(242 days)
Alfa Wassermann ACE Clinical Chemistry System
No
The description focuses on the chemical reactions and optical measurements performed by the system, and there is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is an in vitro diagnostic (IVD) system used for quantitative determination of constituents in blood and other fluids, which is used for diagnosis and treatment of diseases, but does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system "is intended for in vitro diagnostic use" and that the cholesterol measurements "are used in the diagnosis and treatment of 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 very first sentence of the "Intended Use / Indications for Use" section 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."
- Reagent Intended Use: Each reagent description also explicitly states "For in vitro diagnostic use only."
- Purpose of the Device: The device and its associated reagents are designed to perform quantitative determinations of substances (cholesterol, HDL-C, LDL-C, triglycerides) in biological samples (blood and other fluids) to aid in the diagnosis and treatment of various medical conditions. This is the core function of an in vitro diagnostic device.
- Care Setting: The intended users are clinical laboratories or physician office laboratories, which are typical settings for performing in vitro diagnostic testing.
Therefore, based on the provided text, the ACE Axcel Clinical Chemistry System and its associated reagents are clearly intended for in vitro diagnostic use.
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 Cholesterol Reagent is intended for the quantitative determination of cholesterol concentration in serum using the ACE Axcel Clinical Chemistry System. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE HDL-C Reagent is intended for the quantitative determination of high density lipoprotein cholesterol (HDL-C) concentration in serum using the ACE Axcel Clinical Chemistry System. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE LDL-C Reagent is intended for the quantitative determination of low density lipoprotein cholesterol (LDL-C) concentration in serum using the ACE Axcel Clinical Chemistry System. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE Triglycerides Reagent is intended for the quantitative determination of triglyceride concentration in serum using the ACE Axcel Clinical Chemistry System. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism or various endocrine disorders. 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, CHH, LBS, MRR, CDT
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 Cholesterol Reagent assay, cholesterol esters in serum are completely hydrolyzed by cholesterol esterase to free cholesterol and free fatty acids. The cholesterol liberated by the esterase, plus any endogenous free cholesterol, are both oxidized by cholesterol oxidase to yield hydrogen peroxide. The hydrogen peroxide then acts to oxidatively couple p-hydroxybenzoic 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/647 nm, is directly proportional to the cholesterol concentration in the sample.
The HDL-C Assay utilizes two reagents, the second containing a unique detergent. This detergent solubilizes only the HDL lipoprotein particles, thus releasing HDL cholesterol to react with the cholesterol esterase and cholesterol oxidase, in the presence of a chromogen to enzymes with LDL, VLDL and chylomicron lipoproteins by adsorbing to their surfaces. The amount of chromogen formed, determined by measuring the increase in absorbance bichromatically at 592/692 nm, is directly proportional to the HDL cholesterol concentration in the sample.
In the ACE LDL-C Reagent assay, detergent 1 solubilizes non-LDL lipoprotein particles (HDL, VLDL and chylomicrons) and releases cholesterol. The cholesterol is consumed by cholesterol esterase and cholesterol oxidase in a non-color forming reaction. In a second reaction, detergent 2 solublizes the remaining LDL particles and forms peroxide, via the enzymes cholesterol esterase and cholesterol oxidase. The peroxide, in the presence of peroxidase and two peroxidase sub- strates, 4-aminoantipyrine and DSBmT, results in a purple-red color. The amount of color formed, determined by measuring the increase in absorbance bichromatically at 544/692 nm, is directly proportional to the LDL cholesterol concentration in the sample.
In the ACE Triglycerides Reagent Assay, triglycerides in serum are hydrolyzed by lipase to form glycerol and free fatty acids. In the presence of adenosine triphosphate (ATP) and glycerol kinase, the glycerol is converted to glycerol-1-phosphate and the ATP to adenosine diphosphate. Glycerol-1-phosphate is oxidized by glycerol phosphate oxidase to yield hydrogen peroxide. The hydrogen peroxide then acts to oxidatively couple p-chlorophenol 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/692 nm, is directly proportional to the triglycerides concentration 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 Cholesterol Reagent
Precision: In testing conducted at four cholesterol levels for 22 days, the within-run CV ranged from 1.3 to 2.0%, and total CV ranged from 1.6 to 2.2%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.7 to 1.5% and total CV ranged from 1.0 to 1.7%.
