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510(k) Data Aggregation
(140 days)
i-Stat Alinity System with i-Stat Glucose test
The i-STAT Alinity System with i-STAT Glucose test is intended for use or clinical laboratory settings. The i-STAT Alinity System with Glucose test is intended for the quantitative measurement of glucose in arterial and venous whole blood.
Glucose measurements are used in the diagnosis, monitoring, and treatment of carbohydrate metabolism disorders including, but not limited to, diabetes mellitus, idiopathic hypoglycemia, and pancreatic islet cell carcinoma. The i-STAT Glucose test with the i-STAT Alinity System has not been evaluated in neonates.
For in vitro diagnostic use.
The i-STAT System is a handheld, in vitro diagnostic analytical device designed to run only i-STAT test cartridges. 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 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 test reagents which are located on the sensors. 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.
Here's a breakdown of the acceptance criteria and the study used to prove the device meets them, based on the provided text:
Device: i-STAT Alinity System with i-STAT Glucose test
Intended Use: Quantitative measurement of glucose in arterial and venous whole blood for diagnosis, monitoring, and treatment of carbohydrate metabolism disorders.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" vs. "reported performance" in a single, consolidated table with specific pass/fail thresholds. Instead, it details various performance characteristics and their observed results, implying that meeting these results demonstrates acceptable performance. I will construct a table reflecting this, drawing from the "Performance Characteristics" section.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance and Results |
|---|---|---|
| Precision (Aqueous) | Demonstrate acceptable within-laboratory, within-run, between-run, and between-day precision across 5 glucose levels. | CV L1 (26.9 mg/dL): ST: 0.42 (1.56%CV), Sr: 0.22 (0.82%CV), Srr: 0.34 (1.26%CV), Sdd: 0.12 (0.45%CV) |
| CV L2 (41.0 mg/dL): ST: 0.34 (0.83%CV), Sr: 0.20 (0.49%CV), Srr: 0.18 (0.44%CV), Sdd: 0.21 (0.51%CV) | ||
| CV L3 (125.0 mg/dL): ST: 0.32 (0.26%CV), Sr: 0.21 (0.17%CV), Srr: 0.23 (0.18%CV), Sdd: 0.09 (0.07%CV) | ||
| CV L4 (286.7 mg/dL): ST: 0.77 (0.27%CV), Sr: 0.53 (0.18%CV), Srr: 0.52 (0.18%CV), Sdd: 0.22 (0.08%CV) | ||
| CV L5 (600.6 mg/dL): ST: 3.47 (0.58%CV), Sr: 2.42 (0.40%CV), Srr: 2.26 (0.38%CV), Sdd: 1.06 (0.18%CV) | ||
| All results fall within typical expectations for precision in diagnostic devices. | ||
| Precision (Whole Blood) | Demonstrate acceptable within-instrument and total precision across 6 glucose levels. | Concentration (mg/dL) / Total SD / Total %CV: |
| 30-50: 0.36-0.51 / 0.97-1.16% | ||
| 51-110: 0.22-0.51 / 0.21-0.61% | ||
| 111-150: 0.48-0.64 / 0.38-0.54% | ||
| 151-250: 0.54-0.70 / 0.22-0.38% | ||
| 251-400: 1.43-2.53 / 0.41-0.73% | ||
| 401-700: 2.81-7.46 / 0.49-1.36% | ||
| All results fall within typical expectations for precision in diagnostic devices, with CVs generally below 2%. | ||
| Linearity | Demonstrate linearity across the reportable range (20-700 mg/dL). | Best fitting regression model was a second-order model. Absolute value of non-linearity ranged from 0.00 to 23.8 mg/dL. Demonstrated linearity over the reportable range (20-700 mg/dL). |
| Recovery | Demonstrate acceptable recovery bias and % recovery across the reportable range (20-700 mg/dL). | % recovery ranged from 94.6% to 100.3% across the glucose reportable range (20-700 mg/dL). |
| Limit of Quantitation (LoQ) | Establish the LoQ. | LoQ determined to be 5.558 mg/dL. |
| Interference | Identify compounds that do and do not interfere with glucose measurements (difference > 10% from control). | Non-interfering compounds (at specified concentrations): Acetaminophen, Acetaldehyde, Acetoacetate, L-Ascorbic Acid, Acetyl Cysteine, Ammonium Chloride, Bromide, β-Hydroxybutyric Acid, Dopamine, Ethanol, Fluoride, Formaldehyde, Glycolic Acid, Gentamicin, Glucosamine, Glutathione, Guaifenesin, Hemoglobin, Heparin, Ibuprofen, Isoniazid, Lactate, Mannose, Maltose, pH, Pyruvate, Salicylate, Thiocyanate, Triglyceride, Uric Acid, Sodium Thiosulfate, Bilirubin, Cholesterol, Creatinine, Fructose, Galactose, Xylose. |
| Interfering compound (at specified concentrations): Hydroxyurea concentration above 0.43 mmol/L may falsely elevate i-STAT glucose by >10%. | ||
| Anticoagulant Study | Demonstrate equivalence between heparinized and non-anticoagulated whole blood. | Deming regression result: slope of 1.00 and correlation coefficient of 1.00. |
| Altitude Study | Demonstrate equivalent performance at altitudes up to 10,000 feet compared to sea level. | Performance at altitude up to 10,000 feet was found to be equivalent to performance at sea level. |
| Oxygen Study | Demonstrate equivalent glucose results at low and high oxygen levels. | This study demonstrated equivalent glucose results when evaluated at low and high oxygen levels for all glucose concentrations tested. |
| Method Comparison with Predicate Device | Demonstrate substantial equivalence to the predicate device (i-STAT 1 Wireless Analyzer). | Weighted Deming regression for all 3 sites combined: slope of 0.999, intercept of 1.164, and correlation coefficient of 1.000. These results demonstrate substantial equivalence. |
2. Sample sizes used for the test set and the data provenance
This section generally refers to the performance studies.
- Precision (Aqueous):
- Sample Size: 80 measurements per level for 5 levels (Total N = 400 test results).
- Data Provenance: Not explicitly stated, but typically performed in a controlled laboratory setting (likely within the US, given the FDA submission). Retrospective/Prospective not specified, but usually prospective for such evaluations.
- Precision (Whole Blood):
- Sample Size: 21 test results per sample (3 tests x 7 instruments) for each of 6 concentration levels, across 3 sites. The total number of unique patient samples is not explicitly stated (the text mentions "venous whole blood (native or altered) samples targeted to six different glucose levels"). If each target level had a unique set of samples across sites, it would be at least 18 distinct sample pools (6 levels x 3 sites), each with 21 replicates.
- Data Provenance: Performed at 3 point-of-care sites. Likely prospective, collecting fresh whole blood samples. Country of origin not specified, but likely US.
- Linearity:
- Sample Size: Not explicitly stated as a number of patient samples. It evaluated a "series of glucose concentration levels in whole blood."
- Data Provenance: Not specified.
- Recovery:
- Sample Size: A "series of glucose concentration levels in whole blood." Not a specific count.
- Data Provenance: Not specified.
- Limit of Quantitation (LoQ):
- Sample Size: Not explicitly stated, involved "whole blood that was altered to low glucose concentrations (
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