(210 days)
No
The device description details a chemical reaction and photometric measurement process, with no mention of AI or ML. The performance studies focus on standard clinical chemistry metrics like linear regression and correlation, not AI/ML performance metrics.
No
The device is described as a reagent for the quantitative determination of cholesterol, HDL-C, LDL-C, and triglycerides, which are used in the diagnosis and treatment of various disorders. It is explicitly stated as being for "in vitro diagnostic use only", indicating it's a diagnostic tool, not a therapeutic one that provides direct treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the measurements obtained from these reagents "are used in the diagnosis and treatment of disorders." This directly indicates a diagnostic purpose.
No
The device described is a set of in vitro diagnostic reagents used with specific clinical chemistry systems, which are hardware devices. The description focuses on the chemical reactions and performance characteristics of the reagents, not software functionality.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states that the reagents are "intended for the quantitative determination of cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides in serum and lithium heparin plasma." It also states that these measurements are "used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders," and other related conditions. This clearly indicates a diagnostic purpose.
- For in vitro diagnostic use only: This phrase is explicitly stated for each reagent, which is a common and definitive indicator of an IVD.
- Intended User / Care Setting: The reagents are intended for use in "clinical laboratories or physician office laboratories," which are typical settings for in vitro diagnostic testing.
- Device Description: The description details the chemical reactions that occur when the reagents interact with the patient sample (serum or plasma) to produce a measurable result (color change and absorbance). This is characteristic of an in vitro diagnostic test.
- Summary of Performance Studies: The performance studies describe how the reagents perform when testing patient samples, comparing results between serum and plasma. This type of validation is required for IVD devices.
- Predicate Device(s): The listing of predicate devices with K numbers (K931786, K971526, K991733) further confirms that these reagents are being submitted as medical devices, specifically IVDs, as K numbers are associated with FDA clearance for medical devices, including IVDs.
All of these factors align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
CHH, LBS, MRR, CDT
Device Description
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-amin-oantipyrine 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 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 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.
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
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Intended User / Care Setting
clinical laboratories or physician office laboratories.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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 and ACE Alera Clinical Chemistry Systems included matrix comparison data:
ACE Cholesterol Reagent:
ACE Clinical Chemistry System: A study was performed on the ACE Clinical Chemistry System by running 102 cholesterol 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 lipoprotein cholesterol concentrate. The serum results ranged from 40 to 568 mg/dL. Linear regression analysis (Deming) yielded the following results (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 by running an unspecified number of cholesterol determinations in singlicate on paired samples drawn from the same patients in serum and lithium heparin 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.
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) yielded 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) yielded the following results (serum = x, plasma = y): 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: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation Coefficient, Std. Error Est., Confidence Interval Slope, Confidence Interval Intercept were reported for linear regression analysis.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1175 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
K112538
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: | 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 Kinase
Enzyme, Triglycerides
(21 C.F.R. § 862.1705)
Product Code CDT |
1
| Predicate
| Devices: | Manufacturer for reagent system predicates: |
|---|---|
| Alfa Wassermann ACE plus ISE/Clinical Chemistry System | |
| ACE Reagents (K931786, K971526, K991733) | |
| Device | |
| Descriptions: | 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-amin- | |
| oantipyrine 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 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 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 | |
| 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. |
.
2
and the comments of the comments of the comments of
.
3
| Technological
Characteristics: | 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 and ACE Alera Clinical Chemistry Systems
included matrix comparison data: | | | | | | | | | | |
| | ACE Cholesterol Reagent | | | | | | | | | | |
| | ACE Clinical Chemistry System | | | | | | | | | | |
| | A study was performed on the ACE Clinical Chemistry System by
running 102 cholesterol 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 lipoprotein
cholesterol concentrate. The serum results ranged from 40 to 568
mg/dL. Linear regression analysis (Deming) yielded the following
results (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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:
4
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 |
5
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):
6
| 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.
7
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).
8
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
9
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
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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