EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT

K072249 · Medica Corp. · CHH · Feb 20, 2008 · Clinical Chemistry

Device Facts

• Record ID: K072249
• Device Name: EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT
• Applicant: Medica Corp.
• Product Code: CHH · Clinical Chemistry
• Decision Date: Feb 20, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1175
• Device Class: Class 1

Intended Use

EasyRA Calcium Reagent is intended for the quantitative determination of total calcium concentration in serum using the Medica EasyRA Chemistry Analyzer. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). For in-vitro diagnostic use only. For Professional use only. The EasyRA Cholesterol Reagent is intended for the quantitative determination of cholesterol in human serum on the Medica EasyRA Chemistry analyzer to screen for elevated cholesterol as a risk factor in coronary artery disease. For in-vitro diagnostic use only. For Professional Use Only.

Device Story

Reagents for quantitative serum analysis on Medica EasyRA Chemistry Analyzer; professional use in clinical settings. Calcium assay: two-reagent system (Arsenazo III/8-hydroxyquinoline-5-sulfonic acid) forms blue complex proportional to calcium concentration; measured at 650 nm. Cholesterol assay: enzymatic endpoint (cholesterol esterase/oxidase/peroxidase) produces quinoneimine dye proportional to cholesterol concentration. Output: quantitative concentration values (mg/dL). Healthcare providers use results for diagnosis/treatment of metabolic/cardiovascular conditions.

Clinical Evidence

Bench testing only. Precision/reproducibility evaluated per CLSI EP5-A2. Linearity confirmed across 1-15 mg/dL (calcium) and 10-600 mg/dL (cholesterol). Analytical specificity tested against hemoglobin, bilirubin, intralipid, glucose, and ascorbic acid. Method comparison performed against Roche COBAS MIRA analyzer (n=49 for calcium, n=53 for cholesterol) showing high correlation (R²=0.9874 and 0.9992 respectively).

Technological Characteristics

Ready-to-use liquid enzyme assay reagents. Calcium: Arsenazo III colorimetric method. Cholesterol: Enzymatic Trinder endpoint reaction. Analyzed via Medica EasyRA Chemistry Analyzer. Connectivity: Integrated with analyzer system. No specific materials of construction or software algorithm class provided beyond standard clinical chemistry photometric detection.

Indications for Use

Indicated for quantitative determination of total calcium and cholesterol in human serum. Calcium: used in diagnosis/treatment of parathyroid disease, bone diseases, chronic renal disease, and tetany. Cholesterol: used to screen for elevated cholesterol as a risk factor for coronary artery disease. For professional, in-vitro diagnostic use.

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.

Predicate Devices

• Cobas Ready Cholesterol Reagent
• Cobas Ready Calcium Reagent

Submission Summary (Full Text)

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# 510(k) Summary

| Date of summary | February 15, 2007 |
|-----------------|---------------------------------------------------------------------------------------------------|
| Product Name | EasyRA Cholesterol Reagent<br>EasyRA Calcium Reagent |
| Sponsor | Medica Corporation<br>5 Oak Park Drive<br>Bedford, MA 01730 |
| Correspondent | MDC Associates, LLC<br>Fran White, Regulatory Consultant<br>163 Cabot Street<br>Beverly, MA 01915 |

### Substantially Equivalent Device

Manufacturer: Roche Diagnostic Systems, Inc. Product: Cobas Ready Cholesterol Reagent Cobas Ready Calcium Reagent

| Product Attribute | Medica Cholesterol and<br>Calcium Reagents | Roche Cobas Reagents | Substantial<br>Equivalent |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Intended use | Cholesterol - clinical<br>chemistry reagent used to<br>provide a quantitative<br>measurement of total<br>cholesterol in human serum<br>using the EasyRA<br>Chemistry Analyzer.<br>Calcium – clinical<br>chemistry reagent used to<br>provide a quantitative<br>measurement of total<br>calcium in human serum<br>using the EasyRA<br>Chemistry Analyzer. | Cholesterol - clinical<br>chemistry reagent used to<br>provide a quantitative<br>measurement of total<br>cholesterol in human serum<br>using the Roche Cobas<br>Chemistry Analyzer.<br>Calcium – clinical<br>chemistry reagent used to<br>provide a quantitative<br>measurement of total<br>calcium in human serum<br>using the Roche Cobas<br>Chemistry Analyzer. | √ |
| Sample | Serum | Serum | √ |
| Test<br>methodology | Cholesterol - EasyRA<br>Analyzer ready-to-use<br>enzyme assay reagents. | Cholesterol- Cobas<br>Chemistry Analyzer<br>Ready to use enzyme assay | √ |

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Request for Additional Information

| Calcium - EasyRA<br>Analyzer ready-to-use<br>reagents using AZO<br>methodology. | reagents.<br>Calcium – Cobas<br>Chemistry Analyzer Ready<br>to use reagents using AZO<br>methodology | |
|---------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|--|
|---------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|--|

# Intended Use

Calcium

EasyRA Calcium Reagent is intended for the quantitative determination of total calcium concentration in serum using the Medica EasyRA Chemistry Analyzer.

For in-vitro diagnostic use only. For Professional use only.

# Cholesterol

The EasyRA Cholesterol Reagent is intended for the quantitative determination of cholesterol in human serum on the Medica EasyRA Chemistry analyzer in clinical laboratories to screen for elevated cholesterol as a risk factor in coronary artery disease.

For in-vitro diagnostic use only. For Professional Use Only.

