(140 days)
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 (< 20 mg/dL)."
- Data Provenance: Not specified.
- Interference:
- Sample Size: Evaluated "whole blood test samples based on CLSI EP07-A2." Not a specific count of unique samples, but rather a set of samples spiked with various compounds.
- Data Provenance: Not specified.
- Anticoagulant Study:
- Sample Size: 40 blood samples.
- Data Provenance: Not specified.
- Altitude Study:
- Sample Size: Not a count of patient samples, but evaluated against "commercially available i-STAT Glucose control materials that represented 3 Glucose levels."
- Data Provenance: Not specified, likely laboratory simulation.
- Oxygen Study:
- Sample Size: "whole blood samples... at four glucose levels." Not a specific count.
- Data Provenance: Not specified, likely laboratory simulation.
- Method Comparison with Predicate Device:
- Sample Size: 237 subjects.
- Data Provenance: Conducted across 3 point-of-care sites. Likely prospective collection of fresh venous or arterial whole blood samples. Country of origin not specified, but again, likely US.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is an in vitro diagnostic (IVD) device for quantitative measurement of glucose. The "ground truth" or reference values are established by laboratory methods, typically using a validated reference method (like hexokinase method on a central lab analyzer) or traceable reference materials, not expert human interpretation. The clinical method comparison is against a legally marketed predicate device, not against expert consensus.
4. Adjudication method for the test set
Not applicable. This device provides a quantitative measurement of a biomarker. "Adjudication" typically refers to resolving discrepancies in human interpretation or classification, which isn't the primary mechanism for establishing ground truth for a glucose measurement device. The "ground truth" for the device's accuracy would be established by comparison to a traceable reference method.
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 is an in vitro diagnostic device for quantitative chemical measurement, not an AI-assisted diagnostic imaging or interpretation device that would involve human "readers" or "AI assistance."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes. All performance characteristics listed (Precision, Linearity, Recovery, LoQ, Interference, Anticoagulant, Altitude, Oxygen studies) represent the standalone performance of the i-STAT Alinity System with the i-STAT Glucose test. The "Method Comparison with Predicate Device" also evaluates the standalone performance of the new device against another standalone device. There is no AI component or human-in-the-loop aspect described for the glucose measurement itself; the device provides a direct quantitative result.
7. The type of ground truth used
The type of ground truth used for the analytical performance studies (Precision, Linearity, Recovery, LoQ, Interference) would typically be:
- For Precision (Aqueous) and Linearity: Certified reference materials (e.g., NIST SRM965 is mentioned for test traceability) or highly characterized control materials with assigned values. For linearity, serially diluted or spiked samples measured against a reference method.
- For Precision (Whole Blood) and Method Comparison: Typically, a validated and highly accurate laboratory reference method for glucose measurement (e.g., spectrophotometric hexokinase method) performed on a central laboratory analyzer would serve as the "ground truth" or comparator for blood samples. The document states a comparison to the predicate device (i-STAT 1 Wireless Analyzer) for method comparison, which itself would have been validated against such a reference.
- For Recovery, LoQ, Interference, Anticoagulant, Altitude, Oxygen Studies: These studies involve specific sample preparations (e.g., spiked samples, altered concentrations, different oxygen levels) and the "ground truth" would be either the known prepared concentration or the measurement by a trusted reference method.
8. The sample size for the training set
Not applicable. This is a traditional in vitro diagnostic device, not an AI/Machine Learning device that requires a "training set." Its operation is based on established electrochemical principles, not on learning from data.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 10, 2017
ABBOTT POINT OF CARE INC. MARIA L. FIGUEROA SR. SPECIALIST REGULATORY AFFAIRS 400 COLLEGE ROAD EAST PRINCETON NJ 08540
Re: K163271
Trade/Device Name: i-STAT Alinity System with i-STAT Glucose test Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: CGA Dated: March 13, 2017 Received: March 14, 2017
Dear Ms. Maria Figueroa:
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. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kellie B. Kelm -S
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K163271
Device Name i-STAT Alinity System with i-STAT Glucose test
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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 21CFR 807.92.
| 1. | Submitter InformationOwner | Abbott Point of Care Inc.400 College Road EastPrinceton, NJ 08540 | ||
|---|---|---|---|---|
| Contact | Primary: Maria L FigueroaSr. Specialist Regulatory Affairsmaria.l.figueroa@abbott.comPhone: 609-454-9271 | |||
| Secondary: Susan TibedoDirector Regulatory Affairssusan.tibedo@abbott.comPhone: 609-454-9360 | ||||
| Date Prepared | April 6, 2017 |
2. Device Information
Proprietary Name i-STAT Alinity System with the i-STAT Glucose test 510(k) Number: K163271
| Productcode | Device Classificationname | RegulationNumber | Class | Panel |
|---|---|---|---|---|
| CGA | Glucose Test System | 862.1345 | II | Clinical Chemistry |
3. Predicate Device
| Proprietary Name | i-STAT 1 Wireless Analyzer |
|---|---|
| ------------------ | ---------------------------- |
510(k) Number K103195
| Productcode | Device Classificationname | RegulationNumber | Class | Panel |
|---|---|---|---|---|
| CGA | Glucose Test System | 862.1345 | II | Clinical Chemistry |
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4. Device Description
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.
5. Intended Use Statement
The i-STAT Alinity System with i-STAT Glucose test is intended for use in point of care 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.
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| Similarities and Differences: System (Test and Instrument) | ||
|---|---|---|
| Feature orCharacteristic | Predicate Device (K103195)i-STAT Glucose test with thei-STAT 1 Wireless Analyzer | Candidate Devicei-STAT Glucose test with thei-STAT Alinity instrument |
| Intended Use | The i-STAT 1 Wireless Analyzeris used by trained medicalprofessionals for running avariety of clinical chemistry testsand test panels contained in i-STAT test cartridges.The test for glucose, as part ofthe i-STAT System, is intendedfor use in the in vitroquantification of glucose inarterial, venous, or capillarywhole blood. | The i-STAT Alinity System withi-STAT Glucose test is intendedfor use in point of care or clinicallaboratory settings. The i-STATAlinity System with Glucose testis intended for the quantitativemeasurement of glucose inarterial and venous whole blood. |
| Glucose measurements are usedin the diagnosis, monitoring, andtreatment of carbohydratemetabolism disorders including,but not limited to, diabetesmellitus, neonatal hypoglycemia,idiopathic hypoglycemia, andpancreatic islet cell carcinoma. | Glucose measurements are usedin the diagnosis, monitoring, andtreatment of carbohydratemetabolism disorders including,but not limited to, diabetesmellitus, idiopathichypoglycemia, and pancreaticislet cell carcinoma.The i-STAT Glucose test withthe i-STAT Alinity System hasnot been evaluated in neonates.For in vitro diagnostic use. | |
| Principle ofMeasurement | Glucose is measuredamperometrically. Oxidation ofglucose, catalyzed by the enzymeglucose oxidase, produceshydrogen peroxide (H2O2). | |
| Calibration | 1-point on-board (contained withinthe cartridge) | Same |
| TestTraceability | NIST SRM965 | Same |
| TestReportableRange | 20 - 700 mg/dL | Same |
| Sample Type | Fresh capillary, arterial or venouswhole blood. | Fresh arterial or venous wholeblood. |
| SampleVolume | 65 - 95 µL | Same |
| Similarities and Differences: System (Test and Instrument) | ||
| Feature orCharacteristic | Predicate Device (K103195)i-STAT Glucose test with thei-STAT 1 Wireless Analyzer | Candidate Devicei-STAT Glucose test with thei-STAT Alinity instrument |
| Time to test | ~2 minutes | Same |
| Test Format | Cartridge | Same |
| Testpreparation | Ready to use | Same |
| Test Storageand Stability | Storage: 2°C to 8°C (35-46°F) | Same |
| Quality Checks | A series of quality checks areautomatically run each test cycleprior to the system generating aresult. Quality checks verify theanalyzer motor, electrical,pressure and temperature systemsand cartridge elements. | Same |
| Wirelessconnectivitycapability | Yes | Same |
| Power | Two 9-volt lithium batteries, orrechargeable battery. | Lithium-Ion rechargeable battery |
| Barcodescanningcapability | Yes | Same |
| Data storagecapability | Yes | Same |
| User Interface | 19 keys for data entry | LCD touch screen |
| User InterfaceScreen | A grey scale LCD (3.5 in.) | A color LCD screen (5 in.) |
6. Summary Comparison of Technological Characteristics
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7. Performance Characteristics
Analytical Performance
a. Precision
Precision 20 days (aqueous materials)
The precision of the i-STAT Glucose Test on the i-STAT Alinity Instrument 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 10 instruments and one test cartridge lot over 20 days at one site. Total precision ('within-laboratory', Sr), within-run, (Sr), between-run, (Sr) and between-day, (Saa) were estimated for each level. The results of the 20-day precision study are shown in Table 1.
