(53 days)
Eurotrol GAS-ISE Hct QC is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i-STAT® POCT analyzer. It is intended that Eurotrol GAS-ISE Hct QC should be used in the periodic verification of the precision and accuracy of the Abbott i-STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. Eurotrol GAS-ISE Hct QC is for in vitro diagnostic use only.
Eurotrol GAS-ISE Hct LVM is an assayed aqueous blood gas, electrolyte and metabolite control material for professional use suitable for calibration of the Abbott i-STAT® POCT analyzer.
It is intended that Eurotrol GAS-ISE Hct LVM should be used in the periodic verification of the precision and accuracy of the Abbott i-STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. Eurotrol GAS-ISE Hct LVM is for in vitro diagnostic use only.
Eurotrol GAS-ISE Hct QC quality controls are prepared using salts in an aqueous, physiologically buffered matrix. Tonometry with predetermined levels of oxygen and carbon dioxide balanced with nitrogen and different salt concentrations provides distinct levels for each parameter, simulating clinically significant ranges of acid-base and electrolyte balance, respiratory function, glucose, lactate, urea and creatinine concentrations, within the reportable range of the Abbott i-STAT POCT analyzer.
Eurotrol GAS-ISE Hct QC is a non-hazardous aqueous solution that contains no biological materials.
Eurotrol GAS-ISE Hct QC provides three (3) physiological relevant levels, each ampule containing 2.5 mL of solution.
Eurotrol GAS-ISE Hct QC is packed in a carton box containing 10 ampules of a separate level.
Eurotrol GAS-ISE Hct LVM provides five (5) physiological relevant levels, each ampule containing 2.5 mL of solution. Eurotrol GAS-ISE Hct LVM quality controls are prepared using salts in an aqueous, physiologically buffered matrix. Tonometry with predetermined levels of oxygen and carbon dioxide balanced with nitrogen and different salt concentrations provides five (5) distinct levels for each parameter, simulating clinically significant ranges of acid-base and electrolyte balance, respiratory function, glucose, lactate, urea and creatinine concentrations, within the reportable range of the Abbott i-STAT POCT analyzer.
Eurotrol GAS-ISE Hct LVM is a non-hazardous aqueous solution that contains no biological materials.
Eurotrol GAS-ISE Hct LVM provides five (5) physiological relevant levels, each ampule containing 2.5 mL of solution.
Eurotrol GAS-ISE Hct LVM is packed in a carton box containing a set of 5 ampules; one ampule of each level.
The provided 510(k) summary (K131595) for Eurotrol GAS-ISE Hct QC and Eurotrol GAS-ISE Hct LVM describes quality control materials for blood gas, electrolyte, and metabolite analysis. This submission focuses on the performance claims and stability of these control materials for use with the Abbott i-STAT® POCT analyzer.
Here's an analysis of the acceptance criteria and supporting study information, based on the provided document:
Acceptance Criteria and Reported Device Performance
The device itself is a quality control material, not a diagnostic device that produces patient-specific results. Therefore, the "device performance" in this context refers to the assigned values and ranges for the various analytes within the control material, and its stability.
The acceptance criteria are implicitly defined by the assigned value ranges for each analyte, which are developed to verify the precision and accuracy of the Abbott i-STAT® POCT analyzer. The reported device performance is specifically the mean and range provided for each analyte in the lot-specific value sheets.
For example, section {3} and {5} provide tables for Eurotrol GAS-ISE Hct QC (Lot 17401215, Level 1) with specific values and ranges for various analytes.
| Analyte | Unit | Mean (X) | Range (R) |
|---|---|---|---|
| pH | 1 | 6.973 | 6.893 - 7.054 |
| pCO₂ | mmHg | 73.0 | 58.6 - 87.4 |
| pO₂ | mmHg | 66 | 46 - 86 |
| Na⁺ | mmol/L, mEq/L | 119 | 115 - 124 |
| K⁺ | mmol/L, mEq/L | 2.7 | 2.3 - 3.1 |
| iCa⁺⁺ | mmol/L | 1.40 | 1.29 - 1.51 |
| Cl⁻ | mmol/L, mEq/L | 83 | 77 - 88 |
| tCO₂ | mmol/L, mEq/L | 19 | 10 - 28 |
| Glucose | mg/dL | 303 | 257 - 349 |
| Lactate | mmol/L | 8.49 | 7.57 - 9.41 |
| Urea | mmol/L | 21.9 | 19.4 - 24.5 |
| Creatinine | μmol/L | 324 | 248 - 400 |
(Note: The tables in the input have some inconsistencies and overlapping information. The table above consolidates and clarifies based on the available data for 'Level 1' of the 'Eurotrol GAS-ISE Hct QC' found in {3} and {5}.)
Study Design and Evidence Pertaining to Acceptance Criteria
The studies described are primarily focused on value assignment, stability, and traceability of the control materials, rather than a clinical study evaluating diagnostic accuracy against a ground truth.
1. Sample size used for the test set and the data provenance:
- Test Set Description: The "test set" in this context refers to the samples of the control materials from each lot that are analyzed to determine their assigned values and ranges.
- Sample Size: "Multiple replicates of test samples" are measured. The exact number of replicates is not specified, but it's stated that values are determined by "the mean of multiple determinations performed on randomly selected samples from each lot." This implies multiple ampules from each production lot are tested multiple times.
- Data Provenance: The studies are conducted by Eurotrol B.V., which is based in The Netherlands. The testing involves the Abbott i-STAT 300 System and various Abbott i-STAT cartridge types (CG4+, CG8+, EC8+, CHEM8+, Crea). The data is generated prospectively during the manufacturing and quality control process for each lot.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- No external experts are explicitly mentioned for establishing a "ground truth" in the typical sense of diagnostic imaging or clinical assessment.
- The "ground truth" for these control materials is established by traceable reference materials and the performance of the specified analytical instruments. Section
{13}meticulously lists the NIST Standard Reference Materials (SRMs) and other reference materials used for each analyte (e.g., NIST SRM 186 I/II, 185, 187, 191 and 192 for pH; NIST SRM 956b for Na+, K+, Ca++, Cl-). - The "experts" involved are likely the highly trained laboratory personnel at Eurotrol B.V. who perform the value assignment using validated methods and traceable standards. Their specific qualifications are not detailed in the summary.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- No explicit adjudication method is described. The value assignment process involves taking the "mean of multiple determinations." This approach intrinsically averages out minor variations, but there isn't a stated independent review or adjudication process by multiple individuals or systems beyond the initial measurements.
4. 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 MRMC study was performed. This device is a quality control material for an in-vitro diagnostic device (Abbott i-STAT POCT analyzer), not an AI-based diagnostic tool for human interpretation. Therefore, the concept of "human readers improving with AI" is not applicable here.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not an algorithm-only device. It is a physical quality control material. However, the value assignment process (section
{12}) for the control material is a "standalone" process in the sense that the control material is characterized independently of its ultimate use by individual operators, and these assigned values define its expected performance. The performance of the Abbott i-STAT analyzer itself with this control material is what's being verified.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the content of these control materials is established through traceability to internationally recognized reference materials (NIST SRMs) and other certified reference materials (Biomed DuoCal, Precipath U plus, Precinorm U plus, Hanna Instruments Conductivity Standards). This provides a highly accurate and standardized basis for the assigned values.
7. The sample size for the training set:
- No specific "training set" in the context of machine learning is described. The concept of training data doesn't apply directly to this type of device. The control material itself is manufactured, and then its properties (assigned values and ranges) are determined.
- However, the validation and establishment of the value assignment methodology would have relied on extensive testing and historical data for the Abbott i-STAT system, which could be considered analogous to a "training" phase for the manufacturer's internal processes. The summary mentions using "multiple cartridges of the latest available batches of the following cartridge types: CG4+, CG8+, EC8+, CHEM8+ and Crea" for value assignment, suggesting a broad basis for establishing the expected performance on the target analyzer.
