(210 days)
ACE Cholesterol Reagent is intended for the quantitative determination of cholesterol in serum and lithium heparin plasma using the ACE and ACE Alera Clinical Chemistry Systems. 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.
ACE HDL-C Reagent is intended for the homogeneous, quantitative determination of HDL cholesterol (HDL-C) in serum and lithium heparin plasma using the ACE and ACE Alera Clinical Chemistry Systems. 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.
ACE LDL-C Reagent is intended for the quantitative determination of low density lipoprotein cholesterol (LDL-C) in serum and lithium heparin plasma using the ACE and ACE Alera Clinical Chemistry Systems. 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.
ACE Triglycerides Reagent is intended for the quantitative determination of triglycerides in serum and lithium heparin plasma using the ACE and ACE Alera Clinical Chemistry Systems. 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.
In the ACE Cholesterol Reagent assay, cholesterol esters in serum or heparin plasma 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 produce color. The detergent also inhibits the reaction of the cholesterol 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 substrates, 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 or heparin plasma 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.
Here's a breakdown of the acceptance criteria and study details for the Alfa Wassermann ACE Cholesterol Reagent, ACE HDL-C Reagent, ACE LDL-C Reagent, and ACE Triglycerides Reagent, based on the provided 510(k) summary:
The studies presented are "matrix comparison data" studies, aiming to demonstrate substantial equivalence between using serum and lithium heparin plasma samples with the new ACE reagents on the ACE and ACE Alera Clinical Chemistry Systems. The performance is assessed by comparing quantitative measurements from paired serum/plasma samples.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly based on demonstrating strong correlation and agreement between serum and plasma measurements, specifically looking for regression equations close to y=x (slope near 1, intercept near 0) and high correlation coefficients. The provided confidence intervals for slope and intercept also serve as an implicit measure of acceptance.
| Reagent / System | Metric | Acceptance Criteria (Implicit) | Reported Device Performance (ACE Clinical Chemistry System) | Reported Device Performance (ACE Alera Clinical Chemistry System) |
|---|---|---|---|---|
| ACE Cholesterol Reagent | Regression Equation (y = plasma, x = serum) | Slope near 1, Intercept near 0 | y = 0.985x - 1.7 | y = 0.994x - 2.5 |
| Correlation Coefficient | High (e.g., > 0.95 or 0.98) | 0.9947 | 0.9934 | |
| Std. Error Est. | Low | 9.6 | 11.5 | |
| Confidence Interval Slope | Should enclose 1 (e.g., 0.9-1.1) | 0.965 to 1.005 | 0.971 to 1.016 | |
| Confidence Interval Intercept | Should enclose 0 (e.g., -10 to 10) | -5.7 to 2.3 | -7.0 to 2.1 | |
| ACE HDL-C Reagent | Regression Equation | Slope near 1, Intercept near 0 | y = 1.015x - 0.6 | y = 0.989x + 0.4 |
| Correlation Coefficient | High (e.g., > 0.95 or 0.98) | 0.9884 | 0.9874 | |
| Std. Error Est. | Low | 3.4 | 3.5 | |
| Confidence Interval Slope | Should enclose 1 | 0.984 to 1.045 | 0.957 to 1.020 | |
| Confidence Interval Intercept | Should enclose 0 | -2.1 to 0.8 | -1.2 to 1.9 | |
| ACE LDL-C Reagent | Regression Equation | Slope near 1, Intercept near 0 | y = 1.008x - 2.6 | y = 0.995x - 1.3 |
| Correlation Coefficient | High (e.g., > 0.95 or 0.98) | 0.9954 | 0.9954 | |
| Std. Error Est. | Low | 7.3 | 7.2 | |
| Confidence Interval Slope | Should enclose 1 | 0.989 to 1.028 | 0.976 to 1.014 | |
| Confidence Interval Intercept | Should enclose 0 | -5.0 to -0.2 | -3.7 to 1.0 | |
| ACE Triglycerides Reagent | Regression Equation | Slope near 1, Intercept near 0 | y = 1.005x - 7.9 | y = 1.007x - 7.4 |
| Correlation Coefficient | High (e.g., > 0.95 or 0.98) | 0.9977 | 0.9973 | |
| Std. Error Est. | Low | 11.1 | 11.8 | |
| Confidence Interval Slope | Should enclose 1 | 0.991 to 1.019 | 0.992 to 1.021 | |
| Confidence Interval Intercept | Should enclose 0 | -11.1 to -4.7 | -10.8 to -4.0 |
2. Sample Size Used for the Test Set and Data Provenance
- ACE Cholesterol Reagent (ACE Clinical Chemistry System): 102 paired samples (serum and lithium heparin plasma). 5 samples spiked.