# Methodology

## Calcium

The EasyRA Calcium reagent utilizes Arsenazo III, which is very stable and has a high affinity for calcium at neutral pH. Interference from magnesium is eliminated by the addition of 8-hydroxyquinoline-5-sulfonic acid. Arsenazo III reacts with calcium to form a 1:1 blue complex with an absorption maximum at 650 nm. The concentration of calcium is proportional to the intensity of the blue color

### Cholesterol

The EasyRA Cholesterol reagent uses the enzymatic Trinder endpoint reaction, which is based on the work of Allain et al. In this method, cholesterol esters are hydrolyzed by cholesterol esterase to cholesterol and fatty acids. Cholesterol is oxidized by cholesterol oxidase to delta 4cholestenone with the simultaneous production of hydrogen peroxide. In the presence of peroxidase, hydrogen peroxide oxidizes phenol and 4aminoantipyrine to give a quinoneimine dye colored red. The absorbance of the resulting quinoneimine dye is measured at 520 nm with 600 nm as a blanking wavelength. The intensity of the color produced is proportional to the concentration of cholesterol in the sample.

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### Performance Data

## Linearity

Linearity studies, based on CLSI EP-6A, were performed using NIST-traceable commercial linearity standards on EasyRA Chemistry analyzers. The EasyRA Calcium Reagent is linear from 1mg/dL to 15mg/dL. The EasyRA Cholesterol reagent is linear from 10mg/dL to 600mg/dL.

# Within Run Precision

Within run precision; Twenty replicates of three levels of commercial human-based QC material were tested.

EasyRA Calcium Reagent

| QC Level | Within Run SD | Within Run CV |
|----------|---------------|---------------|
| mg/dL | mg/dL | % |
| 12.81 | 0.23 | 1.8 |
| 9.73 | 0.19 | 1.9 |
| 5.24 | 0.17 | 3.3 |

EasyRA Cholesterol Reagent

| QC Level | Within Run SD | Within Run CV |
|----------|---------------|---------------|
| mg/dL | mg/dL | % |
| 215.90 | 4.13 | 1.9 |
| 168.05 | 1.76 | 1.0 |
| 105.70 | 1.34 | 1.3 |

### Total Precision

Total Imprecision: Duplicate measurements of each of three levels of QC material were tested twice a day for 20 days.

EasyRA Calcium Reagent

| QC Level | Total Imprecision (SD) | Total Imprecision (CV) |
|----------|------------------------|------------------------|
| mg/dL | mg/dL | % |
| 11.78 | 0.16 | 1.33 |
| 9.03 | 0.13 | 1.46 |
| 5.95 | 0.12 | 1.95 |

### EasyRA Cholesterol Reagent

| QC Level<br>mg/dL | Total Imprecision (SD)<br>mg/dL | Total Imprecision (CV)<br>% |
|-------------------|---------------------------------|-----------------------------|
| 168.5 | 2.5 | 1.5 |
| 302.9 | 3.6 | 1.2 |
| 106.2 | 1.3 | 1.2 |

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# Method Comparison

Method comparison was based on EP7-A. At least 40 samples for each analyte were tested in duplicate on the EasyRA Chemistry Analyzer and the Roche COBAS MIRA analyzer.

Both reagents correlated excellently with the predicate device.

## Sample Carryover

Sample carryover, within-run drift, was tested based on CLSI EP10-A2. 11 samples that are L (low) M (mid-range) and H (high) in a predefined sequence twice in a single day. There was no evidence of sample carryover

# Interference Testing

Testing for interfering substances was based on CLSI EP-7A. The following substances were tested: Hemoglobin to 500 mg/dL; Bilirubin to 20 mg/dL; and Lipemia (using Intralipid).

EasyRA Calcium Reagent

| Hemoglobin | no interference up to 500 mg/dL |
|---------------|----------------------------------|
| Bilirubin | no interference up to 20 mg/dL |
| Triglycerides | no interference up to 2250 mg/dL |

EasyRA Cholesterol Reagent

| Hemoglobin | no interference up to 500 mg/dL |
|---------------|----------------------------------|
| Bilirubin | no interference up to 5 mg/dL |
| Lipemia | no interference up to 2250 mg/dL |
| Glucose | no interference up to 600 mg/dL |
| Ascorbic Acid | no interference up to 9 mg/dL |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

FEB 20 2008

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Medica Corp. c/o Ms. Fran White MDC Associates, LLC 163 Cabot Street Beverly, MA 01915

> k072249 Trade Name: EasyRA Calcium Reagent, EasyRA Cholesterol Reagent Regulation Number: 21 CFR 862.1145 Regulation Name: Calcium test system Regulatory Class: Class II Product Code: CJY, CHH Dated: January 31, 2008 Received: February 05, 2008

Dear Ms. White:

Re:

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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Page 2 -

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.

Jean 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

510(k) Number (if known): K072249

Device Name:

EasyRA Calcium Reagent EasyRA Cholesterol Reagent

Indications for Use:

EasyRA Calcium

EasyRA Calcium Reagent is intended for the quantitative determination of total calcium concentration in serum using the Medica EasyRA Chemistry Analyzer. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). For in-vitro diagnostic use only. For Professional use only.

EasyRA Cholesterol

The EasyRA Cholesterol Reagent is intended for the quantitative determination of cholesterol in human serum on the Medica EasyRA Chemistry analyzer to screen for elevated cholesterol as a risk factor in coronary artery disease.

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 OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k072249