(197 days)
The ACE Axcel Clinical Chemistry System is an automated, discrete, bench-top, random access analyzer that is intended for in vitro diagnostic use in the quantitative measurement of general chemistry assays for clinical use in physician office laboratories or clinical laboratories.
The ACE Axcel Clinical System includes an Ion Selective Electrode (ISE) module for the measurement of sodium, potassium and chloride in serum. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
- Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance
- Potassium measurements are used to monitor electrolyte balance and in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
- Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The ACE Glucose Reagent is intended for the quantitative determination of glucose concentration in serum using the ACE Axcel Clinical Chemistry System. 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. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE Axcel Clinical Chemistry System consists of two major components, the chemistry instrument and an integrated Panel PC. The instrument accepts the physical patient samples, performs the appropriate optical or potentiometric measurements on those samples and communicates that data to an integral Panel PC. The Panel PC uses keyboard or touch screen input to manually enter a variety of data, control and accept data from the instrument, manage and maintain system information and generate reports relative to patient status and instrument performance. The Panel PC also allows remote download of patient requisitions and upload of patient results via a standard interface.
In the ACE Glucose Reagent assay, glucose in serum reacts with adenosine triphosphate in the presence of hexokinase and magnesium with the formation of glucose-6-phosphate and adenosine diphosphate. Glucose-6-phosphate dehydrogenase catalyzes the oxidation of glucose-6-phosphate with NAD+ to form 6-phosphogluconate and NADH. NADH absorbs strongly at 340 nm, whereas NAD+ does not. The total amount of NADH formed is proportional to the concentration of glucose in the sample. The increase in absorbance is measured bichromatically at 340 nm/378 nm.
The ACE Ion Selective Electrode (ISE) Module is used with ACE CAL A and CAL B Calibration Solutions in the performance of a two-point calibration in order to measure concentrations of sodium, potassium and chloride in undiluted serum. The ISE module uses a potentiometric method to simultaneously measure sodium, potassium and chloride in undiluted serum. Each electrode uses an ion-specific membrane to measure the difference in ionic concentration between an inner electrolyte solution and the sample. This difference causes an electro-chemical potential to form on the membrane of the active electrode. The connection of the amplifier and ground (reference electrode) to the ion selective electrode forms the measuring system. The two-point calibration with CAL A and CAL B with precisely known ion concentrations (two-point calibration) and the measured voltage difference of the sample and CAL A are used to determine the ion concentration in the sample.
Here's a summary of the acceptance criteria and study information for the Alfa Wassermann ACE Axcel Clinical Chemistry System, ACE Ion Selective Electrode (ISE) Module, and ACE Glucose Reagent, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the "Accuracy" data, where the device (y) is compared to a predicate device (x). The close correlation, with slopes near 1 and intercepts near 0, along with high correlation coefficients, indicates acceptable accuracy. Precision is evaluated by the Coefficient of Variation (CV%).
| Measurement (Reagent/Module) | Performance Metric | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (ACE Axcel Clinical Chemistry System) |
|---|---|---|---|
| ACE Glucose Reagent | Precision (Within-run CV) | (Not explicitly stated, but low CV is desirable) | 1.0 to 1.4% (lab setting, 4 levels, 22 days); 0.3 to 2.2% (POL sites, 3 locations, 5 days) |
| Precision (Total CV) | (Not explicitly stated, but low CV is desirable) | 1.0 to 1.9% (lab setting); 0.5 to 2.2% (POL sites) | |
| Accuracy (Correlation Coefficient) | Close to 1.0 | 0.9998 (lab setting, 122 samples); 0.9992 to 0.9998 (POL sites, 3 locations) | |
| Accuracy (Slope) | Close to 1.0 | 1.001 to 1.009 (lab setting); 0.972 to 1.021 (POL sites) | |
| Accuracy (Intercept) | Close to 0 | -1.5 to 0.1 (lab setting); -3.0 to 4.1 (POL sites) | |
| Detection Limit | (Not explicitly stated, but low is desirable) | 3.1 mg/dL | |
| ACE Axcel Sodium ISE | Precision (Within-run CV) | (Not explicitly stated, but low CV is desirable) | 0.4 to 1.0% (lab setting, 4 levels, 21 days); 0.6 to 1.0% (POL sites, 3 locations, 5 days) |
| Precision (Total CV) | (Not explicitly stated, but low CV is desirable) | 0.8 to 1.4% (lab setting); 0.8 to 1.4% (POL sites) | |
