(268 days)
No
The device description and performance studies focus on standard chemical reactions and optical measurements, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is an in vitro diagnostic (IVD) device used for quantitative determination of various substances in serum to aid in the diagnosis and treatment of diseases, not for direct therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the BUN, Creatinine, Uric Acid, and CK measurements are "used in the diagnosis and treatment of certain renal and metabolic diseases," "renal diseases," "numerous renal and metabolic disorders," and "myocardial infarction and muscle diseases," respectively. These phrases indicate that the output of the device is used in the diagnostic process.
No
The device description clearly states that the system consists of two major components: a chemistry instrument (hardware) and an integrated Panel PC. The instrument performs physical measurements on samples. While the Panel PC includes software functionality, the overall device is a system that includes hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states that the reagents are "intended for the quantitative determination of [analyte] concentration in serum" and are used "in the diagnosis and treatment of certain renal and metabolic diseases." It also states "For in vitro diagnostic use only." This clearly indicates the device is intended for testing biological samples (serum) outside of the body to provide information for medical diagnosis or treatment.
- Device Description: The description details how the system and reagents work together to perform chemical reactions on patient samples and measure the results optically. This process is characteristic of in vitro diagnostic testing.
- Intended User/Care Setting: The intended users are "clinical laboratories or physician office laboratories," which are typical settings for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The ACE BUN/Urea Reagent is intended for the quantitative determination of blood urea nitrogen (BUN) concentration in serum using the ACE Axcel Clinical Chemistry System. BUN measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE Creatinine Reagent is intended for the quantitative determination of creatinine concentration in serum using the ACE Axcel Clinical Chemistry System. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE Uric Acid Reagent is intended for the quantitative determination of uric acid concentration in serum using the ACE Axcel Clinical Chemistry System. Uric acid measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions and of patients receiving cytotoxic drugs. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE CK Reagent is intended for the quantitative determination of creatine kinase activity in serum using the ACE Axcel Clinical Chemistry System. Measurement of creatine kinase is used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Product codes (comma separated list FDA assigned to the subject device)
JJE, CDN, CGX, KNK, CGS
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 BUN/Urea Reagent assay, urea in serum is hydrolyzed to yield ammonia and carbon dioxide in the presence of urease. The ammonia formed then reacts with 2-oxoglutarate and NADH in the presence of glutamate dehydrogenase to yield glutamate and NAD. Two moles of NADH are oxidized for each mole of urea present. NADH absorbs strongly at 340 nm, whereas NAD+ does not. The initial rate of decrease in absorbance, monitored bichromatically at 340 nm/647 nm, is proportional to the urea concentration in the sample.
In the ACE Creatinine Reagent assay, creatinine reacts with picric acid in an alkaline medium to form a red-orange colored complex, which absorbs strongly at 505 nm. The rate of complex formation, determined by measuring the increase in absorbance bichromatically at 505 nm/573 nm during a fixed time interval, is directly proportional to the creatinine concentration in the sample.
In the ACE Uric Acid Reagent assay, uric acid in serum is oxidized by uricase to allantoin and hydrogen peroxide. The hydrogen peroxide then acts to oxdatively couple dichlorohydroxybenzene sulfonic acid and 4-aminoantipyrine in a reaction catalyzed by peroxidase, producing a red colored quinoneimine complex, which absorbs strongly at 505 nm. The amount of chromogen formed, determined by measuring the increase in absorbance bichromatically at 505 nm/610 nm, is directly proportional to the uric acid concentration in the sample.
In the ACE CK Reagent assay, serum creatine kinase initiates the conversion of creatine phosphate to creatine with the transfer of a phosphate group to adenosine diphosphate (ADP), forming ATP. The ATP is then used in the phosphorylation of D-glucose to form D-glucose-6-phosphate and ADP. This reaction is catalyzed by hexokinase. The enzyme glucose-6-phosphate dehydrogenase catalyzes the reduction of D-glucose-6-phosphate and nicotinamide adenine dinucleotide phosphate (NADP+). The series of reactions triggered by serum creatine kinase and ending in the formation of NADPH. NADPH strongly absorbs at 340 nm, whereas NADP+ does not. Therefore, the rate of conversion of NADP+ to NADPH can be determined by monitoring the increase in absorbance bichromatically at 340 nm/378 nm. This rate of conversion from NADP+ to NADPH is a function of the activity of CK 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 BUN/Urea Reagent
- Precision: In testing conducted at four BUN levels for 22 days, the within-run CV ranged from 1.1 to 3.3%, and total CV ranged from 3.5 to 4.6%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.0 to 2.6% and total CV ranged from 3.0 to 5.2%.
