(200 days)
No
The device description and performance studies focus on chemical reagents and standard analytical methods for measuring cholesterol, with no mention of AI or ML.
No.
This device is an in vitro diagnostic (IVD) test kit used for the quantitative determination of cholesterol, which is a diagnostic purpose, not a therapeutic one. It provides information for diagnosis and treatment decisions related to cholesterol disorders but does not directly treat or alleviate a disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "Cholesterol measurements are used in the diagnosis and treatments of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders." This indicates that the device aids in diagnosis.
No
The device is a Cholesterol kit assay consisting of ready-to-use reagent solutions, which are physical chemical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" explicitly states "For the quantitative in vitro determination of Cholesterol in serum and plasma." The term "in vitro" is a key indicator of an IVD. It also mentions the use of these measurements in the "diagnosis and treatments of disorders," which is a common purpose of IVDs.
- Device Description: The description details a "kit assay" consisting of "ready to use reagent solutions." This is typical of IVD kits used for laboratory testing.
- Performance Studies: The document describes various performance studies (Precision, Linearity, Detection limit, Analytical Specificity, Method comparison, Matrix comparison) which are standard evaluations for IVD devices to demonstrate their accuracy and reliability for diagnostic purposes.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K923504) indicates that this device is being compared to a previously cleared IVD device, which is a requirement for regulatory submission of new IVDs.
All these elements strongly point to this device being an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
For the quantitative in vitro determination of Cholesterol in serum and plasma. Cholesterol measurements are used in the diagnosis and treatments of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders.
Product codes
CHH
Device Description
The Cholesterol kit assay consists of ready to use reagent solutions.
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
Not Found
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
Precision was evaluated consistent with C.L.S.I documents EP5-A2. Precision studies were performed by two operators on two RX Daytona plus systems using control material and unaltered human serum samples that were spiked with Cholesterol concentrations or diluted to achieve concentrations based on established ranges =240 mg/dl high cholesterol levels. Testing was conducted for two reagent lots of Cholesterol, one lot on each RX Daytona plus system, twice per day for 20 non-consecutive days. Two replicates per run were performed for each sample.
Linearity studies were performed at 11 levels. Linearity samples were prepared at 11 levels covering the measuring range. Each level was run in replicates of five on two lots of cholesterol reagent on one RX Daytona plus system.
Correlation studies were carried out in accordance with C.L.S.I. guideline EP9-A2 'Method Comparison and Bias Estimation Using Patient Samples: Approved Guideline - Second Edition'. 107 serum patient samples spanning the range 25 to 599 mg/dl were tested by two operators on two lots of cholesterol reagent on two RX Daytona plus analyzers and one RX Imola system across 3 working days with each sample tested in singlicate.
Matrix method comparisons for the cholesterol assay was tested by one operator on one RX Daytona plus system and was assessed for two lots of cholesterol reagents. Both serum and lithium heparin and K2EDTA plasma were tested. Patient samples were drawn in matched pairs - one sample serum (x) and the second sample lithium heparin plasma (y). A minimum of 54 matched patient sample pairs were analyzed spanning the 25 to 613 mg/dl. Patient samples were drawn in matched pairs – one sample serum (x) and the second sample potassium 2 EDTA plasma (y). A minimum of 50 matched patient sample pairs were analyzed spanning the 29 to 603 mg/dl.
Summary of Performance Studies
Precision / Reproducibility:
Study type: Precision studies
Sample size: Multiple measurements on control material and unaltered human serum samples (717UE, 724UE, 952UN, three diluted patient samples, linearity pool, sensitivity pool) for two reagent lots, tested twice per day for 20 non-consecutive days.
Key results: For method Lot 1, total CV(%) ranged from 2.0% to 8.8%. For method Lot 2, total CV(%) ranged from 1.9% to 10.3%.
Linearity / Assay reportable range:
Study type: Linearity studies
Sample size: 11 levels, each run in replicates of five on two lots of cholesterol reagent on one RX Daytona plus system.
Key results: Linearity over the range 25 – 618 mg/dl. Regression equation slope = 0.99, intercept = -3.71, r = 0.999.
Detection limit:
Study type: Sensitivity studies (Limit of Blank, Limit of Detection, Limit of Quantification)
Sample size: 240 determinations with 4 low level samples.
