(28 days)
Not Found
No
The device description focuses on chemical reactions and absorbance measurements, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is for in vitro diagnostic use, intended for quantitative determination of cholesterol, HDL-C, LDL-C, and triglycerides in serum and plasma, which assists in diagnosis and treatment but does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the tests are used "in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders," and "For in vitro diagnostic use only."
No
The device description clearly states that the device is a reagent, which is a chemical substance used in a chemical reaction. This is a physical component, not software. The summary also mentions performance studies related to the reagent's interaction with samples and a clinical chemistry system, further indicating it is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section for each reagent clearly states: "For in vitro diagnostic use only."
- Intended Use: The reagents are intended for the quantitative determination of specific analytes (cholesterol, HDL-C, LDL-C, triglycerides) in human biological specimens (serum and lithium heparin plasma). This is a core characteristic of IVDs.
- Clinical Context: The intended use describes how the measurements are used in the diagnosis and treatment of various disorders, further confirming their diagnostic purpose.
- Intended User/Setting: The reagents are intended for use in clinical laboratories or physician office laboratories, which are typical settings for IVD testing.
- Device Description: The description details the chemical reactions and processes used to analyze the biological samples, which is consistent with the function of an IVD reagent.
N/A
Intended Use / Indications for Use
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.
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 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratories or physician office laboratories.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data for the Alfa Wassermann ACE Reagents run on the Alfa Wassermann ACE Axcel Clinical Chemistry System included matrix comparison data and precision/reproducibility data.
Precision/Reproducibility: 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.
Matrix Comparison: Matrix comparison studies were carried out following guideline EP9-A2-IR. The studies consisted of running a series of paired serum (x) and lithium heparin plasma (y) specimens in singlicate with varying levels of analyte that cover the assay's dynamic range on the ACE Axcel Clinical Chemistry System. Results were analyzed using Deming regression.
Cholesterol: 54 pairs, Range 24-574 mg/dL. Results: Slope: 0.987, Intercept: -1.9, Correlation: 0.9987, Std. Error Est: 4.7, Confidence Interval Slope: 0.974 to 1.001, Confidence Interval Intercept: -4.6 to 0.8.
HDL: 53 pairs, Range 6-112 mg/dL. Results: Slope: 1.011, Intercept: -1.1, Correlation: 0.9981, Std. Error Est: 1.5, Confidence Interval Slope: 0.993 to 1.028, Confidence Interval Intercept: -2.0 to -0.2.
LDL: 54 pairs, Range 10-428 mg/dL. Results: Slope: 1.006, Intercept: -1.6, Correlation: 0.9981, Std. Error Est: 4.7, Confidence Interval Slope: 0.989 to 1.023, Confidence Interval Intercept: -3.7 to 0.5.
Triglycerides: 55 pairs, Range 34-994 mg/dL. Results: Slope: 0.992, Intercept: -3.6, Correlation: 0.9993, Std. Error Est: 7.2, Confidence Interval Slope: 0.981 to 1.002, Confidence Interval Intercept: -6.2 to -0.9.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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
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
1
.
| | | 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 Wassermann
Diagnostic Technologies,
LLC | Alfa Wassermann Diagnostic
Technologies, LLC |
| | Name | ACE Axcel Clinical
Chemistry System, ACE
Cholesterol Reagent | ACE Axcel Clinical Chemistry
System, ACE Cholesterol Reagent |
| | Intended Use/
Indications
for Use | Same | 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. |
| | Instrument
Platform | Same | ACE Axcel Clinical Chemistry
System |
| | Basic
Principle | Same | Enzymatic method for cholesterol |
| | Reagent
Composition
Reactive
Ingredients | Same | 4-Aminoantipyrene
p-Hydroxybenzoic acid
Cholesterol oxidase (Nocardia)
Cholesterol esterase (porcine
pancreas and Pseudomonas)
Peroxidase (Horseradish) |
| | Differences | | |
| | Sample
Type | 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, ACE | ||
| HDL-C Reagent | System, ACE HDL-C Reagent | |
| Intended Use/ | ||
| Indications | ||
| for Use | Same | 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 | ||
