(191 days)
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.
Not Found
Here's a summary of the acceptance criteria and study information for the EasyRA Calcium Reagent and EasyRA Cholesterol Reagent, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Explicit or Implied) | EasyRA Calcium Reagent Performance | EasyRA Cholesterol Reagent Performance |
|---|---|---|---|
| Linearity | Must be linear within specified ranges. | Linear from 1mg/dL to 15mg/dL. | Linear from 10mg/dL to 600mg/dL. |
| Within Run Precision | No explicit numerical criteria stated, but typically demonstrated by low SD/CV values at various QC levels. | QC Level 12.81 mg/dL: SD 0.23 mg/dL, CV 1.8% QC Level 9.73 mg/dL: SD 0.19 mg/dL, CV 1.9% QC Level 5.24 mg/dL: SD 0.17 mg/dL, CV 3.3% | QC Level 215.90 mg/dL: SD 4.13 mg/dL, CV 1.9% QC Level 168.05 mg/dL: SD 1.76 mg/dL, CV 1.0% QC Level 105.70 mg/dL: SD 1.34 mg/dL, CV 1.3% |
| Total Imprecision | No explicit numerical criteria stated, but typically demonstrated by low SD/CV values at various QC levels. | QC Level 11.78 mg/dL: SD 0.16 mg/dL, CV 1.33% QC Level 9.03 mg/dL: SD 0.13 mg/dL, CV 1.46% QC Level 5.95 mg/dL: SD 0.12 mg/dL, CV 1.95% | QC Level 168.5 mg/dL: SD 2.5 mg/dL, CV 1.5% QC Level 302.9 mg/dL: SD 3.6 mg/dL, CV 1.2% QC Level 106.2 mg/dL: SD 1.3 mg/dL, CV 1.2% |
| Method Comparison | "Correlated excellently" with the predicate device (Roche COBAS MIRA analyzer). | Correlated excellently with the predicate device. | Correlated excellently with the predicate device. |
| Sample Carryover | No evidence of sample carryover. | No evidence of sample carryover. | No evidence of sample carryover. |
| Interference Testing | No interference from specified substances up to certain concentrations. | Hemoglobin: no interference up to 500 mg/dL Bilirubin: no interference up to 20 mg/dL Triglycerides: no interference up to 2250 mg/dL | 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 |
2. Sample Size Used for the Test Set and Data Provenance
- Linearity: The number of unique samples is not specified, but the study used "NIST-traceable commercial linearity standards." The data provenance (country, retrospective/prospective) is not explicitly stated.
- Within Run Precision: Twenty replicates of three levels of commercial human-based QC material were tested. The provenance of the QC material is not specified, but it's "commercial human-based."
- Total Imprecision: Duplicate measurements of each of three levels of QC material were tested twice a day for 20 days. This means 3 levels * 2 replicates/day * 20 days = 120 measurements per reagent. The provenance of the QC material is not specified.
- Method Comparison: At least 40 samples for each analyte were tested. The data provenance is not specified.
- Sample Carryover: 11 samples (L, M, H) in a predefined sequence, tested twice in a single day. The data provenance is not specified.
- Interference Testing: The number of samples for each interfering substance is not explicitly stated, but it involved testing Hemoglobin, Bilirubin, Lipemia (Intralipid), Glucose, and Ascorbic Acid up to specified concentrations. The data provenance is not specified.
In general, the data provenance (country of origin, retrospective/prospective) for these studies is not explicitly mentioned in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device and study. The device is an in-vitro diagnostic reagent for quantitative measurement of analytes (Calcium and Cholesterol) in serum. The "ground truth" is established by reference methods, certified materials (like NIST-traceable standards), or comparison to a legally marketed predicate device, rather than human expert consensus on interpretations of images or complex clinical scenarios.
4. Adjudication Method for the Test Set
This information is not applicable as the studies are focused on analytical performance of a quantitative reagent, not on classifying or interpreting results where human adjudication would be necessary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This information is not applicable. This is an in-vitro diagnostic reagent, not an AI-assisted diagnostic imaging or interpretation device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This concept is not applicable to a chemical reagent. The device itself is the reagent used in an automated analyzer. The "standalone" performance refers to the analytical performance of the reagent on the EasyRA Chemistry Analyzer, which is precisely what the performance data describes (linearity, precision, interference, carryover). There is no "human-in-the-loop" aspect to the measurement itself; human operators are involved in running the analyzer and interpreting the quantitative results in a clinical context.
7. The Type of Ground Truth Used
- Linearity: NIST-traceable commercial linearity standards.
- Precision (Within Run & Total): Commercial human-based QC material with known (or established) values.
- Method Comparison: Analytical results obtained from the predicate device (Roche COBAS MIRA analyzer), which serves as the comparative "truth" for substantial equivalence.
- Interference Testing: Known concentrations of interfering substances added to samples to assess their impact on the measurement.
8. The Sample Size for the Training Set
This information is not applicable. This device is a chemical reagent and does not use machine learning or AI that requires a "training set" in the conventional sense. Its performance specifications are determined through analytical validation studies as detailed.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this type of device.
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510(k) Summary
| Date of summary | February 15, 2007 |
|---|---|
| Product Name | EasyRA Cholesterol ReagentEasyRA Calcium Reagent |
| Sponsor | Medica Corporation5 Oak Park DriveBedford, MA 01730 |
| Correspondent | MDC Associates, LLCFran White, Regulatory Consultant163 Cabot StreetBeverly, MA 01915 |
Substantially Equivalent Device
Manufacturer: Roche Diagnostic Systems, Inc. Product: Cobas Ready Cholesterol Reagent Cobas Ready Calcium Reagent
| Product Attribute | Medica Cholesterol andCalcium Reagents | Roche Cobas Reagents | SubstantialEquivalent |
|---|---|---|---|
| Intended use | Cholesterol - clinicalchemistry reagent used toprovide a quantitativemeasurement of totalcholesterol in human serumusing the EasyRAChemistry Analyzer.Calcium – clinicalchemistry reagent used toprovide a quantitativemeasurement of totalcalcium in human serumusing the EasyRAChemistry Analyzer. | Cholesterol - clinicalchemistry reagent used toprovide a quantitativemeasurement of totalcholesterol in human serumusing the Roche CobasChemistry Analyzer.Calcium – clinicalchemistry reagent used toprovide a quantitativemeasurement of totalcalcium in human serumusing the Roche CobasChemistry Analyzer. | √ |
| Sample | Serum | Serum | √ |
| Testmethodology | Cholesterol - EasyRAAnalyzer ready-to-useenzyme assay reagents. | Cholesterol- CobasChemistry AnalyzerReady to use enzyme assay | √ |
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Request for Additional Information
| Calcium - EasyRAAnalyzer ready-to-usereagents using AZOmethodology. | reagents.Calcium – CobasChemistry Analyzer Readyto use reagents using AZOmethodology | |
|---|---|---|
| --------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------ | -- |
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 Levelmg/dL | Total Imprecision (SD)mg/dL | Total Imprecision (CV)% |
|---|---|---|
| 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 (240) 276-0490. 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 (800) 638-2041 or (240) 276-3150 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
§ 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.