Search Results

Abbott Point of Care Inc.

Manufacturer

Date Cleared

2020-02-28

(427 days)

Product Code

JPI

Regulation Number

864.6400

Type

Hepatology / Hepatic (HE)

Panel

Reference & Predicate Devices

k163342

Intended Use

The i-STAT CHEM8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of hematocrit in arterial or venous whole blood in point of care or clinical laboratory settings. 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.

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 hematocrit (HCT). 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 medical device discussed in these documents is the i-STAT CHEM8+ cartridge with the i-STAT 1 System for measuring hematocrit.

Here's a breakdown of the acceptance criteria and the study information, structured as requested:

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Metric)	Acceptance Criteria	Reported Device Performance
Precision (Aqueous Materials)	Not explicitly stated as acceptance criteria, but study results presented for various levels.	CV L2/Control L1: 1.1%
Precision (Whole Blood) - Venous	Not explicitly stated as acceptance criteria, but study results presented for various ranges.	≤ 35%PCV: 1.6% CV
Precision (Whole Blood) - Arterial	Not explicitly stated as acceptance criteria, but study results presented for various ranges.	≤ 35%PCV: 7.1% CV
Linearity	Absolute degree of nonlinearity results meet acceptance criteria.	Demonstrated linearity over 15 - 75 %PCV. (Regression R² = 0.9973)
Limit of Quantitation (LoQ)	LoQ must be below the lower limit of the reportable range.	LoQ = 12.4 %PCV (below reportable range of 15%PCV)
Limit of Blank (LoB)	Not explicitly stated as a numerical acceptance criteria.	LoB = 0.66 %PCV
Limit of Detection (LoD)	Not explicitly stated as a numerical acceptance criteria.	LoD = 1.38 %PCV
Interference	95% CI of the difference between test & control samples must be within allowable error (Ea).	Most substances showed no interference. Lithium Bromide, Total Protein (high/low), and White Blood Cells (>50,000 WBC/uL) showed interference.
Method Comparison (Slope vs. Predicate)	Not explicitly stated as a numerical acceptance criteria.	1.030
Method Comparison (Intercept vs. Predicate)	Not explicitly stated as a numerical acceptance criteria.	-0.530
Method Comparison (Correlation vs. Predicate)	Not explicitly stated as a numerical acceptance criteria.	1.00

Sample Size Used for the Test Set and Data Provenance
- Precision (Aqueous Materials): N=80-81 for each of the 4 levels. Data provenance not specified (likely internal laboratory data).
- Precision (Whole Blood): 190 samples (123 venous, 67 arterial). Data collected across three point-of-care sites. Data provenance not specified (implies retrospective collection from clinical sites).
- Linearity: Whole blood samples of varying analyte levels. Number of samples not specified. Data provenance not specified.
- Limit of Quantitation: Four whole blood samples. Study conducted over 3 days using 2 cartridge lots. Data provenance not specified.
- Limit of Blank/Detection: Whole blood samples (one "blank" and two "low" Hct concentrations). Data provenance not specified.
- Interference: Whole blood test samples. Number of samples not specified for each substance. Data provenance not specified.
- Method Comparison: N=194 (venous and arterial blood specimens). Data provenance not specified (implies collection at sites performing method comparison).
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- No information provided regarding the use of experts to establish a "ground truth" in the traditional sense. These are analytical performance studies, where the reference method (e.g., predicate device, microhematocrit method) serves as the comparator or reference.
Adjudication Method for the Test Set
- Not applicable/Not mentioned. These are objective analytical measurements compared against established reference methods or statistical criteria, not subjective interpretations requiring adjudication.
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 device is an in-vitro diagnostic (IVD) instrument for quantitative measurement of hematocrit, not an AI imaging or diagnostic algorithm that assists human readers.
If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
- Yes, the entire submission focuses on the standalone analytical performance of the i-STAT CHEM8+ cartridge with the i-STAT 1 System, a fully automated measurement device. There is no human-in-the-loop component in the measurement itself, beyond loading the sample and operating the device.
The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Analytical Performance: The ground truth or reference method for analytical performance studies is implicitly or explicitly stated.
  - Precision: Statistical variability of repeated measurements.
  - Linearity: Expected values based on dilutions or known concentrations.
  - LoQ/LoB/LoD: Statistical determination from low-level samples.
  - Interference: Comparison of spiked samples to unspiked controls.
  - Method Comparison: The predicate device (i-STAT Hematocrit test on the i-STAT Alinity Instrument) was used as the comparative method. The "Test Traceability" section also notes the Microhematocrit Method as the basis for traceability.
The Sample Size for the Training Set
- Not applicable. This device is a quantitative measurement system, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its performance is based on its electrochemical sensing mechanisms and calibration, rather than on parameters learned from a data set.
How the Ground Truth for the Training Set Was Established
- Not applicable, as no training set (for machine learning) is relevant to this device.

