(224 days)
No
The description details a standard automated clinical chemistry analyzer performing quantitative measurements based on chemical reactions and optical absorbance. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as an "in vitro diagnostic use" system, intended for quantitative determination of constituents in blood and other fluids for diagnosis and treatment of disorders. It does not provide direct therapy.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the ACE Axcel Clinical Chemistry System "is intended for in vitro diagnostic use." It also specifies that measurements from the system and its reagents "are used in the diagnosis and treatment of numerous potentially serious disorders."
No
The device description explicitly states that the system consists of two major components: a chemistry instrument (hardware that performs measurements) and an integrated Panel PC (which includes software). This indicates it is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section explicitly states: "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 determination of constituents in blood and other fluids."
- Explicit Statement in Reagent Intended Use: Each reagent listed also states: "For in vitro diagnostic use only."
- Nature of the Device and Reagents: The system and its associated reagents are designed to perform quantitative measurements of substances (carbon dioxide, bilirubin, magnesium) in biological fluids (blood, serum). These measurements are used in the diagnosis and treatment of various medical conditions. This aligns directly with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment.
N/A
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 vitro diagnostic use in the quantitative determination of constituents in blood and other fluids.
The ACE Carbon Dioxide (CO2-LC) Reagent is intended for the quantitative determination of carbon dioxide concentration in serum using the ACE Axcel Clinical Chemistry System. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE Direct Bilirubin Reagent is intended for the quantitative determination of direct bilirubin concentration in serum using the ACE Axcel Clinical Chemistry System. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder block. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE Total Bilirubin Reagent is intended for the quantitative determination of total bilirubin concentration in serum using the ACE Axcel Clinical Chemistry System. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder block. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE Magnesium Reagent is intended for the quantitative determination of magnesium concentration in serum using the ACE Axcel Clinical Chemistry System. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low serum levels of magnesium) and hypermagnesemia (abnormally high serum levels of magnesium). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Product codes
JJE, KHS, CIG, JGJ
Device Description
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 Carbon Dioxide (CO2-LC) Reagent assay, serum carbon dioxide (in the form of bicarbonate) reacts with phosphoenolpyruvate in the presence of phosphoenolpyruvate carboxylase and magnesium to yield oxaloacetic acid and phosphate. In the presence of malate dehydrogenase, the reduced cofactor is oxidized by oxaloacetic acid. The reduced cofactor absorbs strongly at 408 nm whereas its oxidized form does not. The rate of decrease in absorbance, monitored bichromatically at 408 nm/692 nm, is proportional to the carbon dioxide content of the sample.
In the ACE Direct Bilirubin Reagent assay, sodium nitrite added to sulfanilic acid forms diazotized sulfanilic acid. Bilirubin glucuronide in serum reacts with diazotized sulfanilic acid to form azobilirubin, which absorbs strongly at 554 nm. The increase in absorbance, measured bichromatically at 554 nm/692 nm, one minute after sample addition, is directly proportional to the direct bilirubin concentration.
In the ACE Total Bilirubin Reagent assay, sodium nitrite, when added to sulfanilic acid, forms diazotized sulfanilic acid. Bilirubin in serum reacts with diazotized sulfanilic acid to form azobilirubin, which absorbs strongly at 554 nm. The inclusion of dimethyl sulfoxide (DMSO) in the reagent as an accelerator causes both direct and indirect bilirubin to react rapidly. The increase in absorbance, measured bichromatically at 554 nm/692 nm, is directly proportional to the total bilirubin concentration in the sample.
Magnesium ions in serum react with Xylidyl blue-1 in an alkaline medium to produce a red complex which is measured bichromatically at 525 nm/692 nm. The intensity of color produced is directly proportional to the magnesium concentration in the sample. EGTA prevents calcium interference by preferential chelation of calcium present in the sample.
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
clinical laboratories or physician office laboratories.
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
Performance data for the Alfa Wassermann ACE Reagents run on the Alfa Wassermann ACE Axcel Clinical Chemistry System included precision, accuracy, and detection limit data.
ACE Carbon Dioxide (CO2-LC) Reagent:
Precision: In testing conducted at four CO2 levels for 22 days, the within-run CV ranged from 1.6 to 8.7%, and total CV ranged from 4.3 to 12.2%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 1.0 to 2.6% and total CV ranged from 1.8 to 5.7%.