| Accuracy (Correlation Coefficient) | Close to 1.0 | 0.9963 (lab setting, 113 samples); 0.9917 to 0.9995 (POL sites, 3 locations) | |
| Accuracy (Slope) | Close to 1.0 | 0.992 to 1.024 (lab setting); 0.989 to 1.067 (POL sites) | |
| Accuracy (Intercept) | Close to 0 | -3.60 to 0.92 (lab setting); -8.85 to 2.30 (POL sites) | |
| ACE Axcel Potassium ISE | Precision (Within-run CV) | (Not explicitly stated, but low CV is desirable) | 0.6 to 3.5% (lab setting, 4 levels, 21 days); 1.0 to 1.6% (POL sites, 3 locations, 5 days) |
| Precision (Total CV) | (Not explicitly stated, but low CV is desirable) | 1.3 to 3.5% (lab setting); 1.1 to 1.6% (POL sites) | |
| Accuracy (Correlation Coefficient) | Close to 1.0 | 0.9974 (lab setting, 115 samples); 0.9973 to 0.9996 (POL sites, 3 locations) | |
| Accuracy (Slope) | Close to 1.0 | 0.989 to 1.015 (lab setting); 0.960 to 1.035 (POL sites) | |
| Accuracy (Intercept) | Close to 0 | -0.050 to 0.095 (lab setting); -0.194 to 0.216 (POL sites) | |
| ACE Axcel Chloride ISE | Precision (Within-run CV) | (Not explicitly stated, but low CV is desirable) | 0.5 to 1.0% (lab setting, 4 levels, 21 days); 0.9 to 1.5% (POL sites, 3 locations, 5 days) |
| Precision (Total CV) | (Not explicitly stated, but low CV is desirable) | 1.1 to 1.5% (lab setting); 1.1 to 2.6% (POL sites) | |
| Accuracy (Correlation Coefficient) | Close to 1.0 | 0.9855 (lab setting, 111 samples); 0.9885 to 0.9996 (POL sites, 3 locations) | |
| Accuracy (Slope) | Close to 1.0 | 0.939 to 1.002 (lab setting); 0.976 to 1.088 (POL sites) | |
| Accuracy (Intercept) | Close to 0 | -1.07 to 5.63 (lab setting); -8.16 to 2.22 (POL sites) |
2. Sample Size Used for the Test Set and Data Provenance
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ACE Glucose Reagent:
- Accuracy (Correlation Study): 122 samples (ranging from 6 to 729 mg/dL).
- Accuracy (Patient Correlation Studies): Data from three separate Physician Office Laboratory (POL) sites. Specific sample numbers per POL site are not provided, but the combined sites yielded multiple correlation coefficients, standard error estimates, and confidence intervals for slope and intercept.
- Provenance: Not explicitly stated, but likely from a laboratory setting and Physician Office Laboratories, presumably within the US given the submission to the FDA. The nature of the samples (e.g., patient samples, control materials) is not specified as prospective or retrospective.
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ACE Axcel Sodium ISE:
- Accuracy (Correlation Study): 113 samples (ranging from 45.1 to 194.0 mmol/L).
- Accuracy (Patient Correlation Studies): Data from three separate Physician Office Laboratory (POL) sites.
- Provenance: Same as Glucose – likely US lab/POL, nature of samples not specified.
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ACE Axcel Potassium ISE:
- Accuracy (Correlation Study): 115 samples (ranging from 1.57 to 14.20 mmol/L).
- Accuracy (Patient Correlation Studies): Data from three separate Physician Office Laboratory (POL) sites.
- Provenance: Same as Glucose – likely US lab/POL, nature of samples not specified.
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ACE Axcel Chloride ISE:
- Accuracy (Correlation Study): 111 samples (ranging from 63.4 to 176.0 mmol/L).
- Accuracy (Patient Correlation Studies): Data from three separate Physician Office Laboratory (POL) sites.
- Provenance: Same as Glucose – likely US lab/POL, nature of samples not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. For this type of in vitro diagnostic device, "ground truth" is established by comparing the performance of the new device to a legally marketed predicate device (Alfa Wassermann ACE Clinical Chemistry System and ACE Reagents) using quantitative measurements, not by expert interpretation. The predicate device itself acts as the reference method in these correlation studies.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is a quantitative comparison against a predicate device, not an interpretation-based ground truth requiring adjudication.
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
Not applicable. This device is a clinical chemistry analyzer, an automated system for measuring analytes in samples. It does not involve human readers interpreting images or data where AI assistance would be relevant in the context of MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance studies described are inherently "standalone" in the sense that they evaluate the performance of the ACE Axcel Clinical Chemistry System (including its reagents and ISE module) in producing quantitative results independently. The accuracy studies compare its output directly against a predicate device's output. There isn't a "human-in-the-loop" aspect to the core measurement performance itself.