- ACE Cholesterol Reagent (ACE Alera Clinical Chemistry System): 100 paired samples (serum and lithium heparin plasma). 6 samples spiked.
- ACE HDL-C Reagent (ACE Clinical Chemistry System): 101 paired samples (serum and lithium heparin plasma).
- ACE HDL-C Reagent (ACE Alera Clinical Chemistry System): 100 paired samples (serum and lithium heparin plasma).
- ACE LDL-C Reagent (ACE Clinical Chemistry System): 99 paired samples (serum and lithium heparin plasma). 4 samples spiked.
- ACE LDL-C Reagent (ACE Alera Clinical Chemistry System): 99 paired samples (serum and lithium heparin plasma). 4 samples spiked.
- ACE Triglycerides Reagent (ACE Clinical Chemistry System): 101 paired samples (serum and lithium heparin plasma). 5 samples spiked.
- ACE Triglycerides Reagent (ACE Alera Clinical Chemistry System): 101 paired samples (serum and lithium heparin plasma). 5 samples spiked.
Data Provenance: The data provenance is described as "paired samples drawn from the same patients." There is no explicit mention of the country of origin of the data, but the context of an FDA 510(k) submission for commercialization in the USA suggests it would likely be from a US-based or internationally recognized clinical setting. The studies are prospective in nature, as they involve drawing paired samples for direct comparison. Spiking of some samples was done to extend the measurement range.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study does not involve "experts" establishing a ground truth in the traditional sense of medical image interpretation or clinical diagnosis. Instead, the ground truth for each measurement type (Cholesterol, HDL-C, LDL-C, Triglycerides) is the quantitative value obtained from the serum sample, which serves as the established reference matrix. The performance of the devices is then compared against this reference when using plasma samples. Therefore, no external experts were used for this purpose; the "ground truth" is the instrumental measurement itself.
4. Adjudication Method for the Test Set
Not applicable. This is a quantitative laboratory test performance study, not an expert-driven adjudication of medical findings. The comparison is statistical (Deming regression) between instrument measurements from two different sample matrices (serum vs. plasma).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a study evaluating the performance of in-vitro diagnostic reagents and systems, not an AI-assisted diagnostic device involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This study evaluates the standalone performance of the reagent and instrument system when used with different biological matrices (serum vs. plasma). There is no "human-in-the-loop" component in the interpretation of the numerical results beyond standard laboratory quality control and reporting procedures. The results provided are direct numerical outputs from the analytical instruments.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" used in these studies is the quantitative measurement of the analytes (Cholesterol, HDL-C, LDL-C, Triglycerides) obtained from serum samples using the same ACE and ACE Alera Clinical Chemistry Systems. Serum is generally considered the standard matrix for these assays. The purpose of the study is to demonstrate that lithium heparin plasma samples yield comparable results to serum samples.
8. The sample size for the training set
Not applicable. This is a performance validation study for a medical device (reagents and instrument system), not a machine learning model that requires a distinct training set. The "training" in this context would refer to the development and optimization of the reagents and assay protocols, which typically occurs during the R&D phase and doesn't involve a formal "training set" as understood in AI/ML.
9. How the ground truth for the training set was established
Not applicable, as there is no training set in the context of machine learning. The reagents are developed to specifically measure the target analytes based on well-established biochemical principles (enzymatic reactions). The "ground truth" for the development of such assays would involve chemical standards, certified reference materials, and comparison to established reference methods, but this is part of the assay development, not a "training set" for the reported performance studies.