8. How the ground truth for the training set was established:
- As there is no "training set" in the machine learning sense, this question is not directly applicable. If we consider the "ground truth" for setting the manufacturing specifications and the value assignment methodology, it would again stem from traceability to reference materials, established analytical chemistry principles, and comprehensive statistical analysis of the performance on the Abbott i-STAT system over time.
{0}------------------------------------------------
510(k) Summary K131595
-
- This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92
2. Submitter
Eurotrol B.V. Keplerlaan 20 6716 BS Ede, The Netherlands T +31 318 69577 F +31 318 695770 E office@eurotrol.com
3. Submitter Contact
JUL 2 6 2013
Paul B.P. Kooiimans Regulatory Affairs manager Eurotrol B.V. Keplerlaan 20 6716 BS Ede, The Netherlands T +31 318 695777 F +31 318 695770 E pkooiimans@eurotrol.com
4. Device identification
Proprietary Name: Eurotrol GAS-ISE Hct QC and Eurotrol GAS-ISE Hct LVM Common Name: Blood gas, electrolyte and metabolite control Classification Name: Class I, reserved Product code: JJY; Multi-analyte controls, all kinds (assayed) (21 CFR 862.1660)
Predicate Device 5.
Device Name: Roche Combitrol Plus B. Manufacturer: Bionostics, Inc., 510(k) number: K032453, Decision Date: 08/28/2003
6. Intended Use
Eurotrol GAS-ISE Hot QC
Eurotrol GAS-ISE Hct QC is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i-STAT® POCT analyzer. It is intended that Eurotrol GAS-ISE Hct QC should be used in the periodic verification of the precision and accuracy of the Abbott i-STAT POCT analyzer when measuring; pH, pO2, pCO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit.
Eurotrol GAS-ISE Hot LVM
Eurotrol GAS-ISE Hct LVM is an assayed aqueous blood gas, electrolyte and metabolite control material for professional use suitable for calibration verification of the Abbott i-STAT® POCT analyzer.
It is intended that Eurotrol GAS-ISE Hct LVM should be used in the periodic verification of the precision and accuracy of the Abbott i-STAT POCT analyzer when measuring; pH, pO2, pCO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit.
7. Device description
Eurotrol GAS-ISE Hct QC
Eurotrol GAS-ISE Hct QC quality controls are prepared using salts in an aqueous, physiologically buffered matrix. Tonometry with predetermined levels of oxygen and carbon dioxide balanced with nitrogen and different salt concentrations provides distinct levels for each parameter, simulating clinically significant ranges of acid-base and electrolyte balance, respiratory function, glucose, lactate, urea and creatinine concentrations, within the reportable range of the Abbott i-STAT POCT analyzer.
Eurotrol GAS-ISE Hct QC is a non-hazardous aqueous solution that contains no biological materials.
Eurotrol GAS-ISE Hct QC provides three (3) physiological relevant levels, each ampule containing 2.5 mL of solution.
Eurotrol GAS-ISE Hct QC is packed in a carton box containing 10 ampules of a separate level.
{1}------------------------------------------------
Eurotrol GAS-ISE Hct LVM
Eurotrol GAS-ISE Hct LVM provides five (5) physiological relevant levels, each ampule containing 2.5 mL of solution. Eurotrol GAS-ISE Hct LVM quality controls are prepared using salts in an aqueous, physiologically buffered matrix. Tonometry with predetermined levels of oxygen and carbon dioxide balanced with nitrogen and different salt concentrations provides five (5) distinct levels for each parameter, simulating clinically significant ranges of acid-base and electrolyte balance, respiratory function, glucose, lactate, urea and creatinine concentrations, within the reportable range of the Abbott i-STAT POCT analyzer.
Eurotrol GAS-ISE Hct LVM is a non-hazardous aqueous solution that contains no biological materials.
Eurotrol GAS-ISE Hct LVM provides five (5) physiological relevant levels, each ampule containing 2.5 mL of solution.
Eurotrol GAS-ISE Hct LVM is packed in a carton box containing a set of 5 ampules; one ampule of each level.
