(28 days)
The ACE Cholesterol Reagent is intended for the quantitative determination of cholesterol concentration in serum and lithium heparin plasma 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 and lithium heparin plasma 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 and lithium heparin plasma 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 and lithium heparin plasma 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.
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 HDL-C Reagent assay utilizes two reagent bottles, 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 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.
The provided text describes a 510(k) submission for the ACE Axcel Clinical Chemistry System and its associated reagents for Cholesterol, HDL-C, LDL-C, and Triglycerides. The submission focuses on demonstrating substantial equivalence to a predicate device (K113262) by showing that the new device has "Same" intended use, instrument platform, basic principle, and reagent composition, with the only difference being the expanded sample type (serum and lithium heparin plasma for the candidate device vs. serum only for the predicate device).
The acceptance criteria are implicitly defined by the performance characteristics demonstrated in the study, which aim to show that the expanded sample type (lithium heparin plasma) does not negatively impact the accuracy and precision of the measurements compared to serum. The study largely relies on analytical performance data rather than clinical outcomes or expert consensus on interpretations.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in the document; instead, the study intends to demonstrate comparable performance to the predicate device and acceptable analytical characteristics. The reported device performance for precision and matrix comparison is provided below, which implicitly became the "accepted" performance for the expanded sample type.
| Analyte | Metric / Acceptance Criteria (Implied: Acceptable analytical performance and comparability) | Reported Device Performance (Precision) | Reported Device Performance (Matrix Comparison: Serum vs. Plasma) |
|---|---|---|---|
| Cholesterol | Precision (SD, %CV) at various concentrations for serum and plasma | Serum: Low: 2.4, 1.6%; Mid: 3.6, 1.4%; High: 6.8, 1.3% Plasma: Low: 2.7, 2.1%; Mid: 4.1, 1.2%; High: 7.9, 1.4% | Slope: 0.987, Intercept: -1.9, Correlation: 0.9987 (54 pairs) |
| HDL-C | Precision (SD, %CV) at various concentrations for serum and plasma | Serum: Low: 2.0, 4.3%; Mid: 2.0, 2.6%; High: 2.4, 2.2% Plasma: Low: 1.3, 3.1%; Mid: 1.2, 1.7%; High: 2.7, 2.6% | Slope: 1.011, Intercept: -1.1, Correlation: 0.9981 (53 pairs) |
| LDL-C | Precision (SD, %CV) at various concentrations for serum and plasma | Serum: Low: 2.4, 2.6%; Mid: 3.7, 2.3%; High: 7.1, 2.1% Plasma: Low: 1.8, 2.3%; Mid: 5.6, 2.6%; High: 9.6, 2.6% | Slope: 1.006, Intercept: -1.6, Correlation: 0.9981 (54 pairs) |
| Triglycerides | Precision (SD, %CV) at various concentrations for serum and plasma | Serum: Low: 1.4, 2.1%; Mid: 3.4, 1.0%; High: 4.3, 0.7% Plasma: Low: 2.2, 3.2%; Mid: 3.5, 1.0%; High: 13.5, 2.3% | Slope: 0.992, Intercept: -3.6, Correlation: 0.9993 (55 pairs) |
2. Sample size used for the test set and the data provenance
- Precision/Reproducibility Study (Test Set):
- For each analyte (Cholesterol, HDL-C, LDL-C, Triglycerides), for both serum and plasma, 3 levels of samples were used.
- Each level was tested with 2 replicates, twice a day, on 5 separate days, yielding a total of 20 replicates per level (3 levels * 2 sample types * 20 replicates/level = 120 total measurements per analyte category, e.g., Cholesterol on Serum).
- Data Provenance: Not explicitly stated, but typically these studies are conducted in a laboratory setting, likely in the US (given the FDA submission). It is a prospective analytical study designed to evaluate device performance under controlled conditions.
