(123 days)
Not Found
Not Found
No
The device description and performance studies focus on chemical reactions and optical measurements, with no mention of AI or ML.
No
The device is a reagent for in vitro diagnostic testing to determine HDL Cholesterol levels, which helps in diagnosis but does not provide therapy or treatment.
Yes
The device quantitatively determines HDL Cholesterol, which "can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease." This explicitly states its role in diagnosis.
No
The device description clearly outlines a chemical reagent kit (R1 and R2) that interacts with a sample and is read optically by a chemistry analyzer. This involves physical components and chemical reactions, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of High Density Lipoprotein Cholesterol in human serum." This involves testing a sample taken from the human body (serum) outside of the body (in vitro).
- Purpose: The intended use also states it "can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease." This indicates a medical purpose related to diagnosis and patient management.
- Device Description: The description details a chemical reaction and optical measurement performed on a sample, which is characteristic of in vitro diagnostic tests.
- Performance Studies: The document includes performance studies like linearity, precision, and method comparison, which are standard for evaluating the performance of IVD devices.
- Predicate Device: The mention of a "Predicate Device" (Cobas Ready HDL Cholesterol Reagent) is common in regulatory submissions for IVD devices, where a new device is compared to an already cleared device.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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
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.
Product codes (comma separated list FDA assigned to the subject device)
LBS, JIT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratories
For professional use only.
For in-vitro diagnostic use only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Results:
Bio-Rad L1: EasyRA #2 Grand Mean 32.5, Std. Dev. 0.63, CV% 1.9%; EasyRA #3 Grand Mean 32.1, Std. Dev. 0.69, CV% 2.2%
Randox L2: EasyRA #2 Grand Mean 64.3, Std. Dev. 0.94, CV% 1.5%; EasyRA #3 Grand Mean 62.8, Std. Dev. 0.62, CV% 1.0%
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.
Results:
Bio-Rad L1: EasyRA #2 Grand Mean 33.1, Std. Dev. 0.82, CV% 2.47%; EasyRA #3 Grand Mean 33.2, Std. Dev. 0.84, CV% 2.51%
Randox L2: EasyRA #2 Grand Mean 64.6, Std. Dev. 1.37, CV% 2.12%; EasyRA #3 Grand Mean 64.2, Std. Dev. [blank], CV% 1.91%
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).
Results:
Hemoglobin: No interferences up to 500mg/dl
Billirubin: No interferences up to 32.5mg/dl
Lipemia: No interferences up to 1000mg/dl
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Analytical sensitivity: 0.86 mg/dl
Lower limit of detection: 1.3 mg/dl
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.
Not Found
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.
Not Found
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).
Not Found
§ 862.1475 Lipoprotein test system.
(a)
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.(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.
0
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 | |
| 5 Oak Park Drive | ||
| Bedford, MA 01730 | ||
| Correspondent: | Photios Makris | |
| Director QA/RA | ||
| Medica Corporation | ||
| 5 Oak Park Drive | ||
| Bedford, MA 01730 |
Substantial Equivalent Device:
| Manufacturer: | Genzyme Corporation | |
|---|---|---|
| Product: | Cobas Ready HDL Cholesterol Reagent |
| Product
Attribute | Medica HDL Cholesterol
Reagent | Genzyme HDL Cholesterol
Reagent for Cobas-Mira | Substantial
Equivalent |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Intended Use | Clinical chemistry reagent
used to provide a
quantitative measurement of
High Density Lipoprotein
(HDL) in human serum
using the EasyRA chemistry
analyzer. | Clinical chemistry reagent
used to provide a quantitative
measurement of High
Density Lipoprotein (HDL)
in human serum using the
Roche Cobas-Mira chemistry
analyzer. | √ |
| Sample | Serum | Serum | √ |
| Test
Methodology | EasyRA ready-to-use
enzymatic assay reagent | Cobas-Mira ready-to-use
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
1
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% |
2
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 |
3
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).
4
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.
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
5
Page 25
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