Key results: Limit of Detection (LoD) is 6.31 mg/dl. Limit of Blank (LoB) is 3.1 mg/dl. Limit of Quantitation (LoQ) is 23.2 mg/dl (≤20% imprecision).
Analytical Specificity:
Study type: Interference studies
Key results: No significant interference found up to: Haemoglobin 750mg/dL, Total Bilirubin 60mg/dL, Conjugate Bilirubin 60mg/dL, Intralipid® 1000mg/dL, Ascorbic Acid 6mg/dL.
Method comparison with predicate device:
Study type: Correlation studies
Sample size: 107 serum patient samples
Key results: Linear regression equation: Y = 1.00x - 4.77, Correlation coefficient of r = 0.997.
Matrix comparison:
Study type: Matrix method comparisons
Sample size: Minimum of 54 matched serum and lithium heparin plasma pairs; minimum of 50 matched serum and potassium 2 EDTA plasma pairs.
Key results: For Lithium Heparin: Y = 1.01x - 6.54, Correlation coefficient of r = 0.997. For Potassium 2 EDTA: Y = 0.99x + 2.85, Correlation coefficient of r = 0.998.
Key Metrics
Not Found (Specific metrics such as sensitivity, specificity, PPV, NPV are not applicable for this type of quantitative test result, rather the performance is given in terms of precision, linearity, and correlation coefficients)
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
RANDOX LABORATORIES, LTD. PAULINE ARMSTRONG QA/RA MANAGER 55 DIAMOND ROAD CRUMLIN BT29 4QY GREAT BRITAN
September 29, 2015
Re: K150654
Trade/Device Name: Cholesterol Regulation Number: 21 CFR 862.1175 Regulation Name: Cholesterol (total) test system Regulatory Class: Class I, meets the limitation of exemption 21 CFR §862.9(c)(4) Product Code: CHH Dated: September 21, 2015 Received: September 24, 2015
Dear Dr. Armstrong:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -S
For: Courtney H. Lias Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K150654
Device Name Cholesterol
Indications for Use (Describe)
For the quantitative in vitro deternination of Cholesterol in serum and plasma. Cholesterol measurements are used in the diagnosis and treatments of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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510(K) SUMMARY, CHOLESTEROL REAGENT
1. SAFETY AND EFFECTIVENESS AS REQUIRED BY 21 CFR 807.92 STATEMENT
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirement 21 CFR 807.92.
SUBMITTER NAME AND ADDRESS 2.
Name: Dr Pauline Armstrong
Address: Randox Laboratories Limited 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom.
Telephone: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 E-mail: Pauline.Armstrong@randox.com
Date of Summary Preparation: September 29, 2015
3. 510k NUMBER, DEVICE PROPRIETARY NAME, COMMON NAME, PURPOSE FOR SUBMISSION, REGULATORY CLASSIFCATION, PANEL, PRODUCT CODE AND 21 CFR NUMBER
510k No: K150654
Device Proprietary Name: Cholesterol
Common Name: Cholesterol
Purpose for Submission: New Device
| Product
| Code | Regulation Name | Classification | Regulation Section | Panel |
|---|---|---|---|---|
| CHH | Cholesterol (Total) | |||
| test system | Class I, meets the | |||
| limitation of exemption | ||||
| 21 CFR §862.9(c)(4) | 21 CFR §862.1175 | |||
| Cholesterol (total) Test | ||||
| System | Clinical | |||
| Chemistry | ||||
| (75) |
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4. PREDICATE DEVICE PROPRIETARY NAMES AND 510 (k) NUMBERS
Predicate Device Proprietary Name:
Randox Laboratories Ltd, Cholesterol reagent
510 (k) Number: K923504
5. INTENDED USE
For the quantitative in vitro determination of Cholesterol in serum and plasma. Cholesterol measurements are used in the diagnosis and treatments of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
6. DEVICE DESCRIPTION
The Cholesterol kit assay consists of ready to use reagent solutions.
