(41 days)
Not Found
No
The device description and performance studies focus on the chemical composition and stability of a calibration serum, with no mention of AI or ML technologies.
No.
The device is an in vitro diagnostic calibrator used for laboratory testing, not for treating diseases or conditions.
No
This device is a calibration serum used to calibrate diagnostic devices, not a diagnostic device itself. The "Intended Use" states it is "for in vitro diagnostic use in the calibration of Aldolase on the Randox RX Daytona and Beckman Coulter AU640 systems."
No
The device description clearly states it is a lyophilized serum supplied in vials, which is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for in vitro diagnostic use".
- Device Description: The description details a product used in a laboratory setting (calibration of Aldolase on specific systems) and involves testing biological material (human serum).
- Prescription Use: The indication for "prescription use only" is common for IVD devices.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in the in vitro examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or inborn abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The Aldolase Calibration Serum is intended for in vitro diagnostic use in the calibration of Aldolase on the Randox RX Daytona and Beckman Coulter AU640 systems. This device is intended for prescription use only.
Product codes (comma separated list FDA assigned to the subject device)
JIT
Device Description
The Aldolase Calibrator is supplied in a kit containing 3x1ml vial of Ivophilized serum is reconstituted with exactly 1 ml of distilled water and is stable for 5 days when reconstituted and stored at +2°C to +8° C.
The base matrix used for the manufacture of the Aldolase Calibration Serum is Human Serum with added chemicals.
Human source material from which this product has been derived and has been tested at the donor level for the Human Immunodeficiency Virus (HIV1 & HIV2) antibody, Hepatitis B surface antigen (HbsAg) and the Hepatitis C virus (HCV) antibody and were found to be non-reactive based on FDA approved methods.
However, since no method can offer complete assurance as to the absence of infectious agents, this material and all patient samples should be handled as though capable of transmitting infectious diseases and disposed of accordingly.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Open vial stability: The study assessed the open vial stability of the Aldolase Calibration Serum by reconstituting the material and storing it at +2 to +8°C for 7 days, then testing for Aldolase. The acceptance criterion was a percentage deviation of reconstituted to fresh of ≤5%. Current studies support a reconstituted claim of 5 days when stored at +2°C to +8°C.
Real Time Testing: This study verified and validated the predicted shelf life. Controls were stored at +2 - +8°C and at ultra-frozen conditions -75 to -90°C. For real time assessment, routinely stored calibrators were compared to ultra-frozen calibrators at various time points. The acceptance criteria states that the calibrator recovery for routinely stored compared to ultra-frozen should be within +/-5% deviation and all controls should be within range. Current Real Time studies support a 2 year shelf life.
Value Assignment:
- A mean value for new lots was established by nested testing against a master lot. The master lot's value was derived by nest testing on a suitable clinical Chemistry/Immunoassay Analyzer using a Randox calibrator with established consensus values or an International reference preparation (IRP) where available and applicable. Master lot values must fall within predetermined acceptance criteria.
- Value assignment was determined by analyzing ten replicates of the test calibrator on two or more systems, calculating mean, SD, and CV. The acceptance criteria for precision measured by CV should be less than or equal to 3%.
| Aldolase Calibration Serum | N | Mean (U/L) | System Specific Value (U/L) | CV % |
|---|---|---|---|---|
| RX Daytona | 10 | 18.4 | 18.7 | 2.2 |
| Beckman Coulter AU640 | 10 | 19 | 18.7 | 1.8 |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, with a design that resembles an abstract bird or wing shape above them. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 18, 2014
RANDOX LABORATORIES, LTD. PAULINE ARMSTRONG, QA/RA MANAGER 55 DIAMOND ROAD ARDMORE, CRUMLIN, COUNTY ANTRIM, BT29 40Y UNITED KINGDOM
Re: K142181
Trade/Device Name: Randox Aldolase Calibration Serum Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator, Secondary Regulatory Class: II Product Code: JIT Dated: August 6, 2014 Received: August 8, 2014
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/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
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
2
Indications for Use
510(k) Number (if known)
K142181 Device Name Randox Aldolase Calibration Serum
Indications for Use (Describe)
The Aldolase Calibration Serum is intended for in vitro diagnostic use in the calibration of Aldolase on the Randox RX Daytona and Beckman Coulter AU640 systems.
This 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)
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."
3
510(K) SUMMARY,RANDOX ALDOLASE CALIBRATION SERUM
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.
2. SUBMITTER NAME AND ADDRESS
Submitter: Randox Laboratories Limited
Address: Randox Laboratories Limited 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom.
Contact: Dr. Pauline Armstrong Telephone: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 E-mail: Pauline.Armstrong@randox.com
Date of Summary Preparation: September 11, 2014
3. 510k NUMBER, DEVICE PROPRIETARY NAME, COMMON NAME, PURPOSE FOR SUBMISSION, REGULATORY CLASSIFCATION, PANEL, PRODUCT CODE AND 21 CFR NUMBER
510k No: K142181
Device Proprietary Name: Randox Aldolase Calibration Serum
Common Name: Aldolase Calibration Serum
Purpose for Submission: New Device
Requlatory Classification: Calibrator,Secondary
Classification: Class II
Panel: Clinical Chemistry (75)
Product Code: JIT (Calibrator, Secondary) 21 CFR Number: 21 CFR 862.1150.