- Matrix Comparison Study (Test Set):
- Cholesterol: 54 paired serum and lithium heparin plasma specimens.
- HDL-C: 53 paired serum and lithium heparin plasma specimens.
- LDL-C: 54 paired serum and lithium heparin plasma specimens.
- Triglycerides: 55 paired serum and lithium heparin plasma specimens.
- These specimens covered the assay's dynamic range.
- Data Provenance: Not explicitly stated, but likely from a clinical laboratory setting, potentially within the US. The samples are retrospective specimens collected for analytical comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of submission for in vitro diagnostic reagents does not typically involve human experts establishing "ground truth" through interpretation. The "ground truth" for the test set is established by comparative measurements against a reference method or the predicate device, and by the inherent chemical/physical properties of the samples used in reproducibility studies. No information about experts or their qualifications is provided or relevant in this context.
4. Adjudication method for the test set
Not applicable. This is an analytical performance study for laboratory reagents, not a clinical study involving human interpretation that would require an adjudication method.
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 not an AI/imaging device, nor does it involve human readers or case interpretations. It is an in vitro diagnostic reagent.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is an analytical device, and its performance is inherently standalone in terms of generating a quantitative result. The results are then interpreted by clinicians in the overall diagnostic process. The study evaluates the standalone performance of the reagents on the ACE Axcel Clinical Chemistry System.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this type of analytical validation is established by:
- Reference methods and/or the predicate device: For the matrix comparison, the serum measurements on the candidate device (which is substantially equivalent to the predicate) serve as the reference against plasma measurements. The predicate device's performance also implicitly serves as a benchmark for comparison.
- Known concentrations: For precision studies, samples are "clinically relevant decision levels" meaning they have known or well-characterized concentrations of the analytes. These concentrations are typically determined by highly accurate laboratory methods.
8. The sample size for the training set
Not applicable. This is not an AI or machine learning device that requires a training set. The reagents are chemical formulations, and the system is an automated analyzer.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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122 757
Alfa Wassermann Diagnostic Technologies, LLC
510(k) Submission ACE Axcel Clinical Chemistry System ACE Reagents
OCT
5 2012
.
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 September 6, 2012 Prepared: Device: Trade Name: ACE Cholesterol Reagent Classification: Class 1, meets limitations of exemption per 21 CFR § 862.9(c)(4) and (c)(9) Common/Classification Name: Enzymatic Esterase-Oxidase, Cholesterol (21 CFR § 862.1175) Product Code CHH Trade Name: ACE HDL-C Reagent Classification: Class 1, meets limitations of exemption per 21 CFR § 862.9(c)(4) and (c)(9) Common/Classification Name: LDL & VLDL Precipitation, Cholesterol Via Esterase-Oxidase, HDL (21 CFR § 862.1475) Product Code LBS Trade Name: ACE LDL-C Reagent Classification: Class 1, meets limitations of exemption per 21 CFR § 862.9(c)(4) and (c)(9) Common/Classification Name: System, Test, Low Density, Lipoprotein (21 CFR § 862.1475) Product Code MRR Trade Name: ACE Triglycerides Reagent Classification: Class 1, meets limitations of exemption per 21 CFR § 862.9(c)(4) and (c)(9) Common/Classification Name: Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides (21 CFR § 862.1705) Product Code CDT Predicate Predicates: Devices:
.
September 6, 2012
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.