8. Special Instrument Required
For an appropriate use of Eurotrol GAS-ISE Hct QC and Eurotrol GAS-ISE Hct LVM the use of the Abbott i-STAT System, including test cartridges, is required.
Predicate Device Comparison 9.
Comparison of Eurotrol GAS-ISE Het QC and Eurotrol GAS-ISE Hot LVM to the predicate device for substantial equivalence:
| New Device | Predicate Device | |
|---|---|---|
| Eurotrol GAS-ISE Hct | Roche Combitrol Plus B | |
| 510(k), date | K032453, 08/28/2003 | |
| Number oflevels | - Eurotrol GAS-ISE Hct QC: 3- Eurotrol GAS-ISE Hct LVM: 5 | 3 |
| Analytes | pH, pO2, pCO2, Na+, K+, Ca++, Cl-,Glucose, Lactate, Urea, Creatinine,TCO2 and Hematocrit (Conductivity) | pH, blood gases, Na+, K+,iCa++ Cl-, Li+, iMg++, Glucose,Lactate, BUN, Creatinine, tHb,Hb derivatives and bilirubin |
| Container | Clear glass ampules | Clear glass ampules |
| FillingVolume | 2,5 mL | 1,7 mL |
| Color | Clear, colorless | Red |
| Storagetemperature | 2 - 8°C/35 - 46°F | 2 - 8°C/35 - 46°F |
| Indicationsfor Use | Verification of the precision andaccuracy of the Abbott i-STAT POCTand cartridges. | To be used to monitor and evaluatethe analytical performance of theRoche OMNI S for analytes listed inthe package insert. |
| Matrix/Materials | Eurotrol GAS-ISE Hct controls areprepared using salts in aphysiologically buffered aqueousmatrix. Tonometry with predeterminedlevels of oxygen and carbon dioxidebalanced with nitrogen and differentsalt concentrations provide five distinctlevels for each parameter. | Buffered, aqueous electrolyte solutionequilibrated with carbon dioxide andoxygen gas mixture |
| Form | Liquid | Liquid |
| OpenAmpuleStability | 30 seconds | Use immediately and only use onceafter opening |
| Values | Lot specific | Lot specific |
| Shelf life | 24 months at 2-8°C10 days at 20-25°C | 24 months at 2-8°C3 months at room temperature |
| Where used | Clinical Laboratories, Point of Caretesting sites | Clinical Laboratories, Intensive CareUnits (ICU), Emergency Rooms (ER),Operating rooms (OR), Remote orSTAT-labs, Recovery Rooms,Neonatal Units and Renal Dialysis. |
{2}------------------------------------------------
10. Standards and quidelines reference
- CLSI EP5-A2; Evaluation of Precision Performance of Quantitative Measurement Methods; l Approved Guideline - Second Edition, Vol 24, No. 25, August 2004
- CLSI EP25-A; Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline, Vol --29, No. 20, September 2009
11. Stability
Real time stability studies have been performed for Eurotrol GAS-ISE Hct QC and Eurotrol GAS-ISE Hct LVM. The claimed stability is 24 months when the product is stored at 2-8°C, 10 days when the product is stored unopened at room temperature and 30 seconds after opening the ampules.
12. Value Assignment
Multiple replicates of test samples are measured at the beginning and end of the production run on various analyzers for metabolites and on blood gas analyzers for blood gas and pH values. Values are assigned on the Abbott i-STAT 300 System, using multiple cartridges of the latest available batches of the following cartridge types: CG4+, CG8+, EC8+, CHEM8+ and Crea. Values are determined by taking the mean of multiple determinations performed on randomly selected samples from each lot. Ranges are assigned using pre-determined intervals. Value assignment is performed for each lot of Eurotrol GAS-ISE Hct QC and Eurotrol GAS-ISE Hct LVM and for each new software (CLEW) update of the Abbott i-STAT 300 System.
The assigned values of each batch are available on a value sheet as per the example in Annex 1. on page 4 - 7.