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K Number

K191360

Device Name

Abbott Point of Care, Inc.

Manufacturer

Date Cleared

2020-02-14

(269 days)

Product Code

JFP

Regulation Number

862.1145

Type

Panel

Reference & Predicate Devices

K061597

Intended 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.

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.

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.

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K Number

K183678

Device Name

Abbott point of Care, Inc.

Manufacturer

Date Cleared

2020-02-07

(406 days)

Product Code

CGA,CGL

Regulation Number

862.1345

Type

Panel

Reference & Predicate Devices

K042291

Intended Use

The i-STAT CHEM8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of glucose, and creatinine in arterial or venous whole blood in point of care or clinical laboratory settings.

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.

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 glucose and creatinine. 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.

AI/ML Overview

The provided text describes the analytical performance studies for the i-STAT CHEM8+ cartridge with the i-STAT 1 System for measuring glucose and creatinine. While it details numerous performance characteristics, it does not explicitly state "acceptance criteria" for each test. However, the study design and "results met the acceptance criteria" statements imply that certain predefined thresholds were successfully achieved.

Let's break down the information available to address your request:

Acceptance Criteria and Reported Device Performance

The document doesn't provide a consolidated table of explicit acceptance criteria. Instead, it states that results "met the acceptance criteria" for linearity, and it outlines the method for identifying interference (difference between control and test samples outside of the allowed error (Ea)). For precision studies, statistical metrics like Total Standard Deviation (ST) and Coefficient of Variation (CV) are presented, and for method comparison, slope, intercept, and correlation coefficient (r) are given. The implied acceptance is that these values fall within acceptable ranges for a diagnostic device of this type.

Implied Acceptance Criteria and Reported Performance (derived from text):

Performance Characteristic	Implicit Acceptance Criteria (based on common IVD standards)	Reported Device Performance (Summary)
Precision (Aqueous Materials)	Low CV values across levels (e.g., 500 mmHg for creatinine and 25 to >500 mmHg for glucose."
Altitude	Correlation coefficient and slope results met acceptance criteria.	Creatinine: r 1.00, Slope 1.13 (up to 6367 feet)
Glucose: r 1.00, Slope 1.00 (up to 9523 feet)
Interference	Absence of significant interference; difference between control/test samples within allowed error (Ea).	Glucose: Lithium Bromide (≥ 11.8 mmol/L) increased results; Hydroxyurea (≥ 0.08 mmol/L) increased results.
Creatinine: Lithium Bromide (≥ 18.3 mmol/L) increased results; Hydroxyurea (≥ 0.03 mmol/L) increased results. (Other listed substances showed no interference).
Method Comparison (vs. Predicate)	High correlation (r), slope near 1, intercept near 0.	Glucose: N=185, Slope 0.98, Intercept 0.00, r 1.00
Creatinine: N=180, Slope 1.043, Intercept -0.062, r 1.00

Study Details:

Sample Size used for the Test Set and Data Provenance:
- Precision (Aqueous): N=80 or 81 for each level of Creatinine and Glucose. Data provenance is not specified (e.g., country of origin) but implied to be laboratory-based ("one site"). It is an analytical performance study, not a clinical study on patient samples.
- Precision (Whole Blood): Sample sizes vary per site and level (e.g., N=14 to N=21). The study used "venous whole blood (native or altered) samples." The study was conducted at "3 point of care sites."
- Linearity: Whole blood samples of "varying analyte levels" were prepared. Specific N not provided for this particular section.
- LoQ, LoB/LoD: Whole blood samples were "altered to low glucose" or "blank" concentrations. Specific N not provided for this section.
- Hematocrit Sensitivity: Three hematocrit levels evaluated across four glucose levels. Specific N not provided.
- Oxygen Sensitivity: High and low ranges of oxygen. Specific N not provided.
- Altitude: Not explicitly stated, but results given for "average measured altitude." Specific N not provided.
- Interference: Whole blood samples based on CLSI guidelines. Specific N not provided, but multiple substances tested.
- Method Comparison: N=185 for Glucose, N=180 for Creatinine. Used "Venous and arterial blood specimens" for the i-STAT device and "plasma specimens" for the predicate device. Data provenance is not specified.
Overall Provenance: The studies are "analytical performance" studies, primarily laboratory-based and conducted on various prepared or native samples. There is no indication of geographic origin or whether samples were retrospective or prospective, though for analytical performance, prospective collection for the purpose of the study is common.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is an in vitro diagnostic (IVD) device. The "ground truth" for analytical performance studies is established by reference methods or highly accurate laboratory analyzers (the "comparative method"), not by human experts interpreting images or clinical outcomes. In this case, "ground truth" (or comparative method) for the method comparison study was the Beckman DxC, a laboratory analyzer.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is an IVD device measuring analytes, not interpretations of images or clinical assessments requiring human adjudication.
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 an IVD device for measuring chemical analytes in blood, not an imaging device assisted by AI to be read by human experts.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The i-STAT device functions as a standalone analyzer that quantifies glucose and creatinine. The performance studies described (precision, linearity, LoQ, LoD, interference, method comparison) are standalone performance studies of the device's ability to measure these analytes. While a human initiates the test and interprets the quantitative result, the measurement process itself is automated (algorithm only).
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For the method comparison study, the ground truth was essentially the measurements from a legally marketed predicate device (Beckman DxC), which serves as the comparative method in analytical validation. For other analytical performance studies (precision, linearity, LoQ/LoD), the "ground truth" is based on the known concentrations of prepared reference materials or controls, or the statistical evaluation of repeated measurements of samples.
The sample size for the training set:
- The documentation does not discuss a "training set" in the context of machine learning or AI models, as this is a traditional IVD device based on electrochemical principles, not an AI/ML device. Therefore, no separate training set is mentioned or applicable in the way it would be for an AI-powered diagnostic.
How the ground truth for the training set was established:
- Not applicable, as there is no explicitly mentioned "training set" in the context of an AI/ML model for this traditional IVD device.

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K Number

K183688

Device Name

Abbott Point of Care, Inc.

Manufacturer

Date Cleared

2020-02-07

(406 days)

Product Code

JGS,CDS,CEM,CGZ

Regulation Number

862.1665

Type

Panel

Reference & Predicate Devices

K042291

Intended Use

The i-STAT CHEM8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of sodium, potassium, chloride and blood urea nitrogen 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 monitoring of diseases and clinical conditions that manifest high and low potassium levels.

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

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, potassium, chloride and blood urea nitrogen. The test is contained in a single-use, disposable cartridges require two to three drops of whole blood which are typically applied to the cartridge using a transfer device.

AI/ML Overview

The i-STAT CHEM8+ cartridge with the i-STAT 1 System is intended for in vitro quantification of sodium, potassium, chloride, and blood urea nitrogen (BUN) in arterial or venous whole blood in point-of-care or clinical laboratory settings.

Here's an analysis of the acceptance criteria and the study results:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the precision and method comparison studies aiming to demonstrate substantial equivalence to a predicate device (Beckman DxC). While explicit "acceptance criteria" are not listed in terms of specific thresholds for precision or correlation, the studies aim to show that the i-STAT CHEM8+ performs comparably to the predicate. The "Reportable Range" serves as one aspect of the acceptance criteria for each analyte.

Analyte	Acceptance Criteria (Reportable Range)	Reported Device Performance (Precision) - Aqueous Materials (Total CV)	Reported Device Performance (Precision) - Whole Blood (Total %CV) (Range)	Reported Device Performance (Method Comparison - Correlation (r))
Sodium	100 - 180 mmol/L	0.2% - 0.3%	0.2% - 0.5%	0.96
Potassium	2.0 - 9.0 mmol/L	0.3% - 0.4%	0.0% - 1.9%	0.99
Chloride	65 - 140 mmol/L	0.4% - 0.7%	0.2% - 1.2%	0.96
BUN	3 - 140 mg/dL	0.8% - 3.7%	0.0% - 9.4%	0.99

Interference:

Sodium: Increased results ≥ 3.1 mmol/L with Sodium Thiosulfate.
Potassium: No identified interferents from the tested substances.
Chloride: Increased results ≥ 2.4 mmol/L with Lithium Bromide, Increased results ≥ 4.19 mmol/L with Sodium Thiosulfate.
BUN: Increased results ≥ 10.2 mmol/L with Triglyceride.