| ACE Cholesterol Reagent (K113262)ACE HDL-C Reagent (K113262)ACE LDL-C Reagent (K113262)ACE Triglycerides Reagent (K113262) | |||
|---|---|---|---|
| Similarities | Candidate Device | Predicate Device | |
| 510(k) # | K122757 | K113262 | |
| Company | Alfa WassermannDiagnostic Technologies,LLC | Alfa Wassermann DiagnosticTechnologies, LLC | |
| Name | ACE Axcel ClinicalChemistry System, ACECholesterol Reagent | ACE Axcel Clinical ChemistrySystem, ACE Cholesterol Reagent | |
| Intended Use/Indicationsfor Use | Same | The ACE Cholesterol Reagent isintended for the quantitativedetermination of cholesterolconcentration using the ACEAxcel Clinical Chemistry System.Cholesterol measurements areused in the diagnosis andtreatment of disorders involvingexcess cholesterol in the bloodand lipid and lipoproteinmetabolism disorders. This test isintended for use in clinicallaboratories or physician officelaboratories. For in vitrodiagnostic use only. | |
| InstrumentPlatform | Same | ACE Axcel Clinical ChemistrySystem | |
| BasicPrinciple | Same | Enzymatic method for cholesterol | |
| ReagentCompositionReactiveIngredients | Same | 4-Aminoantipyrenep-Hydroxybenzoic acidCholesterol oxidase (Nocardia)Cholesterol esterase (porcinepancreas and Pseudomonas)Peroxidase (Horseradish) | |
| Differences | |||
| SampleType | Serum and lithium heparin | Serum |
{2}------------------------------------------------
| Similarities | Candidate Device | Predicate Device |
|---|---|---|
| 510(k) # | K122757 | K113262 |
| Company | Alfa Wassermann | Alfa Wassermann · |
| Diagnostic Technologies,LLC | DiagnosticTechnologies, LLC | |
| Name | ACE Axcel Clinical | ACE Axcel Clinical Chemistry |
| Chemistry System, ACEHDL-C Reagent | System, ACE HDL-C Reagent | |
| Intended Use/Indicationsfor Use | Same | The ACE HDL-C Reagent isintended for the quantitativedetermination of high densitylipoprotein cholesterol (HDL-C)concentration using the ACEAxcel Clinical ChemistrySystem. Lipoproteinmeasurements are used in thediagnosis and treatment of lipiddisorders (such as diabetesmellitus), atherosclerosis andvarious liver and renal diseases.This test is intended for use inclinical laboratories or physician |
| Instrument | Same | office laboratories. For in vitrodiagnostic use only.ACE Axcel Clinical Chemistry |
| Platform | System | |
| BasicPrinciple | Same | Detergent solubilization ofHDL to selectively measureHDL cholesterol using anenzymatic method. |
| ReagentCompositionReactiveIngredients | Same | Cholesterol oxidase (E. coli)Peroxidase (Horseradish)N, N-bis(4-sulphobutyl)-m-toluidine-disodium saltAcceleratorAscorbic oxidase (Curcurbitasp.)4-AminoantipyreneCholesterol esterase(Pseudomonas) |
| Differences | ||
| Sample Type | Serum and lithium heparinplasma | Serum |
・・
September 6, 2012
{3}------------------------------------------------
| Similarities | Candidate Device | Predicate Device |
|---|---|---|
| 510(k) # | K122757 | K113262 |
| Company | Alfa WassermannDiagnostic Technologies, LLC | Alfa Wassermann DiagnosticTechnologies, LLC |
| Name | ACE Axcel ClinicalChemistry System, ACELDL-C Reagent | ACE Axcel Clinical ChemistrySystem, ACE LDL-C Reagent |
| Intended Use/Indicationsfor Use | Same | The ACE LDL-C Reagent isintended for the quantitativedetermination of low densitylipoprotein cholesterol (LDL-C)concentration using the ACEAxcel Clinical ChemistrySystem. Lipoproteinmeasurements are used in thediagnosis and treatment of lipiddisorders (such as diabetesmellitus), atherosclerosis andvarious liver and renal diseases.This test is intended for use inclinical laboratories or physicianoffice laboratories. For in vitrodiagnostic use only. |
| InstrumentPlatform | Same | ACE Axcel Clinical ChemistrySystem |
| BasicPrinciple | Same | Detergent solubilization of LDLto selectively measure LDLcholesterol using an enzymaticmethod |
