(247 days)
The IVD-GE02 system is a blood gases analyzer intended as an in vitro diagnostic device for the quantitative measurement of whole blood samples in a clinical laboratory. The IVD-GE02 system includes sensors for the measurement of pH, pCO2, pO2, potassium and glucose.
pH, pCO2, pO2: Measurement of blood gases (pCO2, pO2) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.
Potassium: Measurement of potassium are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by high or low potassium levels.
Glucose: Measurement of glucose is used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathetic hypoglycaemia and of pancreatic islet cell carcinoma.
IVD-GE02 calibration solutions are in vitro diagnostic products for the calibration of the IVD-GE02 test system for the measurements of pH, pCO2, pO2, potassium and glucose.
The IVD-GE02 system is an in-vitro diagnostic device for the determination of specified analytes in blood using electrochemical principles. The IVD-GE02 is essentially a modular system consists of the following components .-
- A dedicated combined PC and monitor with a touch screen .
- · A disposable cartridge containing
- o Sensor
- o Electronic circuitry, including an ASIC (Application Specific Integrated Circuit), to process sensor signals and drive the fluid management system.
- ◆ An instrument containing
- o Fluid management components (tubing, pumps and valves)
- o The cartridge (see above)
- o An injection port for samples, calibration solutions and QC solutions
- o Wiring to connect the cartridge to the fluid management components
- Syringes with calibration solutions packed in sealed foil bags .
- Containers with flush solutions ◆ ◆
- A waste container
- A dedicated printer and associated cables
- An ambient temperature and pressure sensor
- Cables to connect the monitor to the instrument and a power supply unit
- Packaging
- Label Copy
Here's a breakdown of the acceptance criteria and the study information for the IVD-GE02 device, as extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria in terms of specific thresholds for R-squared values, standard deviations, or coefficients of variation that the device must meet. Instead, the acceptance is based on demonstrating "comparable performance" or "substantially equivalent" results to a predicate device (Rapidlab 865).
However, the provided performance data implies the target performance levels. The key performance metrics are linearity (R-squared), aqueous precision, and precision in blood (mean, standard deviation, and coefficient of variation), and method comparison (slope, intercept, R-squared).
| Characteristic | Parameter | Acceptance Criteria (Implied / Comparator) | Reported Device Performance (IVD-GE02) |
|---|---|---|---|
| Linearity | R-squared (pH) | Comparable to or >0.99 (based on predicate performance and "substantially equivalent") | >0.99 |
| R-squared (pO2) | Comparable to or >0.99 | >0.99 | |
| R-squared (pCO2) | Comparable to or >0.99 | >0.99 | |
| R-squared (K+) | Comparable to or >0.99 | >0.99 | |
| R-squared (Glucose) | Comparable to or >0.99 | >0.99 | |
| Aqueous Precision | Overall Precision | Comparable to published precision data for other blood analysers within the reference range (predicate device) | Reported as "comparable performance" |
| Precision in Blood | pH (SD) | Comparable to predicate | 0.018 (Blood 1), 0.014 (Blood 2) |
| K+ (SD) | Comparable to predicate | 0.08 (Blood 1), 0.21 (Blood 2) | |
| Glucose (SD) | Comparable to predicate | 0.19 (Blood 1), 0.26 (Blood 2) | |
| pCO2 (SD) | Comparable to predicate | 2.60 (Blood 1), 1.66 (Blood 2) | |
| Method Comparison | pH (R-squared) | Comparable to predicate | 0.9954 |
| pCO2 (R-squared) | Comparable to predicate | 0.9501 | |
| pO2 (R-squared) | Comparable to predicate | 0.9917 | |
| K+ (R-squared) | Comparable to predicate | 0.9523 | |
| Glucose (R-squared) | Comparable to predicate | 0.9559 | |
| pH (Slope) | Expected to be close to 1 | 1.04 | |
| pCO2 (Slope) | Expected to be close to 1 | 1.03 | |
| pO2 (Slope) | Expected to be close to 1 | 0.97 | |
| K+ (Slope) | Expected to be close to 1 | 1.00 | |
| Glucose (Slope) | Expected to be close to 1 | 0.96 | |
| Interference Study | Effect of Interferent | No significant effect observed (or within acceptable limits) | Specific concentrations tested and listed, but no quantitative "acceptance metric" is given in the text regarding the impact of these interferents. However, the "Conclusions" state the performance is "substantially equivalent." |
2. Sample Size Used for the Test Set and Data Provenance
- Linearity Study:
- Sample Size: 7 levels of each analyte, read in duplicate, on each of three IVD-GE02 systems. The predicate device (Rapidlab 865) was also used.
- Data Provenance: Human whole blood. The country of origin is not explicitly stated, but the submitter is based in the UK. The study was conducted following CLSI document EP6-A.
- Aqueous Precision Study:
- Sample Size: Not explicitly stated for specific analytes, but the study design followed CLSI document EP5-A2, which typically involves repeat measurements over multiple days.
- Data Provenance: Not specified, but "aqueous solutions" are used.
- Precision in Blood Study:
- Sample Size: For each analyte, human blood samples were prepared at two different levels. Ten readings were taken at each analyte level.
- Data Provenance: Human whole blood. Blood was drawn into heparinised vacutainers by trained phlebotomists. All blood was used within 24 hours of donation. Country of origin not explicitly stated.
- Method Comparison Study:
- Sample Size:
- pH: 104 samples
- pCO2: 102 samples
- pO2: 105 samples
- K+: 111 samples
- Glucose: 98 samples
- Data Provenance: Human blood samples. The study was conducted in a "clinical setting." Data from the linearity study was also included to extend the analyte range. Country of origin not explicitly stated. The study followed CLSI guideline EP9A-2.
- Sample Size:
- Interferent Study:
- Sample Size: Not explicitly stated, but various interferents at specific concentrations were tested for each analyte.
- Data Provenance: Not specified for the test matrix (e.g., blood matrix or aqueous solution). The study design followed CLSI document EP7-A2.
All studies appear to be prospective, designed specifically for this validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (blood gas analyzer) relies on established analytical chemistry principles and reference methods, not expert human interpretation of images or complex clinical scenarios. Therefore, the concept of "experts establishing ground truth" in the way a radiologist does for an AI image analysis system is not directly applicable.
The "ground truth" for the test set is established by:
- The predicate device (Rapidlab 865), which is itself a legally marketed and established device for these measurements. The method comparison study directly compares the new device to the predicate.
- Reference materials/methods implied by the CLSI guidelines for linearity and precision.
- Known concentrations in calibration solutions and prepared blood samples.
No specific number or qualification of "experts" in the sense of human adjudicators for ground truth is mentioned because the ground truth is analytical measurement, not subjective interpretation.
4. Adjudication Method for the Test Set
Not applicable for a device that performs quantitative analytical measurements against a reference method or predicate device. There is no human "adjudication" in the traditional sense. The comparisons are statistical and direct measurements against the predicate.
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
No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic instrument for direct measurement of blood analytes. It does not involve human "readers" or "AI assistance" in the interpretation of complex cases. Therefore, the concept of improvement in human readers with or without AI assistance is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies described (Linearity, Aqueous Precision, Precision in Blood, Method Comparison, Interferent Study) represent the standalone performance of the IVD-GE02 device. While operators interact with the device to load samples and review results, the core measurement and data generation functionality is autonomous. There isn't an "algorithm only" performance that would be separated from the instrument's operation in this context, as the device itself is the measurement system. The performance metrics reported are for the device operating independently.
7. The Type of Ground Truth Used
The ground truth used for these studies is primarily:
- Reference measurements from the predicate device (Rapidlab 865): This is the direct comparison point for the method comparison study.
- Known concentrations of analytes: For linearity and precision studies, samples with established or prepared concentrations are used.
- Clinical laboratory standards and CLSI guidelines: These define the acceptable ranges and methodologies for establishing device performance.
It's based on objective analytical measurements, not expert consensus, pathology, or outcomes data in the usual sense.
8. The Sample Size for the Training Set
The document does not describe a traditional "training set" like one would find in a machine learning or AI development context. This device relies on electrochemical principles, not a machine learning model that requires a separate training phase. The development of the device's sensor characteristics and algorithms would have been an engineering process, not a data-driven training process in the AI sense.
9. How the Ground Truth for the Training Set Was Established
As there is no explicit "training set" for an AI algorithm, this question is not directly applicable. The device's operational parameters and calibration are established through engineering design, internal testing, and the use of calibrated solutions as part of its normal operation (e.g., the IVD-GE02 calibration solutions mentioned).
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Image /page/0/Picture/0 description: The image shows the word "SPHERE" in large, bold letters. Below the word "SPHERE" is the phrase "RAISING THE STANDARD OF CRITICAL CARE" in smaller letters. The letter "H" in "SPHERE" is stylized to look like a cross.