7. The Type of Ground Truth Used
The "ground truth" for the accuracy studies is the quantitative result obtained from the predicate device (Alfa Wassermann ACE Clinical Chemistry System and ACE Reagents). The studies are correlation studies comparing the new device's measurements (y) to the predicate device's measurements (x).
8. The Sample Size for the Training Set
Not applicable. This document describes a traditional medical device (clinical chemistry analyzer), not a machine learning or AI-based device that typically has a "training set." The device is intended to perform measurements based on established chemical and electrochemical principles.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this device's development as described in the provided text.
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Alfa Wassermann Diagnostic Technologies, LLC
MAY 1 7 2012
510(k) Submission ACE Axcel Clinical Chemistry System ACE Reagents
13253
510(k) SUMMARY
Alfa Wassermann Diagnostic Technologies, LLC 510(k) Owner: 4 Henderson Drive West Caldwell, NJ 07006 Contact: Hyman Katz, Ph.D. Phone: 973-852-0158 Fax: 973-852-0237 Date Summary November 1, 2011 Prepared: Trade Name: ACE Axcel Clinical Chemistry System Device: Class 1 Classification: Common/Classification Name: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use (21 C.F.R. § 862.2610) Product Code JJE ACE Glucose Reagent Trade Name: Classification: Class 2 Common/Classification Name: Hexokinase, Glucose (21 C.F.R. & 862.1345) Product Code CFR ACE Ion Selective Electrode (ISE) Trade Name: Module Classification: Class 2 Common/Classification Name: Electrode, Ion Specific, Sodium, Potassium, Chloride (21 C.F.R. § 862.1665, 862.1600, 862.1170) Product Codes JGS, CEM, CGZ Predicate Manufacturer for analyzer/reagent system predicate: Devices: Alfa Wassermann ACE plus ISE/Clinical Chemistry System ACE Reagents (K931786)
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| Device | The ACE Axcel Clinical Chemistry System consists of two major |
|---|---|
| Descriptions: | components, the chemistry instrument and an integrated Panel PC. Theinstrument accepts the physical patient samples, performs theappropriate optical or potentiometric measurements on those samplesand communicates that data to an integral Panel PC. The Panel PC useskeyboard or touch screen input to manually enter a variety of data,control and accept data from the instrument, manage and maintainsystem information and generate reports relative to patient status andinstrument performance. The Panel PC also allows remote download ofpatient requisitions and upload of patient results via a standardinterface. |
| In the ACE Glucose Reagent assay, glucose in serum reacts withadenosine triphosphate in the presence of hexokinase and magnesiumwith the formation of glucose-6-phosphate and adenosine diphosphate.Glucose-6-phosphate dehydrogenase catalyzes the oxidation ofglucose-6-phosphate with NAD+ to form 6-phosphogluconate andNADH. NADH absorbs strongly at 340 nm, whereas NAD+ does not.The total amount of NADH formed is proportional to the concentrationof glucose in the sample. The increase in absorbance is measuredbichromatically at 340 nm/378 nm. | |
| The ACE Ion Selective Electrode (ISE) Module is used with ACE CALA and CAL B Calibration Solutions in the performance of a two-pointcalibration in order to measure concentrations of sodium, potassiumand chloride in undiluted serum. The ISE module uses a potentiometricmethod to simultaneously measure sodium, potassium and chloride inundiluted serum. Each electrode uses an ion-specific membrane tomeasure the difference in ionic concentration between an innerelectrolyte solution and the sample. This difference causes an electro-chemical potential to form on the membrane of the active electrode.The connection of the amplifier and ground (reference electrode) to theion selective electrode forms the measuring system. The two-pointcalibration with CAL A and CAL B with precisely known ionconcentrations (two-point calibration) and the measured voltagedifference of the sample and CAL A are used to determine the ionconcentration in the sample. | |
| Intended Use: | Indications for Use: |
| The ACE Axcel Clinical Chemistry System is an automated, discrete,bench-top, random access analyzer that is intended for in vitrodiagnostic use in the quantitative determination of constituents in bloodand other fluids. | |
| The ACE Glucose Reagent is intended for the quantitativedetermination of glucose concentration in serum using the ACE AxcelClinical Chemistry System. Glucose measurements are used in thediagnosis and treatment of carbohydrate metabolism disordersincluding diabetes mellitus, neonatal hypoglycemia, and idiopathichypoglycemia, and of pancreatic islet cell carcinoma. This test isintended for use in clinical laboratories or physician office laboratories.For in vitro diagnostic use only. | |