4
4. PREDICATE DEVICE PROPRIETARY NAMES AND 510 (k) NUMBERS
Predicate Device : Randox Calibration Serum Levels 2 and 3
510 (k) Numbers: K053153
5. INTENDED USE
The Aldolase Calibration Serum is intended for in vitro diagnostic use in the calibration of Aldolase on the Randox RX Daytona and Beckman Coulter AU640 systems. This device is for prescription use only.
6. DEVICE DESCRIPTION
The Aldolase Calibrator is supplied in a kit containing 3x1ml vial of Ivophilized serum is reconstituted with exactly 1 ml of distilled water and is stable for 5 days when reconstituted and stored at +2°C to +8° C.
The base matrix used for the manufacture of the Aldolase Calibration Serum is Human Serum with added chemicals.
Human source material from which this product has been derived and has been tested at the donor level for the Human Immunodeficiency Virus (HIV1 & HIV2) antibody, Hepatitis B surface antigen (HbsAg) and the Hepatitis C virus (HCV) antibody and were found to be non-reactive based on FDA approved methods.
However, since no method can offer complete assurance as to the absence of infectious agents, this material and all patient samples should be handled as though capable of transmitting infectious diseases and disposed of accordingly.
5
7. PREDICATE DEVICE COMPARISON TABLE
TABLE 1: COMPARISON OF RANDOX ALDOLASE CALIBRATION SERUM WITH THE PREDICATE DEVICE
| CHARACTERISTICS | ALDOLASE CALIBRATION SERUM
(New Device) | RANDOX CALIBRATIONSERUM
LEVELS 2 AND 3
K053153
(Predicate Device) |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INTENDED USE | The Aldolase Calibration Serum is
intended for in vitro diagnostic use in
the calibration of Aldolase on the
Randox RX Daytona and Beckman
Coulter AU640 systems. This device is
for prescription use only. | For use as a Calibrator in clinical
chemistry assays. Randox
Calibration Sera are based on
lyophilised human serum. The
concentrations and activities are
suitable for calibration of clinical
chemistry assays on a wide range
of automatic analysers. |
| FORMAT | Lyophilised | Same |
| MATRIX | Human Serum | Same |
| ANALYTES | 1 analyte, Aldolase | 43 analytes including Aldolase |
| STORAGE
(Unopened) | 2 to 8 °C
Until expiration date | Same |
| OPEN VIAL CLAIM | Reconstituted serum is stable for 5 days
at +2°C to +8°C. | Reconstituted serum is stable for 7 days
at +2°C to +8°C, 1 month frozen once at
20°C and 8 hours at +25°C. |
| SIZE | 3 x 1ml | 20 x 5ml |
| SHELF LIFE | 24 months | 36 months |
6
8. SUMMARY OF STABILITY STUDIES
Open vial stabiltiy
Open vial stability of the Aldolase Calibration Serum was assessed by reconstituting the material according to the package insert. Samples were reconstituted and stored at +2 to +8°C for 7 days and tested for Aldolase.
The acceptance criteria state the percentage deviation of reconstituted to fresh should be ≤5%.
Current open vial studies support a reconstituted claim of 5 days when stored at +2°C to +8°C.
Real Time Testing
This study was designed to verify and validate the predicted or desirable shelf life of the Aldolase Calibration Serum. Real Time studies are carried out using procedure RRD-1359. Controls are stored at the routinely stored temperature of +2 - +8°C and at ultra-frozen conditions -75 to -90°C. For real time assessment the routinely stored calibrators are compared to the ultra frozen calibrators at various time points.
The acceptance criteria states that the calibrator recovery for routinely stored compared to ultra-frozen should be within +/-5% deviation and all controls should be within range. Current Real Time studies support a 2 year shelf life.
9. SUMMARY OF VALUE ASSIGNMENT
-
A mean value for new lots of the Aldolase calibrator are established by performing nested testing of the new calibrator lot against a master lot. The value assignment of the master lot calibrator was derived by nest testing on a suitable clinical Chemistry/Immunoassay Analyzer using a Randox calibrator with established consensus values or an International reference preparation (IRP) where available and applicable. The master lot values must fall within the predetermined acceptance criteria.
-
The value assignment was determined by analyzing ten replicates of the test calibrator on two or more systems and the mean, SD and CV calculated for each lot before release to the user. The acceptance criteria states the precision measured by the CV should be less than or equal to 3%.
| Aldolase
Calibration Serum | N | Mean (U/L) | System Specific
Value (U/L) | CV % |
|-------------------------------|----|------------|--------------------------------|------|
| RX Daytona | 10 | 18.4 | 18.7 | 2.2 |
| Beckman Coulter
AU640 | 10 | 19 | 18.7 | 1.8 |
10. TRACEABILITY
| ANALYTE | SUPPLIER | PRODUCT
NUMBER | ORIGIN | SOURCE |
|----------|----------|-------------------|---------------|--------------------------------------------|
| Aldolase | Sigma | A2714 | Rabbit Muscle | Commercial Source,
added volumetrically |
11. CONCLUSION
Testing results indicate that the proposed device is substantially equivalent to the predicate device.