(102 days)
Not Found
No
The summary describes a point-of-care analyzer that performs standard clinical chemistry tests using electrochemical sensors. There is no mention of AI or ML in the intended use, device description, or performance studies. The addition of wireless capability is the primary difference from the predicate device.
No
The device is an analyzer used for running various clinical chemistry tests and panels. It provides diagnostic information, but it does not directly provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is used for "running a variety of clinical chemistry tests and test panels" for the "diagnosis, monitoring and treatment" of numerous diseases and conditions. This aligns directly with the definition of a diagnostic device.
No
The device description explicitly states it is an "Analyzer" and works in conjunction with "single use i-STAT Cartridges," which are described as containing "microfabricated electrochemical sensors." This indicates the device includes hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states that the device is used for "running a variety of clinical chemistry tests and test panels contained in i-STAT test cartridges." It then lists numerous specific tests (hematocrit, glucose, blood urea nitrogen, etc.) and their clinical uses, such as "diagnosis and monitoring," "diagnosis, monitoring and treatment," and "aid in the diagnosis and treatment." These are all activities performed on samples taken from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description mentions that the system uses "microfabricated electrochemical sensors located in the disposable cartridges" to test "patient samples." This confirms that the device analyzes biological samples.
- Specific Test Descriptions: Several of the listed tests are explicitly described as "in vitro diagnostic test," such as the i-STAT Kaolin Activated Clotting Time (ACT) test, the i-STAT Cardiac Troponin I (cTnl) test, the i-STAT CKMB test, and the i-STAT BNP test.
The core function of the i-STAT 1 Wireless Analyzer, in conjunction with the cartridges, is to perform tests on biological samples in vitro (outside the body) to provide information for medical purposes. This aligns directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The i-STAT 1 Wireless Analyzer is used by trained medical professionals for running a variety of clinical chemistry tests and test panels contained in i-STAT test cartridges. These tests include hematocrit, glucose, blood urea nitrogen, sodium, potassium, chloride, ionized calcium, blood gases (oxygen, carbon dioxide and pH), creatinine, lactate, activated clotting time, prothrombin time, bicarbonate/carbon dioxide, troponin, creatine phosphokinase, and beta natriuretic peptide.
- Sodium measurements are used for monitoring electrolyte imbalances. .
- Potassium measurements are used for diagnosis and monitoring of diseases and clinical . conditions that manifest high and low Potassium levels.
- . Chloride measurements are primarily used in the diagnosis, monitoring and treatment of electrolyte and metabolic disorders including but not limited to cystic fibrosis, diabetic acidosis and hydration disorders.
- Glucose measurements are used in the diagnosis, monitoring and treatment of carbohydrate . metabolism disorders including but not limited to diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
- Hematocrit measurements can aid in the determination and monitoring of normal or abnormal . total red cell volume status including but not limited to conditions such anemia and erythrocytosis and blood loss related to trauma and surgery.
- Blood urea nitrogen measurements are used for the diagnosis, monitoring and treatment of . certain renal and metabolic diseases.
- Ionized calcium measurements are used in the diagnosis, monitoring and treatment of conditions . including but not limited to parathyroid disease, a variety of bone diseases, chronic renal disease and tetany and disturbances related to surgical and intensive care.
- pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory . disturbances and metabolic and respiratory based acid-base disturbances.
- Creatinine measurements are used in the diagnosis and treatment of renal diseases, in . monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
- The i-STAT lactate test is useful for (1) the diagnosis and treatment of lactic acidosis in ● conjunction with measurements of blood acid/base status, (2) monitoring tissue hypoxia and strenuous physical exertion, and (3) diagnosis of hyperlactatemia.
- The i-STAT Kaolin Activated Clotting Time (ACT) test is an in vitro diagnostic test used to . monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery.
- The i-STAT PT, a prothrombin time test. is useful in monitory patients receiving oral . anticoagulation therapy such as Coumadin or warfarin.
- . Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
- The i-STAT Cardiac Troponin I (cTnl) test is an in vitro diagnostic test for the quantitative . measurement of cardiac troponin I in whole blood or plasma. 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 syndromes with respect to their relative risk of mortality.
- The i-STAT CKMB 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).
- . 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 the anticoagulant. BNP measurements can be used as an aid in the diagnosis and assessment of the severity of congestive heart failure.