- Accuracy: In the correlation study, 113 samples with BUN values ranging from 4 to 96 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 0.9963, a standard error estimate of 1.5, a confidence interval slope of 0.995 to 1.028, and a confidence interval intercept of -0.3 to 0.6. 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 0.9982 to 0.9988, standard error estimates of 1.0 to 1.6, confidence interval slopes of 0.983 to 1.039, and a confidence interval intercepts of -0.7 to 1.6.
ACE Creatinine Reagent
- Precision: In testing conducted at four creatinine levels for 22 days, the within-run CV ranged from 1.3 to 9.6%, and total CV ranged from 2.7 to 9.8%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.9 to 5.1% and total CV ranged from 2.1 to 6.1%.
- Accuracy: In the correlation study, 136 samples with creatinine values ranging from 0.28 to 22.95 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 0.9998, a standard error estimate of 0.082, a confidence interval slope of 0.975 to 0.983, and a confidence interval intercept of -0.022 to 0.010. 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 0.9994 to 0.9998, standard error estimates of 0.123 to 0.192, confidence interval slopes of 0.961 to 1.027, and a confidence interval intercepts of -0.136 to 0.001.
ACE Uric Acid Reagent
- Precision: In testing conducted at four uric acid levels for 22 days, the within-run CV ranged from 1.8 to 4.9%, and total CV ranged from 2.0 to 5.4%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 1.5 to 4.4% and total CV ranged from 1.8 to 5.2%.
- Accuracy: In the correlation study, 106 samples with uric acid values ranging from 1.7 to 15.9 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 0.9958, a standard error estimate of 0.23, a confidence interval slope of 1.023 to 1.060, and a confidence interval intercept of -0.18 to 0.07. 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 0.9961, standard error estimates of 0.22 to 0.44, confidence interval slopes of 0.972 to 1.054, and a confidence interval intercepts of -0.31 to 0.28.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- ACE BUN/Urea Reagent: Detection limit: 1.1 mg/dL.
- ACE Creatinine Reagent: Detection limit: 0.19 mg/dL.
- ACE Uric Acid Reagent: Detection limit: 1.13 mg/dL.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1770 Urea nitrogen test system.
(a)
Identification. A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.(b)
Classification. Class II.
0
AUG 1 0 2012
Alfa Wassermann Diagnostic Technologies, LLC
510(k) Submission ACE BUN, Creatinine, Uric Acid and CK Reagents ACE Axcel Clinical Chemistry System
510(k) SUMMARY
| 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: | November 1, 2011 | | |
| Device: | Trade Name: | System | ACE Axcel Clinical Chemistry |
| | 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 BUN/Urea Reagent |
| | Classification: | | Class 2 |
| | Common/Classification Name:
| Nitrogen | Urease, Photometric, Urea
(21 C.F.R. § 862.1770)
Product Code CDN |
| | Trade Name: | | ACE Creatinine Reagent |
| | Classification: | | Class 2 |
| | Common/Classification Name: | | Alkaline Picrate, Colorimetry,
Creatinine (21 C.F.R. § 862.1225)
Product Code CGX |
| | Trade Name: | | ACE Uric Acid Reagent |
| | Classification: | | Class 1 |
| | Common/Classification Name: | | Acid, Uric, Uricase (Colorimetric)
(21 C.F.R. § 862.1775)
Product Code KNK |
| | Trade Name: | ACE CK Reagent | |
| | Classification: | Class 2 | |
| | Common/Classification Name: | NAD Reduction/NADH
Oxidation, CPK Or Isoenzymes
(21 C.F.R. § 862.1215)
Product Code CGS | |
| Predicate
Devices: | Manufacturer for analyzer/reagent system predicate: | | |
| | Alfa Wassermann ACE Clinical Chemistry System, Calibrators,
Chemistry Controls, plus 12 ACE Reagents (K930104) | | |
| 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 BUN/Urea Reagent assay, urea in serum is hydrolyzed to
yield ammonia and carbon dioxide in the presence of urease. The
ammonia formed then reacts with 2-oxoglutarate and NADH in the
presence of glutamate dehydrogenase to yield glutamate and NAD.
Two moles of NADH are oxidized for each mole of urea present.