13. Traceability
The different levels of Eurotrol GAS-ISE Hct QC and Eurotrol GAS-ISE Hct LVM are traceable to the reference materials as shown in the table below.
| Analyte | Reference Material |
|---|---|
| pH | NIST SRM: 186 I/II, 185, 187, 191 and 192 |
| pCO2 | NIST SRM: 1674b, 2625a, 2658a and 2659a |
| pO2 | NIST SRM: 1674b, 2625a, 2658a and 2659a |
| Na+ | NIST SRM 956b |
| K+ | NIST SRM 956b |
| Ca++ | NIST SRM 956b |
| Cl- | NIST SRM 956b |
| Glucose | NIST SRM 965c |
| Lactate | Biomed DuoCal Multi 10260 |
| Urea | Precipath U plus 159955 + Precinorm U plus 157249 |
| Creatinine | NIST SRM 967a |
| Hematocrit(Conductivity) | Hanna Instruments Conductivity Standard 1.413 mS/cmHanna Instruments Conductivity Standard 5.000 mS/cmHanna Instruments Conductivity Standard 12.88 mS/cm |
Table 2. Traceability of the analytes of Eurotrol GAS-ISE Hct QC and Eurotrol GAS-ISE Hct LVM to reference materials.
14. Conclusion
Eurotrol GAS-ISE Hct QC and Eurotrol GAS-ISE Hot LVM is intended to be used for the same intended use as the predicate and performs similarly as the predicate device.
{3}------------------------------------------------
| LOT 17401215 | |||
|---|---|---|---|
| 17401215 | |||
| cartridge types, all lot numbers | |||
| Units | X (Mean) | R (Range) | |
| pH | 1 | 6.973 | 6.893 - 7.054 |
| pCO₂ | mmHg | 73.0 | 58.6 - 87.4 |
| kPa | 9.71 | 7.80 - 11.62 | |
| pO₂ | mmHg | 66 | 46 - 86 |
| kPa | 8.7 | 6.1 - 11.4 | |
| Na⁺ | mmol/L, mEq/L | 119 | 115 - 124 |
| K⁺ | mmol/L, mEq/L | 2.7 | 2.3 - 3.1 |
| iCa⁺⁺ | mmol/L | 1.40 | 1.29 - 1.51 |
| mEq/L | 2.8 | 2.6 - 3.0 | |
| mg/dL | 5.6 | 5.2 - 6.0 | |
| Cl⁻ | mmol/L, mEq/L | 83 | 77 - 88 |
| tCO₂ | mmol/L, mEq/L | 19 | 10 - 28 |
| Glucose/ | mg/dL | 303 | 257 - 349 |
| Glu | g/L | 3.03 | 2.57 - 3.49 |
| Lactate/ | mmol/L | 16.8 | 14.2 - 19.4 |
| mmol/L | 8.49 | 7.57 - 9.41 | |
| Lac | mg/dL | 76.5 | 68.2 - 84.8 |
| g/L | 0.765 | 0.682 - 0.848 | |
| BUN | mg/dL | 61 | 54 - 69 |
| Urea | mmol/L | 21.9 | 19.4 - 24.5 |
| mg/dL | 132 | 116 - 147 | |
| Creatinine/ | g/L | 1.32 | 1.16 - 1.47 |
| μmol/L | 324 | 248 - 400 |
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{4}------------------------------------------------
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{5}------------------------------------------------
| Level 1LEW: A26/C26/H26/J2014-09ಹಿ | |
|---|---|
| Eurotrol | 1740121517401215 |
| ി അമേരിക്കുകയും പ്രവരിച്ചു. പ്രശസ്ത പ്രവർത്തിച്ചു. പ്രശസ്ത പ്രവർത്തിച്ചു. പ്രശസ്ത പ്രാമത്തിലെ പ്രവാഹ്യമായി പ്രവർത്തിച്ചു. പ്രശസ്തകംExpected values for Abbott i-STAT*(Mean989 989 9072><kPa___________________________________________________________________________________________________________________________________________________________________________ | |
| CG8+, EG7+, EG6+, G3+, Crea & CG4+ LOT]K, L, N, U, W or YEurotrol GAS-ISE Hct QCmmHgUnits- - - - - -pCO,:જન | |
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| mmHg | 66 | 51 - 81 | |
|---|---|---|---|
| kPa | 8.7 | 6.7 - 10.7 | |
| mmol/L, mEq/L | 120 | 116 - 124 | |
| mmol/L, mEq/L | 2.7 | 2.3 - 3.1 | |
| mmol/L | 1.40 | 1.29 - 1.51 | |
| mEq/L | 2.8 | 2.6 - 3.0 | |
| mg/dL | 5.6 | 5.2 - 6.0 | |
| mg/dL | 301 | 259 - 343 | |
| Glucose | g/L | 3.01 | 2.59 - 3.43 |
| Glu | mmol/L | 16.7 | 14.4 - 19.1 |
| Creatinine/ | μmol/L | 319 | 248 - 389 |
| Crea | mg/dL | 3.6 | 2.8 - 4.4 |
| mmol/L | 8.49 | 7.57 - 9.41 | |
| Lactate/Lac | mg/dL | 76.5 | 68.2 - 84.8 |