| The ACE Axcel Clinical System includes an Ion Selective Electrode(ISE) module for the measurement of sodium, potassium and chloridein undiluted serum. This test is intended for use in clinical laboratoriesor physician office laboratories. For in vitro diagnostic use only. | |
| Sodium measurements are used in the diagnosis and treatmentof diseases involving electrolyte imbalance Potassium measurements are used to monitor electrolytebalance and in the diagnosis and treatment of diseasesconditions characterized by low or high blood potassiumlevels. Chloride measurements are used in the diagnosis and treatmentof electrolyte and metabolic disorders such as cysticfibrosis and diabetic acidosis. | |
| TechnologicalCharacteristics: | The following is a description of the major features of the ACE AxcelClinical Chemistry System: System throughput is approximately 160 test results per hour forroutine, single reagent chemistries. System throughput will behigher when the test workload includes ISE's. The instrument has a capacity of 40 reagent containers on board.A reagent cooling system maintains the reagents at 12°C duringinstrument operation. Reagent containers are identified by computer coded labels tosimplify system operation. All reagents in the system mustinclude an identification label on the container. Sample and reagent sensing notify the operator of a depletedcondition during operation. The system performs analysis at a reaction temperature of 37°C. An electrolyte subsystem capable of measuring sodium,potassium and chloride concentrations is included. Primary draw tubes may be introduced one at a time into thesystem for closed tube sampling. Positive tube identification canbe achieved with an optional barcode scanner. An aliquot volumesufficient for all tests ordered is transferred and stored and theclosed tube is returned to the user. |
| • Sample cups are introduced to the system one at a time or bysample ring segment.• Disposable cuvettes are loaded in bulk and then automaticallyinjected as needed by a cuvette hopper system. The ACE Axcelclinical chemistry optical system is capable of monitoring amaximum of 48 cuvettes at one time.• The absorbance optical system is capable of absorbancemeasurements in a linear range of 0.0 to 2.0 absorbance units (at0.67 cm pathlength). Sixteen wavelengths are measuredsimultaneously using a photodiode array. | |
| The ACE Glucose Reagent consists of a single reagent bottle. Thereagent contains nicotinamide adenine dinucleotide (NAD+), adenosine5'-triphosphate (ATP), magnesium, hexokinase and glucose-6-phosphate dehydrogenase. | |
| The ACE Ion Selective Electrode (ISE) Module uses a potentiometricmethod to simultaneously measure sodium, potassium and chloride inundiluted serum. Each electrode uses an ion-specific membrane tomeasure the difference in ionic concentration between an innerelectrolyte solution and the sample. | |
| PerformanceData: | Performance data for the Alfa Wassermann ACE Reagents run on theAlfa Wassermann ACE Axcel Clinical Chemistry System includedprecision, accuracy, and detection limit data. |
| ACE Glucose Reagent | |
| Precision: In testing conducted at four glucose levels for 22 days, thewithin-run CV ranged from 1.0 to 1.4%, and total CV ranged from 1.0to 1.9%. In precision studies at three separate Physician OfficeLaboratory (POL) sites over 5 days, the within-run CV ranged from 0.3to 2.2% and total CV ranged from 0.5 to 2.2%. | |
| Accuracy: In the correlation study, 122 samples with glucose valuesranging from 6 to 729 mg/dL were assayed on the Alfa WassermannACE Axcel Clinical Chemistry System (y) and the Alfa WassermannACE Clinical Chemistry System (x). Least squares regression analysisyielded a correlation coefficient of 0.9998, a standard error estimate of3.1, a confidence interval slope of 1.001 to 1.009, and a confidenceinterval intercept of -1.5 to 0.1. In patient correlation studies at threeseparate POL sites, using the Alfa Wassermann ACE Axcel ClinicalChemistry System (y) and the Alfa Wassermann ACE ClinicalChemistry System (x), least-squares regression analysis yieldedcorrelation coefficients of 0.9992 to 0.9998, standard error estimates of3.6 to 7.0, confidence interval slopes of 0.972 to 1.021, and aconfidence interval intercepts of -3.0 to 4.1. | |
| Detection limit: The detection limit was 3.1 mg/dL. |
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ACE Axcel Sodium ISE
Precision: In testing conducted at four sodium levels for 21 days, the within-run CV ranged from 0.4 to 1.0%, and total CV ranged from 0.8 to 1.4%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.6 to 1.0% and total CV ranged from 0.8 to 1.4%.
