HDL CHOLESTEROL REAGENT, MODEL 10211

K073497 · Medica Corp. · LBS · Apr 14, 2008 · Clinical Chemistry

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)

Submission Summary (Full Text)

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K073497
December 6, 2007

Medica Corporation 510(k) Submission EasyRA HDL Cholesterol Reagent

Page 22

## 510(k) Summary

| Date of summary: | December 6, 2007 | APR 14 2008 |
|------------------|-------------------------------------------------------------------------------------------------|-------------|
| Product Name: | HDL Cholesterol Reagent | |
| Manufacturer: | Medica Corporation<br>5 Oak Park Drive<br>Bedford, MA 01730 | |
| Correspondent: | Photios Makris<br>Director QA/RA<br>Medica Corporation<br>5 Oak Park Drive<br>Bedford, MA 01730 | |

## Substantial Equivalent Device:

| | Manufacturer: | Genzyme Corporation |
|--|---------------|-------------------------------------|
| | Product: | Cobas Ready HDL Cholesterol Reagent |

| Product<br>Attribute | Medica HDL Cholesterol<br>Reagent | Genzyme HDL Cholesterol<br>Reagent for Cobas-Mira | Substantial<br>Equivalent |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Intended Use | Clinical chemistry reagent<br>used to provide a<br>quantitative measurement of<br>High Density Lipoprotein<br>(HDL) in human serum<br>using the EasyRA chemistry<br>analyzer. | Clinical chemistry reagent<br>used to provide a quantitative<br>measurement of High<br>Density Lipoprotein (HDL)<br>in human serum using the<br>Roche Cobas-Mira chemistry<br>analyzer. | √ |
| Sample | Serum | Serum | √ |
| Test<br>Methodology | EasyRA ready-to-use<br>enzymatic assay reagent | Cobas-Mira ready-to-use<br>enzymatic assay reagent | √ |

The EasyRA HDL cholesterol reagent is intended for the quantitative Intended Use: 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

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Medica's HDL cholesterol reagent consists of two parts R1 and R2. Methodology: The first step involves the removal of other non-HDL lipoproteins via selective reaction with reagent R1. In the second step, the selective detergent in R2 solubilizes the HDL cholesterol specifically, which then reacts with a chromagen to develop a color that can be read optically at 600nm. The intensity of the color is proportional to the concentration of HDL cholesterol in the sample.

## Performance Data:

Linearity:

Linearity studies, based on CLSI EP-6A, were performed using NIST-traceable commercial linearity standards on the EasyRA Chemistry analyzers. The HDL cholesterol reagent is linear from 2 to 150mg/dL.

Within-Run Precision:

Within-run precision was determined following CLSI EPA-A2. Five replicates of two levels of a commercial serum-based Quality control material were tested each day for five days on three analyzers.

| | Bio-Rad L1 | | Randox L2 | |
|------------|------------|-----------|-----------|-----------|
| | EasyRA #2 | EasyRA #3 | EasyRA #2 | EasyRA #3 |
| Grand Mean | 32.5 | 32.1 | 64.3 | 62.8 |
| Std. Dev. | 0.63 | 0.69 | 0.94 | 0.62 |
| CV% | 1.9% | 2.2% | 1.5% | 1.0% |

EasyRA HDL cholesterol reagent Within-run precision

Total Precision:

Total precision was determined following CLSI EPA-A2. Two levels of a commercial serum-based Quality control material werc tested in duplicate twice daily for 20 days on three EasyRA nalyzers.

| | Bio-Rad L1 | | Randox L2 | |
|------------|------------|-----------|-----------|-----------|
| | EasyRA #2 | EasyRA #3 | EasyRA #2 | EasyRA #3 |
| Grand Mean | 33.1 | 33.2 | 64.6 | 64.2 |
| Std. Dev. | 0.82 | 0.84 | 1.37 | |
| CV% | 2.47% | 2.51% | 2.12% | 1.91% |

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Method Comparison:

Method comparison was based on EP7-A. At least 40 samples were tested in two EasyRA analyzers using Medica's reagent and in duplicate on a Cobas Mira analyzer using the Genzyme reagent. Medica's HDL cholesterol reagent correlated excellently with the predicate device.

Sample carryover:

Sample carryover, within run drift, was tested based on CLSI EP10-A2. Eleven samples were analyzed that are L (low), M (mid-range) and H (high) range in a predefined sequence twice in a single day. There was no evidence of sample carryover.

Sensitivity:

The limit of detection, or analytical sensitivity, was determined by testing 20 replicates of reagent grade water, then calculating the mean plus two standard deviation units (mean + 2SD). The functional sensitivity was determined as the reagent grade water mean, as determined above, plus seven standard deviation units (mean + 7SD).

The analytical sensitivity of the EasyRA HDL cholesterol reagent is 0.86 mg/dl and the lower limit of detection is 1.3 mg/dl.

Interference testing:

Testing for interference substances was based on CLSI EP-7A. The following substances were tested: Hemoglobin to 500 mg/dl; Billirubin to 20 mg/dl; and Lipemia (using intralipid).

| Hemoglobin | No interferences up to 500mg/dl |
|------------|----------------------------------|
| Billirubin | No interferences up to 32.5mg/dl |
| Lipemia | No interferences up to 1000mg/dl |

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Druq Administration 2098 Gaither Road Rockville MD 20850

Medica Corp. c/o Photios Makris 5 Oak Park Drive Bedford, MA 01730

APR 1 4 2008

k073497 Re:

> Trade/Device Name: Hdl Cholesterol Reagent, Model 10211 Regulation Number: 21 CFR §862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I, meets the limitations to exemption in 21 CFR 862.9(c)(4) Product Code: LBS, JIT Dated: February 28, 2008 Received: March 03, 2008

Dear Mr. Makris:

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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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

k073497 510(k) Number:

Device Name: EasyRA HDL Cholesterol Reagent

Indications 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.

EasyRA HDL Cholesterol Calibrator Device Name:

Indications for Use:

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.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitye Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety