SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL
Device Facts
| Record ID | K042443 |
|---|---|
| Device Name | SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL |
| Applicant | Arkray, Inc. |
| Product Code | CHH · Clinical Chemistry |
| Decision Date | Nov 24, 2004 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1175 |
| Device Class | Class 1 |
Indications for Use
The SpotChem EZ Total Cholesterol, HDL and Triglyceride test and panel system are an in vitro diagnostic procedures intended to measure Total Cholesterol/HDL Triglyceride quantitatively in human serum and plasma on the SpotChem EZ analyzer. Total Cholesterol measurements are used the diagnosis and treatment of lipid and lipoprotein metabolism disorders. HDL-Cholesterol measurements are used the diagnosis and treatment of lipid and lipoprotein metabolism disorders. 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.
Device Story
SpotChem EZ system performs quantitative in vitro diagnostic analysis of human serum and plasma samples. Device measures Total Cholesterol, HDL, and Triglycerides. System consists of analyzer and individual/panel test reagents. Used in clinical settings by healthcare professionals. Provides quantitative results to assist clinicians in diagnosing and managing lipid metabolism disorders, diabetes, and endocrine conditions. Benefits patient through rapid, point-of-care assessment of lipid profiles.
Clinical Evidence
No clinical data provided; substantial equivalence based on bench testing and performance characteristics for in vitro diagnostic measurement.
Technological Characteristics
Plastic test strips with multilayered test fields (sample retention, reagent, support). Quantitative colorimetric enzyme-based sensing. Designed for use on SpotChem EZ Analyzer. Reagent storage 2-8°C. Traceable to NCEP/CRMLN standards.
Indications for Use
Indicated for quantitative measurement of Total Cholesterol, HDL, and Triglycerides in human serum and plasma for patients requiring diagnosis and treatment of lipid/lipoprotein metabolism disorders, diabetes mellitus, nephrosis, liver obstruction, or endocrine disorders.
Regulatory Classification
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.
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Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE
A. 510(k) Number: k042443
B. Purpose for Submission: Notification of intent to manufacture and market the device: SpotChem EZ Total Cholesterol, HDL Cholesterol, Triglyceride and Lipid Panel Strip (Total Cholesterol, HDL and Triglyceride on one strip)
C. Measurand: Total Cholesterol, Triglyceride, HDL Cholesterol
D. Type of Test: Quantitative Colorimetric
E. Applicant: Polymedco, Inc
F. Proprietary and Established Names: Common Names – Total Cholesterol, Triglyceride, HDL-Cholesterol Proprietary Names – SPOTCHEM Total Cholesterol, SPOTCHEM Triglyceride, SPOTCHEM HDL Cholesterol, SPOTCHEM Lipid Panel Strip
G. Regulatory Information:
1. Regulation section: Total Cholesterol – 21 CFR 862.1175, Triglyceride – 21 CFR 862.1705, HDL Cholesterol – 21 CFR 862.1475
2. Classification: Class I, meets limitations of exemptions 21 CFR 862.9 (c)(4)
3. Product code: Total Cholesterol – CHH, Triglyceride – CDT, HDL Cholesterol – LBS
4. Panel: 75 (Chemistry)
H. Intended Use:
1. Intended use(s): The SpotChem EZ Total Cholesterol, HDL Triglyceride, and SPOTCHEM Lipid Panel Strip test and panel system are an in vitro diagnostic procedure intended to measure Total Cholesterol/HDL/Triglyceride quantitatively in human serum and plasma on the SpotChem EZ Analyzer
2. Indication(s) for use: Total Cholesterol measurements are used in the diagnosis and treatment of lipid and lipoprotein metabolism disorders.
Triglyceride measurements are used in the diagnosis and treatment of
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patients with diabetes mellitus, nephrosis, liver obstruction and other diseases involving lipid metabolism or various endocrine disorders.
HDL Cholesterol measurements are used in the diagnosis and treatment of lipid and lipoprotein metabolism disorders.
3. Special conditions for use statement(s): For prescription use only
4. Special instrument requirements: These assays are intended for use on the SpotChem EZ analyzer.
I. Device Description: The Polymedco, Inc SPOTCHEM Cholesterol, Triglyceride, HDL Cholesterol and Lipid Panel Strip are in vitro diagnostic procedures intended to measure Total Cholesterol/HDL/Triglyceride quantitatively in human serum and plasma on the SpotChem EZ Analyzer.
The device is composed of plastic strips to which a multilayered test field is affixed. The layers consist of a sample retention layer, a layer containing the reagents and a support layer. Twenty five strips and one calibration card are packaged together.