IVD-GE02 510(k) Submission
Image /page/0/Picture/2 description: The image shows the text "K101947" in a handwritten style at the top. Below this, the word "Reference" is printed in a simple font. Underneath "Reference", the text "REP059" is printed, also in a simple font.
510(k) SUMMARY
MAR 1 6 20i1
As requested by 21 CFR 807.92, the following 510(k) summary is provided:
SUBMITTER'S INFORMATION
Submitter's Name and Address:
Sphere Medical Ltd. Harston Mill Harston Cambridge UK CB22 7GG
Tel: +44 1223 875222
Contact Person:
Mary Hutchens Regulatory Affairs Manager
Device Information
Proprietary Name: IVD-GE02
Common Name:
Classification:
| NAME | CLASS | REGULATIONNUMBER | PANEL | PRODUCTCODE |
|---|---|---|---|---|
| Electrode, Measurement ofBlood Gasses (pO2, pCO2 )and Blood pH | II | 862.1120 | ClinicalChemistry | CHL |
| Electrode, Ion SpecificPotassium | II | 862.1600 | ClinicalChemistry | CEM |
| Glucose oxidase, Glucose | II | 862.1345 | ClinicalChemistry | CGA |
| Calibrators | II | 862.1150 | ClinicalChemistry | JIX |
Blood Analyser
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PREDICATE DEVICE INFORMATION
| NAME | Rapidlab 865 |
|---|---|
| MANUFACTURER | Siemens HealthcareDiagnostics |
| 510(k) NUMBER | K934907 |
DESCRIPTION OF DEVICE
The IVD-GE02 system is an in-vitro diagnostic device for the determination of specified analytes in blood using electrochemical principles. The IVD-GE02 is essentially a modular system consists of the following components .-
- A dedicated combined PC and monitor with a touch screen .
- · A disposable cartridge containing
- o Sensor
- o Electronic circuitry, including an ASIC (Application Specific Integrated Circuit), to process sensor signals and drive the fluid management system.
- ◆ An instrument containing
- o Fluid management components (tubing, pumps and valves)
- o The cartridge (see above)
- o An injection port for samples, calibration solutions and QC solutions
- o Wiring to connect the cartridge to the fluid management components
- Syringes with calibration solutions packed in sealed foil bags .
- Containers with flush solutions ◆ ◆
- A waste container �
- A dedicated printer and associated cables �
- An ambient temperature and pressure sensor �
- Cables to connect the monitor to the instrument and a power supply unit �
- Packaging � �
.
- Label Copy �
INTENDED USE OF THE DEVICE
Indications for Use:
The IVD-GE02 system is a blood gases analyzer intended as an in vitro diagnostic device for the quantitative measurement of whole blood samples in a clinical laboratory. The IVD-GE02 system includes sensors for the measurement of pH, pCO2, pQ2, potassium and glucose.
pH, pCO2, pO2 Measurement of blood gases (pCO2, pO2) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.
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Potassium. Measurement of potassium are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by high or low potassium levels.
Glucose. Measurement of glucose is used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathetic hypoglycaemia and of pancreatic islet cell carcinoma.
IVD-GE02 calibration solutions are in vitro diagnostic products for the calibration of the IVD-GE02 test system for the measurements of pH, pCO2, pO2, potassium and glucose.
| CHARACTERISTIC | IVD-GE02 | RAPIDLAB 865K934907 |
|---|---|---|
| Intended Use | For use by trainedhealthcare professionals ina clinical laboratory | For use by trained healthcareprofessionals in a clinicallaboratory |
| MeasuredParameters | pH, pCO2, pO2, K+, Glucose | pH, pCO2, pO2, Na+, K+, Ca++,Glucose, Lactate, Cl-, tHb,FHHb, FO₂Hb, FMetHb, FCOHb |
| Sample Type | Whole blood | Whole blood |
| Sensor Array | Multi-analyte chip | Individual sensors |
| Test principle | Electrochemical(potentiometric,amperometric) | Electrochemical (potentiometric,amperometric), biochemical,optical |
| Individual testsensor type | ||
| pH | Potentiometric ISFET | PotentiometricISE |
| pCO2 | PotentiometricISFET | PotentiometricISE |
| pO2 | Amperometric | Amperometric |
| K+ | PotentiometricISFET | PotentiometricISE |
| Glucose | Amperometric | Amperometric |
| Calibrators | Aqueous solutionsTwo level target calibrationContains sodium,potassium, calcium,surfactant, buffer(phosphate), glucose anddissolved, O2, CO2.. | Aqueous solutionsTwo level target calibrationContains sodium, potassium,chloride, surfactant, buffer,glucose. O2, CO2 gas. |
| Stored at 15°C - 25°C | Stored at 4°C - 25°C |
SIMILARITIES AND DIFFERENCES TO PREDICATE DEVICES
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Technological Characteristics
The IVD-GE02 system is contained on a single multi-analyte sensor chip that has an arrav of individual sensors, each of which measures a different analyte. The sensors produce electrical signals in response to the analytes in the blood. The signal from each sensor is proportional to the concentration of analyte.