- 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
Product codes (comma separated list FDA assigned to the subject device)
CGA, NBC, JFL, MYT, MMI, GJS, JBP, KHP, CGL, CHL, JFP, JGS, CEM, CGZ, CDS, JPI
Device Description
The i-STAT 1 Wireless Analyzer (Model 300W) is a variant of the predicate i-STAT 1 Analyzer (Model 300) (K001387) and it provides an additional and alternate method for communication of data to a facility database. The i-STAT 1 Analyzer together with single use i-STAT Cartridges is a complete analytical system that can be used at the point of patient care.
The primary purpose of the analyzer is to run a variety of tests contained in disposable. single-use i-STAT Cartridges. The enabling technology for the i-STAT system is in the microfabricated electrochemical sensors located in the disposable cartridges. The functions related to testing patient samples using this technology are not affected by the addition of the wireless capability.
The capability of the Wireless Analyzer to transmit test results and information by Radio Frequency (RF) transmission is an option that the user may choose but it is not required for the Wireless analyzer to fulfill the intended use or to meet the indications for use.
The principle differences between the i-STAT 1 Wireless Analyzer and the predicate i-STAT l Analyzer are:
- . The i-STAT 1 Wireless Analyzer incorporates a wireless module based upon the IEEE 802.11 b/g communication protocol ("Wi-Fi") to be used to transmit test results to a Data Manager².
- . The i-STAT 1 Wireless Analyzer does not support the measurement of glucose test strips.
This application describes and provides information and background related to the incorporation of the wireless module into the i-STAT 1 Analyzer. This design modification provides a new method for users to transmit patient data to a Data Manager. It does not replace the existing method for transmitting data that uses an Infra-Red (IR) transceiver in the i-STAT 1 Analyzer together with accessories that provide a wired connection to a Data Manager. Which method is used to transmit data is selected by the user. Data Manager includes a server-based or personal computer-based utility that facilitates transmission of results from an i-STAT System to a data base maintained by a medical facility.
The operation of the wireless function is temporally distinct from the operation of the measurement cycle. The control of the i-STAT 1 Wireless Analyzer assures that the RF module is not powered during the measurement cycle. All operations during the measurement cycle are identical in the predicate i-STAT 1 Analyzer and in the Wireless Analyzer. Data is provided that shows the power supply is off during the measurement cycle and also during power down of the analyzer. The measurement cycle activities are identical in the i-STAT 1 Analyzer and in the Wireless Analyzer. Therefore no cartridge tests to compare the test performance of the Wireless Analyzer to the predicate i-STAT 1 Analyzer was carried out.
The following are the same in the i-STAT 1 Analyzer and the i-STAT 1 Wireless Analyzer.
- Both models are compatible with all i-STAT Cartridges. ●
- Both models may be used in the same facility locations and by the same medical . professionals.
- . The indications for use for each individual test apply regardless of which Analyzer is used to run the tests.
- The basic design and the materials used are the same in both models. ●
- Neither model transmits real-time physiologic information or critical information such . as alarms to remote monitoring stations.
- The JAMS software provides for the control of the transmission of data in both . models.
- In the former, the software directs the transmission using the IR port. In the Wireless . Analyzer the software allows the user to direct the transmission using either the wireless module or the IR port.
- Both models use Transmission Control Protocol/Internet Protocol (TCP/IP) and a . Cyclic Redundancy Check (CRC) protocol to ensure that acceptance of corrupted data is improbable. Approximately 99.9985% of any corrupted data will be detected by the CRC.
- Both models conform to the laboratory electromagnetic compatibility (EMC) standard . IEC 61326-2-6 for unintentional emissions and susceptibility.
- Both models, in combination with alternating current-powered accessories, conform to . the electrical safety requirements of UL 61010-1.
The following are different in the i-STAT 1 Wireless Analyzer compared to the i-STAT 1 Analyzer.
- . The Wireless Analyzer incorporates a radio-frequency transceiver (IEEE 802.11 b/g protocol) that has been certified as an unlimited module by a Telecommunications Certification Board and accordingly bears a Federal Communications Commission identification number.
- The wireless communication will rely upon the IEEE 802.11 infrastructure that is . already ubiquitous in medical facilities.
