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510(k) Data Aggregation
(266 days)
i-STAT Hematocrit test with i-STAT Alinity System
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.
| Performance Characteristic | Implicit Acceptance Criteria (based on common lab standards/comparison to predicate) | Reported Device Performance |
|---|---|---|
| Precision (Aqueous Materials) | Acceptable within-run, between-run, and total precision (%CV and SD) for a hematocrit measuring device. | CV L2 (16.9%PCV): ST 0.46, CVt 2.72%; Sr 0.44, CVr 2.60%; Srr 0.09, CVrr 0.53%; Sdd 0.09, CVdd 0.53% |
| CV L3 (33.9%PCV): ST 0.51, CVt 1.50%; Sr 0.48, CVr 1.42%; Srr 0.13, CVrr 0.38%; Sdd 0.11, CVdd 0.32% | ||
| CV L4 (55.2%PCV): ST 0.49, CVt 0.89%; Sr 0.47, CVr 0.85%; Srr 0.12, CVrr 0.22%; Sdd 0.09, CVdd 0.16% | ||
| CV L5 (65.0%PCV): ST 0.39, CVt 0.60%; Sr 0.37, CVr 0.57%; Srr 0.10, CVrr 0.15%; Sdd 0.09, CVdd 0.14% | ||
| Precision (Whole Blood) | Acceptable within-instrument and total precision (%CV and SD) across different hematocrit levels at multiple sites. | Abnormal Low ( 51%PCV): Total SD 0.48, %CV 0.88 (Site 1); Total SD 0.30, %CV 0.57 (Site 2); Total SD 0.22, %CV 0.41 (Site 4) |
| Linearity | Demonstration of linearity across the claimed reportable range (15 - 75 %PCV) with an appropriate regression model. | Demonstrated over the reportable range (15 - 75 %PCV). Best fitting regression was a third-order model, with non-linearity ranging from 0.19 to 0.81 %PCV. (This is generally considered acceptable if the non-linearity is small enough.) |
| Recovery | Acceptable percentage recovery across the reportable range. | % recovery ranged from 100.1% to 102.8%. (This is a very good recovery range, indicating accurate measurement across the range.) |
| Limit of Quantitation (LoQ) | LoQ should be at or below the claimed low end of the reportable range. | LoQ determined to be 14.0 %PCV, which is less than the low end of the reportable range (15 %PCV). (Meets criteria.) |
| Interference | Identification of compounds that do/do not interfere within specified concentrations (difference from reference > 10.8% of mean reference value). | Non-interfering: Bromide ( 12 g/dL) at 26.5-31.5 %PCV Hct level; White Blood Cells (> 50,000 WBC/µL) at 26.5-31.5 %PCV Hct level. (Crucial information for labeling and use.) |
| Anticoagulant Study | Comparability between heparinized and non-anticoagulated whole blood samples. | Deming regression results: slope of 1.00 and correlation coefficient of 1.00. (Indicates excellent agreement.) |
| Microhematocrit Reference Study | Strong correlation and negligible bias when compared to the microhematocrit reference method (K2EDTA). | Deming regression: slope of 1.02, intercept of -0.53, R² of 1.00 (vs K2EDTA reference); and slope of 1.02, intercept of -0.41, R² of 1.00 (vs K2EDTA microhematocrit). (Indicates excellent agreement.) |
| Method Comparison with Predicate Device | Strong correlation and agreement between the new device and the predicate device across the reportable range. | Weighted Deming regression for all 3 sites combined: slope of 1.016 and correlation coefficient (r) of 0.995. (Indicates very strong agreement, supporting substantial equivalence.) |
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 (
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