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K112538
510(k) SUMMARY
| 510(k) Owner: | Alfa Wassermann Diagnostic Technologies, LLC4 Henderson DriveWest Caldwell, NJ 07006 | |
|---|---|---|
| Contact: | Hyman Katz, Ph.D.Phone: 973-852-0158Fax: 973-852-0237 | |
| Date SummaryPrepared: | August 30, 2011 | |
| Device: | 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(21 C.F.R. § 862.1475)Product Code MRR | |
| Trade Name: | ACE Triglycerides Reagent | |
| Classification: | Class 1 | |
| Common/Classification Name: | Lipase Hydrolysis/Glycerol KinaseEnzyme, Triglycerides(21 C.F.R. § 862.1705)Product Code CDT |
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| PredicateDevices: | Manufacturer for reagent system predicates: |
|---|---|
| Alfa Wassermann ACE plus ISE/Clinical Chemistry SystemACE Reagents (K931786, K971526, K991733) | |
| DeviceDescriptions: | In the ACE Cholesterol Reagent assay, cholesterol esters in serum orheparin plasma are completely hydrolyzed by cholesterol esterase tofree cholesterol and free fatty acids. The cholesterol liberated by theesterase, plus any endogenous free cholesterol, are both oxidized bycholesterol oxidase to yield hydrogen peroxide. The hydrogen peroxidethen acts to oxidatively couple p-hydroxybenzoic acid and 4-amin-oantipyrine in a reaction catalyzed by peroxidase, producing a redcolored quinoneimine complex which absorbs strongly at 505 nm. Theamount of chromogen formed, determined by measuring the increase inabsorbance, bichromatically at 505 nm/647 nm, is directly proportionalto the cholesterol concentration in the sample. |
| The HDL-C Assay utilizes two reagents, the second containing aunique detergent. This detergent solubilizes only the HDL lipoproteinparticles, thus releasing HDL cholesterol to react with the cholesterolesterase and cholesterol oxidase, in the presence of a chromogen toproduce color. The detergent also inhibits the reaction of the cholesterolenzymes with LDL, VLDL and chylomicron lipoproteins by adsorbingto their surfaces. The amount of chromogen formed, determined bymeasuring the increase in absorbance bichromatically at 592/692 nm, isdirectly proportional to the HDL cholesterol concentration in thesample. | |
| In the ACE LDL-C Reagent assay, detergent 1 solubilizes non-LDLlipoprotein particles (HDL, VLDL and chylomicrons) and releasescholesterol. The cholesterol is consumed by cholesterol esterase andcholesterol oxidase in a non-color forming reaction. In a secondreaction, detergent 2 solublizes the remaining LDL particles and formsperoxide, 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 inabsorbance bichromatically at 544/692 nm, is directly proportional tothe LDL cholesterol concentration in the sample. | |
| In the ACE Triglycerides Reagent assay, triglycerides in serum orheparin plasma are hydrolyzed by lipase to form glycerol and free fattyacids. In the presence of adenosine triphosphate (ATP) and glycerolkinase, the glycerol is converted to glycerol-1-phosphate and the ATPto adenosine diphosphate. Glycerol-1-phosphate is oxidized by glycerolphosphate oxidase to yield hydrogen peroxide. The hydrogen peroxidethen acts to oxidatively couple p-chlorophenol and 4-aminoantipyrinein a reaction catalyzed by peroxidase, producing a red colored | |
| Intended Use: | 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. |
| Indications for Use: | |
| ACE Cholesterol Reagent is intended for the quantitative determination of cholesterol in serum and lithium heparin plasma using the ACE and ACE Alera Clinical Chemistry Systems. 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. | |
| ACE HDL-C Reagent is intended for the homogeneous, quantitative determination of HDL cholesterol (HDL-C) in serum and lithium heparin plasma using the ACE and ACE Alera Clinical Chemistry Systems. 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. | |
| ACE LDL-C Reagent is intended for the quantitative determination of low density lipoprotein cholesterol (LDL-C) in serum and lithium heparin plasma using the ACE and ACE Alera Clinical Chemistry Systems. 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. | |
| ACE Triglycerides Reagent is intended for the quantitative determination of triglycerides in serum and lithium heparin plasma using the ACE and ACE Alera Clinical Chemistry Systems. 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. |