- The wireless module is not powered during the measurement cycle. ●
- A software utility, used to configure the wireless communication system at installation, . is provided as a CD-ROM.
- . The color is blue (the predicate device is beige) and the word "wireless" is on the bezel.
- t In the Wireless Analyzer, the ability to run a glucose test strip is disabled.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained medical professionals / Point of patient care, medical facility
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Abbott Point of Care Inc. 400 College Road East Princeton, NJ 08540 U.S.A.
609-454-9000 Tel: Fax: 609-419-9370
K103195
FEB - 8 2011
Image /page/0/Picture/18 description: The image shows a stylized letter 'a' in a bold, sans-serif font. The letter is black with a textured or distressed appearance, giving it a slightly rough or aged look. The interior of the 'a' is white, creating a contrast that makes the letter stand out. The overall design is simple yet impactful, with a focus on the letter's shape and texture.
510(k) Summary i-STAT 1 Wireless Analyzer
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1900 and CFR 807.92.
The assigned 510(k) number is: K103195
Summary prepared on: Tuesday, February 1, 2011
Submitted by:
Abbott Point of Care Inc. 400 College Road East Princeton, NJ 08540 Phone: 609-454-9000 FAX: 609-419-9370
Contact:
Larry W. Krasley Abbott Point of Care Inc. 400 College Road East Princeton, NJ 08540 Phone: 609-454-9272 Fax: 609-419-9370 Email: larry.krasley@abbott.com
Establishment Registration Number: 2245578
Identification of Device:
Device Name: i-STAT 1® Wireless Analyzer Proprietary/Trade Name: i-STAT 1® Wireless Analyzer Common Name: i-STAT i® Analyzer, i-STAT Analyzer, handheld Device Classification:
| Class | Name | Regulation
Number | Product
Code | Panel |
|-------|----------------------------------------------------------------|----------------------|-----------------|--------------------|
| II | Glucose Oxidase, Glucose. | 862.1345 | CGA | Clinical Chemistry |
| II | Test, Natriuretic Peptide. | 862.1117 | NBC | Clinical Chemistry |
| II | Bicarbonate/Carbon Dioxide Test System. | 862.1160 | JFL | Clinical Chemistry |
| II | Biosensor, Immunoassay, CPK or Isoenzymes. | 862.1215 | MYT | Clinical Chemistry |
| II | Immunoassay Method, Troponin Subunit. | 862.1215 | MMI | Clinical Chemistry |
| II | Test, Time, Prothrombin. | 864.7750 | GJS | Hematology |
| II | Activated Whole Blood Clotting Time. | 864.7140 | JBP | Hematology |
| II | Acid, Lactic, Enzymatic Method. | 862.1450 | KHP | Clinical Chemistry |
| II | Electrode, Ion Based, Enzymatic, Creatinine. | 862.1225 | CGL | Clinical Chemistry |
| II | Electrode Measurement, Blood-Gases (pCO2,
pO2) And Blood pH | 862.1120 | CHL | Clinical Chemistry |
Image /page/0/Picture/16 description: The image shows the Abbott logo. The logo consists of a stylized letter "a" on the left and the word "Abbott" on the right. Below the word "Abbott" is the tagline "A Promise for Life."
1
| Class | Name | Regulation
Number | Product
Code | Panel |
|-------|-------------------------------------|----------------------|-----------------|--------------------|
| II | Electrode, Ion Specific, Calcium. | 862.1145 | JFP | Clinical Chemistry |
| II | Electrode, Ion Specific, Sodium. | 862.1665 | JGS | Clinical Chemistry |
| II | Electrode, Ion Specific, Potassium. | 862.1600 | CEM | Clinical Chemistry |
| II | Electrode, Ion Specific, Chloride. | 862.1700 | CGZ | Clinical Chemistry |
| II | Electrode, Ion Specific, Urea. | 862.1770 | CDS | Clinical Chemistry |
| II | Hematocrit | 864.6400 | JPI | Hematology |
Identification of the Predicate Device:
Device Name: i-STAT 1® Analyzer
Indications for Use: The i-STAT 1 Wireless Analyzer is used by trained medical professionals for running a variety of clinical chemistry tests and test panels contained in i-STAT test cartridges. These tests include hematocrit, glucose, blood urea nitrogen, sodium, potassium, chloride, ionized calcium, blood gases (oxygen, carbon dioxide and pH), creatinine, lactate, activated clotting time, prothrombin time, bicarbonate/carbon dioxide, troponin, creatine phosphokinase, and beta natriuretic peptide.