The individual sensors use one of two transducer technologies: potentiometric (a field effect transistor structure to measure the potential generated), and amperometric (measuring the current generated).
Many of the transducers on the sensor chip require a covering membrane so that thev can respond to a specific analyte. The membranes used by Sphere on the IVD- GE02 sensor array are based on those already used in other commercially available blood analysers.
Performance Data Summary
Linearity
The study design was based on CSLI document EP6-A "Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach: Approved Guideline"
The study used human whole blood as the test material and was conducted for the analytes pH. pCO2. pO2. K+. and glucose.
7 levels of each analyte were read in duplicate on each of three IVD-GE02 systems and the predicate device (Rapidlab 865 blood gas analyser).
| Analyte | Test Range | Units | R2 |
|---|---|---|---|
| pH | 6.8 – 7.8 | N/A | >0.99 |
| pO2 | 28 - 498 | mmHg | >0.99 |
| pCO2 | 21.8 - 101.9 | mmHg | >0.99 |
| K+ | 2.1 - 9.7 | mM | >0.99 |
| Glucose | 10.8 - 445.3 | m/dL | >0.99 |
Aqueous Precision
Method
The study design is based on CLSI document EP5-A2. Evaluation of Precision Performance of Quantitative Measurement Methods Approved Guideline-Second Edition. On each day the outlier test was applied to the duplicate readings, as described in EP5-A2. Data was analysed as specified in CLSI quideline EP5-A2.
The mean, the repeatability (within run precision), the between-day standard deviation, the between-run standard deviation and the total precision were calculated from the raw data with all calculations beinq performed as recommended in CLSI quideline EP5-A2.
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The precision data collected for the IVD-GE02 shows comparable performance to published precision data for other blood analysers within the reference range.
Precision in Blood
Method.
The study was conducted for the analytes pH, pCO2, pO2, K*, and glucose and for each analyte, human blood samples were prepared at two different levels of analyte. Ten readings of the analyte level in human blood were taken at each analyte level. After each replicate of a blood sample was read on the IVD-GE02 system the same sample was read on the predicate device (Rapidlab 865 blood gas analyser).
Human whole blood was used for the "Precision Study in Blood". Blood was drawn into heparinised vacutainers by trained phlebotomists. All blood was used within 24 hours of donation.
Results
Summary of pH precision in blood data
| Blood 1 | Blood 2 | |
|---|---|---|
| IVD-GE02Monitor 2 | IVD-GE02Monitor 4 | |
| Mean (pH units) | 7.355 | 7.242 |
| Standard deviation | 0.018 | 0.014 |
| Coefficient of variation (%CV) | 0.242 | 0.200 |
Summary of K+ precision in blood data
| Blood 1 | Blood 2 | |
|---|---|---|
| IVD-GE02Monitor 2 | IVD-GE02Monitor 5 | |
| Mean (mM K+) | 4.10 | 6.65 |
| Standard deviation | 0.08 | 0.21 |
| Coefficient of variation (%CV) | 1.99 | 3.17 |
Summary of oxygen precision in blood data
| 100 Blood 1 Blood 1 8 Stock 1 1 Blood 1 2 Blood 1 2 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | . > < > < > < > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > | |
|---|---|---|
| · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · | ||
| tandard deviation | ||
| Coefficient of variation |
Summary of glucose precision in blood data (mM)
| Blood 1 | Blood 2 | |
|---|---|---|
| IVD-GE02Monitor 2 | IVD-GE02Monitor 5 | |
| Mean (mM glucose) | 4.9 | 11.9 |
| Standard deviation | 0.19 | 0.26 |
| Coefficient of variation (%CV) | 3.9 | 2.2 |
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Summary of glucose precision in blood data (mg/dL)
| Blood 1IVD-GE02Monitor 2 | Blood 2IVD-GE02Monitor 5 | |
|---|---|---|
| Mean (mM glucose) | 88.4 | 215.0 |
| Standard deviation | 3.44 | 4.75 |
| Coefficient of variation (%CV) | 3.9 | 2.2 |
Summary of CO2 precision in blood data.