Accuracy: In the correlation study, 120 samples with CO2 values ranging from 3.2 to 47.6 mEq/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 yielded a correlation coefficient of 0.9758, a standard error estimate of 1.31, a confidence interval slope of 0.946 to 1.025, and a confidence interval intercept of -1.15 to 0.73. 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 0.9819 to 0.9952, standard error estimates of 0.80 to 1.21, confidence interval slopes of 0.951 to 1.081, and a confidence interval intercepts of -1.99 to 1.65.
Detection limit: The detection limit was 1.2 mEq/L.
ACE Direct Bilirubin Reagent:
Precision: In testing conducted at four direct bilirubin levels for 22 days, the within-run CV ranged from 0.8 to 16.5%, and total CV ranged from 1.5 to 16.6%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.0 to 4.6% and total CV ranged from 0.0 to 4.6%.
Accuracy: In the correlation study, 116 samples with direct bilirubin values ranging from 0.2 to 12.5 mg/dL 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 yielded a correlation coefficient of 0.9996, a standard error estimate of 0.05, a confidence interval slope of 0.967 to 0.978, and a confidence interval intercept of -0.01 to 0.01. 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 0.9996 to 0.9997, standard error estimates of 0.07 to 0.09, confidence interval slopes of 0.984 to 1.025, and a confidence interval intercepts of -0.03 to 0.03.
Detection limit: The detection limit was 0.1 mg/dL.
ACE Total Bilirubin Reagent:
Precision: In testing conducted at four total bilirubin levels for 22 days, the within-run CV ranged from 0.6 to 10.6%, and total CV ranged from 1.1 to 10.6%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.9 to 22.1% and total CV ranged from 0.0 to 3.3%.
Accuracy: In the correlation study, 117 samples with total bilirubin values ranging from 0.2 to 34.8 mg/dL were assayed on the Alfa Wassermann ACE Axcel Clinical Chemistry System (v) and the Alfa Wassermann ACE Clinical Chemistry System (x). Least squares regression analysis yielded a correlation coefficient of 0.9997, a standard error estimate of 0.13, a confidence interval slope of 0.961 to 0.970, and a confidence interval intercept of -0.02 to 0.03. 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 0.9993 to 1.0000, standard error estimates of 0.08 to 0.25, confidence interval slopes of 1.012 to 1.056, and a confidence interval intercepts of -0.12 to 0.05.
Detection limit: The detection limit was 0.2 mg/dL.
ACE Magnesium Reagent:
Precision: In testing conducted at four magnesium levels for 22 days, the within-run CV ranged from 2.7 to 5.9%, and total CV ranged from 4.1 to 7.6%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 1.2 to 4.1% and total CV ranged from 2.0 to 6.9%.
Accuracy: In the correlation study, 108 samples with magnesium values ranging from 0.6 to 5.5 mg/dL 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 yielded a correlation coefficient of 0.9690, a standard error estimate of 0.14, a confidence interval slope of 0.950 to 1.046, and a confidence interval intercept of -0.07 to 0.12. 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 0.9858 to 0.9930, standard error estimates of 0.11 to 0.18, confidence interval slopes of 0.920 to 1.089, and a confidence interval intercepts of -0.39 to 0.22.
Detection limit: The detection limit was 0.2 mg/dL.
Key Metrics
Correlation coefficient, standard error estimate, confidence interval slope, confidence interval intercept, within-run CV, total CV, detection limit.
Predicate Device(s)
Alfa Wassermann ACE Clinical Chemistry System ACE Reagents (K931786)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1160 Bicarbonate/carbon dioxide test system.
(a)
Identification. A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.(b)
Classification. Class II.
0
UL 2 2012
510(k) SUMMARY K K 11 3 4 3 5
| 510(k) Owner: | Alfa Wassermann Diagnostic Technologies, LLC
4 Henderson Drive
West Caldwell, NJ 07006 | |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Hyman Katz, Ph.D.
Phone: 973-852-0158
Fax: 973-852-0237 | |
| Date Summary
Prepared: | June 25, 2012 | |
| Device: | Trade Name: ACE Axcel Clinical Chemistry System
Classification: Class 1
Common/Classification Name: Analyzer, Chemistry (Photometric, Discrete),
For Clinical Use
(21 C. F.R. § 862.2610)
Product Code JJE | |
| | Trade Name: ACE Carbon Dioxide (CO2-LC) Reagent
Classification: Class 2
Common/Classification Name: Enzymatic, Carbon-Dioxide
(21 C. F.R. § 862.1160)
Product Code KHS | |
| | Trade Name: ACE Direct Bilirubin Reagent
Classification: Class 2
Common/Classification Name: Diazo Colorimetry, Bilirubin
(21 C. F.R. § 862.1110)
Product Code CIG | |
| | Trade Name: ACE Total Bilirubin Reagent
Classification: Class 2
Common/Classification Name: Diazo Colorimetry, Bilirubin
(21 C. F.R. § 862.1110)
Product Code CIG | |
| | | |
| | Trade Name: | ACE Magnesium Reagent |
| | Classification: | Class 1 |
| | Common/Classification Name: | Photometric Method, Magnesium
(21 C. F.R. § 862.1495)
Product Code JGJ |
| Predicate
Devices: | Manufacturer for analyzer/reagent system predicate: | Alfa Wassermann ACE Clinical Chemistry System
ACE Reagents (K931786) |
| Device
Descriptions: | | 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 Carbon Dioxide (CO2-LC) Reagent assay, serum carbon dioxide (in
the form of bicarbonate) reacts with phosphoenolpyruvate in the presence of
phosphoenolpyruvate carboxylase and magnesium to yield oxaloacetic acid and
phosphate. In the presence of malate dehydrogenase, the reduced cofactor is oxi-
dized by oxaloacetic acid. The reduced cofactor absorbs strongly at 408 nm
whereas its oxidized form does not. The rate of decrease in absorbance,
monitored bichromatically at 408 nm/692 nm, is proportional to the carbon dioxide content of the sample. |
| | | In the ACE Direct Bilirubin Reagent assay, sodium nitrite added to sulfanilic acid
forms diazotized sulfanilic acid. Bilirubin glucuronide in serum reacts with
diazotized sulfanilic acid to form azobilirubin, which absorbs strongly at 554 nm.
The increase in absorbance, measured bichromatically at 554 nm/692 nm, one minute after sample addition, is directly proportional to the direct bilirubin concentration. |
| | | In the ACE Total Bilirubin Reagent assay, sodium nitrite, when added to sulfanilic acid.
forms diazotized sulfanilic acid. Bilirubin in serum reacts with diazotized sulfanilic acid to form
azobilirubin, which absorbs strongly at 554 nm. The inclusion of dimethyl sulfoxide (DMSO) in
the reagent as an accelerator causes both direct and indirect bilirubin to react rapidly. The increase in absorbance, measured bichromatically at 554 nm/692 nm, is directly proportional to the total bilirubin concentration in the sample. |
| | | Magnesium ions in serum react with Xylidyl blue-1 in an alkaline medium to produce a red complex which is measured bichromatically at 525 nm/692 nm. The intensity of color produced is directly proportional to the magnesium concentration in the sample. EGTA prevents calcium interference by preferential chelation of calcium present in the sample. A |
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| Intended Use: | Indications for Use: |
|---|---|
| Intended 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 determination of constituents in blood and other fluids. | |
| Intended Use: | The ACE Carbon Dioxide (CO2-LC) Reagent is intended for the quantitative |
| determination of carbon dioxide concentration in serum using the ACE Axcel | |
| Clinical Chemistry System. Bicarbonate/carbon dioxide measurements are used | |
| in the diagnosis and treatment of numerous potentially serious disorders | |
| associated with changes in body acid-base balance. This test is intended for use in | |
| clinical laboratories or physician office laboratories. For in vitro diagnostic use | |
| only. | |
| Intended Use: | The ACE Direct Bilirubin Reagent is intended for the quantitative determination |
| of direct bilirubin concentration in serum using the ACE Axcel Clinical | |
| Chemistry System. Measurements of the levels of bilirubin, an organic compound | |
| formed during the normal and abnormal destruction of red blood cells, is used in | |
| the diagnosis and treatment of liver, hemolytic, hematological and metabolic | |
| disorders, including hepatitis and gall bladder block. This test is intended for use | |
| in clinical laboratories or physician office laboratories. For in vitro diagnostic use | |
| only. | |
| Intended Use: | The ACE Total Bilirubin Reagent is intended for the quantitative determination |
| of total bilirubin concentration in serum using the ACE Axcel Clinical Chemistry | |
| System. Measurements of the levels of bilirubin, an organic compound formed | |