The Lipid Panel Strip consists of a Cholesterol, Triglyceride and HDL Cholesterol Assay on one strip.
J. Substantial Equivalence Information:
1. Predicate device name(s): HDL kit, Bayer Advia 1650, Total Cholesterol kit, Bayer Advia 1650, Triglyceride kit, Bayer Advia 1650
2. Predicate 510(k) number(s): k982341, k923504, k923508
3. Comparison with predicate:
| | Total cholesterol | HDL Cholesterol | Triglycerides |
| --- | --- | --- | --- |
| Predicate Methodology | colorimetric enzyme-based | colorimetric enzyme-based | Colorimetric enzyme-based |
| Test Methodology | colorimetric enzyme-based | colorimetric enzyme-based | Colorimetric enzyme-based |
| Predicate Reagent Storage | 2-8°C | 2-8°C | 2-8°C |
| Test Reagent Storage | 2-8°C | 2-8°C | 2-8°C |
| Predicate Sample types | Serum/Plasma, Whole blood | Serum/Plasma, Whole blood | Serum/Plasma, Whole blood |
| Test Sample Types | Serum/Plasma, Whole blood | Serum/Plasma, Whole blood | Serum/Plasma, Whole blood |
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| Predicate Controls | Recommended | Recommended | Recommended |
| --- | --- | --- | --- |
| Test Controls | Recommended | Recommended | Recommended |
| Correlation with Predicate device | N = 93. Samples spanned from 73 mg/dL to 309 mg/dL. The regression equation was y = 0.927x + 6.04 and r = 0.992 | N = 55. Samples spanned from 21 mg/dL to 87 mg/dL. The regression equation was y = 0.9097 + 3.86 and r = 0.966 | N = 80. Samples spanned from 64.8 mg/dL to 203.4 mg/dL. The regression equation was y = 1.0253x - 0.0893 and r = 0.993. |
K. Standard/Guidance Document Referenced (if applicable): Cholesterol and HDL Cholesterol were certified by the Cholesterol Reference Method Laboratory Network (CRMLN) as meeting the National Cholesterol Program's (NCEP) performance criteria for accuracy and precision.
L. Test Principle: The Total Cholesterol, HDL Cholesterol and Triglyceride assays are based on established colorimetric procedures.
M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Intra-assay precision was assessed by assaying three samples twenty times in one run. The results are presented in the table below:
Intra Assay Precision on Spot Chem Analyzer. Results reported in mg/dL.
| Analyzer Poly Chem | | Level 1 | Level 2 | Level 3 |
| --- | --- | --- | --- | --- |
| Total Cholesterol | n | 20 | 20 | 20 |
| | Mean | 132 | 166 | 246 |
| | SD | 2.49 | 3.08 | 7.74 |
| | %CV | 1.88 | 1.86 | 3.15 |
| HDL | Mean | 40.5 | 55.9 | 92.3 |
| | SD | 1.27 | 1.57 | 3.42 |
| | %CV | 3.15 | 2.81 | 3.71 |
| Triglyceride | Mean | 98.7 | 167.7 | 394.5 |
| | SD | 3.15 | 3.53 | 11.48 |
| | %CV | 3.19 | 2.10 | 2.91 |
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Interassay precision was assessed by assaying three samples in duplicate in ten runs over ten days. The results are presented below.
Inter Assay Precision on Poly-Chem Analyzer. Results reported in mg/dL.
| Analyzer Poly Chem | | Level 1 | Level 2 | Level 3 |
| --- | --- | --- | --- | --- |
| Total Cholesterol | Days | 10 | 10 | 10 |
| | n | 20 | 20 | 20 |
| | Mean | 132 | 168 | 245 |
| | SD | 2.67 | 2.69 | 11.64 |
| | %CV | 2.02 | 1.60 | 4.75 |
| HDL | Mean | 26.2 | 46.1 | 69.8 |
| | SD | 2.10 | 3.38 | 5.80 |
| | %CV | 8.00 | 7.34 | 8.31 |
| Triglyceride | Mean | 93.8 | 166.8 | 389.4 |
| | SD | 4.31 | 5.33 | 14.14 |
| | %CV | 4.59 | 3.19 | 3.63 |
b. Linearity/assay reportable range: The linearity was assessed by assaying serial dilutions. The linearity claim is based on a percent deviation of ≤5% at the two highest concentrations. The results obtained were as follows: Total Cholesterol 50 – 400 mg/dL, HDL Cholesterol 10 – 122 mg/dL and Triglyceride 9.6 – 507 mg/dL.