Accuracy: In the correlation study, 110 samples with cholesterol values ranging from 7 to 527 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 0.9977, a standard error estimate of 5.0. a confidence interval slope of 0.999 to 1.026, and a confidence interval intercept of -6.2 to -0.5. 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 0.9945 to 0.9995, standard error estimates of 3.0 to 8.4. confidence interval slopes of 0.964 to 1.034. and a confidence interval intercepts of -7.3 to 6.7.
Detection limit: The detection limit was 3.6 mg/dL.
ACE HDL-C Reagent
Precision: In testing conducted at four HDL-C levels for 22 days, the within-run CV ranged from 1.4 to 2.7%, and total CV ranged from 3.2 to 4.8%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.7 to 2.6% and total CV ranged from 1.1 to 3.5%.
Accuracy: In the correlation study, 109 samples with HDL-C values ranging from 4 to 122 mg/dL were assaved 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 0.9959, a standard error estimate of 1.7, a confidence interval slope of 0.956 to 0.990, and a confidence interval intercept of -0.5 to 1.4. 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 0.9898 to 0.9970, standard error estimates of 1.7 to 2.4. confidence interval slopes of 0.936 to 1.061, and a confidence interval intercepts of -3.8 to 2.0.
Detection limit: The detection limit was 1.5 mg/dL.
ACE LDL-C Reagent
Precision: In testing conducted at four LDL-C levels for 22 days, the within-run CV ranged from 2.5 to 4.6%, and total CV ranged from 3.2 to 4.9%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 1.7 to 4.4% and total CV ranged from 2.4 to 5.9%.
Accuracy: In the correlation study, 108 samples with LDL-C values ranging from 10 to 422 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 vielded a correlation coefficient of 0.9973, a standard error estimate of 4.7, a confidence interval slope of 0.968 to 0.996, and a confidence interval intercept of -3.1 to 1.0. 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 0.9940 to 0. 9974, standard error estimates of 5.9 to 9.0, confidence interval slopes of 0.991 to 1.071, and a confidence interval intercepts of -8.4 to 4.0.
Detection limit: The detection limit was 4.0 mg/dL.
ACE Triglycerides Reagent
Precision: In testing conducted at four triglycerides levels for 22 days. the within-run CV ranged from 1.2 to 2.9%, and total CV ranged from 1.8 to 3.2%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.5 to 2.3% and total CV ranged from 0.6 to 4.1%.
Accuracy: In the correlation study, 111 samples with triglycerides values ranging from 18 to 996 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 vielded a correlation coefficient of 0.9995, a standard error estimate of 6.6, a confidence interval slope of 1.025 to 1.037, and a confidence interval intercept of -2.7 to 1.1. 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 0.9992 to 0.9996. standard error estimates of 5.9 to 8.4. confidence interval slopes of 0.989 to 1.024, and a confidence interval intercepts of -6.3 to 0.7.
Detection limit: The detection limit was 11.6 mg/dL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Alfa Wassermann ACE plus ISE/Clinical Chemistry System (K931786), ACE Cholesterol Reagent (K931786), ACE HDL-C Reagent (K971526), ACE LDL-C Reagent (K991733), ACE Triglycerides Reagent (K931786)
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
§ 862.1175 Cholesterol (total) test system.
(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(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.