NADH absorbs strongly at 340 nm, whereas NAD+ does not. The
initial rate of decrease in absorbance, monitored bichromatically at 340
nm/647 nm, is proportional to the urea concentration in the sample. | | |
| | In the ACE Creatinine Reagent assay, creatinine reacts with picric acid
in an alkaline medium to form a red-orange colored complex, which
absorbs strongly at 505 nm. The rate of complex formation,
determined by measuring the increase in absorbance bichromatically at
505 nm/573 nm during a fixed time interval, is directly proportional to
the creatinine concentration in the sample. | | |
| | In the ACE Uric Acid Reagent assay, uric acid in serum is oxidized by
uricase to allantoin and hydrogen peroxide. The hydrogen peroxide
then acts to oxdatively couple dichlorohydroxybenzene sulfonic acid
and 4-aminoantipyrine in a reaction catalyzed by peroxidase,
producing a red colored quinoneimine complex, which absorbs
strongly at 505 nm. The amount of chromogen formed, determined by | | |
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| measuring the increase in absorbance bichromatically at 505 nm/610 nm, is directly proportional to the uric acid concentration in the sample. | |
|---|---|
| In the ACE CK Reagent assay, serum creatine kinase initiates the conversion of creatine phosphate to creatine with the transfer of a phosphate group to adenosine diphosphate (ADP), forming ATP. The ATP is then used in the phosphorylation of D-glucose to form D-glucose-6-phosphate and ADP. This reaction is catalyzed by hexokinase. The enzyme glucose-6-phosphate dehydrogenase catalyzes the reduction of D-glucose-6-phosphate and nicotinamide adenine dinucleotide phosphate (NADP+). The series of reactions triggered by serum creatine kinase and ending in the formation of NADPH. NADPH strongly absorbs at 340 nm, whereas NADP+ does not. Therefore, the rate of conversion of NADP+ to NADPH can be determined by monitoring the increase in absorbance bichromatically at 340 nm/378 nm. This rate of conversion from NADP+ to NADPH is a function of the activity of CK in the sample. | |
| Intended Use: | Indications for Use: |
| The ACE BUN/Urea Reagent is intended for the quantitative determination of blood urea nitrogen (BUN) concentration in serum using the ACE Axcel Clinical Chemistry System. BUN measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. | |
| The ACE Creatinine Reagent is intended for the quantitative determination of creatinine concentration in serum using the ACE Axcel Clinical Chemistry System. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. | |
| The ACE Uric Acid Reagent is intended for the quantitative determination of uric acid concentration in serum using the ACE Axcel Clinical Chemistry System. Uric acid measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions and of patients receiving cytotoxic drugs. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. | |
| ACE Axcel Clinical Chemistry System | |
| The ACE CK Reagent is intended for the quantitative determination of | |
| creatine kinase activity in serum using the ACE Axcel Clinical | |
| Chemistry System. Measurement of creatine kinase is used in the | |
| diagnosis and treatment of myocardial infarction and muscle diseases | |
| such as progressive, Duchenne-type muscular dystrophy. This test is | |
| intended for use in clinical laboratories or physician office laboratories. | |
| For in vitro diagnostic use only. | |
| Technological | |
| Characteristics: | The following is a description of the major features of the ACE Axcel |
| Clinical 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 BUN/Urea Reagent consists of a single reagent bottle. The | |
| reagent contains α-ketoglutarate, urease, glutamate dehydrogenase, | |
| adenosine diphosphate (ADP), nicotinamide adenine dinucleotide and | |
| reduced (NADH). | |
| ACE Axcel Clinical Chemistry System | |
| The ACE Creatinine Reagent consists of two reagent bottles (Sodium | |
| Hydroxide Reagent and Picric Acid Reagent). The Sodium Hydroxide | |
| Reagent (R1) contains sodium hydroxide. The Picric Acid Reagent | |
| (R2) contains picric Acid. | |
| The ACE Uric Acid Reagent consists of a single reagent bottle. The | |
| reagent contains 4-aminoantipyrine, dichlorohydroxybenzene sulfonic | |
| acid, peroxidase and uricase. | |
| The ACE CK Reagent consists of two reagent bottles (Buffer and | |
| Substrate). | |
| The Buffer Reagent (R1) contains: imidazole buffer, glucose, N-acetyl- | |
| cysteine, magnesium acetate, EDTA, NADP and hexokinase. The | |
| Substrate Reagent (R2) contains: creatine phosphate, ADP, AMP, | |
| diadenosine pentaphosphate, EDTA and glucose-6-phosphate | |
| dehydrogenase. | |
| 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 BUN/Urea Reagent | |
| Precision: In testing conducted at four BUN levels for 22 days, the | |
| within-run CV ranged from 1.1 to 3.3%, and total CV ranged from 3.5 | |
| to 4.6%. In precision studies at three separate Physician Office | |
| Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.0 | |
| to 2.6% and total CV ranged from 3.0 to 5.2%. | |