Table 1: 20-day Precision Study Results
| CalibrationVerificationLevel | N | Mean(mg/dL) | ST(mg/dL) | CVT(%) | Sr(mg/dL) | CVr(%) | Srr(mg/dL) | CVrr(%) | Sdd(mg/dL) | CVdd(%) |
|---|---|---|---|---|---|---|---|---|---|---|
| CV L1 | 80 | 26.9 | 0.42 | 1.56 | 0.22 | 0.82 | 0.34 | 1.26 | 0.12 | 0.45 |
| CV L2 | 80 | 41.0 | 0.34 | 0.83 | 0.20 | 0.49 | 0.18 | 0.44 | 0.21 | 0.51 |
| CV L3 | 80 | 125.0 | 0.32 | 0.26 | 0.21 | 0.17 | 0.23 | 0.18 | 0.09 | 0.07 |
| CV L4 | 80 | 286.7 | 0.77 | 0.27 | 0.53 | 0.18 | 0.52 | 0.18 | 0.22 | 0.08 |
| CV L5 | 80 | 600.6 | 3.47 | 0.58 | 2.42 | 0.40 | 2.26 | 0.38 | 1.06 | 0.18 |
Precision (whole blood)
The whole blood precision of the i-STAT Glucose Test on the i-STAT Alinity Instrument was evaluated using venous whole blood (native or altered) samples targeted to six different glucose levels within the i-STAT Glucose test reportable range.
One test cartridge lot was used across 3 point of care sites. At each site, each sample was tested 3 times on each of 7 i-STAT Alinity Instruments (total of 21 test results per sample). The results of the whole blood precision are shown in Table 2.
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| ConcentrationLevel(mg/dL) | Site | N | Mean(mg/dL) | Within-Instrument | Total | ||||
|---|---|---|---|---|---|---|---|---|---|
| SD | %CV | SD | SD 95%CI | %CV | %CV 95%CI | ||||
| 30-50 | 1 | 21 | 37.1 | 0.36 | 0.97 | 0.36 | (0.27, 0.52) | 0.97 | (0.74, 1.40) |
| 2 | 21 | 35.3 | 0.56 | 1.59 | 0.56 | (0.43, 0.81) | 1.59 | (1.21, 2.30) | |
| 4 | 21 | 43.6 | 0.51 | 1.16 | 0.51 | (0.39, 0.73) | 1.16 | (0.89, 1.68) | |
| 51-110 | 1 | 21 | 104.0 | 0.22 | 0.21 | 0.22 | (0.17, 0.32) | 0.21 | (0.16, 0.30) |
| 2 | 21 | 84.5 | 0.51 | 0.61 | 0.51 | (0.39, 0.74) | 0.61 | (0.46, 0.88) | |
| 4 | 21 | 92.7 | 0.46 | 0.50 | 0.46 | (0.35, 0.67) | 0.50 | (0.38, 0.72) | |
| 111-150 | 1 | 21 | 134.6 | 0.49 | 0.36 | 0.51 | (0.39, 0.74) | 0.38 | (0.29, 0.55) |
| 2 | 21 | 120.3 | 0.64 | 0.54 | 0.64 | (0.49, 0.93) | 0.54 | (0.41, 0.77) | |
| 4 | 21 | 115.3 | 0.48 | 0.42 | 0.48 | (0.37, 0.70) | 0.42 | (0.32, 0.61) | |
| 151-250 | 1 | 21 | 182.9 | 0.70 | 0.38 | 0.70 | (0.54, 1.01) | 0.38 | (0.29, 0.55) |
| 2 | 21 | 194.0 | 0.63 | 0.33 | 0.63 | (0.48, 0.91) | 0.33 | (0.25, 0.47) | |
| 4 | 21 | 217.2 | 0.49 | 0.22 | 0.54 | (0.41, 0.81) | 0.25 | (0.19, 0.37) | |
| 251-400 | 1 | 21 | 347.3 | 1.71 | 0.49 | 1.71 | (1.31, 2.47) | 0.49 | (0.38, 0.71) |
| 2 | 21 | 352.0 | 1.43 | 0.41 | 1.43 | (1.09, 2.07) | 0.41 | (0.31, 0.59) | |
