HDL CHOLESTEROL REAGENT, MODEL 10211
Device Facts
| Record ID | K073497 |
|---|---|
| Device Name | HDL CHOLESTEROL REAGENT, MODEL 10211 |
| Applicant | Medica Corp. |
| Product Code | LBS · Clinical Chemistry |
| Decision Date | Apr 14, 2008 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1475 |
| Device Class | Class 1 |
Intended Use
The EasyRA HDL cholesterol reagent is intended for the quantitative determination of High Density Lipoprotein Cholesterol in human serum, using the Medica "EasyRA Chemistry analyzer" in clinical laboratories to screen for low HDL levels as a risk factor in coronary artery disease. For in-vitro diagnostic use only. For professional use only.
Device Story
In vitro diagnostic reagent kit for quantitative HDL cholesterol measurement in human serum; used on Medica EasyRA Chemistry Analyzer. Two-reagent system (R1, R2): R1 removes non-HDL lipoproteins; R2 contains detergent to selectively solubilize HDL; HDL reacts with chromagen for colorimetric detection at 600nm. Operated by professional laboratory personnel in clinical settings. Output is HDL concentration (mg/dL) used by clinicians to assess coronary heart disease risk; results interpreted against NCEP ATPIII reference ranges.
Clinical Evidence
No clinical data. Bench testing only. Performance validated via method comparison against predicate (n=61, range 2-148 mg/dL, y=0.93x+1.8, r²=0.9976). Precision evaluated per CLSI EP5-A2; linearity per EP6-A (2-150 mg/dL); interference testing per EP7-A; limit of blank determined as 1.3 mg/dL.
Technological Characteristics
Enzymatic colorimetric assay; two-part reagent (R1/R2). Optical detection at 600nm. Linear range 2-150 mg/dL. Designed for use on Medica EasyRA Chemistry Analyzer. Standards: CLSI EP-6A (linearity), CLSI EP5-A2 (precision), CLSI EP-7A (interference).
Indications for Use
Indicated for quantitative determination of HDL cholesterol in human serum to assist in diagnosis and treatment of patients at risk of coronary heart disease. For professional in-vitro diagnostic use.
Regulatory Classification
Identification
A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
Predicate Devices
- Ultra N-Geneous HDL Cholesterol Reagent and calibrator (k021316)
Related Devices
- K071706 — ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118) · Clinical Data, Inc. · Dec 20, 2007
- K971526 — ACE HDL-C REAGENT · Schiapparelli Biosystems, Inc. · May 21, 1997
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE
A. 510(k) Number:
k073497
B. Purpose for Submission:
Notification of intent to manufacture and market new devices for the determination of High Density Lipoprotein Cholesterol in Serum.
C. Measurand:
High Density Lipoprotein Cholesterol (HDL)
D. Type of Test:
Colorimetric Trinder reaction
E. Applicant:
Medica Corporation
F. Proprietary and Established Names:
Proprietary Name – Medica Corporation EasyRA HDL-Cholesterol Reagent
Established Name – HDL Cholesterol
G. Regulatory Information:
1. Regulation section:
21 CFR 862.1475: Lipoprotein Test System
21 CFR 862.1150: Calibrator
2. Classification:
Class II – Medica Corporation HDL Calibrator
Class I (meets the exemptions 21 CFR 862.9(c)(4)) – Medica Corporation
EasyRA HDL-Cholesterol Reagent
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3. Product code:
Medica Corporation EasyRA HDL-Cholesterol – LBS
Medica Corporation EasyRA HDL-Cholesterol Calibrator – JIT
4. Panel:
75 - Chemistry
H. Intended Use:
1. Intended use(s):
See Indications for Use
2. Indication(s) for use:
The EasyRA HDL Cholesterol reagent is intended for the quantitative determination of High Density Lipoprotein Cholesterol in human serum on the Medica EasyRA Chemistry Analyzer. The Medica EasyRA HDL-Cholesterol reagent can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease.
The EasyRA HDL Cholesterol calibrator is intended for the one point calibration of the HDL reagent prior to patient serum sample analysis on the EasyRA clinical chemistry analyzer.
For in vitro diagnostic use only. For professional use only.
3. Special conditions for use statement(s):
For prescription use only.
4. Special instrument requirements:
For use on the EasyRA Chemistry Analyzer.
I. Device Description:
The Medica EasyRA HDL cholesterol reagent consists of two reagents, R1 and R2.. The direct assay method involves the removal of non-HDL lipoproteins via R1. The second step of the assay involves R2 which contains a detergent which selectively solubilizes HDL. HDL then reacts with a chromagen to develop a color at 600nm.
This device has been certified by the Cholesterol Reference Method Laboratory Network.
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J. Substantial Equivalence Information:
1. Predicate device name(s):
Ultra N-Geneous HDL Cholesterol Reagent and calibrator.
