(132 days)
No
The document describes a standard in vitro diagnostic assay kit for measuring triglycerides in serum. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies. The performance studies focus on analytical validation metrics like precision, linearity, sensitivity, and interference, which are standard for IVD assays.
No.
This device is for the in vitro determination of Triglycerides in serum, used in diagnosis and treatment of diseases involving lipid metabolism and various endocrine disorders. It is an in vitro diagnostic device, not a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Triglyceride measurements are used in the diagnosis and treatment of diseases involving lipid metabolism and various endocrine disorders". This indicates that the device's output (triglyceride levels) is directly used for diagnostic purposes.
No
The device description explicitly states it is a "kit assay consists of ready to use reagent solutions," indicating it is a chemical reagent kit, not software. The performance studies also describe testing on hardware systems (RX Daytona plus, RX Imola).
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states:
- "For the quantitative in vitro determination of Triglycerides in serum." This indicates the test is performed outside of the body using a biological sample (serum).
- "This in vitro diagnostic device is intended for prescription use only." This directly identifies the device as an in vitro diagnostic device.
- "The Randox Triglycerides kit assay consists of ready to use reagent solutions." Reagents used for testing biological samples are a key component of IVDs.
- The entire document describes performance studies (Precision, Linearity, Sensitivity, Interference, Correlation) which are standard requirements for demonstrating the analytical performance of an IVD.
- It also lists a Predicate Device which is another IVD.
All of these points confirm that the device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
For the quantitative in vitro determination of Triglycerides in serum. Triglyceride measurements are used in the diagnosis and treatment of diseases involving lipid metabolism and various endocrine disorders e.g Diabetes mellitus, nephrosis and liver obstruction
This in vitro diagnostic device is intended for prescription use only.
Product codes
CDT
Device Description
"The Randox Triglycerides kit assay consists of ready to use reagent solutions.
CATALOGUE NUMBER: TR8332
R1. Enzyme Reagent 4 x 20 ml
REAGENT COMPOSITION
Contents: Pipes buffer, 4-chloro-phenol, Magnesium ions, 4- aminophenazone, ATP, Lipases, Glycerol kinase, Glycerol-3-phosphate oxidase, Peroxidase, Sodium azide
Initial Concentration: 38.7 mmol/L, pH 7.5; 3.4 mmol/L; 16.9 mmol/L; 0.25 mmol/L; 1.2 mmol/L; ≥ 10 u/mL; ≥ 0.4 u/mL; ≥ 1.5 u/mL; ≥ 0.5 u/mL; 0.05%"
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
Not Found
Summary of Performance Studies
"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 serum based control material and unaltered human serum samples that were spiked with triglycerides concentrations or diluted to achieve concentrations based on established ranges
§ 862.1705 Triglyceride test system.
(a)
Identification. A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 6, 2015
RANDOX LABORATORIES LIMITED PAULINE ARMSTRONG QA/RA MANAGER 55 DIAMOND ROAD CRUMLIN BT29 4QY, GREAT BRITAIN
Re: K150819
Trade/Device Name: Triglycerides (TRIGS) Regulation Number: 21 CFR 862.1705 Regulation Name: Triglyceride test system Regulatory Class: Class I, meets the limitation of exemption 21 CFR §862.9(c)(4) Product Code: CDT Dated: June 18, 2015 Received: June 22, 2015
Dear Pauline 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/Resourcesfor You/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.
Courtney H. Lias -S
Courtney H. Lias, Ph.D. 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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Indications for Use
510(k) Number (if known)
K150819 Device Name Triglycerides (TRIGS)
Indications for Use (Describe)
For the quantitative in vitro determination of Triglyceride measurements are used in the diagnosis and treatment of diseases involving lipid metabolism and various endocrine disorders mellitus, nephrosis and liver obstruction
This in vitro diagnostic device is intended for prescription use only.
Type of Use (Select one or both, as applicable)
V Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(K) SUMMARY, TRIGLYCERIDES ASSAY
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: July 9, 2015
3. 510k NUMBER, DEVICE PROPRIETARY NAME, COMMON NAME, PURPOSE FOR SUBMISSION, REGULATORY CLASSIFCATION, PANEL, PRODUCT CODE AND 21 CFR NUMBER
510k No: K150819
Device Proprietary Name: Triglycerides (TRIGS)
Common Name: Triglycerides
Purpose for Submission: New Device
| Product
| Code | Regulation Name | Classification | Regulation Section | Panel |
|---|---|---|---|---|
| CDT | Triglycerides test | |||
| system | I, meets the | |||
| limitations to | ||||
| exemptions 21 | ||||
| CFR §862.9 (c)(4) | 21 CFR | |||
| 862.1705 | Clinical | |||
| Chemistry | ||||
| (75) |
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4. PREDICATE DEVICE PROPRIETARY NAMES AND 510 (k) NUMBERS
Predicate Device Proprietary Name:
Randox Laboratories Ltd. Triglycerides reagent
510 (k) Number: K923508
5. INTENDED USE
For the quantitative in vitro determination of Triglycerides in serum. Triglyceride measurements are used in the diagnosis and treatment of diseases involving lipid metabolism and various endocrine disorders e.g Diabetes mellitus, nephrosis and liver obstruction
This in vitro diagnostic device is intended for prescription use only.
6. DEVICE DESCRIPTION
The Randox Triglycerides kit assay consists of ready to use reagent solutions.
CATALOGUE NUMBER: TR8332
R1. Enzyme Reagent 4 x 20 ml
REAGENT COMPOSITION
| Contents | Initial Concentration |
|---|---|
| R1. Enzyme Reagent | |
| Pipes buffer | |
| 4-chloro-phenol | |
| Magnesium ions | |
| 4- aminophenazone | |
| ATP | |
| Lipases | |
| Glycerol kinase | |
| Glycerol-3-phosphate oxidase | |
| Peroxidase | |
| Sodium azide | 38.7 mmol/L, pH 7.5 |
| 3.4 mmol/L | |
| 16.9 mmol/L | |
| 0.25 mmol/L | |
| 1.2 mmol/L | |
| ≥ 10 u/mL | |
| ≥ 0.4 u/mL | |
| ≥ 1.5 u/mL | |
| ≥ 0.5 u/mL | |
| 0.05% |
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 Triglycerides test system for the RX Daytona plus to predicate device
| CHARACTERISTICS | Randox Triglycerides Assay for
RX daytona plus
(New Device) | Randox
Triglyceride Assay
(K923508)
(Predicate Device) |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| | Similarities | |
| INTENDED USE | For the quantitative in vitro determination of
Triglycerides in serum. Triglyceride
measurements are used in the diagnosis and
treatment of diseases involving lipid
metabolism and various endocrine disorders
e.g Diabetes mellitus, nephrosis and liver
obstruction | Same |
| ASSAY PROTOCOL | Colorimetric Method | Same |
| STORAGE
(UNOPENED) | Reagents are stable up to the expiry date
when stored unopened at +2 to +8°C | 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. Enzyme Reagent | ||
| Pipes buffer | |||
| pH 7.5 | |||
| 4-chloro-phenol | |||
| Magnesium ions | |||
| 4- aminophenazone | |||
| ATP | |||
| Lipases | |||
| Glycerol kinase | |||
| Glycerol-3-phosphate oxidase | |||
| Peroxidase | |||
| Sodium azide | 38.7 mmol/L | ||
| 3.4 mmol/L | |||
| 16.9 mmol/L | |||
| 0.25 mmol/L | |||
| 1.2 mmol/L | |||
| ≥ 10 u/mL | |||
| ≥ 0.4 u/mL | |||
| ≥ 1.5 u/mL | |||
| ≥ 0.5 u/mL | |||
| 0.05% | R1a. Buffer | ||
| Pipes Buffer 40 mmol/l, pH 7.5 | |||
| 4-chloro-phenol 5.0 mmol/l | |||
| Magnesium-ions 5.0 mmol/l | |||
| R1b. Enzyme Reagent | |||
| 4-aminophenazone 0.4 mmol/l | |||
| ATP 1.0 mmol/l | |||
| Lipases ≥150 U/ml | |||
| Glycerol-kinase ≥ 0.4 U/ml | |||
| Glycerol-3-phosphate | |||
| oxidase ≥ 1.5 U/ml | |||
| Peroxidase ≥ 0.5 U/ml | |||
| TEST RANGE | 12.4 - 1000mg/dl | 11.5 - 1133mg/dl | |
| SAMPLE TYPE | Serum | Serum, heparinized plasma and EDTA | |
| plasma samples are suitable. |
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8. TEST PRINCIPLE
The Triglycerides 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 and read at 510nm.
Image /page/6/Figure/2 description: This image shows four chemical reactions. The first reaction shows triglycerides reacting with H20 to produce glycerol and fatty acids, with Lipases as the catalyst. The second reaction shows glycerol reacting with ATP to produce glycerol-3-phosphate and ADP, with GK as the catalyst. The third reaction shows glycerol-3-phosphate reacting with O2 to produce dihydroxyacetone, phosphate, and H202, with GPO as the catalyst. The fourth reaction shows 2H20 reacting with 4-aminophenazone and 4 chlorophenol to produce quinoneimine, HCl, and 4 H20, with POD as the catalyst.
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 serum based control material and unaltered human serum samples that were spiked with triglycerides concentrations or diluted to achieve concentrations based on established ranges 1000 mg/dL, which are diluted and remeasured to obtain values within the measuring range.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Refer to K053153 Calibrator and K942458 Control for Triglycerides.
Randox Calibration Serum Level 3 is traceable to Triglycerides reference method ID-GC/MS.
d. Detection limit:
Sensitivity studies have been carried out in accordance with C.L.S.I. guideline EP17-A2 'Evaluation of detection capability for clinical laboratory measurement procedures; Approved Guideline Second Edition'. 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 Triglycerides on the RX Daytona Plus is 3.96 mg/dl based on 240 determinations, with 4 low level samples.
The Limit of Blank (LoB) is 2.65 mg/dl.
The Limit of Quantitation (LoQ) is 12.4 mg/dl as determined by the lowest concentration at which precision is still met.
e. Analytical Specificity:
Interference studies have been carried out in accordance with C.L.S.I. guideline EP7-A2 'Interference testing in clinical chemistry; Approved Guideline Second Edition' 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:
The criteria for no significant interference is recovery within ±10% of the initial value of Triglycerides concentration of 150mg/dL and 496mg/dL
| Haemoqlobin | No significant interference up to 750mg/dL |
|---|---|
| Total Bilirubin | No significant interference up to 60mg/dL |
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Coniugate Bilirubin No significant interference up to 60mg/dL Ascorbic Acid No significant interference up to 3.0mg/dL
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'.
109 serum patient samples spanning the range 14.2 to 986 mg/dl were tested by two operators on two lots of Triglycerides reagent on one RX Daytona plus analyzer and the predicate device tested on 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 = 0.97x + 1.22 Correlation coefficient of r = 0.999
Expected values/Reference range:
The NCEP (American National Cholesterol Education Program) has established the following classification for triglyceride levels according to the risk of developing coronary heart diseases:
Table 4 Reference Ranges
| Analyte | Expected Values |
|---|---|
| Triglycerides (1) | Normal |