| g/L | 0.765 | 0.682 - 0.848 | |
| %PCV | 17 | 14 - 20 |
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{6}------------------------------------------------
| Level 1_EW: A26/C26/H26/J2014-09ದ | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 57 | Eurotrol | מותחים של המוזיקה של המועד המונחים של המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המועד המו | |||||||
| QC | និងជាមួយនឹង នាង និង និង និង និង និង នាង និង និង និង និង និង និង និង និង និង និង និង និង និង និង និង និង និង និង និង និង និង និង និង និង និង និង និង និង និង និង និង និង និង នរ ត្រព កំពត ប្រធាន | ន់ ទឹក នាង នេះ នឹង ដ | 27 BE | 8 원 전 등 등 | |||||
| Expected values for Abbott I-STAT®Eurotrol GAS-ISE Hct | 100mmoll, mEqui mmovil, mEquil mmovit, mEquil mmolit, mEquil mmolitUnits | mg/dl m/d/dmEqL | mmoVl.g/L | mmoVL, mEq/Lprovi | mg/dl | mg/d mmoVLmg/di | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ||
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{7}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized emblem resembling an eagle or bird in flight, composed of three curved lines. The logo is black and white and appears to be a seal or official emblem.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Ge Silver Spring, MD 20993-0002
July 26, 2013
Eurotrol B.V. C/O Paul B.P. Kooiimans Keplerlaan 20 6716 BS Ede, The Netherlands
Re: K131595
Trade/Device Name: Eurotrol GAS-ISE Hct QC Eurotrol GAS-ISE Hct LVM Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: 1 Reserved Product Code: JJY Dated: June 20, 2013 Received: June 21, 2013
Dear Mr. Kooijmans:
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 Part 801); 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.
{8}------------------------------------------------
Page 2-Mr. Kooijmans
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOfTice:s/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to promarket notification" (21CFR 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/dcfault.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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Courtney H. Lias, Ph.D.
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): K131595
Eurotrol GAS-ISE Hot QC Device Name: Eurotrol GAS-ISE Hct LVM
Indications for Use:
Eurotrol GAS-ISE Hct QC
Eurotrol GAS-ISE Hct QC is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i-STAT® POCT analyzer. It is intended that Eurotrol GAS-ISE Hct QC should be used in the periodic verification of the precision and accuracy of the Abbott i-STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. Eurotrol GAS-ISE Hot QC is for in vitro diagnostic use only.
Eurotrol GAS-ISE Hct LVM
Eurotrol GAS-ISE Hct LVM is an assayed aqueous blood gas, electrolyte and metabolite control material for professional use suitable for calibration of the Abbott i-STAT® POCT analyzer.
It is intended that Eurotrol GAS-ISE Hct LVM should be used in the periodic verification of the precision and accuracy of the Abbott i-STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. Eurotrol GAS-ISE Hot LVM is for in vitro diagnostic use only.
Prescription Use __ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use ... (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Denise Johnson-lyles -S 2013.07.26 11:42:59 -04'00'
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health (OIR)
510(K) K131595
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§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.