c. Traceability, Stability, Expected values (controls, calibrators, or methods): Polymedco has documented traceability to the National Cholesterol Education Program's recommended accuracy base for Total Cholesterol and HDL Cholesterol by performing a direct comparison with a Cholesterol Reference Method Laboratory Network laboratory using fresh human specimens which cover the NCEP medical decision points.
d. Detection limit: Functional sensitivity was assessed by diluting a pool of 10 different concentrations below the lower limit of the analyte range. Three runs were performed over three different days on the SpotChem EZ analyzer. The mean, standard deviation and coefficient of variation was calculated for the ten replicates of each dilution. The functional sensitivity of the test was defined as the value of the dilution where the CV is approximately 20% (taking into consideration that the actual mean was within ±10% of the expected target). It was determined as follows: 33mg/dL with a CV reported at 4.5% for Total Cholesterol, 8.2 mg/dL with a CV of 4.1% for HDL, and 9.6mg/dL with a CV reported at 5.4% for Triglyceride.
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e. Analytical specificity: Studies were performed to assess common or known substances that could interfere with the method. A summary of the data for known interferents appears for the common interferents in the table below:
| | Total Cholesterol | HDL | Triglyceride |
| --- | --- | --- | --- |
| Sample | Highest Level Tested with No Interference | Highest Level Tested with No Interference | Highest Level Tested with No Interference |
| Hemoglobin | 500 mg/dL | 50 mg/dL | 350 mg/dL |
| Bilirubin | 9 mg/dL | 3.0 mg/dL | 3.0 mg/dL |
| Triglycerides | 200 mg/dL | 200 mg/dL | |
f. Assay cut-off: N/A
2. Comparison studies:
a. Method comparison with predicate device: A clinical correlation study was performed comparing the Total Cholesterol, HDL and Triglyceride tests and Total Cholesterol, HDL and Triglyceride strip results generated by the SpotChem against the results from the Bayer Advia. Additionally, the Total Cholesterol and HDL cholesterol reagent systems were certified by CRMLN. The comparison with the predicate device yielded the following results: Total Cholesterol - N = 93, samples spanned from 73 mg/dL to 309 mg/dL, regression equation was Y = 0.927x + 6.04 and r = 0.992; HDL Cholesterol - N = 55, samples spanned from 21 mg/dL to 87 mg/dL, regression equation was Y = 0.9097 + 3.86 and r = 0.966; Triglycerides - N = 80, samples spanned from 64.8 mg/dL to 203.4 mg/dL, regression equation was Y = 1.0253x - 0.0893 and r = 0.993.
b. Matrix comparison: A clinical correlation study was performed comparing the Total Cholesterol, HDL and Triglyceride test results generated against the results generated from whole blood samples when performed on the SPOTCHEM EZ Analyzer. The HDL regression equation was Y = 1.123x + 0.9756 and r² = 0.981344, N=29. For Total Cholesterol Serum and Whole Blood Comparison the regression equation was Y = 1.0108x - 4.3387 and r² = 0.9668, N=29. For Triglycerides Serum and Whole Blood Comparison the regression equation was Y = 2.623x + 1.050x and r² = 0.9993, N=31.
3. Clinical studies:
a. Clinical Sensitivity: N/A
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b. Clinical specificity: N/A
c. Other clinical supportive data (when a. and b. are not applicable):
4. Clinical cut-off: N/A
5. Expected values/Reference range:
Cholesterol - (NCEP guidelines)
Risk levels
| Value | Interpretation |
| --- | --- |
| < 200 mg/dL (5.17 mMol/L) | Desirable blood cholesterol |
| 200-239 mg/dL (5.17 - 6.18 mMol/L) | Borderline-high blood cholesterol |
| ≥ 240 mg/dL (6.20 mMol/L) | High blood cholesterol |
Normal Triglyceride Values¹: 50 - 130 mg/dL (0.56 - 1.47 mmol/L)
The following upper limits are recommended for the determination of the risk factor hypertriglyceridemia:
Borderline-high from: 150 mg/dL or (1.71 mmol/L)
High from: 200 mg/dL or (2.29 mmol/L)
Very high: ≥500 mg/dL or (5.64 mmol/L)
HDL Cholesterol - (NCEP guidelines)
| mg/dL | mMol/L | |
| --- | --- | --- |
| ≤ 40 | ≤1.04 | Low |
| ≥60 | ≥1.55 | High |
N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
¹ J of Am. Med. Assoc. 1984,251:1196-2000