Limit of Quantitation (LoQ):

Sodium: 91 mmol/L
Potassium: 1.5 mmol/L
Chloride: 56 mmol/L
BUN: 1 mg/dL

2. Sample Sizes and Data Provenance

Precision (Aqueous Materials):
- Sample Size: 80 or 81 data points for each of 5 levels per analyte (e.g., 81 for Sodium CV L1, 80 for Sodium CV L4). This study was conducted using multiple instruments and one test cartridge lot (implied prospective, in-house laboratory study).
- Data Provenance: Not explicitly stated as country of origin, but implies an in-house or specialized laboratory setting. It is a prospective analytical study.
Precision (Whole Blood):
- Sample Size: 21 test results per sample per instrument (total of 21 test results per sample). This study involved at least 3 levels per analyte, 3 point of care sites, and 7 i-STAT 1 Analyzers. The number of unique whole blood samples is not specified, but the total number of measurements is significant (e.g., for Sodium, there are 19 rows of data, each representing a mean derived from 20 or 21 measurements).
- Data Provenance: Not explicitly stated as country of origin, but indicates multiple point-of-care sites. This is a prospective analytical study.
Linearity:
- Sample Size: Not explicitly stated as a number of individual samples, but involves preparing "whole blood samples of varying analyte levels that spanned the reportable range of the tests."
- Data Provenance: Implied laboratory-based prospective analytical study.
Limit of Quantitation (LoQ):
- Sample Size: Not explicitly stated, but involved whole blood samples (and plasma for Chloride) altered to low concentrations and two test cartridge lots.
- Data Provenance: Implied laboratory-based prospective analytical study.
Interference:
- Sample Size: Not explicitly stated ("whole blood samples").
- Data Provenance: Implied laboratory-based prospective analytical study.
Method Comparison:
- Sample Size:
  - Sodium: N=187
  - Potassium: N=189
  - Chloride: N=176
  - BUN: N=184
- Data Provenance: Venous and arterial blood specimens were evaluated. Not explicitly stated as country of origin, but indicates clinical laboratory settings. This is a prospective analytical study comparing the i-STAT 1 System to the Beckman DxC.

3. Number of Experts and Qualifications for Ground Truth

This type of device (in vitro diagnostic for laboratory analytes) does not typically involve human expert adjudication for ground truth. The "ground truth" for analytical performance studies is established by:

The reference method (Beckman DxC in the method comparison study).
Precisely prepared calibrators or control materials with known concentrations (for precision, linearity, LoQ, and interference studies).
NIST Standard Reference Materials (SRM) were used for traceability and calibration (NIST SRM 918, 919, 956, 912, 909).

4. Adjudication Method for the Test Set

Not applicable, as this is an analytical device for quantitative measurements, not an imaging device requiring expert clinical interpretation. The ground truth is established by reference measurement systems and documented analytical methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done. This type of study is typically for evaluating the performance of diagnostic imaging devices that rely on human interpretation, often with and without AI assistance. This device is an in vitro diagnostic (IVD) analyzer that provides quantitative results.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

Yes, the studies presented (precision, linearity, LoQ, interference, and method comparison) represent the standalone performance of the i-STAT CHEM8+ cartridge with the i-STAT 1 System. The device provides a direct quantitative measurement without human interpretation of its internal algorithm's output in the manner implied by "human-in-the-loop performance" for AI/ML devices.

7. The Type of Ground Truth Used

The ground truth for the analytical performance studies was established using:

Reference instrumentation run by trained laboratory personnel: For the method comparison, the Beckman DxC clinical analyzer served as the comparative method.
Prepared aqueous and whole blood materials with known analyte concentrations: Used for precision, linearity, LoQ, and interference studies.
NIST Standard Reference Materials (SRM): Used for traceability and calibration.

8. The Sample Size for the Training Set

Not applicable. This device is a traditional in vitro diagnostic device, not an AI/ML device that requires a "training set" in the machine learning sense. The "training" for such devices typically refers to the development and optimization of the electrochemical sensors and algorithms during the R&D phase, which is not described in terms of a quantifiable "training set size" in a regulatory submission for a traditional IVD.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" in the AI/ML context for this traditional IVD device. The accuracy of the device's measurement principles is established through rigorous analytical verification and validation using reference materials and comparative methods, as detailed in the performance characteristics section.

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K Number

K191298

Device Name

Abbott Point of Care Inc.

Manufacturer

Date Cleared

2020-02-07

(269 days)

Product Code

JFL

Regulation Number

862.1160

Type

Panel