| ReagentCompositionReactiveIngredients | Same | Cholesterol esteraseCholesterol oxidasePeroxidase4-AminoantipyrineAscorbic acid oxidaseBufferN,N-bis (4-sulfobutyl)-m-toluidine, disodium salt |
| Differences | ||
| Sample Type | Serum and lithium heparin | Serum |
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| Similarities | Candidate Device | Predicate Device | |||
|---|---|---|---|---|---|
| 510(k) # | K122757 | K113262 | |||
| Company | Alfa Wassermann | Alfa Wassermann Diagnostic | |||
| Diagnostic Technologies, | Technologies, LLC | ||||
| rro | |||||
| Name | ACE Axcel Clinical | ACE Axcel Clinical Chemistry | |||
| Chemistry System, ACE | System, ACE Triglycerides | ||||
| Triglycerides Reagent | Reagent | ||||
| Intended Use/ | Same | The ACE Triglycerides Reagent | |||
| Indications | is intended for the quantitative | ||||
| for Use | determination of triglyceride | ||||
| concentration 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. | |||||
| InstrumentPlatform | Same | ACE Axcel Clinical Chemistry | |||
| Basic | System | ||||
| Principle | Same | Coupled enzymatic reaction | |||
| Reagent | Same | 4-Aminoantipyrine | |||
| Composition | adenosine 5'-triphosphate | ||||
| Reactive | p-Chlorophenol | ||||
| Ingredients | Glycerol phosphate oxidase | ||||
| (Microorganism) | |||||
| Lipase (Pseudomonas) | |||||
| Peroxidase (Horseradish) | |||||
| Glycerol kinase (Cellulomonas) | |||||
| Differences | |||||
| Sample Type | Serum and lithium heparin | Serum | |||
| plasma | |||||
| Device | In the ACE Cholesterol Reagent assay, cholesterol esters in serum are completely | ||||
| Descriptions: | 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-amin- | |||||
| oantipyrine in a reaction catalyzed by peroxidase, producing a red colored |
{5}------------------------------------------------
| quinoneimine complex which absorbs strongly at 505 nm. The amount ofchromogen formed, determined by measuring the increase in absorbance,bichromatically at 505 nm/647 nm, is directly proportional to the cholesterolconcentration in the sample. | |
|---|---|
| The HDL-C Reagent assay utilizes two reagent bottles, the second containing aunique detergent. This detergent solubilizes only the HDL lipoprotein particles,thus releasing HDL cholesterol to react with the cholesterol esterase andcholesterol oxidase, in the presence of a chromogen to produce color. Thedetergent also inhibits the reaction of the cholesterol enzymes with LDL, VLDLand chylomicron lipoproteins by adsorbing to their surfaces. The amount ofchromogen formed, determined by measuring the increase in absorbancebichromatically at 592/692 nm, is directly proportional to the HDL cholesterolconcentration in the sample. | |
| In the ACE LDL-C Reagent assay, detergent 1 solubilizes non-LDL lipoproteinparticles (HDL, VLDL and chylomicrons) and releases cholesterol. Thecholesterol is consumed by cholesterol esterase and cholesterol oxidase in a non-color forming reaction. In a second reaction, detergent 2 solublizes the remainingLDL particles and forms peroxide, via the enzymes cholesterol esterase andcholesterol oxidase. The peroxide, in the presence of peroxidase and twoperoxidase substrates, 4-aminoantipyrine and DSBmT, results in a purple-redcolor. The amount of color formed, determined by measuring the increase inabsorbance bichromatically at 544/692 nm, is directly proportional to the LDLcholesterol concentration in the sample. | |
| In the ACE Triglycerides Reagent assay, triglycerides in serum are hydrolyzed bylipase to form glycerol and free fatty acids. In the presence of adenosinetriphosphate (ATP) and glycerol kinase, the glycerol is converted to glycerol-1-phosphate and the ATP to adenosine diphosphate. Glycerol-1-phosphate isoxidized by glycerol phosphate oxidase to yield hydrogen peroxide. Thehydrogen peroxide then acts to oxidatively couple p-chlorophenol and 4-aminoantipyrine in a reaction catalyzed by peroxidase, producing a red coloredquinoneimine complex which absorbs strongly at 505 nm. The amount ofchromogen formed, determined by measuring the increase in absorbancebichromatically at 505 nm/692 nm, is directly proportional to the triglyceridesconcentration in the sample. | |
