FDA Test Categorizations

View the U.S. FDA CLIA CLIA: The Clinical Laboratory Improvement Amendments of 1988, established to improve the quality of laboratory testing no matter where the testing is performed. database information for the i-STAT 1 System (300 series). Select a cartridge type and choose the test complexity. Print this information for inclusion with state laboratory license applications or organizational new product acquisition packets. Links to the FDA’s 510k submission summaries are provided.


  • EC8+
  • CG8+
  • EG7+
  • CHEM8+
  • EG6+
  • CG4+
  • 6+
  • G3+
  • EC4+
  • E3+
  • GlucoseGlucose: Intended Use
    The test for glucose, as part of the i-STAT System, is intended for use in the in vitro quantification of glucose in arterial, venous, capillary whole blood.
  • CREACREA: Intended Use
    The test for creatinine, as part of the i-STAT System, is intended for use in the in vitro quantification of creatinine in arterial, venous, or capillary whole blood.
  • ACTkACTk: Intended Use
    The i-STAT Kaolin Activated Clotting Time (Kaolin ACT) test is an in vitro diagnostic test that uses fresh whole blood to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery.
  • ACTcACTc: Intended Use
    The i-STAT Celite ACT test is useful for monitoring patients receiving heparin for treatment of pulmonary embolism or venous thrombosis, and for monitoring anticoagulation therapy in patients undergoing medical procedures such as catheterization, cardiac surgery, surgery, organ transplant, and dialysis.
  • PT/INRPT/INR: Intended Use
    The i-STAT PT, a prothrombin time test, is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin® or warfarin.
  • cTnIcTnI: Intended Use
    The i-STAT cTnI test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin (cTnI) in whole blood or plasma samples. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndrome with respect to their relative risk of mortality.
  • CK-MBCK-MB: Intended Use
    The i-STAT CK-MB test is an in vitro diagnostic test for the quantitative measurement of creatinine kinase MB mass in whole blood or plasma samples. CK-MB measurements can be used as an aid in the diagnosis and treatment of myocardial infarction (MI).
  • BNPBNP: Intended Use
    The i-STAT BNP test is an in vitro diagnostic test for the quantitative measurement of B-type natriuretic peptide (BNP) in whole blood or plasma samples using EDTA as an anticoagulant. BNP measurements can be used as an aid in the diagnosis and assessment of the severity of congestive heart failure.
EC8+
EC8+ Cartridge
Sample Type:
Moderate Complexity

Arterial, capillary, or venous whole blood sample.

Sample Type:
Waived Waived: Tests categorized as “waived” include simple laboratory examinations and procedures that are so easy to perform that they have insignificant risk of an erroneous result.

Chemistry

Sodium (Na)

Potassium (K)

Chloride (Cl)

Anion Gap*

Glucose (Glu)

Urea Nitrogen (BUN/Urea)

pH

PCO2

TCO2*

HCO3*

Base Excess (BE)*

Not applicable

Hematology/
Coagulation

Hematocrit (Hct)

Hemoglobin* (Hgb)

Not applicable

CG8+
CG8+ Cartridge
Sample Type:
Moderate Complexity

Arterial, capillary, or venous whole blood sample.

Sample Type:
Waived Waived: Tests categorized as “waived” include simple laboratory examinations and procedures that are so easy to perform that they have insignificant risk of an erroneous result.

Chemistry

Sodium (Na)

Potassium (K)

Ionized Calcium (iCa)

Glucose (Glu)

pH

PCO2

PO2

TCO2*

HCO3*

Base Excess (BE)*

sO2*

Not applicable

Hematology/
Coagulation

Hematocrit (Hct)

Hemoglobin* (Hgb)

Not applicable

EG7+
EG7+ Cartridge
Sample Type:
Moderate Complexity

Arterial, capillary, or venous whole blood sample.

Sample Type:
Waived Waived: Tests categorized as “waived” include simple laboratory examinations and procedures that are so easy to perform that they have insignificant risk of an erroneous result.

Chemistry

Sodium (Na)

Potassium (K)

Ionized Calcium (iCa)

pH

PCO2

PO2

TCO2*

HCO3*

Base Excess (BE)*

sO2*

Not applicable

Hematology/
Coagulation

Hematocrit (Hct)

Hemoglobin* (Hgb)

Not applicable

CHEM8+
CHEM8+ Cartridge
Sample Type:
Moderate Complexity

Arterial, capillary, or venous whole blood sample.

Sample Type:
Waived Waived: Tests categorized as “waived” include simple laboratory examinations and procedures that are so easy to perform that they have insignificant risk of an erroneous result.

Venous whole blood samples collected in sodium or lithium heparin evacuated tubes (green top tubes) when run on the i-STAT 1 System.

Chemistry

Sodium (Na)

Potassium (K)

Chloride (Cl)

TCO2

Anion Gap*

Ionized Calcium (iCa)

Glucose (Glu)

Urea Nitrogen (BUN/Urea)

Creatinine (Crea)

Sodium (Na)

Potassium (K)

Chloride (Cl)

TCO2

Anion Gap*

Ionized Calcium (iCa)

Glucose (Glu)

Urea Nitrogen (BUN/Urea)

Creatinine (Crea)

Hematology/
Coagulation

Hematocrit (Hct)

Hemoglobin* (Hgb)

Hematocrit (Hct)

Hemoglobin* (Hgb)

EG6+
EG6+ Cartridge
Sample Type:
Moderate Complexity

Arterial, capillary, or venous whole blood sample.

Sample Type:
Waived Waived: Tests categorized as “waived” include simple laboratory examinations and procedures that are so easy to perform that they have insignificant risk of an erroneous result.

Chemistry

Sodium (Na)

Potassium (K)

pH

PCO2

PO2

TCO2*

HCO3*

Base Excess (BE)*

sO2*

Not applicable

Hematology/
Coagulation

Hematocrit (Hct)

Hemoglobin* (Hgb)

Not applicable

CG4+
CG4+ Cartridge
Sample Type:
Moderate Complexity

Arterial, capillary, or venous whole blood sample.

Sample Type:
Waived Waived: Tests categorized as “waived” include simple laboratory examinations and procedures that are so easy to perform that they have insignificant risk of an erroneous result.

Chemistry

Lactate

pH

PCO2

PO2

TCO2*

HCO3*

Base Excess (BE)*

sO2*

Not applicable

Hematology/
Coagulation

Not applicable

Not applicable

6+
6+ Cartridge
Sample Type:
Moderate Complexity

Arterial, capillary, or venous whole blood sample.

Sample Type:
Waived Waived: Tests categorized as “waived” include simple laboratory examinations and procedures that are so easy to perform that they have insignificant risk of an erroneous result.

Venous whole blood samples collected in sodium or lithium heparin evacuated tubes (green top tubes) when run on the i-STAT 1 System.

Chemistry

Sodium (Na)

Potassium (K)

Chloride (Cl)

Glucose (Glu)

Urea Nitrogen (BUN/Urea)

Sodium (Na)

Potassium (K)

Chloride (Cl)

Glucose (Glu)

Urea Nitrogen (BUN/Urea)

Hematology/
Coagulation

Hematocrit (Hct)

Hemoglobin* (Hgb)

Hematocrit (Hct)

Hemoglobin* (Hgb)

G3+
G3+ Cartridge
Sample Type:
Moderate Complexity

Arterial, capillary, or venous whole blood sample.

Sample Type:
Waived Waived: Tests categorized as “waived” include simple laboratory examinations and procedures that are so easy to perform that they have insignificant risk of an erroneous result.

Chemistry

pH

PCO2

PO2

TCO2*

HCO3*

Base Excess (BE)*

sO2*

Not applicable

Hematology/
Coagulation

Not applicable

Not applicable

EC4+
EC4+ Cartridge
Sample Type:
Moderate Complexity

Arterial, capillary, or venous whole blood sample.

Sample Type:
Waived Waived: Tests categorized as “waived” include simple laboratory examinations and procedures that are so easy to perform that they have insignificant risk of an erroneous result.

Venous whole blood samples collected in sodium or lithium heparin evacuated tubes (green top tubes) when run on the i-STAT 1 System.

Chemistry

Sodium (Na)

Potassium (K)

Glucose (Glu)

Sodium (Na)

Potassium (K)

Glucose (Glu)

Hematology/
Coagulation

Hematocrit (Hct)

Hemoglobin* (Hgb)

Hematocrit (Hct)

Hemoglobin* (Hgb)

E3+
E3+ Cartridge
Sample Type:
Moderate Complexity

Arterial, capillary, or venous whole blood sample.