Accuracy: In the correlation study, 113 samples with sodium values ranging from 45.1 to194.0 mmol/L were assayed on the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x). Least squares regression analysis vielded a correlation coefficient of 0.9963, a standard error estimate of 1.65, a confidence interval slope of 0.992 to 1.024, and a confidence interval intercept of -3.60 to 0.92. In patient correlation studies at three separate POL sites, using the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x), least-squares regression analysis yielded correlation coefficients of 0.9917 to 0.9995, standard error estimates of 0.74 to 3.07, confidence interval slopes of 0.989 to 1.067, and a confidence interval intercepts of -8.85 to 2.30.
ACE Axcel Potassium ISE
Precision: In testing conducted at four potassium levels for 21 days, the within-run CV ranged from 0.6 to 3.5%, and total CV ranged from 1.3 to 3.5%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 1.0 to 1.6% and total CV ranged from 1.1 to 1.6%.
Accuracy: In the correlation study, 115 samples with potassium values ranging from 1.57 to 14.20 mmol/L were assayed on the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x). Least squares regression analysis vielded a correlation coefficient of 0.9974, a standard error estimate of 0.146, a confidence interval slope of 0.989 to 1.015, and a confidence interval intercept of -0.050 to 0.095. In patient correlation studies at three separate POL sites, using the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x), least-squares regression analysis vielded correlation coefficients of 0.9973 to 0.9996, standard error estimates of 0.064 to 0.182, confidence interval slopes of 0.960 to 1.035, and a confidence interval intercepts of -0.194 to 0.216.
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| Conclusions: | ACE Axcel Chloride ISEPrecision: In testing conducted at four chloride levels for 21 days, thewithin-run CV ranged from 0.5 to 1.0%, and total CV ranged from 1.1to 1.5%. In precision studies at three separate Physician OfficeLaboratory (POL) sites over 5 days, the within-run CV ranged from 0.9to 1.5% and total CV ranged from 1.1 to 2.6%.Accuracy: In the correlation study, 111 samples with chloride valuesranging from 63.4 to 176.0 mmol/L were assayed on the AlfaWassermann ACE Axcel Clinical Chemistry System (y) and the AlfaWassermann ACE Clinical Chemistry System (x). Least squaresregression analysis yielded a correlation coefficient of 0.9855, astandard error estimate of 2.05, a confidence interval slope of 0.939 to1.002, and a confidence interval intercept of -1.07 to 5.63. In patientcorrelation studies at three separate POL sites, using the AlfaWassermann ACE Axcel Clinical Chemistry System (y) and the AlfaWassermann ACE Clinical Chemistry System (x), least-squaresregression analysis yielded correlation coefficients of 0.9885 to 0.9996,standard error estimates of 0.55 to 3.05, confidence interval slopes of0.976 to 1.088, and a confidence interval intercepts of -8.16 to 2.22. |
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| Based on the foregoing data, the device is safe and effective. Thesedata also indicate substantial equivalence to the predicate device. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
ALFA WASSERMANN Diagnostic Technologies, Inc c/o Hyman Katz 4 Henderson Drive West Caldwell, NJ 07006
MAY 1 7 2012
K113253 Re:
.
Trade Name: ACE Axcel Clinical Chemistry System, ACE Ion Selective Electrode (ISE) Module, ACE Glucose Reagent
Regulation Number: 21 CFR §862.1345
Regulation Name: Glucose test system
Regulatory Class: Class II
Product Codes: CFR, JGS, CEM, CGZ, JJE
Dated: April 12, 2012
Received: April 13, 2012
Dear Dr. Katz:
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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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/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) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours,
signature
Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K113253
Device Name: ACE Axcel Clinical Chemistry System, ACE Ion Selective Electrode (ISE) Module, ACE Glucose Reagent
Indications for Use:
The ACE Axcel Clinical Chemistry System is an automated, discrete, bench-top, random access analyzer that is intended for in vitro diagnostic use in the quantitative measurement of general chemistry assays for clinical use in physician office laboratories or clinical laboratories.
The ACE Axcel Clinical System includes an Ion Selective Electrode (ISE) module for the measurement of sodium, potassium and chloride in serum. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
- Sodium measurements are used in the diagnosis and treatment of . diseases involving electrolyte imbalance
- Potassium measurements are used to monitor electrolyte balance . and in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
- Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The ACE Glucose Reagent is intended for the quantitative determination of glucose concentration in serum using the ACE Axcel Clinical Chemistry System. 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. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Prescription Use X (21 CFR Part 801 Subpart D) AND/OR
Over-The-Counter Use. (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In vitro Diagnostic Devices (OIVD)
Ruta chulen
Division Sign-Off Office of In vitro Diagnostic Device Evaluation and Safety
k 1 13 253 510(k)
§ 862.2160 Discrete photometric chemistry analyzer for clinical use.
(a)
Identification. A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.