2. Predicate K number(s):
k021316
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Indication for Use | The EasyRA HDL Cholesterol reagent is intended for the quantitative determination of High Density Lipoprotein Cholesterol in human serum on the Medica EasyRA Chemistry Analyzer. | For the quantitative determination of high density lipoprotein cholesterol (HDL-C) in human serum or plasma |
| Type of Test | Quantitative | Quantitative |
| Specimen Type | Serum | Serum or Plasma |
| Calibrator | Lyophilized | Lyophilized |
K. Standard/Guidance Document Referenced (if applicable):
The following standards have been used to support this submission:
CLSI:
EP05-A2 – Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition
EP06-A - Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline
EP7-P Interference Testing in Clinical Chemistry Approved Guideline – Second Edition
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EP09-A2 – Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline -Second Edition
EP10-A3 - Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures
EP17-A - Protocols for Determination of Limits of Detection
EP21-A - Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline
## L. Test Principle:
Colorimetric Trinder reaction (Cholesterol Oxidase and Cholesterol Esterase)
## M. Performance Characteristics (if/when applicable):
### 1. Analytical performance:
#### a. Precision/Reproducibility:
Total and within run precision were determined based upon CLSI EP5-A2. Three levels of commercial serum based quality control material were tested on multiple EasyRA analyzers (Level 1 and 2 on EasyRA #2, Easy RA #3 and Level 3 on EasyRA #2, Easy RA #3, and analyzer 08011000).
Within Run Precision
| | Level 1 | | Level 2 | | Level 3 | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | EasyRA #2 | EasyRA #3 | EasyRA #2 | EasyRA #3 | PP03 | PP11 | 08011000 |
| N | 80 | 80 | 80 | 80 | 80 | 80 | 80 |
| Mean | 64.6 | 64.2 | 33.1 | 33.2 | 38.7 | 38.8 | 39.6 |
| SD | 0.96 | 0.83 | 0.46 | 0.65 | 0.62 | 0.43 | 0.79 |
| CV% | 1.49 | 1.29 | 1.39 | 1.96 | 1.61 | 1.12 | 2.00 |
Total Precision
| | Level 1 | | Level 2 | | Level 3 | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | EasyRA #2 | EasyRA #3 | EasyRA #2 | EasyRA #3 | PP03 | PP11 | 08011000 |
| N | 80 | 80 | 80 | 80 | 80 | 80 | 80 |
| Mean | 64.6 | 33.1 | 64.2 | 33.2 | 38.7 | 38.8 | 39.6 |
| SD | 1.37 | 0.82 | 1.22 | 0.83 | 0.89 | 0.72 | 1.21 |
| CV% | 2.12 | 2.47 | 1.91 | 2.51 | 2.27 | 1.86 | 3.05 |
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b. Linearity/assay reportable range:
Linearity determination was based upon CLSI EP6-A and was performed separately on two Medica EasyRA analyzers. Each level was measured in duplicate. Nine samples were serially diluted from a level of 150 to 2 mg/dL. The linear regression results for analyzer 1 were y=1.0289x-1.1945, r²=0.9999, and for analyzer 2 were y=1.0066x-0.8358, r²=0.9994.
The claimed reportable range of the assay is 2 – 150 mg/dL.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Accelerated stability studies were performed using acceptable protocols for on-board and shelf life stability. Real-time studies are on-going. The stored stability (shelf-life) is 24 months and the on-board stability is 24 days when stored at 2 – 8°C.
The EasyRA HDL-Cholesterol calibrator was previously cleared under k021316.
d. Detection limit:
Twenty replicates of water were analyzed on three EasyRA analyzers to determine the Limit of Blank. A serum sample was prepared with a value close to the lower measuring range of the assay. The sample was analyzed twenty times on three EasyRA analyzers to determine performance with a low concentration sample. The limit of a blank sample is 1.3 mg/dL. The low end of the claimed measuring range is 2 mg/dL.
e. Analytical specificity:
To determine the level of interference from substances normally present in human serum, the Medica EasyRA HDL-Cholesterol Assay was tested with normal serum samples containing about 39 mg/dL HDL-C spiked with various concentrations of potentially interfering substances following CLSI guideline EP7-A on the Medica EasyRA Chemistry Analyzer. The following substances normally present in serum produced less than 10% deviation when tested at levels equal to the following concentrations:
| Interference Substance | Concentration |
| --- | --- |
| Bilirubin | 32.50 mg/dL |
| Hemoglobin | 500 mg/dL |
| Lipemia using Intralipid | 1000 mg/dL |
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f. Assay cut-off:
Not applicable
2. Comparison studies:
a. Method comparison with predicate device:
A total of 61 samples were tested on the device and compared with results on the same samples tested using a predicate assay on the Cobas Mira. Samples ranged from 2 to 148 mg/dL. The resulting regression statistics are as follows: y = 0.93x+1.8, r² = 0.9976. Samples within the clinically relevant range between 2 and 80 mg/dL demonstrated linear regression results of y = 0.965x + 0.37, r² = 0.9965.
b. Matrix comparison:
Not applicable
3. Clinical studies:
a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable
4. Clinical cut-off:
Not applicable
5. Expected values/Reference range:
Less than 40 mg/dL – A risk factor for heart disease
60 mg/dL and above – Considered protective against heart disease
* Third report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and treatment of High Blood Cholesterol in Adults (NCEP ATPIII)
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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.
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