| Instrument | Same | office laboratories. For in vitro |
| diagnostic use only. | ||
| ACE Axcel Clinical Chemistry | ||
| Platform | System | |
| Basic | ||
| Principle | Same | Detergent solubilization of |
| HDL to selectively measure | ||
| HDL cholesterol using an | ||
| enzymatic method. | ||
| Reagent | ||
| Composition | ||
| Reactive | ||
| Ingredients | Same | Cholesterol oxidase (E. coli) |
| Peroxidase (Horseradish) | ||
| N, N-bis(4-sulphobutyl)-m- | ||
| toluidine-disodium salt | ||
| Accelerator | ||
| Ascorbic oxidase (Curcurbita | ||
| sp.) | ||
| 4-Aminoantipyrene | ||
| Cholesterol esterase | ||
| (Pseudomonas) | ||
| Differences | ||
| Sample Type | Serum and lithium heparin | |
| plasma | Serum |
・・
September 6, 2012
3
| Similarities | Candidate Device | Predicate Device |
|---|---|---|
| 510(k) # | K122757 | K113262 |
| Company | Alfa Wassermann | |
| Diagnostic Technologies, LLC | Alfa Wassermann Diagnostic | |
| Technologies, LLC | ||
| Name | ACE Axcel Clinical | |
| Chemistry System, ACE | ||
| LDL-C Reagent | ACE Axcel Clinical Chemistry | |
| System, ACE LDL-C Reagent | ||
| Intended Use/ | ||
| Indications | ||
| for Use | Same | The ACE LDL-C Reagent is |
| intended for the quantitative | ||
| determination of 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. | ||
| Instrument | ||
| Platform | Same | ACE Axcel Clinical Chemistry |
| System | ||
| Basic | ||
| Principle | Same | Detergent solubilization of LDL |
| to selectively measure LDL | ||
| cholesterol using an enzymatic | ||
| method | ||
| Reagent | ||
| Composition | ||
| Reactive | ||
| Ingredients | Same | Cholesterol esterase |
| Cholesterol oxidase | ||
| Peroxidase | ||
| 4-Aminoantipyrine | ||
| Ascorbic acid oxidase | ||
| Buffer | ||
| N,N-bis (4-sulfobutyl)-m- | ||
| toluidine, disodium salt | ||
| Differences | ||
| Sample Type | Serum and lithium heparin | Serum |
4
| 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. | |||||
| Instrument | |||||
| Platform | 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 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 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. |
| Intended Use: | Indications for Use:
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. |
| | |
·
6
| | 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. |
| 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 Axcel Clinical Chemistry System included matrix comparison
data and precision/reproducibility data. |
| | Precision/Reproducibility |
،
ﺮ
7
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) | ||||
|---|---|---|---|---|---|
| Cholesterol | |||||
| mg/dL | Mean | Within- | |||
| Run | Between | ||||
| Run | Between | ||||
| Day | 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% |
| Analyte
HDL-C
| mg/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-C | ||||||
| mg/dL | Mean | Within- | ||||
| Run | Between | |||||
| Run | Between | |||||
| Dav | 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) | ||||
|---|---|---|---|---|---|
| Triglycerides | |||||
| mg/dL | Mean | Within- | |||
| Run | Between | ||||
| Run | Between | ||||
| Day | 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. The |
| studies consisted of running a series of paired serum (x) and lithium heparin | |
| plasma (y) specimens in singlicate with varying levels of analyte that cover the | |
| assay's dynamic range on the ACE Axcel Clinical Chemistry System. Results | |
| were analyzed using Deming regression. |
ﺮ ﺗﻢ
9
ﻦ
| Reagent | Range | Results ACE Axcel Serum vs. Plasma |
|---|---|---|
| Cholesterol | ||
| 54 pairs | 24-574 mg/dL | Slope: 0.987 |
| Intercept: -1.9 | ||
| Correlation: 0.9987 | ||
| Std. Error Est: 4.7 | ||
| Confidence Interval Slope: 0.974 to 1.001 | ||
| Confidence Interval Intercept: -4.6 to 0.8 | ||
| HDL | ||
| 53 pairs | 6-112 mg/dL | Slope: 1.011 |
| Intercept: -1.1 | ||
| Correlation: 0.9981 | ||
| Std. Error Est: 1.5 | ||
| Confidence Interval Slope: 0.993 to 1.028 | ||
| Confidence Interval Intercept: -2.0 to -0.2 | ||
| LDL | ||
| 54 pairs | 10-428 mg/dL | Slope: 1.006 |
| Intercept: -1.6 | ||
| Correlation: 0.9981 | ||
| Std. Error Est: 4.7 | ||
| Confidence Interval Slope: 0.989 to 1.023 | ||
| Confidence Interval Intercept: -3.7 to 0.5 | ||
| Triglycerides | ||
| 55 pairs | 34-994 mg/dL | Slope: 0.992 |
| Intercept: -3.6 | ||
| Correlation: 0.9993 | ||
| Std. Error Est: 7.2 | ||
| Confidence Interval Slope: 0.981 to 1.002 | ||
| Confidence 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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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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