Interferences - Limitations
The numbers in the System Evaluation report are reported in a different way than in the past.
Substances were tested at concentrations described by the Clinical Lab Standard Institute in document EP7-A2—Interference Testing in Clinical Chemistry; Approved Guideline, when available. Testing was conducted according to the ISO 15197:2013 standard. This is a standard used in labs. The way these concentrations are displayed will be changing, as reflected in this report. Concentrations are shown in exponential notation, in order to display values in a uniform manner across the wide range of concentrations.
To convert these values:
>Positive Exponent: Move the decimal point to the right by the number of places specified by the exponent (number after E). Acarbose Highest Concentration Tested: 6.00E+01 6.00 x 10 = 60 mg/dL
>Negative Exponent: Move the decimal point to the left by the number of places specified by the exponent (number after E). Acarbose Upper Therapeutic Concentration: 1.00E–02 1.00 / 100 = 0.01 mg/dL
>00 Exponent: Use the stated value with no adjustment. Acetaminophen Upper Therapeutic Concentration: 5.20E+00 = 5.20 mg/dL
The Accu‑Chek Instant S system fulfills the ISO 15197:2013/EN ISO 15197:2015 standards and delivers even tighter 10/10 accuracy for reliable results you can trust.
10/10 references an ISO‑compliant internal testing protocol. For three different lots of test strips, 95% of results fall within ± 15 mg/dL when <100 mg/dL or ± 15% when ≥ 100 mg/dL.
The Accu‑Chek Instant S meter is one of the most accurate systems our organisation has ever manufactured and meets ISO 15197:2013/EN ISO 15197:2015 standards for accuracy. It has 10/10 analytical accuracy. While this is a highly accurate system, there are other manufacturers that make a similar accuracy claim.
The Accu‑Chek Instant S meter is our latest development in providing accuracy in blood glucose testing technologies. The Accu‑Chek Guide, Accu‑Chek Guide Me, Accu-Chek Instant and Accu‑Chek Instant S meters are very accurate meters.
Yes, the Accu‑Chek Instant S meter complies with the requirements of ISO 15197:2013/ EN ISO 15197:2015 (In vitro diagnostic test systems– Requirements for blood glucose monitoring systems for self‑testing in managing diabetes mellitus).
The numbers in the System Evaluation report are reported in a different way than in the past.
Substances were tested at concentrations described by the Clinical Lab Standard Institute in document EP7-A2—Interference Testing in Clinical Chemistry; Approved Guideline, when available. Testing was conducted according to the ISO 15197:2013 standard. This is a standard used in labs. The way these concentrations are displayed will be changing, as reflected in this report. Concentrations are shown in exponential notation, in order to display values in a uniform manner across the wide range of concentrations.
To convert these values:
>Positive Exponent: Move the decimal point to the right by the number of places specified by the exponent (number after E). Acarbose Highest Concentration Tested: 6.00E+01 6.00 x 10 = 60 mg/dL
>Negative Exponent: Move the decimal point to the left by the number of places specified by the exponent (number after E). Acarbose Upper Therapeutic Concentration: 1.00E–02 1.00 / 100 = 0.01 mg/dL
>00 Exponent: Use the stated value with no adjustment. Acetaminophen Upper Therapeutic Concentration: 5.20E+00 = 5.20 mg/dL
Yes, through Bluetooth connectivity.
Yes, we can say the minimum amount is ≥ 10 mg/dL.
The numbers in the System Evaluation report are reported in a different way than in the past.
Substances were tested at concentrations described by the Clinical Lab Standard Institute in document EP7-A2—Interference Testing in Clinical Chemistry; Approved Guideline, when available. Testing was conducted according to the ISO 15197:2013 standard. This is a standard used in labs. The way these concentrations are displayed will be changing, as reflected in this report. Concentrations are shown in exponential notation, in order to display values in a uniform manner across the wide range of concentrations.
To convert these values:
>Positive Exponent: Move the decimal point to the right by the number of places specified by the exponent (number after E). Acarbose Highest Concentration Tested: 6.00E+01 6.00 x 10 = 60 mg/dL
>Negative Exponent: Move the decimal point to the left by the number of places specified by the exponent (number after E). Acarbose Upper Therapeutic Concentration: 1.00E–02 1.00 / 100 = 0.01 mg/dL
>00 Exponent: Use the stated value with no adjustment. Acetaminophen Upper Therapeutic Concentration: 5.20E+00 = 5.20 mg/dL
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