| Intended Use: | Indications for Use:The ACE Cholesterol Reagent is intended for the quantitative determination ofcholesterol concentration in serum and lithium heparin plasma using the ACEAxcel Clinical Chemistry System. Cholesterol measurements are used in thediagnosis and treatment of disorders involving excess cholesterol in the blood andlipid and lipoprotein metabolism disorders. This test is intended for use in clinicallaboratories or physician office laboratories. For in vitro diagnostic use only. |
·
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| The ACE HDL-C Reagent is intended for the quantitative determination of highdensity lipoprotein cholesterol (HDL-C) concentration in serum and lithiumheparin plasma using the ACE Axcel Clinical Chemistry System. Lipoproteinmeasurements are used in the diagnosis and treatment of lipid disorders (such asdiabetes mellitus), atherosclerosis, and various liver and renal diseases. This testis intended for use in clinical laboratories or physician office laboratories. For invitro diagnostic use only. | |
|---|---|
| The ACE LDL-C Reagent is intended for the quantitative determination of lowdensity lipoprotein cholesterol (LDL-C) concentration in serum and lithiumheparin plasma using the ACE Axcel Clinical Chemistry System. Lipoproteinmeasurements are used in the diagnosis and treatment of lipid disorders (such asdiabetes mellitus), atherosclerosis, and various liver and renal diseases. This testis intended for use in clinical laboratories or physician office laboratories. For invitro diagnostic use only. | |
| The ACE Triglycerides Reagent is intended for the quantitative determination oftriglyceride concentration in serum and lithium heparin plasma using the ACEAxcel Clinical Chemistry System. Triglyceride measurements are used in thediagnosis and treatment of patients with diabetes mellitus, nephrosis, liverobstruction, other diseases involving lipid metabolism or various endocrinedisorders. This test is intended for use in clinical laboratories or physician officelaboratories. For in vitro diagnostic use only. | |
| TechnologicalCharacteristics: | The ACE Cholesterol Reagent is composed of a single reagent bottle. The reagentcontains 4-aminoantipyrine, p-hydroxybenzoic acid, cholesterol oxidase,cholesterol esterase and peroxidase. |
| The ACE HDL-C Reagent is composed of two reagent bottles (Buffer and ColorReagent). The reagents contain Good's buffer, cholesterol oxidase, peroxidase,N,N-bis(4-sulphobutyl)-m-toluidine-disodium salt, ascorbic oxidase, cholesterolesterase 4-aminoantipyrine and a detergent. | |
| The ACE LDL-C Reagent is composed of two reagent bottles (Buffer and ColorReagent). The reagents contain MES Buffer (pH 6.3), detergent 1, cholesterolesterase, cholesterol oxidase, peroxidase, 4-aminoantipyrine, ascorbic acidoxidase, detergent 2 and N,N-bis(4-sulphobutyl)-m-toluidine-disodium salt. | |
| The ACE Triglycerides Reagent is composed of a single reagent bottle. Thereagent contains aminoantipyrine, adenosine 5'-triphosphate, p-chlorophenol,glycerol phosphate oxidase, lipase, peroxidase and glycerol kinase. | |
| PerformanceData: | Performance data for the Alfa Wassermann ACE Reagents run on the AlfaWassermann ACE Axcel Clinical Chemistry System included matrix comparisondata and precision/reproducibility data. |
| Precision/Reproducibility |
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Precision was evaluated following the guideline EP10-A3. Two replicates each of 3 levels of samples at clinically relevant decision levels were tested twice a day on 5 separate days, yielding 20 replicates total. The results are presented in the tables below: .
