(252 days)
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No
The summary describes a standard in vitro diagnostic test for measuring enzyme activity and does not mention any AI or ML components.
No.
This device is an in vitro diagnostic test for measuring ALP levels, which are used in diagnosis and monitoring, not for treating or providing therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "Measurements of alkaline phosphatase are used in the diagnosis, treatment and investigation of hepatobiliary disease and in bone disease." This indicates the device is used for diagnostic purposes.
No
The device is an in vitro diagnostic test system consisting of reagent solutions, which are physical components, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states that the device is intended for the "quantitative in vitro determination of Alkaline Phosphatase (ALP) activity in serum and lithium heparinized plasma." The term "in vitro" is a key indicator of an IVD.
Furthermore, the description of the device as a "test system" and the performance studies conducted (Precision, Linearity, Detection limit, Analytical Specificity, Method comparison, Matrix comparison) are all characteristic of an in vitro diagnostic device used in a clinical laboratory setting to analyze biological samples.
N/A
Intended Use / Indications for Use
The Randox RX Daytona Plus Alkaline Phosphatase (ALP) test system is intended for the quantitative in vitro determination of Alkaline Phosphatase (ALP) activity in serum and lithium heparinized plasma. Measurements of alkaline phosphatase are used in the diagnosis, treatment and investigation of hepatobiliary disease and in bone disease.
Product codes
CJE
Device Description
The Randox RX Daytona Plus Alkaline Phosphatase (ALP) assay consists of ready to use reagent solutions.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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
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 altered human serum samples and unaltered human serum samples that were spiked with ALP concentrations or diluted to achieve concentrations based on established ranges of 30 to 120 U/L for adults. Testing was conducted for two reagent lots of ALP, 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. Both lots yielded similar results.
Linearity studies have been carried out in accordance with C.L.S.I. standard EP6-A. Linearity studies were performed at 11 levels to determine the analytical range of an assay - that is the range where the reported result is a linear function to the analyte concentration. The linearity samples were prepared at 11 levels, ranging from 7.50 UVI to approximately 922 U/I. Each level was run in replicates of five on two lots of ALP reagent on one RX Daytona Plus system.
Sensitivity studies have been carried out in accordance with C.L.S.I. quideline EP17-A2 ‘Protocols for Determination of Limits of Detection and Limits of Quantification; Approved Guideline’. A Limit of Blank (LoB), a Limit of Detection (LoD) and a Limit of Quantification (LoQ) were performed on two lots of reagents tested by two operators on one RX Daytona Plus system.
Analytical Specificity: The following analytes were tested up to the levels indicated at ALP concentrations of 80 U/I and 240 U/I and found not to interfere with the ALP assay: Haemoglobin, Total Bilirubin, Conjugate Bilirubin, Triglycerides, Intralipid, Ascorbic Acid.
Method comparison with predicate device: Correlation studies were carried out in accordance with C.L.S.I. quideline EP9-A2 'Method Comparison and Bias Estimation Using Patient Samples: Approved Guideline - Second Edition'. 106 serum patient samples spanning the range 8 to 883 U/L were tested by one operator on two lots of Randox ALP reagent on one RX daytona plus analyzer and one lot of Siemens ALPAMP reagent on one Advia 1800 system, across 3 working days with each sample tested in duplicate.
Matrix comparison: Matrix method comparisons for the Randox RX Daytona Plus Alkaline Phosphatase (ALP) assay were tested by one operator on one RX Daytona Plus system and was assessed for two lots of ALP reagents. Both serum and lithium heparin plasma were tested. Patient samples were drawn in matched pairs - one sample serum (x) and the second sample lithium heparin plasma (y). A total of 46 matched patient sample pairs were analyzed spanning the 15.3 to 773.1 U/L.
Expected values/Reference range: Referenced from literature. Reference intervals for ALP was verified using NCCLS C28-A3 guidelines. In a study, human serum from 30 normal donors were tested in singlicate on the RX Daytona Plus.
Key Metrics
Precision:
| Sample | N | ALP Mean (IU/L) | Within-Run SD | Within-Run %CV | Total SD | Total %CV |
|---|---|---|---|---|---|---|
| QC1 | 80 | 127.83 | 0.5 | 0.4 | 2.87 | 2.2 |
| QC2 | 80 | 328.94 | 1.19 | 0.4 | 6.53 | 2.0 |
| QC3 | 80 | 353.25 | 1.26 | 0.4 | 7.61 | 2.2 |
| Serum 1 | 80 | 81.44 | 1.56 | 1.9 | 1.89 | 2.3 |
| Serum 2 | 80 | 212.76 | 3.35 | 1.6 | 3.44 | 1.6 |
| Serum 3 | 80 | 244.36 | 3.63 | 1.5 | 3.77 | 1.5 |
| Serum 4 | 80 | 349.39 | 4.41 | 1.3 | 5.31 | 1.5 |
| Serum 5 | 80 | 24.86 | 0.80 | 3.2 | 1.31 | 5.3 |
| Serum 6 | 80 | 480.71 | 3.65 | 0.8 | 15.26 | 3.2 |
| Serum 7 | 80 | 706.24 | 4.87 | 0.7 | 24.48 | 3.5 |
| Serum 8 | 80 | 895.00 | 4.49 | 0.5 | 30.79 | 3.4 |
Linearity:
Linear Regression: y = 1.00x + 6.49
r = 1.000
Claimed range: 8 – 918 U/L.
Detection limit:
Limit of Detection (LoD): 1.0 U/L
Limit of Blank (LoB): 0.14 U/L
Limit of Quantitation (LoQ): 7.5 U/L
Method comparison with predicate device:
Linear regression equation: y = 1.005x - 3.95
Correlation coefficient: r = 0.999
Matrix comparison:
Linear regression equation: y = 1.00x - 0.13
Correlation coefficient: r = 1.00
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1050 Alkaline phosphatase or isoenzymes test system.
(a)
Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.(b)
Classification. Class II.
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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 features a stylized depiction of an eagle or bird-like figure with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 21, 2017
RANDOX LABORATORIES LIMITED PAULINE ARMSTRONG, QA/RA MANAGER 55 DIAMOND ROAD CRUMLIN, COUNTY ANTRIM, BT29 4QY GREAT BRITAIN
Re: K162275
Trade/Device Name: Randox RX Daytona Plus Alkaline Phosphatase (ALP) Regulation Number: 21 CFR 862.1050 Regulation Name: Alkaline phosphatase or isoenzymes test system Regulatory Class: II Product Code: CJE Dated: March 21, 2017 Received: March 23, 2017
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,
Kellie B. Kelm -S
for 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K162275
Device Name
Randox RX Daytona Plus Alkaline Phosphatase (ALP)
Indications for Use (Describe)
The Randox RX Daytona Plus Alkaline Phosphatase (ALP) test system is intended for the quantitative in vitro determination of Alkaline Phosphatase (ALP) activity in serum and lithium heparinized plasma. Measurements of alkaline phosphatase are used in the diagnosis, treatment and investigation of hepatobiliary disease.
| 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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K162275
510(K) SUMMARY
RANDOX RX DAYTONA PLUS ALKALINE PHOSPHATASE (ALP)
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: 20 April 2017
3. 510k NUMBER, DEVICE PROPRIETARY NAME, COMMON NAME, PURPOSE FOR SUBMISSION, REGULATORY CLASSIFCATION, PANEL, PRODUCT CODE AND 21 CFR NUMBER
510(k) No: K162275
Device Proprietary Name: Randox RX Daytona Plus Alkaline Phosphatase (ALP)
Common Name: RX Daytona Plus Alkaline Phosphatase (ALP)
Purpose for Submission: New Device
| Product
| Code | Regulation Name | Classification | Regulation Section | Panel |
|---|---|---|---|---|
| CJE | Alkaline | |||
| Phosphatase or | ||||
| isoenzymes test | ||||
| system. | II | 21 CFR 862.1050 | Clinical | |
| Chemistry | ||||
| (75) |
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4. PREDICATE DEVICE PROPRIETARY NAMES AND 510 (k) NUMBERS
Predicate Device Proprietary Name: Siemens Alkaline Phosphatase (ALPAMP)
510(k) Number: K991576
5. INTENDED USE
The Randox RX Daytona Plus Alkaline Phosphatase (ALP) test system is intended for the quantitative in vitro determination of Alkaline Phosphatase (ALP) activity in serum and lithium heparinized plasma. Measurements of alkaline phosphatase are used in the diagnosis, treatment and investigation of hepatobiliary disease and in bone disease.