- . Sodium measurements are used for monitoring electrolyte imbalances.
- . Potassium measurements are used for diagnosis and monitoring of diseases and clinical conditions that manifest high and low Potassium levels.
- . Chloride measurements are primarily used in the diagnosis, monitoring and treatment of electrolyte and metabolic disorders including but not limited to cystic fibrosis, diabetic acidosis and hydration disorders.
- . Glucose measurements are used in the diagnosis, monitoring and treatment of carbohydrate metabolism disorders including but not limited to diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
- Hematocrit measurements can aid in the determination and monitoring of normal or abnormal . total red cell volume status including but not limited to conditions such anemia and erythrocytosis and blood loss related to trauma and surgery.
- . Blood urea nitrogen measurements are used for the diagnosis, monitoring and treatment of certain renal and metabolic diseases.
- lonized calcium measurements are used in the diagnosis, monitoring and treatment of . conditions including but not limited to parathyroid disease, a variety of bone diseases, chronic renal disease and tetany and disturbances related to surgical and intensive care.
- . pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-base disturbances.
- Creatinine measurements are used in the diagnosis and treatment of renal diseases, in . monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
- The i-STAT lactate test is useful for (1) the diagnosis and treatment of lactic acidosis in conjunction . with measurements of blood acid/base status, (2) monitoring tissue hypoxia and strenuous physical exertion, and (3) diagnosis of hyperlactatemia.
- The i-STAT Kaolin Activated Clotting Time (ACT) test is an in vitro diagnostic test used to monitor . high-dose heparin anticoagulation frequently associated with cardiovascular surgery.
Image /page/1/Picture/15 description: The image shows the Abbott logo. The logo consists of a stylized letter 'a' on the left, followed by the word 'Abbott' in bold, sans-serif font. Below the word 'Abbott' is the tagline 'A Promise for Life' in a smaller font size.
2
- . The i-STAT PT, a prothrombin time test, is useful in monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin.
- . Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
- . The i-STAT Cardiac Troponin I (cTnl) test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in whole blood or plasma. 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 syndromes with respect to their relative risk of mortality.
- . The i-STAT CKMB 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).
- . 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 the anticoagulant. BNP measurements can be used as an aid in the diagnosis and assessment of the severity of congestive heart failure.
- . 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, organ transplant and dialysis
The i-STAT 1 Wireless Analyzer (Model 300W) is a variant of the predicate i-STAT 1 Analyzer (Model 300) (K001387) and it provides an additional and alternate method for communication of data to a facility database. The i-STAT 1 Analyzer together with single use i-STAT Cartridges is a complete analytical system that can be used at the point of patient care.
The primary purpose of the analyzer is to run a variety of tests contained in disposable. single-use i-STAT Cartridges. The enabling technology for the i-STAT system is in the microfabricated electrochemical sensors located in the disposable cartridges. The functions related to testing patient samples using this technology are not affected by the addition of the wireless capability.
The capability of the Wireless Analyzer to transmit test results and information by Radio Frequency (RF) transmission is an option that the user may choose but it is not required for the Wireless analyzer to fulfill the intended use or to meet the indications for use.
The principle differences between the i-STAT 1 Wireless Analyzer and the predicate i-STAT l Analyzer are:
- . The i-STAT 1 Wireless Analyzer incorporates a wireless module based upon the IEEE 802.11 b/g communication protocol ("Wi-Fi") to be used to transmit test results to a Data Manager2.
- . The i-STAT 1 Wireless Analyzer does not support the measurement of glucose test strips.
This application describes and provides information and background related to the incorporation of the wireless module into the i-STAT 1 Analyzer. This design modification provides a new method for users to transmit patient data to a Data Manager. It does not replace the existing method for transmitting data that uses an Infra-Red (IR) transceiver in the
1 i-STAT is a registered trademark of Abbott Point of Care Inc., Princeton, NJ.
2 For the purposes of this application, the term Data Manager will mean either a facility computer that has i-STAT Central Data Station application or a facility server that has i-STAT/DE application installed in it. Data Manager provides a link to transfer of information from the i-STAT System to a hospital maintained database.
