interfering substance.
- For method comparison, the predicate device (Epocal EPOC Blood Analysis System) serves as the "ground truth" or reference for comparison.
The sample size for the training set:
- Not applicable. This document describes a traditional IVD device validation, not a machine learning or AI model development that requires a "training set" in the conventional sense of AI. The device's underlying technology relies on ion-selective electrodes, not a learned model from a large dataset.
How the ground truth for the training set was established:
- Not applicable. See point 8.

Summary

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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

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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

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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)

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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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

Productcode	Device Classificationname	RegulationNumber	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

Productcode	Device Classificationname	RegulationNumber	Class	Panel
JFP	Electrode, Ion Specific,Calcium	862.1145	II	Clinical Chemistry

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4. Device Description

5. Intended Use Statement

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

Feature orCharacteristic	Predicatelonized Calcium Test withEPOC Blood Analysis System(K061597)	Candidatelonized Calcium Test with i-STAT 1System
Intended Use	Measurement of Ionized Calciumis used in diagnosis andtreatment of parathyroid disease,a variety of bone diseases,chronic renal disease andtetany.	The i-STAT CHEM8+ cartridge withthe i-STAT 1 System is intended foruse in the in vitro quantification ofionized calcium in arterial or venouswhole blood in point of care or clinicallaboratory settings.
		lonized calcium measurements areused in the diagnosis and treatmentof parathyroid disease, a variety ofbone diseases, chronic renal disease

6. Summary Comparison of Technological Characteristics

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Feature orCharacteristic	Predicatelonized Calcium Test withEPOC Blood Analysis System(K061597)	Candidatelonized Calcium Test with i-STAT 1System
		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-STATTest	CalibrationVerificationLevel	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

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CalibrationVerificationLevel	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 <0.010), the median value was used to calculate %CV.

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 taking into consideration the lower and upper limits of the reference interval, 1.12 mmol/L and 1.32 mmol/L.

The results are provided in Table 2 and Table 3 below:

Table 2: Venous whole blood
Sample Range(mmol/L)	N	Mean(mmol/L)	SD	CV (%)
0.25 - 0.75	10	0.438	0.0097	2.2
0.75 – 1.2	ರಿತ	1.094	0.0173	1.6
1.2 — 1.5	22	1.278	0.0134	1.0
1.5 — 2.5	7	2.109	0.0183	0.9

Table 3: Arterial whole blood
Sample Range(mmol/L)	N	Mean(mmol/L)	SD	CV (%)
0.25 - 0.75	3	0.445	0.0041	0.9
0.75 – 1.2	73	1.110	0.0329	3.0
1.2 – 1.5	27	1.244	0.0105	0.8
1.5 – 2.5	6	1.725	0.0091	0.5

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 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 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. Therefore, the i-STAT iCa demonstrated linearity over the reportable range

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0.25 - 2.50 mmol/L. Regression summary of the iCa response versus the concentration of the whole blood samples of varying analyte levels is provided in Table 4.

Table 4: Regression Summary for the i-STAT iCa test on the i-STAT 1 Analyzer
i-STAT Test(mmol/L)	ReportableRange (mmol/L)	Range Tested(mmol/L)	Slope	Intercept	R2
iCa	0.25 - 2.50	0.22 - 2.81	0.9738	0.360	0.999

c. Limit of Quantitation (LoO)

The study was based on the CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline-Second Edition.

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 (< 0.25 mmol/L). The study was conducted over four (4) days using two (2) cartridge lots. The LoQ for the i-STAT iCa test was determined to be 0.21 mmol/L, which is below the lower limit of the i-STAT iCa test reportable range (0.25 - 2.50 mmol/L).

d. Limit of Blank and Detection (LoB/LoD)

The study was based on CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline–Second Edition.

The LoB/LoD of the i-STAT iCa test was evaluated on the i-STAT 1 Analyzer using whole blood that was altered to a "blank" ionized calcium concentration for LoB testing and two "low" ionized calcium concentrations for LoD testing. The LoB and LoD were determined based on the maximal LoB or LoD value obtained for each cartridge lot tested. The LoB for i-STAT iCa test was determined to be 0.14 mmol/L and the LoD was determined to be 0.15 mmol/L.

e. Interference

The interference performance of the i-STAT iCa test on the i-STAT 1 Analyzer was evaluated using whole blood samples based on CLSI EP07 ED3: Interference Testing in Clinical Chemistry, Third Edition. The effect of each substance was evaluated by comparing the performance of a control sample, spiked with blank solvent solution, with the test results from a sample spiked with the potentially interfering substance at the toxic/pathological concentration based on CLSI EP37 ED1: Supplemental Tables for Interference Testing in Clinical Chemistry, First Edition, as applicable. A substance was identified as an interferent if the difference between the control and test samples was outside of the allowed error (Ea) for the i-STAT test.

Table 5 contains the list of potentially interfering substances tested for the i-STAT Ionized Calcium test and the interference results.

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test		Test Concentration	Interference
Substance	mmol/Lmg/dL		(Yes/No)	Interference Results
Acetaminophen	1.03	15.6	No
Bilirubin	0.684	40	No
Cholesterol	10.3	400	No
Hemoglobin	10 g/L	1000	No
β-Hydroxybutyric Acid	6.0*	62.46	No
L-Ascorbic Acid	0.298	5.25	No
Leflunomide	0.722*	19.5	Yes	Decreased results≥ 0.4 mmol/L
Lithium Bromide	37.5*	325.69	No
Lithium Lactate	10	90	Yes	Decreased results≥ 6.3 mmol/L
Lithium Salicylate	0.207	2.86	No
Lithium Thiocyanate	0.898	5.22	Yes	Decreased results≥ 0.874 mmol/L
Magnesium Chloride	4.1	10	No
N-Acetyl-L-Cysteine	0.92	15.0	No
Potassium Chloride	8	59.6	No
Sodium Chloride	170	993.48	No
Sodium lodide	2.99*	44.82	No
Sodium Thiosulfate	16.7*	264.04	Yes	Decreased results≥ 5.5 mmol/L
Teriflunomide	0.722*	19.5	Yes	Decreased results≥ 0.1 mmol/L
Triglyceride	16.94	1500	No

Table E. Cummary

No CLSI EP37-ED1 test concentration available. 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.

Comparison Study

f. Method Comparison with Predicate Device

Method comparison was demonstrated in a study comparing the i-STAT iCa test performance on the i-STAT 1 to the EPOC Blood Analysis System. The study was based on CLSI guideline EP09c-ED3. Venous and arterial blood specimens were evaluated and analyzed on the i-STAT 1 against venous and arterial blood specimens on the EPOC Blood Analysis System. A Passing-Bablok linear regression analysis was performed using the first replicate result from the i-STAT 1 versus the singlicate result of the comparative method.

The i-STAT System automatically runs a comprehensive set of quality checks of both the analyzer and cartridge performance each time a sample is tested. This internal quality system will suppress results by generating a Quality Check Code (QCC) if the analyzer, cartridge or sample does not meet certain internal specifications. When a QCC occurs, a single code number, the type of problem and

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the next step to be taken will be displayed on the i-STAT Analyzer. The failure rate for a single cartridge due to QCCs may be as high as 4%. The rate of failure for two consecutive cartridges due to QCCs may be as high as 1.7%.

Table 6: Method Comparison Results
i-STAT Test	N	Slope	Intercept	r
iCa	250	1.00	-0.02	0.99

8. Conclusion

The results of these studies demonstrate that performance of the i-STAT CHEM8+ Ionized Calcium test with the i-STAT 1 System are substantially equivalent to the comparative method.

Regulation Number and Section

§ 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.