6. DEVICE DESCRIPTION
The Randox RX Daytona Plus Alkaline Phosphatase (ALP) assay consists of ready to use reagent solutions.
CATALOGUE NUMBER: AP8302
| R1. Buffer | 4 x 20 m |
|---|---|
| R2. Substrate | 4 x 7 ml |
REAGENT COMPOSITION
| Contents | Concentrations in the Test |
|---|---|
| R1. Buffer | |
| 2-amino-2-methyl-I-propanol | |
| Mg2+ | 0.35 mol/l, pH 10.4 |
| 2.0 mmol/l | |
| R2. Substrate | |
| p-nitrophenylphosphate | 10 mmol/l |
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7. PREDICATE DEVICE COMPARISON TABLE
Table 1 - Comparison of Randox RX Daytona Plus Alkaline Phosphatase (ALP) to Predicate Device (Siemens Alkaline Phosphatase (ALPAMP)
| CHARACTERISTICS | Candidate Device
Randox RX Daytona Plus
Alkaline Phosphatase (ALP) Assay
(K162275) | Predicate Device
Siemens Alkaline Phosphatase
(ALPAMP) Assay
(K991576) |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Similarities | |
| INTENDED USE | For the quantitative in vitro determination of
Alkaline Phosphatase (ALP) activity in serum
and plasma. Measurements of alkaline
phosphatase are used in the diagnosis,
treatment and investigation of hepatobilary
disease and in bone disease. | For the quantitative in vitro determination of
Alkaline Phosphatase (ALP) activity in
serum and plasma. Such measurements
are used in the diagnosis and treatment of
hepatobiliary and bone disease. |
| ASSAY PROTOCOL | Colorimetric Method IFCC | 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) | Same |
| REAGENT
COMPOSITION | R1. Buffer
2-amino-2-methyl-l-propanol | R1.
AMP |
| | $0.35 \text{ mol/l, (pH 10.4)}$
$\text{Mg}^{2+}$
$2.0 \text{ mmol/l}$ | $0.438 \text{ mol/l}$
$0.09%$
Sodium azide |
| | R2. Substrate
p-nitrophenylphosphate
$10 \text{ mmol/l}$ | R2.
p-nitrophenylphosphate
$60 \text{ mmol/l}$
Sodium azide
$0.09%$ |
| REAGENT
PREPARATION | Liquid, ready to use | Same |
| CONTROL
FREQUENCY | Randox Assayed Multisera Levels 2 & 3
Two levels of control should be assayed at
least once a day | Commercially available controls are
recommended
Analyse at least two levels of controls daily |
| MEASURING
RANGE | 8 – 918 U/I | 0 – 1100 U/I |
| CHARACTERISTICS | Candidate Device
Randox RX Daytona Plus
Alkaline Phosphatase (ALP) Assay
(K162275) | Predicate Device
Siemens Alkaline Phosphatase (ALPAMP)
Assay
(K991576) |
| | Differences | |
| CALIBRATOR | Randox Calibration Serum Level 3 | Fixed System Factor Value |
| CALIBRATION
FREQUENCY | A 2 point calibration is recommended every
7 days or with a change of reagent lot | Not Required |
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Table 1: Comparison of Randox RX Daytona Plus Alkaline Phosphatase (ALP) to Predicate Device (Siemens Alkaline Phosphatase (ALPAMP)
8. TEST PRINCIPLE (1)
The substrate p-nitrophenyl phosphate is hydrolyzed by Alkaline Phosphatase from the sample, in the presence of Magnesium ions, to form p-nitrophenol which is yellow in colour and can be read at 405 nm.