| 4 | 21 | 348.7 | 2.53 | 0.73 | 2.53 | (1.94, 3.66) | 0.73 | (0.56, 1.05) | |
| 401-700 | 1 | 21 | 548.9 | 7.46 | 1.36 | 7.46 | (5.70, 10.78) | 1.36 | (1.04, 1.96) |
| 2 | 21 | 575.8 | 2.60 | 0.45 | 2.81 | (2.13, 4.13) | 0.49 | (0.37, 0.72) | |
| 4 | 21 | 526.5 | 3.56 | 0.68 | 3.56 | (2.72, 5.14) | 0.68 | (0.52, 0.98) |
Table 2: Whole Blood Precision Results
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 Glucose test was evaluated on the i-STAT Alinity Instruments by preparing a series of glucose concentration levels in whole blood that spanned the reportable range of the test. The best fitting regression model was a second order model, and the absolute value of non-linearity ranged from 0.00 to 23.8 mg/dL. The i-STAT Glucose test used with the i-STAT Alinity Instruments demonstrated linearity over the reportable range (20-700 mg/dL).
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c. Recovery
The recovery of the i-STAT Glucose test was evaluated on the i-STAT Alinity Instrument by creating a series of glucose concentration levels in whole blood, measuring their assigned value on the predicate and determining the recovery bias and % recovery. The % recovery ranged from 94.6% to 100.3% across the glucose reportable range (20-700 mg/dL).
d. Limit of Ouantitation (LoO)
The study was based on the CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition. The LoO of the i-STAT Glucose test was evaluated on the i-STAT Alinity Instruments using whole blood that was altered to low glucose concentrations (< 20 mg/dL) and two test cartridge lots. The LoQ for the i-STAT Glucose test on the i-STAT Alinity Instrument was determined to be 5.558 mg/dL.
e. Interference
The interference performance of the i-STAT Glucose test on the i-STAT Alinity Instrument was evaluated using whole blood test samples based on CLSI EP07-A2: Interference Testing in Clinical Chemistry; Approved Guideline – Second Edition. The effect of each potentially interfering compound was evaluated by comparing the performance of a test sample spiked to a high concentration of the compound and a control test sample spiked with an equal volume of solvent. A compound was identified as an interferent if the difference between the spiked test sample and the control was > 10% of the mean of glucose test results for the control sample. Compounds that do not interfere with the glucose test are shown in
Table 3; those compounds that do interfere are shown in Error! Reference source not found..