| during the normal and abnormal destruction of red blood cells, is used in the | |
| diagnosis and treatment of liver, hemolytic, hematological and metabolic | |
| disorders, including hepatitis and gall bladder block. This test is intended for use | |
| in clinical laboratories or physician office laboratories. For in vitro diagnostic use | |
| only. | |
| Intended Use: | The ACE Magnesium Reagent is intended for the quantitative determination of |
| magnesium concentration in serum using the ACE Axcel Clinical Chemistry | |
| System. Magnesium measurements are used in the diagnosis and treatment of | |
| hypomagnesemia (abnormally low serum levels of magnesium) and | |
| hypermagnesemia (abnormally high serum levels of magnesium). This test is | |
| intended for use in clinical laboratories or physician office laboratories. For in | |
| vitro diagnostic use only. |
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and the state of the state
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| Technological | The following is a description of the major features of the ACE Axcel Clinical |
|---|---|
| Characteristics: | Chemistry System: System throughput is approximately 160 test results per hour for routine, |
| single reagent chemistries. System throughput will be higher 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 during instrument operation. Reagent containers are identified by computer coded labels to simplify | |
| system operation. All reagents in the system must include an identification | |
| label on the container. Sample and reagent sensing notify the operator of a depleted condition | |
| 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 the system for | |
| closed tube sampling. Positive tube identification can be achieved with an | |
| optional barcode scanner. An aliquot volume sufficient for all tests ordered | |
| is transferred and stored and the closed tube is returned to the user. | |
| Sample cups are introduced to the system one at a time or by sample ring | |
| segment. | |
| Disposable cuvettes are loaded in bulk and then automatically injected as | |
| needed by a cuvette hopper system. The ACE Axcel clinical chemistry | |
| optical system is capable of monitoring a maximum of 48 cuvettes at one | |
| time. | |
| The absorbance optical system is capable of absorbance measurements in a | |
| linear range of 0.0 to 2.0 absorbance units (at 0.67 cm pathlength). Sixteen | |
| wavelengths are measured simultaneously using a photodiode array. | |
| The ACE Carbon Dioxide (CO2-LC) Reagent consists of a single reagent bottle. | |
| The reagent contains Phosphoenolpyruvate, nicotinamide adenine dinucleotide, | |
| analog, reduced, phosphoenol pyruvate carboxylase and malate dehydrogenase. | |
| The ACE Direct Bilirubin Reagent is composed of two reagent bottles (Direct | |
| Bilirubin Reagent and Sodium Nitrite Reagent). The reagents contain sulfanilic | |
| Acid, hydrochloric acid, and sodium nitrite. | |
| The ACE Total Bilirubin Reagent is composed of two reagent bottles (Total | |
| Bilirubin Reagent and Sodium Nitrite Reagent). The reagents contain sulfanilic | |
| acid, hydrochloric Acid, DMSO and sodium Nitrite. | |
| The ACE Magnesium Reagent is composed of a single reagent bottle. The | |
| reagent contains Xylidyl blue-1 and EGTA. | |
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| Performance Data: | Performance data for the Alfa Wassermann ACE Reagents run on the Alfa
Wassermann ACE Axcel Clinical Chemistry System included precision,
accuracy, and detection limit data. |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ACE Carbon Dioxide (CO2-LC) Reagent |
| | Precision: In testing conducted at four CO2 levels for 22 days, the within-run CV
ranged from 1.6 to 8.7%, and total CV ranged from 4.3 to 12.2%. In precision
studies at three separate Physician Office Laboratory (POL) sites over 5 days, the
within-run CV ranged from 1.0 to 2.6% and total CV ranged from 1.8 to 5.7%. |
| | Accuracy: In the correlation study, 120 samples with CO2 values ranging from
3.2 to 47.6 mEq/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 yielded a correlation coefficient of 0.9758,
a standard error estimate of 1.31, a confidence interval slope of 0.946 to 1.025,
and a confidence interval intercept of -1.15 to 0.73. 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 0.9819 to
0.9952, standard error estimates of 0.80 to 1.21, confidence interval slopes of
0.951 to 1.081, and a confidence interval intercepts of -1.99 to 1.65. |
| | Detection limit: The detection limit was 1.2 mEq/L. |
| | ACE Direct Bilirubin Reagent |
| | Precision: In testing conducted at four direct bilirubin levels for 22 days, the
within-run CV ranged from 0.8 to 16.5%, and total CV ranged from 1.5 to 16.6%.