0
JUL
`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 3, 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 Cholesterol Reagent |
| | Classification: | Class 1 |
| | Common/Classification Name: | Enzymatic Esterase-Oxidase,
Cholesterol (21 C. F.R. §
862.1175)
Product Code CHH |
| | Trade Name: | ACE HDL-C Reagent |
| | Classification: | Class 1 |
| | Common/Classification Name: | LDL & VLDL Precipitation,
Cholesterol Via Esterase-Oxidase,
HDL
(21 C. F.R. § 862.1475)
Product Code LBS |
| | Trade Name: | ACE LDL-C Reagent |
| | Classification: | Class 1 |
| | Common/Classification Name: | System, Test, Low Density,
Lipoprotein |
| | | Product Code MRR |
| | Trade Name: | ACE Triglycerides Reagent |
| | Classification: | Class 1 |
| | Common/Classification Name: | Lipase Hydrolysis/Glycerol Kinase
Enzyme, Triglycerides
(21 C. F.R. § 862.1705)
Product Code CDT |
| Predicate
Devices: | Manufacturer for analyzer/reagent system predicates: | Alfa Wassermann ACE plus ISE/Clinical Chemistry System (K931786)
ACE Cholesterol Reagent (K931786)
ACE HDL-C Reagent (K971526)
ACE LDL-C Reagent (K991733)
ACE Triglycerides Reagent (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 Cholesterol Reagent assay, cholesterol esters in serum are
completely hydrolyzed by cholesterol esterase to free cholesterol and
free fatty acids. The cholesterol liberated by the esterase, plus any
endogenous free cholesterol, are both oxidized by cholesterol oxidase
to yield hydrogen peroxide. The hydrogen peroxide then acts to
oxidatively couple p-hydroxybenzoic 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/647 nm, is directly proportional
to the cholesterol concentration in the sample. |
| | | The HDL-C Assay utilizes two reagents, the second containing a
unique detergent. This detergent solubilizes only the HDL lipoprotein
particles, thus releasing HDL cholesterol to react with the cholesterol
esterase and cholesterol oxidase, in the presence of a chromogen to |
| | enzymes with LDL, VLDL and chylomicron lipoproteins by adsorbing to their surfaces. The amount of chromogen formed, determined by measuring the increase in absorbance bichromatically at 592/692 nm, is directly proportional to the HDL cholesterol concentration in the sample. | |
| | In the ACE LDL-C Reagent assay, detergent 1 solubilizes non-LDL lipoprotein particles (HDL, VLDL and chylomicrons) and releases cholesterol. The cholesterol is consumed by cholesterol esterase and cholesterol oxidase in a non-color forming reaction. In a second reaction, detergent 2 solublizes the remaining LDL particles and forms peroxide, via the enzymes cholesterol esterase and cholesterol oxidase. The peroxide, in the presence of peroxidase and two peroxidase sub- strates, 4-aminoantipyrine and DSBmT, results in a purple-red color. The amount of color formed, determined by measuring the increase in absorbance bichromatically at 544/692 nm, is directly proportional to the LDL cholesterol concentration in the sample. | |
| | In the ACE Triglycerides Reagent Assay, triglycerides in serum are hydrolyzed by lipase to form glycerol and free fatty acids. In the presence of adenosine triphosphate (ATP) and glycerol kinase, the glycerol is converted to glycerol-1-phosphate and the ATP to adenosine diphosphate. Glycerol-1-phosphate is oxidized by glycerol phosphate oxidase to yield hydrogen peroxide. The hydrogen peroxide then acts to oxidatively couple p-chlorophenol 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/692 nm, is directly proportional to the triglycerides concentration 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 vitro diagnostic use in the quantitative determination of constituents in blood and other fluids. | |
| | The ACE Cholesterol Reagent is intended for the quantitative determination of cholesterol concentration in serum using the ACE Axcel Clinical Chemistry System. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. This test is | |
| The ACE HDL-C Reagent is intended for the quantitative
determination of high density lipoprotein cholesterol (HDL-C)
concentration in serum using the ACE Axcel Clinical Chemistry
System. Lipoprotein measurements are used in the diagnosis and
treatment of lipid disorders (such as diabetes mellitus), atherosclerosis,
and various liver and renal diseases. This test is intended for use in
clinical laboratories or physician office laboratories. For in vitro
diagnostic use only. | | |
| The ACE LDL-C Reagent is intended for the quantitative determination
of low density lipoprotein cholesterol (LDL-C) concentration in serum
using the ACE Axcel Clinical Chemistry System. Lipoprotein
measurements are used in the diagnosis and treatment of lipid disorders