Sample Type:
Waived Waived: Tests categorized as “waived” include simple laboratory examinations and procedures that are so easy to perform that they have insignificant risk of an erroneous result.

Venous whole blood samples collected in sodium or lithium heparin evacuated tubes (green top tubes) when run on the i-STAT 1 System.

Chemistry

Sodium (Na)

Potassium (K)

Sodium (Na)

Potassium (K)

Hematology/
Coagulation

Hematocrit (Hct)

Hemoglobin* (Hgb)

Hematocrit (Hct)

Hemoglobin* (Hgb)

Glucose
Glucose Cartridge
Sample Type:
Moderate Complexity

Arterial, capillary, or venous whole blood sample.

Sample Type:
Waived Waived: Tests categorized as “waived” include simple laboratory examinations and procedures that are so easy to perform that they have insignificant risk of an erroneous result.

Venous whole blood samples collected in sodium or lithium heparin evacuated tubes (green top tubes) when run on the i-STAT 1 System.

Chemistry

Glucose (Glu)

Glucose (Glu)

Hematology/
Coagulation

Not applicable

Not applicable

CREA
CREA Cartridge
Sample Type:
Moderate Complexity

Arterial, capillary, or venous whole blood sample.

Sample Type:
Waived Waived: Tests categorized as “waived” include simple laboratory examinations and procedures that are so easy to perform that they have insignificant risk of an erroneous result.

Venous whole blood samples collected in sodium or lithium heparin evacuated tubes (green top tubes) when run on the i-STAT 1 System.

Chemistry

Creatinine (Crea)

Creatinine (Crea)

Hematology/
Coagulation

Not applicable

Not applicable

ACTk
ACTk Cartridge
Sample Type:
Moderate Complexity

Arterial or venous whole blood sample.

Sample Type:
Waived Waived: Tests categorized as “waived” include simple laboratory examinations and procedures that are so easy to perform that they have insignificant risk of an erroneous result.

Chemistry

Not applicable

Not applicable

Hematology/
Coagulation

ACT Kaolin

Not applicable

ACTc
ACTc Cartridge
Sample Type:
Moderate Complexity

Arterial or venous whole blood sample.

Sample Type:
Waived Waived: Tests categorized as “waived” include simple laboratory examinations and procedures that are so easy to perform that they have insignificant risk of an erroneous result.

Chemistry

Not applicable

Not applicable

Hematology/
Coagulation

ACT Celite®

Not applicable

PT/INR
PT/INR Cartridge
Sample Type:
Moderate Complexity

Capillary or venous whole blood sample.

Sample Type:
Waived Waived: Tests categorized as “waived” include simple laboratory examinations and procedures that are so easy to perform that they have insignificant risk of an erroneous result.

Chemistry

Not applicable

Not applicable

Hematology/
Coagulation

PT/INR

Not applicable

cTnI
cTnI Cartridge
Sample Type:
Moderate Complexity

Whole blood or plasma sample.

Sample Type:
Waived Waived: Tests categorized as “waived” include simple laboratory examinations and procedures that are so easy to perform that they have insignificant risk of an erroneous result.

Chemistry

cTnI

Not applicable

Hematology/
Coagulation

Not applicable

Not applicable

CK-MB
CK-MB Cartridge
Sample Type:
Moderate Complexity

Whole blood or plasma sample.

Sample Type:
Waived Waived: Tests categorized as “waived” include simple laboratory examinations and procedures that are so easy to perform that they have insignificant risk of an erroneous result.

Chemistry

CK-MB

Not applicable

Hematology/
Coagulation

Not applicable

Not applicable

BNP
BNP Cartridge
Sample Type:
Moderate Complexity

Whole blood or plasma sample.

Sample Type:
Waived Waived: Tests categorized as “waived” include simple laboratory examinations and procedures that are so easy to perform that they have insignificant risk of an erroneous result.

Chemistry

BNP

Not applicable

Hematology/
Coagulation

Not applicable

Not applicable



For in vitro diagnostic testing only. See CTI Sheets for full details.

Many files on this site require Adobe Acrobat.
Download Now

X