| Analyte | Precision (SD, %CV) | ||||
|---|---|---|---|---|---|
| Cholesterolmg/dL | Mean | Within-Run | BetweenRun | BetweenDay | Total |
| Serum Low | 150.9 | 2.3, 1.5% | 0.0, 0.0% | 0.8, 0.6% | 2.4, 1.6% |
| Serum Mid | 252.5 | 2.5, 1.0% | 2.5, 1.0% | 0.0, 0.0% | 3.6, 1.4% |
| Serum High | 522.4 | 5.8, 1.1% | 3.5, 0.7% | 0.0, 0.0% | 6.8, 1.3% |
| Plasma Low | 130.2 | 2.4, 1.8% | 0.5, 0.4% | 1.1, 0.8% | 2.7, 2.1% |
| Plasma Mid | 338.0 | 4.1, 1.2% | 0.0, 0.0% | 0.0, 0.0% | 4.1, 1.2% |
| Plasma High | 550.8 | 6.6, 1.2% | 0.0, 0.0% | 4.4, 0.8% | 7.9, 1.4% |
| AnalyteHDL-Cmg/dL | Precision (SD, %CV) | Mean | Within-Run | Between Run | Between Day | Total |
|---|---|---|---|---|---|---|
| Serum Low | 47.6 | 1.8, 3.8% | 0.9, 1.9% | 0.3, 0.7% | 2.0, 4.3% | |
| Serum Mid | 76.4 | 1.9, 2.5% | 0.0, 0.0% | 0.5, 0.7% | 2.0, 2.6% | |
| Serum High | 105.7 | 1.8, 1.7% | 0.0, 0.0% | 1.5, 1.4% | 2.4, 2.2% | |
| Plasma Low | 41.3 | 1.1, 2.6% | 0.0, 0.0% | 0.7, 1.6% | 1.3, 3.1% | |
| Plasma Mid | 71.2 | 0.7, 1.0% | 0.3, 0.4% | 1.0, 1.3% | 1.2, 1.7% | |
| Plasma High | 102.9 | 2.2, 2.1% | 1.5, 1.5% | 0.0, 0.0% | 2.7, 2.6% |
| Analyte | Precision (SD, %CV) | |||||
|---|---|---|---|---|---|---|
| LDL-Cmg/dL | Mean | Within-Run | BetweenRun | BetweenDav | Total | |
| Serum Low | 92.4 | 2.1, 2.3% | 0.7, 0.8% | 1.0, 1.1% | 2.4, 2.6% | |
| Serum Mid | ા રેતે રે | 3.0, 1.9% | 2.0, 1.2% | 0.7.0.4% | 3.7, 2.3% | |
| Serum High | 345.6 | 5.9. 1.7% | 3.9.1.1% | 0.0. 0.0% | 7.1,2.1% | |
| Plasma Low | 78.7 | 1.2, 1.6% | 0.6, 0.8% | 1.1.1.4% | 1.8.2.3% | |
| Plasma Mid | 214.8 | 5.5. 2.6% | 0.7, 0.3% | 0.3. 0.2% | 5.6, 2.6% | |
| Plasma High | 364.8 | 5.9, 1.6% | 2.5, 0.7% | 7.2, 2.0% | 9.6, 2.6% |
| Analyte | Precision (SD, %CV) | ||||
|---|---|---|---|---|---|
| Triglyceridesmg/dL | Mean | Within-Run | BetweenRun | BetweenDay | Total |
| Serum Low | 67.5 | 0.9, 1.4% | 0.5, 0.7% | 0.9, 1.4% | 1.4, 2.1% |
| Serum Mid | 330.2 | 2.5, 0.8% | 1.6. 0.5% | 1.6. 0.5% | 3.4. 1.0% |
| Serum High | 596.6 | 3.6, 0.6% | 0.0, 0.0% | 2.3, 0.4% | 4.3.0.7% |
| Plasma Low | 69.5 | 0.8, 1.2% | 1.1.1.5% | 1.8. 2.5% | 2.2, 3.2% |
| Plasma Mid | 341.5 | 2.5. 0.7% | 2.4, 0.7% | 0.0. 0.0% | 3.5, 1.0% |
| Plasma High | 601.0 | 6.0, 1.0% | 7.3, 1.2% | 9.6, 1.6% | 13.5, 2.3% |
{8}------------------------------------------------
| Linearity/assay reportable range: | Refer to previously cleared submission K113262 |
|---|---|
| Traceability, Stability, Expected values (controls, calibrators, or methods): | Refer to previously cleared submission K113262 |
| Expected values/Reference range: | Refer to previously cleared submission K113262 |
| Detection Limit: | Refer to previously cleared submission K113262 |
| Analytical specificity: | Refer to previously cleared submission K113262 |
| Method Comparison/Bias Determination: | Refer to previously cleared submission K113262 |
| Matrix Comparison: | Matrix comparison studies were carried out following guideline EP9-A2-IR. Thestudies consisted of running a series of paired serum (x) and lithium heparinplasma (y) specimens in singlicate with varying levels of analyte that cover theassay's dynamic range on the ACE Axcel Clinical Chemistry System. Resultswere analyzed using Deming regression. |