In precision studies at three separate Physician Office Laboratory (POL) sites
over 5 days, the within-run CV ranged from 0.0 to 4.6% and total CV ranged
from 0.0 to 4.6%. |
| | Accuracy: In the correlation study, 116 samples with direct bilirubin values
ranging from 0.2 to 12.5 mg/dL 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 yielded a correlation
coefficient of 0.9996, a standard error estimate of 0.05, a confidence interval
slope of 0.967 to 0.978, and a confidence interval intercept of -0.01 to 0.01. 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 0.9996 to 0.9997, standard error estimates of 0.07 to
0.09, confidence interval slopes of 0.984 to 1.025, and a confidence interval
intercepts of -0.03 to 0.03. |
| | Detection limit: The detection limit was 0.1 mg/dL. |
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ACE Total Bilirubin Reagent
Precision: In testing conducted at four total bilirubin levels for 22 days, the within-run CV ranged from 0.6 to 10.6%, and total CV ranged from 1.1 to 10.6%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.9 to 22.1% and total CV ranged from 0.0 to 3.3%.
Accuracy: In the correlation study, 117 samples with total bilirubin values ranging from 0.2 to 34.8 mg/dL were assayed on the Alfa Wassermann ACE Axcel Clinical Chemistry System (v) and the Alfa Wassermann ACE Clinical Chemistry System (x). Least squares regression analysis yielded a correlation coefficient of 0.9997, a standard error estimate of 0.13, a confidence interval slope of 0.961 to 0.970, and a confidence interval intercept of -0.02 to 0.03. 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 0.9993 to 1.0000, standard error estimates of 0.08 to 0.25, confidence interval slopes of 1.012 to 1.056, and a confidence interval intercepts of -0.12 to 0.05.
Detection limit: The detection limit was 0.2 mg/dL.
ACE Magnesium Reagent
Precision: In testing conducted at four magnesium levels for 22 days, the withinrun CV ranged from 2.7 to 5.9%, and total CV ranged from 4.1 to 7.6%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 1.2 to 4.1% and total CV ranged from 2.0 to 6.9%.
Accuracy: In the correlation study, 108 samples with magnesium values ranging from 0.6 to 5.5 mg/dL 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 yielded a correlation coefficient of 0.9690, a standard error estimate of 0.14, a confidence interval slope of 0.950 to 1.046, and a confidence interval intercept of -0.07 to 0.12. 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 0.9858 to 0.9930, standard error estimates of 0.11 to 0.18, confidence interval slopes of 0.920 to 1.089, and a confidence interval intercepts of -0.39 to 0.22.
Detection limit: The detection limit was 0.2 mg/dL.
Based on the foregoing data, the device is safe and effective. These data also Conclusions: indicate substantial equivalence to the predicate device.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
Alfa Wassermann Diagnostic Technologies, Inc c/o Hyman Katz Ph.D. 4 Henderson Drive West Caldwell, NJ 07006
Re: K113435
Trade Name: ACE Carbon Dioxide (CO2-LC) Reagent ACE Direct Bilirubin Reagent ACE Total Bilirubin Reagent ACE Magnesium Reagent Regulation Number: 21 CFR §862.1160 Regulation Name: Bicarbonate/Carbon-Dioxide test system Regulatory Class: Class II Product Codes: KHS, CIG, JGJ Dated: May 11, 2012 Received: May 14, 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).
2 2012 JUL
Image /page/6/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. The eagle is depicted in black and white.
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Page 2
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 prease note the regarding postmarket surveillance, please contact CDRH3s 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/Resourcesfor You/Industry/default.htm
Sincerely yours.
S. H. Liu, Ph.D.
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
8
Indications for Use
K113435 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ACE Carbon Dioxide (CO2-LC) Reagent
Indications for Use:
The ACE Carbon Dioxide (CO2-LC) Reagent is intended for the quantitative determination of carbon dioxide concentration in serum using the ACE Axcel Clinical Chemistry System. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Device Name: ACE Direct Bilirubin Reagent
Indications for Use:
The ACE Direct Bilirubin Reagent is intended for the quantitative determination of direct bilirubin concentration in serum using the ACE Axcel Clinical Chemistry System. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder block. 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)
Bute Cum
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K113435
Page 1 of 2
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ACE Total Bilirubin Reagent
Indications for Use:
The ACE Total Bilirubin Reagent is intended for the quantitative determination of total bilirubin concentration in serum using the ACE Axcel Clinical Chemistry System. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder block. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Device Name: ACE Magnesium Reagent
Indications for Use:
The ACE Magnesium Reagent is intended for the quantitative determination of magnesium concentration in serum using the ACE Axcel Clinical Chemistry System. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low serum levels of magnesium) and hypermagnesemia (abnormally high serum levels of magnesium). 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)
Butte chim
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
k 113435 510(k)
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