(191 days)
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No
The summary describes a chemical reagent for use with a chemistry analyzer, focusing on analytical performance characteristics like linearity, precision, and method comparison. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as a reagent for in-vitro diagnostic use, specifically for measuring calcium and cholesterol levels in serum, which is used for diagnosis and monitoring, not for direct therapy.
Yes
The intended use statements explicitly state that the calcium measurements are used "in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany" and that the cholesterol reagent is used "to screen for elevated cholesterol as a risk factor in coronary artery disease." These clearly indicate a diagnostic purpose.
No
The device described is a reagent (EasyRA Calcium Reagent and EasyRA Cholesterol Reagent) intended for use with a chemistry analyzer (Medica EasyRA Chemistry Analyzer). Reagents are chemical substances, not software.
Yes, based on the provided text, both the EasyRA Calcium Reagent and the EasyRA Cholesterol Reagent are IVDs (In Vitro Diagnostics).
Here's why:
- Explicit Statement: Both descriptions explicitly state "For in-vitro diagnostic use only."
- Intended Use: The intended use for both reagents is the quantitative determination of specific substances (calcium and cholesterol) in human serum, which is a biological sample. This analysis is performed in vitro (outside the body) to aid in diagnosis and treatment.
- Professional Use: The indication "For Professional use only" further supports their use in a clinical or laboratory setting for diagnostic purposes.
Therefore, the text clearly indicates that these devices are intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae, which is the definition of an IVD.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
CJY, CHH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
For Professional use only.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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: Twenty replicates of three levels of commercial human-based QC material were tested.
Total Imprecision: Duplicate measurements of each of three levels of QC material were tested twice a day for 20 days.
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, 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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510(k) Summary
| Date of summary | February 15, 2007 |
|---|---|
| Product Name | EasyRA Cholesterol Reagent |
| EasyRA Calcium Reagent | |
| Sponsor | Medica Corporation |
| 5 Oak Park Drive | |
| Bedford, MA 01730 | |
| Correspondent | MDC Associates, LLC |
| Fran White, Regulatory Consultant | |
| 163 Cabot Street | |
| 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
Calcium Reagents | Roche Cobas Reagents | Substantial
Equivalent |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Intended use | Cholesterol - clinical
chemistry reagent used to
provide a quantitative
measurement of total
cholesterol in human serum
using the EasyRA
Chemistry Analyzer.
Calcium – clinical
chemistry reagent used to
provide a quantitative
measurement of total
calcium in human serum
using the EasyRA
Chemistry Analyzer. | Cholesterol - clinical
chemistry reagent used to
provide a quantitative
measurement of total
cholesterol in human serum
using the Roche Cobas
Chemistry Analyzer.
Calcium – clinical
chemistry reagent used to
provide a quantitative
measurement of total
calcium in human serum
using the Roche Cobas
Chemistry Analyzer. | √ |
| Sample | Serum | Serum | √ |
| Test
methodology | Cholesterol - EasyRA
Analyzer ready-to-use
enzyme assay reagents. | Cholesterol- Cobas
Chemistry Analyzer
Ready to use enzyme assay | √ |
1
Request for Additional Information
| Calcium - EasyRA
Analyzer ready-to-use
reagents using AZO
methodology. | reagents.
Calcium – Cobas
Chemistry Analyzer Ready
to use reagents using AZO
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
mg/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 |
4
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
6
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