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and the comments of the comments of the comments of
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| TechnologicalCharacteristics: | 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 (Bufferand Color Reagent). The reagents contain Good's buffer, cholesteroloxidase, peroxidase, N,N-bis(4-sulphobutyl)-m-toluidine-disodium salt,ascorbic oxidase, cholesterol esterase 4-aminoantipyrine and adetergent. | |||||||||||
| The ACE LDL-C Reagent is composed of two reagent bottles (Bufferand 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 andglycerol kinase. | |||||||||||
| PerformanceData: | Performance data for the Alfa Wassermann ACE Reagents run on theAlfa Wassermann ACE and ACE Alera Clinical Chemistry Systemsincluded matrix comparison data: | ||||||||||
| ACE Cholesterol Reagent | |||||||||||
| ACE Clinical Chemistry System | |||||||||||
| A study was performed on the ACE Clinical Chemistry System byrunning 102 cholesterol determinations in singlicate on paired samplesdrawn from the same patients in serum and lithium heparin plasmatubes. Five paired serum/plasma samples were spiked with lipoproteincholesterol concentrate. The serum results ranged from 40 to 568mg/dL. Linear regression analysis (Deming) yielded the followingresults (serum = x, plasma = y): | |||||||||||
| Regression Equation y = 0.985x - 1.7 Correlation Coefficient 0.9947 Std. Error Est. 9.6 Confidence Interval Slope 0.965 to 1.005 Confidence Interval Intercept -5.7 to 2.3 | |||||||||||
| ACE Alera Clinical Chemistry System | |||||||||||
| A study was performed on the ACE Alera Clinical Chemistry System |
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plasma tubes. Six paired serum/plasma samples were spiked with lipoprotein cholesterol concentrate. The serum results ranged from 42 to 577 mg/dL. Linear regression analysis (Deming) yielded the following results (serum = x, plasma = y):
| Regression Equation | $y = 0.994x - 2.5$ |
|---|---|
| Correlation Coefficient | 0.9934 |
| Std. Error Est. | 11.5 |
| Confidence Interval Slope | 0.971 to 1.016 |
| Confidence Interval Intercept | -7.0 to 2.1 |
ACE HDL-C Reagent
ACE Clinical Chemistry System
A study was performed on the ACE Clinical Chemistry System by running 101 HDL determinations in singlicate on paired samples drawn from the same patients in serum and lithium heparin plasma tubes. The serum results ranged from 6 to 120 mg/dL. Linear regression analysis (Deming) yielded the following results (serum = x, plasma = y):
| Regression Equation | $y = 1.015x - 0.6$ |
|---|---|
| Correlation Coefficient | 0.9884 |
| Std. Error Est. | 3.4 |
| Confidence Interval Slope | 0.984 to 1.045 |
| Confidence Interval Intercept | -2.1 to 0.8 |
ACE Alera Clinical Chemistry System
A study was performed on the ACE Alera Clinical Chemistry System by running 100 HDL determinations in singlicate on paired samples drawn from the same patients in serum and lithium heparin plasma tubes. The serum results ranged from 7 to 123 mg/dL. Linear regression analysis (Deming) yielded the following results (serum = x, plasma = y):
| Regression Equation | $y = 0.989x + 0.4$ |
|---|---|
| Correlation Coefficient | 0.9874 |
| Std. Error Est. | 3.5 |
| Confidence Interval Slope | 0.957 to 1.020 |
| Confidence Interval Intercept | -1.2 to 1.9 |
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ACE LDL-C Reagent
ACE Clinical Chemistry System
A study was performed on the ACE Clinical Chemistry System by running 99 LDL determinations in singlicate on paired samples drawn from the same patients in serum and lithium heparin plasma tubes. Four paired serum/plasma samples were spiked with LDL cholesterol concentrate. The serum results ranged from 9 to 460 mg/dL. Linear regression analysis (Deming) yielded the following results (serum = x, plasma = y):
| Regression Equation | y = 1.008x - 2.6 |
|---|---|
| Correlation Coefficient | 0.9954 |
| Std. Error Est. | 7.3 |
| Confidence Interval Slope | 0.989 to 1.028 |
| Confidence Interval Intercept | -5.0 to -0.2 |
ACE Alera Clinical Chemistry System
A study was performed on the ACE Alera Clinical Chemistry System by running 99 LDL determinations in singlicate on paired samples drawn from the same patients in serum and lithium heparin plasma tubes. Four paired serum/plasma samples were spiked with LDL cholesterol concentrate. The serum results ranged from 9 to 464 mg/dL. Linear regression analysis (Deming) vielded the following results (serum == x, plasma = y):