3
i-STAT 1 Analyzer together with accessories that provide a wired connection to a Data Manager. Which method is used to transmit data is selected by the user. Data Manager includes a server-based or personal computer-based utility that facilitates transmission of results from an i-STAT System to a data base maintained by a medical facility.
The operation of the wireless function is temporally distinct from the operation of the measurement cycle. The control of the i-STAT 1 Wireless Analyzer assures that the RF module is not powered during the measurement cycle. All operations during the measurement cycle are identical in the predicate i-STAT 1 Analyzer and in the Wireless Analyzer. Data is provided that shows the power supply is off during the measurement cycle and also during power down of the analyzer. The measurement cycle activities are identical in the i-STAT 1 Analyzer and in the Wireless Analyzer. Therefore no cartridge tests to compare the test performance of the Wireless Analyzer to the predicate i-STAT 1 Analyzer was carried out.
This 510(k) application establishes the i-STAT 1 Wireless Analyzer to be substantially equivalent to the i-STAT 1 Analyzer. The design modification does not create significant risks and particular attention has been paid to those concerns and issues highlighted in the "Radio-Frequency Wireless Technology in Medical Devices Draft Guidance" FDA January 3, 2007.
The use of the industry standard IEEE 802.11 provides a high degree of confidence to the users that the coexistence of the i-STAT 1 Wireless Analyzer within a medical facility is predictable, easily managed, and provides a high degree of assurance that there is a low risk that intentional electromagnetic radiation from the Wireless Analyzer will result in unacceptable interference with other medical equipment in the immediate vicinity.
There is an acceptable, low risk that the radio frequency emissions will result in thermal injury to a patient or user. This is based on Specific Absorption Rate tests conducted by the supplier of the radio frequency module.
The following are the same in the i-STAT 1 Analyzer and the i-STAT 1 Wireless Analyzer.
- Both models are compatible with all i-STAT Cartridges. ●
- Both models may be used in the same facility locations and by the same medical . professionals.
- . The indications for use for each individual test apply regardless of which Analyzer is used to run the tests.
- The basic design and the materials used are the same in both models. ●
- Neither model transmits real-time physiologic information or critical information such . as alarms to remote monitoring stations.
- The JAMS software provides for the control of the transmission of data in both . models.
- In the former, the software directs the transmission using the IR port. In the Wireless . Analyzer the software allows the user to direct the transmission using either the wireless module or the IR port.
- Both models use Transmission Control Protocol/Internet Protocol (TCP/IP) and a . Cyclic Redundancy Check (CRC) protocol to ensure that acceptance of corrupted data is improbable. Approximately 99.9985% of any corrupted data will be detected by the CRC.
- Both models conform to the laboratory electromagnetic compatibility (EMC) standard . IEC 61326-2-6 for unintentional emissions and susceptibility.
Image /page/3/Picture/15 description: The image shows the Abbott logo. The logo consists of a stylized letter "A" on the left, followed by the word "Abbott" in bold, sans-serif font. Below the word "Abbott" is the tagline "A Promise for Life" in a smaller, lighter font.
4
-
Both models, in combination with alternating current-powered accessories, conform to . the electrical safety requirements of UL 61010-1.
The following are different in the i-STAT 1 Wireless Analyzer compared to the i-STAT 1 Analyzer. -
. The Wireless Analyzer incorporates a radio-frequency transceiver (IEEE 802.11 b/g protocol) that has been certified as an unlimited module by a Telecommunications Certification Board and accordingly bears a Federal Communications Commission identification number.
-
The wireless communication will rely upon the IEEE 802.11 infrastructure that is . already ubiquitous in medical facilities.
-
The wireless module is not powered during the measurement cycle. ●
-
A software utility, used to configure the wireless communication system at installation, . is provided as a CD-ROM.
-
. The color is blue (the predicate device is beige) and the word "wireless" is on the bezel.
-
t In the Wireless Analyzer, the ability to run a glucose test strip is disabled.