| Blood 1 | Blood 2 | |
|---|---|---|
| IVD-GE02 | IVD-GE02 | |
| Monitor 4 | Monitor 7 | |
| Mean (mmHg CO2) | 39.3 | 68.3 |
| Standard deviation | 2.60 | 1.66 |
| Coefficient of variation (%CV) | 6.61 | 2.42 |
METHOD COMPARISON
The Method Comparison study compared the IVD-GE02 with the Rapidlab 865 predicate device. The study was conducted in a clinical setting with human blood samples. Data from the linearity study was also included to extend the analyte range used.
Method
The objective of the study was to compare the IVD-GE02 system and the Rapidlab 865 blood gas analyser for measurements on human blood of pH, potassium, oxygen, glucose and carbon dioxide.
The study design is based on the CSLI guideline EP9A-2 and a review of similar 510(k) submissions.
Summary Results Table
| Analyte | N | Slope(calculatedby Demingregression) | Intercept(calculated byDemingregression) | R2 (calculatedusing leastsquares linearregression) | Sample rangetested |
|---|---|---|---|---|---|
| pH (pH units) | 104 | 1.04 | -0.26 | 0.9954 | 6.815-7.797 |
| pCO2 (mmHg) | 102 | 1.03 | -1.00 | 0.9501 | 20.8-100 |
| pO2 (mmHg) | 105 | 0.97 | 3.66 | 0.9917 | 38.7-496.9 |
| K+ (mmol/L) | 111 | 1.00 | 0.29 | 0.9523 | 2.5-8.9 |
| Glucose(mg/dL) | 98 | 0.96 | 8.69 | 0.9559 | 48.6-397.8 |
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Interferent Study
The study design is based on CLSI document EP7-A2: Interference Testing in Clinical Chemistry; Approved Guideline Second Edition and was designed to ascertain the effect of potential interfering substances of the performance of the IVD-GE02
| Analyte | Interferent | Concentration ofInterferent Tested |
|---|---|---|
| pH | Acetyl salicylic acid | 2170μΜ |
| pO2 (levels < 22mmHg) | Halothane | >253 μΜ |
| pCO2 | Sodium pentothal | 20.6 μΜ |
| Potassium | Sodium pentothal | >248 μΜ |
| Glucose | Acetaminophen | 662 μΜ |
| O2 | ≤ 30mmHg | |
| Triglyceride | >15mM |
Compounds showing an interferent effect on IVD-GE02 readings
Conclusions
7
For all analytes the observed precision, linearity and method comparison of the IVD-GE02 system is substantially equivalent to that seen for the predicate device (Rapidlab 865).
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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle.
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
MAR 1 6 2011
Sphere Medical Ltd. c/o Ms. Mary Hutchens Regulatory Affairs Manager Harston Mill. Harston Cambridge, CB22 7GG, United Kingdom
K101947 Trade Name: IVD-GE02 Regulation Number: 21 CFR §862.1120 Regulation Name: Blood Gases (pCO2, pO2) and Blood pH Test System. Regulatory Class: Class II Product Codes: CHL, CEM, CGA, JIX Dated: February 4, 2011 Received: February 7, 2011
Dear Ms. Hutchens:
Re:
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.
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 801 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).
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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 (301) 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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
G.C.
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
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Indications for Use Form
510(k) Number (if known): K101947_________________________________________________________________________________________________________________________________________
Device Name: _______IVD-GE02 _________________________________________________________________________________________________________________________________________________
Indications for Use:
The IVD-GE02 system is a blood gases analyzer intended as an in vitro diagnostic device for the quantitative measurement of whole blood samples in a clinical laboratory. The IVD-GE02 system includes sensors for the measurement of pH, pCO2, pO2, potassium and glucose.
pH, pCO2, pO2: Measurement of blood gases (pCO2, pO2) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.
Potassium: Measurement of potassium are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by high or low potassium levels.
Glucose: Measurement of glucose is used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathetic hypoglycaemia and of pancreatic islet cell carcinoma.
IVD-GE02 calibration solutions are in vitro diagnostic products for the calibration of the IVD-GE02 test system for the measurements of pH, pCO2, pO2, potassium and glucose.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Co
(21 CFR 801
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K101947
Page 1 of 1
§ 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.