(such as diabetes mellitus), atherosclerosis, and various liver and renal
diseases. This test is intended for use in clinical laboratories or
physician office laboratories. For in vitro diagnostic use only. | | |
| The ACE Triglycerides Reagent is intended for the quantitative
determination of triglyceride concentration in serum using the ACE
Axcel Clinical Chemistry System. Triglyceride measurements are used
in the diagnosis and treatment of patients with diabetes mellitus,
nephrosis, liver obstruction, other diseases involving lipid metabolism
or various endocrine disorders. 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 | |
| | 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 Cholesterol Reagent is composed of a single reagent bottle. The reagent contains 4-aminoantipyrine, p-hydroxybenzoic acid, cholesterol oxidase, cholesterol esterase and peroxidase. | |
| | The ACE HDL-C Reagent is composed of two reagent bottles (Buffer and Color Reagent). The reagents contain Good's buffer, cholesterol oxidase, peroxidase, N,N-bis(4-sulphobutyl)-m-toluidine-disodium salt, ascorbic oxidase, cholesterol esterase 4-aminoantipyrine and a detergent. | |
| | The ACE LDL-C Reagent is composed of two reagent bottles (Buffer and Color Reagent). The reagents contain MES Buffer (pH 6.3), detergent 1, cholesterol esterase, cholesterol oxidase, peroxidase, 4-aminoantipyrine, ascorbic acid oxidase, detergent 2 and N,N-bis(4-sulphobutyl)-m-toluidine-disodium salt. | |
| | The ACE Triglycerides Reagent is composed of a single reagent bottle. The reagent contains aminoantipyrine, adenosine 5'-triphosphate, p-chlorophenol, glycerol phosphate oxidase, lipase, peroxidase and glycerol kinase. | |
| 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 Cholesterol Reagent | |
| | Precision: In testing conducted at four cholesterol levels for 22 days, the within-run CV ranged from 1.3 to 2.0%, and total CV ranged from 1.6 to 2.2%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.7 to 1.5% and total CV ranged from 1.0 to 1.7%. | |
| | Accuracy: In the correlation study, 110 samples with cholesterol values ranging from 7 to 527 mg/dL were assayed on the Alfa Wassermann | |
1
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ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x). Least squares regression analysis yielded a correlation coefficient of 0.9977, a standard error estimate of 5.0. a confidence interval slope of 0.999 to 1.026, and a confidence interval intercept of -6.2 to -0.5. 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 0.9945 to 0.9995, standard error estimates of 3.0 to 8.4. confidence interval slopes of 0.964 to 1.034. and a confidence interval intercepts of -7.3 to 6.7.
Detection limit: The detection limit was 3.6 mg/dL.
ACE HDL-C Reagent
Precision: In testing conducted at four HDL-C levels for 22 days, the within-run CV ranged from 1.4 to 2.7%, and total CV ranged from 3.2 to 4.8%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.7 to 2.6% and total CV ranged from 1.1 to 3.5%.
Accuracy: In the correlation study, 109 samples with HDL-C values ranging from 4 to 122 mg/dL were assaved 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 0.9959, a standard error estimate of 1.7, a confidence interval slope of 0.956 to 0.990, and a confidence interval intercept of -0.5 to 1.4. 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 0.9898 to 0.9970, standard error estimates of 1.7 to 2.4. confidence interval slopes of 0.936 to 1.061, and a confidence interval intercepts of -3.8 to 2.0.
Detection limit: The detection limit was 1.5 mg/dL.
ACE LDL-C Reagent
Precision: In testing conducted at four LDL-C levels for 22 days, the within-run CV ranged from 2.5 to 4.6%, and total CV ranged from 3.2 to 4.9%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 1.7
6
to 4.4% and total CV ranged from 2.4 to 5.9%.
Accuracy: In the correlation study, 108 samples with LDL-C values ranging from 10 to 422 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 vielded a correlation coefficient of 0.9973, a standard error estimate of 4.7, a confidence interval slope of 0.968 to 0.996, and a confidence interval intercept of -3.1 to 1.0. 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 0.9940 to 0. 9974, standard error estimates of 5.9 to 9.0, confidence interval slopes of 0.991 to 1.071, and a confidence interval intercepts of -8.4 to 4.0.
Detection limit: The detection limit was 4.0 mg/dL.
ACE Triglycerides Reagent
Precision: In testing conducted at four triglycerides levels for 22 days. the within-run CV ranged from 1.2 to 2.9%, and total CV ranged from 1.8 to 3.2%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.5 to 2.3% and total CV ranged from 0.6 to 4.1%.