| Substance | Test Concentration | |
|---|---|---|
| (mmol, unless specified) | mg/dL | |
| Acetaminophen | 1.33 | 20.10 |
| Acetaldehyde | 0.045 | 0.20 |
| Substance | Test Concentration | |
| (mmol, unless specified) | mg/dL | |
| Acetoacetate | 2.0 | 21.60 |
| L-Ascorbic Acid | 0.342 | 6.02 |
| Acetyl Cysteine | 10.2 | 166.45 |
| Ammonium Chloride | 2.0 | 10.70 |
| Bromide | 37.5 | 325.69 |
| β-Hydroxybutyric Acid | 6.00 | 62.47 |
| Dopamine | 0.006 | 0.09 |
| Ethanol | 86.8 | 399.89 |
| Fluoride | 0.105 | 0.27 |
| Formaldehyde | 0.133 | 0.40 |
| Glycolic Acid | 10.0 | 76.05 |
| Gentamicin | 0.021 | 3.13 |
| Glucosamine | 0.030 | 0.54 |
| Glutathione, reduced | 3 | 92.20 |
| Guaifenesin | 15 | 297.33 |
| Hemoglobin | 2g/L | 200 |
| Heparin | 3U/mL | n/a |
| Ibuprofen | 2.425 | 50.03 |
| Isoniazid | 0.292 | 4.00 |
| Lactate | 6.6 | 63.37 |
| Mannose | 1.00 | 18.02 |
| Maltose | 13.3 | 455.26 |
| pH | 8.0 | n/a |
| Pyruvate | 0.309 | 2.90 |
| Salicylate | 4.34 | 62.52 |
| Thiocyanate | 6.9 | 44.86 |
| Triglyceride | 37 | 3233.80 |
| Uric Acid | 1.4 | 23.54 |
| Sodium Thiosulfate | 16.7 | 264.04 |
| Bilirubin | 0.342 | 19 |
| Cholesterol | 13 | 503 |
| Creatinine | 0.442 | 5 |
| Fructose | 1 | 18 |
| Galactose | 0.84 | 15 |
| Xylose | 3 | 45 |
Table 3: Non-Interfering Compounds and Test Concentrations
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A hydroxyurea concentration above 0.43 mmol/L may give a falsely elevated i-STAT glucose test result of more than 10%.
f. Anticoagulant Study
The sample type comparison study was performed using the i-STAT Glucose Test on the i-STAT Alinity Instrument and 40 blood samples across the glucose concentration range. The comparator condition for this study was heparinized whole blood and the test condition was non-anticoagulated whole blood. The Deming regression result was a slope of 1.00 and a correlation coefficient of 1.00.
g. Altitude study
The effects of altitude were evaluated for the i-STAT Glucose test on the i-STAT Alinity Instrument at altitude of up to 10.000 feet above sea level. The altitude performance was evaluated using two lots of cartridges, commercially available i-STAT Glucose control materials that represented 3 Glucose levels.
The performance of the i-STAT Glucose test used with the i-STAT Alinity Instrument at altitude up to 10,000 feet was found to be equivalent to the performance of the i-STAT Glucose test at sea level.
h. Oxygen study
The effects of Oxygen were evaluated for the i-STAT Glucose test on the i-STAT Alinity Instrument using whole blood samples. The performance of the i-STAT Glucose test was evaluated at low and high levels of oxygen at four glucose levels
This study demonstrated equivalent glucose results when evaluated at low and high oxygen levels for all glucose concentrations tested.
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Comparison Study
Method Comparison with Predicate Device i.
The method comparison study compared the clinical results of the i-STAT Glucose Test on the i-STAT Alinity Instrument to the i-STAT Glucose Test performance on the i-STAT 1 Wireless Analyzer (predicate). This study was conducted across 3 point of care sites. The study included 237 subjects using whole blood (venous or arterial) samples covering the measuring range 24 to 673 mg/dL. The Weighted Deming regression for all 3 sites combined had a regression slope of 0.999, intercept of 1.164 and correlation coefficient of 1.000.
8. Conclusion
Analytical and clinical studies have shown the i-STAT Glucose test with the i-STAT Alinity System to be safe and effective for its intended use. The results of these studies demonstrate that performance of the i-STAT Glucose test with the i-STAT Alinity System is substantially equivalent to the predicate device.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.