| Regression Equation | $y = 0.995x - 1.3$ |
|---|---|
| Correlation Coefficient | 0.9954 |
| Std. Error Est. | 7.2 |
| Confidence Interval Slope | 0.976 to 1.014 |
| Confidence Interval Intercept | -3.7 to 1.0 |
ACE Triglycerides Reagent
ACE Clinical Chemistry System
A study was performed on the ACE Clinical Chemistry System by running 101 triglycerides determinations in singlicate on paired samples drawn from the same patients in serum and lithium heparin plasma tubes. Five paired serum/plasma samples were spiked with triglycerides. The serum results ranged from 39 to 887 mg/dL. Linear regression analysis (Deming) vielded the following results (serum = x. plasma = y):
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| Regression Equation | $y = 1.005x - 7.9$ |
|---|---|
| Correlation Coefficient | 0.9977 |
| Std. Error Est. | 11.1 |
| Confidence Interval Slope | 0.991 to 1.019 |
| Confidence Interval Intercept | -11.1 to -4.7 |
ACE Alera Clinical Chemistry System
Conclus
A study was performed on the ACE Alera Clinical Chemistry System by running 101 triglycerides determinations in singlicate on paired samples drawn from the same patients in serum and lithium heparin plasma tubes. Five paired serum/plasma samples were spiked with triglycerides. The serum results ranged from 38 to 884 mg/dL. Linear regression analysis (Deming) yielded the following results (serum = x, plasma = y):
| Regression Equation | $y = 1.007x - 7.4$ |
|---|---|
| Correlation Coefficient | 0.9973 |
| Std. Error Est. | 11.8 |
| Confidence Interval Slope | 0.992 to 1.021 |
| Confidence Interval Intercept | -10.8 to -4.0 |
rin plasma sample collection tubes to the use of serum sample collection tubes on the ACE and the ACE Alera Clinical Chemistry Systems.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, with three overlapping profiles facing to the right.
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
Alfa Wassermann Diagnostic Technologies, LLC c/o Hyman Katz 4 Henderson Drive West Caldwell, NJ 07006
MAR 2 9 2012
K112538 Re: Re:
Trade Name: ACE Cholesterol Reagent, ACE HDL-C Reagent, ACE LDL-C Reagent, and ACE Triglyceride Reagent Regulation Number: 21 CFR §862.1175 Regulation Name: Cholesterol Test Reagent Regulatory Class: Class I, meets limitations per 21CFR862.9(c)(4) Product Codes: CHH, LBS, MRR, CDT Dated: March 19, 2012 Received: March 20, 2012
Dear Dr. Katz,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not-mean-that-FDA-has-made-a-determination-that-your-device.complies-with.other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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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/Resourcesfor You/Industry/default.htm
Sincerely yours,
N
Couriney 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
112538 510(k) Number (if known):
Device Name: ACE Cholesterol Reagent
Indications for Use:
ACE Cholesterol Reagent is intended for the quantitative determination of cholesterol in serum and lithium heparin plasma using the ACE and ACE Alera Clinical Chemistry Systems. 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:
ACE HDL-C Reagent is intended for the homogeneous, quantitative determination of HDL cholesterol (HDL-C) in serum and lithium heparin plasma using the ACE and ACE Alera Clinical Chemistry Systems. 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)
AND/OR
Over-The-Counter Use. (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Ruta Chala
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
.510(k) K112538
Page 1 of 2
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Indications for Use
510(k) Number (if known): K 112538
Device Name: ACE LDL-C Reagent
Indications for Use:
ACE LDL-C Reagent is intended for the quantitative determination of low density lipoprotein cholesterol (LDL-C) in serum and lithium heparin plasma using the ACE and ACE Alera Clinical Chemistry Systems. 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:
ACE Triglycerides Reagent is intended for the quantitative determination of triglycerides in serum and lithium heparin plasma using the ACE and ACE Alera Clinical Chemistry Systems. 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)
Qute. Cheslie
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K112534
Page 2 of 2
§ 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.