The following table summarizes features and functions that are in the Wireless Analyzer but are not present in the predicate i-STAT 1 Analyzer.
| Feature or Function | Wireless Analyzer |
|---|---|
| Data integrity protection (wireless). | IEEE 802.11 b/g |
| Components required for wireless function. | RF module. Isolated power supply. |
| Device Label | FCC ID Number included. |
| Wireless Configuration Utility | Provided as CD-ROM. |
| Ability to run MediSense Glucose strips. | Disabled |
| Appearance | Blue keypad and bezel with "WIRELESS" |
| label. | |
| Battery Life | Shortened up to 30% |
Image /page/4/Picture/10 description: The image shows the Abbott logo. The logo consists of a stylized letter "a" on the left and the word "Abbott" on the right. Below the word "Abbott" is the tagline "A Promise for Life."
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three heads, representing the department's focus on health, human services, and the well-being of individuals and families. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
FEB C 8 2011
Abbott Point of Care Inc. c/o Larry W. Kraslev Regulatory Scientist 400 College Road East Princeton, NJ 08540
Re: K103195 Trade Name: i-STAT 1 Wireless Analyzer Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: CGA, CDS, CEM, CGL, CGZ, CHL, GJS, JBP, JFL, JFP, JGS, JPI, MMI, MYT, NBC, KHP Dated: December 21, 2010
Received: December 23, 2010
Dear Mr. Krasley:
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 de 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 mishner of devil adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 80 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
6
Page 2 –
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (30) ) 796-5450. 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/Medical/Devices/Safety/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its tolli-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
CJC.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Indications for Use Form
510(k) Number (if known): K103195
Device Name: i-STAT 1 Wireless Analyzer
Indications for Use:
The i-STAT 1 Wireless Analyzer is used by trained medical professionals for running a variety of clinical chemistry tests and test panels contained in i-STAT test cartridges. These tests include hematocrit, glucose, blood urea nitrogen, sodium, potassium, chloride, ionized calcium, blood gases (oxygen, carbon dioxide and pH), creatinine, lactate, activated clotting time, prothrombin time, bicarbonate/carbon dioxide, troponin, creatine phosphokinase, and beta natriuretic peptide.
- Sodium measurements are used for monitoring electrolyte imbalances. .
- Potassium measurements are used for diagnosis and monitoring of diseases and clinical . conditions that manifest high and low Potassium levels.
- . Chloride measurements are primarily used in the diagnosis, monitoring and treatment of electrolyte and metabolic disorders including but not limited to cystic fibrosis, diabetic acidosis and hydration disorders.
- Glucose measurements are used in the diagnosis, monitoring and treatment of carbohydrate . metabolism disorders including but not limited to diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
- Hematocrit measurements can aid in the determination and monitoring of normal or abnormal . total red cell volume status including but not limited to conditions such anemia and erythrocytosis and blood loss related to trauma and surgery.
- Blood urea nitrogen measurements are used for the diagnosis, monitoring and treatment of . certain renal and metabolic diseases.
- Ionized calcium measurements are used in the diagnosis, monitoring and treatment of conditions . including but not limited to parathyroid disease, a variety of bone diseases, chronic renal disease and tetany and disturbances related to surgical and intensive care.
- pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory . disturbances and metabolic and respiratory based acid-base disturbances.
- Creatinine measurements are used in the diagnosis and treatment of renal diseases, in . monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K103195
8
Indications for Use Form
510(k) Number (if known): K103195
Device Name: i-STAT 1 Wireless Analyzer
Indications for Use: (continued)
- The i-STAT lactate test is useful for (1) the diagnosis and treatment of lactic acidosis in ● conjunction with measurements of blood acid/base status, (2) monitoring tissue hypoxia and strenuous physical exertion, and (3) diagnosis of hyperlactatemia.
- The i-STAT Kaolin Activated Clotting Time (ACT) test is an in vitro diagnostic test used to . monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery.
- The i-STAT PT, a prothrombin time test. is useful in monitory patients receiving oral . anticoagulation therapy such as Coumadin or warfarin.
- . Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
- The i-STAT Cardiac Troponin I (cTnl) test is an in vitro diagnostic test for the quantitative . measurement of cardiac troponin I in whole blood or plasma. 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 syndromes with respect to their relative risk of mortality.
- The i-STAT CKMB 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).
- . 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 the anticoagulant. BNP measurements can be used as an aid in the diagnosis and assessment of the severity of congestive heart failure.
- 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
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
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Concurrence of CDRH
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510(k) K103195
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