| Accuracy: In the correlation study, 113 samples with BUN values | |
| ranging from 4 to 96 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 0.9963, a standard error estimate of | |
| 1.5, a confidence interval slope of 0.995 to 1.028, and a confidence | |
| interval intercept of -0.3 to 0.6. 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 0.9982 to 0.9988, standard error estimates of | |
| 1.0 to 1.6, confidence interval slopes of 0.983 to 1.039, and a | |
| confidence interval intercepts of -0.7 to 1.6. | |
| Detection limit: The detection limit was 1.1 mg/dL. | |
| ACE Axcel Clinical Chemistry System | |
| ACE Creatinine Reagent | Precision: In testing conducted at four creatinine levels for 22 days, the |
| within-run CV ranged from 1.3 to 9.6%, and total CV ranged from 2.7 | |
| to 9.8%. In precision studies at three separate Physician Office | |
| Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.9 | |
| to 5.1% and total CV ranged from 2.1 to 6.1%. |
Accuracy: In the correlation study, 136 samples with creatinine values
ranging from 0.28 to 22.95 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 0.9998, a
standard error estimate of 0.082, a confidence interval slope of 0.975 to
0.983, and a confidence interval intercept of -0.022 to 0.010. 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 0.9994 to 0.9998,
standard error estimates of 0.123 to 0.192, confidence interval slopes of
0.961 to 1.027, and a confidence interval intercepts of -0.136 to 0.001.
Detection limit: The detection limit was 0.19 mg/dL. |
| ACE Uric Acid Reagent | Precision: In testing conducted at four uric acid levels for 22 days, the
within-run CV ranged from 1.8 to 4.9%, and total CV ranged from 2.0
to 5.4%. In precision studies at three separate Physician Office
Laboratory (POL) sites over 5 days, the within-run CV ranged from 1.5
to 4.4% and total CV ranged from 1.8 to 5.2%.
Accuracy: In the correlation study, 106 samples with uric acid values
ranging from 1.7 to 15.9 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 0.9958, a standard error estimate of
0.23, a confidence interval slope of 1.023 to 1.060, and a confidence
interval intercept of -0.18 to 0.07. 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 0.9961, standard error estimates of
0.22 to 0.44, confidence interval slopes of 0.972 to 1.054, and a
confidence interval intercepts of -0.31 to 0.28.
Detection limit: The detection limit was 1.13 mg/dL. |
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November 1, 2011
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human profile, rendered in black.
10903 New Hampshire Avenue Silver Spring, MD 20993
AUG 1 0 2012
Alfa Wassermann Diagnostic Technologies, LLC c/o Hyman Katz, Ph.D. Vice President, Quality and Regulatory Affairs 4 Henderson Drive West Caldwell, NJ 07006
Re: K113389
Trade/Device Name: ACE BUN Reagent, ACE Creatinine Reagent, ACE Uric Acid Reagent, ACE CK Reagent Regulation Number: 21 CFR 862.1770 Regulation Name: Urea nitrogen test system Regulatory Class: Class II Product Code: CDN, CGX, KNK, CGS Dated: July 31, 2012 Received: August 1, 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
7
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 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,
C. K. Linn, 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
5100k) Number (if known):
Device Name: ACE BUN/Urea Reagent
The ACE BUN/Urea Reagent is intended for the quantitative Indications for Use: determination of blood urea nitrogen (BUN) concentration in serum using the ACE Axcel Clinical Chemistry System. BUN measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Device Name: ACE Creatinine Reagent
The ACE Creatinine Reagent is intended for the quantitative Indications for Use: determination of creatinine concentration in serum using the ACE Axcel Clinical Chemistry System. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. 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)
Q. Chul
Division Sign-Off Office of In vitro Diagnostic Device Evaluation and Safety
510(k) 113389
Page 1 of 2
9
Indications for Use
510(k) Number (if known): K113389
Device Name: ACE Uric Acid Reagent
The ACE Uric Acid Reagent is intended for the quantitative Indications for Use: determination of uric acid concentration in serum using the ACE Axcel Clinical Chemistry System. Uric acid measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions and of patients receiving cytotoxic drugs. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Device Name: ACE CK Reagent
The ACE CK Reagent is intended for the quantitative determination of Indications for Use: creatine kinase activity in serum using the ACE Axcel Clinical Chemistry System. Measurement of creatine kinase is used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. 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)
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Concurrence of CDRH, Office of In vitro Diagnostic Devices (OIVD)
R chin
Division Sign-Off Office of In vitro Diagnostic Device Evaluation and Safety
510(k) 11389
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