Accuracy: In the correlation study, 111 samples with triglycerides values ranging from 18 to 996 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 vielded a correlation coefficient of 0.9995, a standard error estimate of 6.6, a confidence interval slope of 1.025 to 1.037, and a confidence interval intercept of -2.7 to 1.1. 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 0.9992 to 0.9996. standard error estimates of 5.9 to 8.4. confidence interval slopes of 0.989 to 1.024, and a confidence interval intercepts of -6.3 to 0.7.
Detection limit: The detection limit was 11.6 mg/dL.
Conclusions: Based on the foregoing data, the device is safe and effective. These data also indicate substantial equivalence to the predicate device.
7
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
10903 New Hampshire Avenue Silver Spring, MD 20993
Alfa Wassermann Diagnostic Technologies, LLC c/o Hyman Katz, Ph. D. C/O Hymeldent, Quality and Regulatory Affairs 4 Henderson Drive West Caldwell, NJ 07006
JUL 3 2012
Re: K113262
:
K113262
Trade/Device Name: ACE Cholesterol Reagent, ACE HDL-C Reagent, ACE LDL-C Reagent, ACE ` Triglycerides Reagent
Regulation Number: 21 CFR 862.1175
Regulation Name: Cholesterol (total) test system Regulation Name: "Choroscros (vimitations of exemption per 21 CFR 862.9(c)(4)
Product Code: CHH, LBS, MRR, CDT
Dated: May 31, 2012
Received: June 1, 2012
Dear Dr. Katz:
We have reviewed your Section 510(k) premarket notification of intent to market the device in the indication we nave revewed your Section 510(x) premarter neme in the indications for the indications for referenced above and nave determined the devices marketed in interstate commence
use stated in the enclosure) to legally marketed predicated in interest to devices that use stated in the enclosure) to legally mankelou processarial device Amendments, or to devices that prior to May 26, 1976, the enactions and of the Federal Food. Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Federal From Wall of the move Act (Act) that do not require approval of a premarket approval application (PMA). The mays Act (Act) that do not require approval or a provisions of the Act . The general
therefore, market the device, subject to the general controls provisions of devices of devices therefore, market the device, subject to the general some some so annual registration, list in the mice controls provisions of the Net merade requiritions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (see above) the United on to regulations affecting your device can be
may may be subject to such adultional comrois: Entering and on 895. In addition, FDA may found in The 21, Code of Peacharters concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised mat FDA s Issualled of a substainler squire with other requirements of the Act or that FDA has made a determination that your covices Federal agencies. You must comply
any Federal statutes and regulations administered by other Federal section and lightng any Federal Statules and regulations animinate of our registration and listing (2) CFR Part
with all the Act's requirements, including, but not for registration progrise requ with all the Act's requirents, including, but not not not works on the more of the requirements as set
807); labeling (21 CFR Parts 801 and 809); and good man as 300 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 11 you active 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 CITY at 807.97). For questions regarding (OSB's) Division of Postmarket Surveillance at (301) 016-5760. 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,
Countney 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 (if known):
Device Name: ACE Cholesterol Reagent
Indications for Use:
The ACE Cholesterol Reagent is intended for the quantitative determination of cholesterol concentration in serum using the ACE Axcel Clinical Chemistry System. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Device Name: ACE HDL-C Reagent
Indications for Use:
The ACE HDL-C Reagent is intended for the quantitative determination of high density lipoprotein cholesterol (HDL-C) concentration in serum using the ACE Axcel Clinical Chemistry System. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. 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) Over-The-Counter Use. (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K113262
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Indications for Use
510(k) Number (if known):
Device Name: ACE LDL-C Reagent
The ACE LDL-C Reagent is intended for the quantitative Indications for Use: determination of low density lipoprotein cholesterol (LDL-C) concentration in serum using the ACE Axcel Clinical Chemistry System. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Device Name: ACE Triglycerides Reagent
Indications for Use: The ACE Triglycerides Reagent is intended for the quantitative determination of triglyceride concentration in serum using the ACE Axcel Clinical Chemistry System. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism or various endocrine disorders. 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)
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Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K113262
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