CATALOGUE NUMBER: CH8310
R1. Reagent 4 x 20 ml
REAGENT COMPOSITION
| Contents | Concentrations in the Test |
|---|---|
| R1. Reagent | |
| 4-Aminoantipyrine | |
| Phenol | |
| Peroxidase | |
| (E.C.1.11.1.7, Horse Radish, +25°C) | |
| Cholesterol esterase | |
| (E.C.3.1.1.13. Pseudomonas, +37°C) | |
| Cholesterol oxidase | |
| (E.C.1.1.3.6. Nocardia, +37°C) | |
| Sodium Azide | 0.25 mmol/l |
| 6.00 mmol/l | |
| ≥0.50 U/ml | |
| ≥ 0.20 U/ml | |
| ≥0.10 U/ml | |
| 0.09% |
MATERIALS REQUIRED BUT NOT PROVIDED
Randox Assayed Multisera Level 2 (Cat. No. HN 1530) and Level 3 (Cat. No. HE 1532); 510(k) # K942458 Randox Calibration Serum Level 3 (Cat. No. CAL 2351); 510(k) # K053153 RX series Saline (Cat. No. SA 8396)
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7. PREDICATE DEVICE COMPARISON TABLE
Table 1 Comparison of Cholesterol test system for the RX Daytona plus to predicate device
| CHARACTERISTICS | Cholesterol Assay for
RX daytona plus
(New Device) | Randox
Cholesterol (K923504)
(Predicate Device) | | | | | | | |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|--|--|--|--|--|--|--|
| Similarities | | | | | | | | | |
| INTENDED USE | For the quantitative in vitro determination of
Cholesterol in serum and plasma. Cholesterol
measurements are used in the diagnosis and
treatments of disorders involving excess
cholesterol in the blood and lipid and
lipoprotein metabolism
disorders | Same | | | | | | | |
| ASSAY PROTOCOL | Enzymatic Endpoint Method | Same | | | | | | | |
| STORAGE
(UNOPENED) | Reagents are stable up to the expiry date
when stored unopened at +2 to +8°C | Same | | | | | | | |
| SAMPLE TYPE | Serum
Plasma (Li Heparin & K2 EDTA) | Same | | | | | | | |
| CONTROL
FREQUENCY | Randox assayed human multisera Level 2 & 3
Two levels of control should be assayed at
least once a day | Same | | | | | | | |
| CALIBRATION
FREQUENCY | Every 28 days, with a change of
reagent lot or as indicated by quality control
procedures. | Same | | | | | | | |
| Differences | ||
|---|---|---|
| REAGENT | ||
| COMPOSITION | R1. Reagent | |
| 4-Aminoantipyrine 0.25 mmol/l | ||
| Phenol 6.00 mmol/l | ||
| Peroxidase ≥0.50 U/ml | ||
| (E.C.1.11.1.7, Horse Radish, +25°C) | ||
| Cholesterol esterase ≥ 0.20 U/ml | ||
| (E.C.3.1.1.13. Pseudomonas, +37°C) | ||
| Cholesterol oxidase ≥ 0.10 U/ml | ||
| (E.C.1.1.3.6. Nocardia, +37°C) | ||
| Sodium Azide 0.09% | R1. Reagent | |
| Pipes Buffer 80 mmol/l, pH 6.8 | ||
| 4-Aminoantipyrine 0.25 mmol/l | ||
| Phenol 6 mmol/l | ||
| Peroxidase ≥0.5 U/ml | ||
| (E.C.1.11.1.7, Horse Radish, +25°C) | ||
| Cholesterol esterase ≥0.15 U/ml | ||
| (E.C.3.1.1.13. Pseudomonas, 37°C) | ||
| Cholesterol oxidase ≥0.10 U/ml | ||
| (E.C.1.1.3.6. Nocardia, 37°C) | ||
| MEASURING | ||
| RANGE | 25 to 618 mg/dl | 0.55 to 750 mg/dl |
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8. TEST PRINCIPLE (1)
The cholesterol is determined after enzymatic hydrolysis and oxidation. The indicator quinoneimine is formed from hydrogen peroxide and 4-aminoantipyrine in the presence of phenol and peroxidase.
Image /page/6/Figure/2 description: This image shows three chemical reactions. The first reaction shows cholesterol ester and H20 reacting to form cholesterol and fatty acids, with cholesterol-esterase as the catalyst. The second reaction shows cholesterol and O2 reacting to form cholestene-3-one and H202, with cholesterol oxidase as the catalyst. The third reaction shows 2H202, phenol, and 4-Aminoantipyrine reacting to form quinoneimine and 4H20, with peroxidase as the catalyst.
