Search Results

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.

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.

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:

1. 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

2. 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).

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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

   • Not applicable, as no training set (for machine learning) is relevant to this device.

Ask a specific question about this device

The i-STAT Alinity instrument with i-STAT tests is intended for use in point of care or clinical laboratory settings. The i-STAT Alinity system is intended for the quantitative measurement of various analytes in arterial and venous whole blood.

The i-STAT Hematocrit test is intended for use in the in vitro quantification of packed red blood cell volume fraction in arterial or venous heparinized whole blood, or in arterial or venous non-anticoagulated whole blood.

Hematocrit measurements can aid in the determination of normal or abnormal total red cell volume status that can be associated with conditions including anemia and erythrocytosis.

The i-STAT Hematocrit test with the i-STAT Alinity System has not been evaluated in neonates.

The i-STAT Hematocrit test with the i-STAT Alinity System is not for use with capillary samples.

For in vitro diagnostic use.

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.

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 test cartridge contains sensors which are located on the biosensors chips. The instrument interacts with the cartridge to move fluid across the sensors and generate a quantitative result. Cartridges require two to three drops of whole blood which are typically applied to the cartridge using a syringe.

The provided document describes the FDA 510(k) premarket notification for the i-STAT Hematocrit test with the i-STAT Alinity System. This is a point-of-care device for quantitative measurement of packed red blood cell volume fraction (hematocrit) in whole blood.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Important Note: This document primarily focuses on demonstrating substantial equivalence to a predicate device (i-STAT Hematocrit test with i-STAT 1 Wireless Analyzer). Therefore, the "acceptance criteria" are largely implied by the performance characteristics demonstrated to be comparable or better than the predicate, or to fall within acceptable laboratory limits for precision, linearity, etc. There isn't an explicit table of pre-defined acceptance criteria with pass/fail thresholds in the same way one might find for, say, an AI diagnostic algorithm's sensitivity/specificity. The criteria are implicitly the successful demonstration of analytical performance, rather than clinical efficacy against a true disease state, as it's a quantitative measurement device.

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit, pre-defined acceptance criteria with numerical thresholds (e.g., "sensitivity > 90%") are not stated for this type of device and submission. Instead, the acceptance is based on demonstrating sound analytical performance characteristics comparable to or better than a legally marketed predicate device. The performance data presented below indicate that the device met its internal performance specifications, which are implicitly the "acceptance criteria" for this submission type.

2. Sample Size Used for the Test Set and Data Provenance

For a quantitative measurement device like this, there isn't a single "test set" in the context of an AI model. Instead, various test samples are used for different analytical performance studies:

• Precision (Aqueous Materials): 4 levels of aqueous materials tested over 20 days. N=80 for each level (total of 320 measurements).
• Precision (Whole Blood): Venous whole blood samples (native or altered) at low abnormal, normal, and high abnormal hematocrit levels. N=21 for each level at each of 3 sites (total of 9 samples, each tested 21 times, so 9 * 21 = 189 measurements described in the table, across an unspecified total number of individual blood samples).
• Linearity: A series of whole blood samples used to span the reportable range. (Specific N not provided, but typically would involve multiple dilutions).
• Recovery: A series of whole blood samples spanning the reportable range. (Specific N not provided).
• Limit of Quantitation (LoQ): Whole blood samples altered to low hematocrit levels (

Ask a specific question about this device