ﺮ ﺗﻢ
{9}------------------------------------------------
ﻦ
| Reagent | Range | Results ACE Axcel Serum vs. Plasma |
|---|---|---|
| Cholesterol54 pairs | 24-574 mg/dL | Slope: 0.987Intercept: -1.9Correlation: 0.9987Std. Error Est: 4.7Confidence Interval Slope: 0.974 to 1.001Confidence Interval Intercept: -4.6 to 0.8 |
| HDL53 pairs | 6-112 mg/dL | Slope: 1.011Intercept: -1.1Correlation: 0.9981Std. Error Est: 1.5Confidence Interval Slope: 0.993 to 1.028Confidence Interval Intercept: -2.0 to -0.2 |
| LDL54 pairs | 10-428 mg/dL | Slope: 1.006Intercept: -1.6Correlation: 0.9981Std. Error Est: 4.7Confidence Interval Slope: 0.989 to 1.023Confidence Interval Intercept: -3.7 to 0.5 |
| Triglycerides55 pairs | 34-994 mg/dL | Slope: 0.992Intercept: -3.6Correlation: 0.9993Std. Error Est: 7.2Confidence Interval Slope: 0.981 to 1.002Confidence Interval Intercept: -6.2 to -0.9 |
| Conclusions: | Based on the foregoing data, the device is safe and effective. These data also indicate substantial equivalence to the predicate device. |
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:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/10/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 a stylized image of an eagle.
10903 New Hampshire Avenue Silver Spring, MD 20993
OCT 5 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: K122757
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
Regulatory Class: Class I, meets limitations per 21 CFR§ 862.9(c)(4) (9)
Product Code: CHH, LBS, MRR, CDT
Dated: September 6, 2012
Received: September 7, 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).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Devices and Radiological Health 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) 796-576-. 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,
2
Courtney H. Lias, Ph.D Director Division of Chemistry and Toxicology Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K122757
Device Name: ACE Cholesterol Reagent
Indications for Use: The ACE Cholesterol Reagent is intended for the quantitative determination of cholesterol concentration 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 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) 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)
Yung Chan
Divis Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k/22757
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Indications for Use
510(k) Number (if known): _k122757
Device Name: ACE LDL-C Reagent
The ACE LDL-C Reagent is intended for the quantitative determination of Indications for Use: low density lipoprotein cholesterol (LDL-C) concentration 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 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)
Yung Chan
Divisidn Sign Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K122757
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§ 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.