- Abell, L.L, Levey, B.B., Brodie B.B., et al, J. Biol Chem 195 : 357, 1952
9. PERFORMANCE CHARACTERISTICS
Analytical performance:
a. Precision/Reproducibility:
Precision was evaluated consistent with C.L.S.I documents EP5-A2 Precision studies were performed by two operators on two RX Daytona plus systems using control material and unaltered human serum samples that were spiked with Cholesterol concentrations or diluted to achieve concentrations based on established ranges 618mg/dl, which are diluted and remeasured to obtain values within the measuring range.
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c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Refer to K053153 Calibrator and K942458 Control for Cholesterol.
Randox Calibration Serum Level 3 is traceable to Cholesterol reference material NIST 1952a.
d. Detection limit:
Sensitivity studies have been carried out in accordance with C.L.S.I. guideline EP17-A2 'Protocols for Determination of Limits of Detection and Limits of Quantification: Approved Guideline'. A Limit of Blank (L.o.B.), a Limit of Detection (L.o.D.) and a Limit of Quantification were performed on two lots of reagents tested by two operators on one RX Daytona Plus system.
The Limit of Detection (LoD) for Cholesterol on the RX Daytona Plus is 6.31 mg/dl based on 240 determinations, with 4 low level samples.
The Limit of Blank (LoB) is 3.1 mg/dl.
The Limit of Quantitation (LoQ) is 23.2 mg/dl as determined by the lowest concentration detected with ≤20% imprecision.
e. Analytical Specificity:
The effects of potential interferents were determined by calculating the mean value of the spiked interferent with the corresponding control solution. The spiked sample results were compared to control samples prepared without the potential interferents.
Acceptance Criteria: % of Control ± 10%
The following analytes were tested up to the levels indicated at Cholesterol concentrations of 150 mg/dl and 250 mg/dl and found not to interfere:
| Haemoglobin | No significant interference up to 750mg/dL |
|---|---|
| Total Bilirubin | No significant interference up to 60mg/dL |
| Conjugate Bilirubin | No significant interference up to 60mg/dL |
| Intralipid® | No significant interference up to 1000mg/dL |
| Ascorbic Acid | No significant interference up to 6mg/dL |
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f. Method comparison with predicate device:
Correlation studies were carried out in accordance with C.L.S.I. guideline EP9-A2 'Method Comparison and Bias Estimation Using Patient Samples: Approved Guideline - Second Edition'.
107 serum patient samples spanning the range 25 to 599 mg/dl were tested by two operators on two lots of cholesterol reagent on two RX Daytona plus analyzers and one RX Imola system across 3 working days with each sample tested in singlicate. The test method was compared to the predicate device and the following linear regression equation was obtained:
Y = 1.00x — 4.77 Correlation coefficient of r = 0.997
q. Matrix comparison:
Matrix method comparisons for the cholesterol assay was tested by one operator on one RX Daytona plus system and was assessed for two lots of cholesterol reagents. Both serum and lithium heparin and K₂EDTA plasma were tested to determine whether method accuracy with plasma specimens are equivalent to serum results and that lithium heparin and K₂EDTA plasma does not interfere with either the method or the system.
Cholesterol matrix comparison on the RX Daytona plus (Lithium Heparin)
Patient samples were drawn in matched pairs - one sample serum (x) and the second sample lithium heparin plasma (y). A minimum of 54 matched patient sample pairs were analyzed spanning the 25 to 613 mg/dl and the following linear regression equation was obtained:
Y = 1.01x - 6.54 Correlation coefficient of r = 0.997
Cholesterol matrix comparison on the RX Daytona plus (Potassium 2 EDTA)
Patient samples were drawn in matched pairs – one sample serum (x) and the second sample potassium 2 EDTA plasma (y). A minimum of 50 matched patient sample pairs were analyzed spanning the 29 to 603 mg/dl and the following linear regression equation was obtained:
Y = 0.99x + 2.85 Correlation coefficient of r = 0.998
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Expected values/Reference range:
Referenced from literature
Table 4 Reference Ranges
| Analyte | Serum |
|---|---|
| Cholesterol (2) |