The intensity of colour produced is proportional to the Alkaline Phosphatase activity in the sample.
p-nitrophenyl phosphate + H2O phosphate + p-nitrophenol
-
- Bowers, G.N., and R.B. Mc Comb., Clin Chem. 1975; 21: 1988.
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 altered human serum samples and unaltered human serum samples that were spiked with ALP concentrations or diluted to achieve concentrations based on established ranges of 30 to 120 U/L for adults. Testing was conducted for two reagent lots of ALP, one lot on each RX daytona plus system, twice per day for 20 non-consecutive days. Two replicates per run
7
were performed for each sample. Both lots yielded similar results. The results of one representative lot are summarized in the following table:
Table 2 - Precision Summary
Lot 1
| Within-Run | Total | |||||
|---|---|---|---|---|---|---|
| Sample | N | ALP Mean | ||||
| (IU/L) | SD | %CV | SD | %CV | ||
| QC1 | 80 | 127.83 | 0.5 | 0.4 | 2.87 | 2.2 |
| QC2 | 80 | 328.94 | 1.19 | 0.4 | 6.53 | 2.0 |
| QC3 | 80 | 353.25 | 1.26 | 0.4 | 7.61 | 2.2 |
| Serum 1 | 80 | 81.44 | 1.56 | 1.9 | 1.89 | 2.3 |
| Serum 2 | 80 | 212.76 | 3.35 | 1.6 | 3.44 | 1.6 |
| Serum 3 | 80 | 244.36 | 3.63 | 1.5 | 3.77 | 1.5 |
| Serum 4 | 80 | 349.39 | 4.41 | 1.3 | 5.31 | 1.5 |
| Serum 5 | 80 | 24.86 | 0.80 | 3.2 | 1.31 | 5.3 |
| Serum 6 | 80 | 480.71 | 3.65 | 0.8 | 15.26 | 3.2 |
| Serum 7 | 80 | 706.24 | 4.87 | 0.7 | 24.48 | 3.5 |
| Serum 8 | 80 | 895.00 | 4.49 | 0.5 | 30.79 | 3.4 |
b. Linearity/assay reportable range:
Linearity studies have been carried out in accordance with C.L.S.I. standard EP6-A. Linearity studies were performed at 11 levels to determine the analytical range of an assay - that is the range where the reported result is a linear function to the analyte concentration.
Acceptance Criteria: LoQ / L1 pool ≤ 20% deviation to target L2 to L11 0.95
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The linearity samples were prepared at 11 levels. The range was from 7.50 UVI analyte concentration up to a high concentration of approximately 922 U/I. The low and high level pools were mixed to create 9 intermediate levels. Each level was run in replicates of five on two lots of ALP reagent on one RX Daytona Plus system. The results are summarized in the following table:
| Analyte | ALP (U/I) |
|---|---|
| Linear | |
| Regression | $y = 1.00x + 6.49$ |
| r | 1.000 |
Table 3 - Linearity Summary Serum
The claimed range of the assav is 8 - 918 U/l.
c. Calibration
The use of Saline and Randox Calibration Serum Level 3 is recommended for calibration of the Randox RX Daytona Plus Alkaline Phosphatase (ALP) assay.
d. Detection limit:
Sensitivity studies have been carried out in accordance with C.L.S.I. quideline EP17-A2 'Protocols for Determination of Limits of Detection and Limits of Quantification; Approved Guideline'. A Limit of Blank (LoB), a Limit of Detection (LoD) and a Limit of Quantification (LoQ) were performed on two lots of reagents tested by two operators on one RX Daytona Plus system.
The Limit of Detection (LoD) for ALP on the RX Daytona Plus is 1.0 U/L based on 240 determinations, with 4 low level samples.
The Limit of Blank (LoB) is 0.14 U/L.
The Limit of Quantitation (LoQ) is 7.5 U/L as determined as the lowest concentration which meets an imprecision of