(228 days)
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No
The summary describes a quality control material for laboratory testing, with no mention of AI or ML in its intended use, device description, or any other section.
No
The device is an in vitro diagnostic quality control material used to monitor the precision of laboratory testing systems, not to treat or diagnose patients.
No
The device is an in vitro diagnostic quality control material used to monitor the precision of laboratory testing systems, not a diagnostic device itself.
No
The device description clearly states it is a lyophilized material prepared from human serum, requiring reconstitution with water. This indicates a physical, chemical-based control material, 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 controls are "intended for in vitro diagnostic use".
- Device Description: The description details a material used to monitor the precision of laboratory testing systems, which is a key function of an IVD quality control.
- Prescription Use: The statement "This device is for prescription use only" is also common for IVD devices used in a clinical laboratory setting.
N/A
Intended Use / Indications for Use
The Randox Immunoassay Speciality Control (II), Level 1, Level 2, Level 3 are intended for in vitro diagnostic use as assayed quality control material for Calcitonin. Gastrin, and Procalcitonin to monitor the precision of the laboratory testing systems listed in the package insert. This device is for prescription use only.
Product codes
JJY
Device Description
Randox Immunoassay Speciality Control (II) is manufactured at three levels, Level 1, Level 2 and Level 3.
Each control is prepared from human serum with added constituents of human origin, chemicals, stabilizers and preservatives. They are supplied in lyophilised form in 5x1ml vials and require reconstitution with 1ml of distilled water.
The analyte concentrations in each of the three levels have been chosen to span a range that includes the chemically significant or medical decision level(s). The analyte concentrations have been reviewed by a panel of experts to ensure that the concentrations are clinically relevant for use in routine hospital laboratories.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
laboratory testing systems
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
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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Image /page/0/Picture/0 description: The image shows a handwritten string of characters. The string is "K121603". The characters are written in a simple, clear style, making them easily readable. The image appears to be a close-up of the handwritten string.
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
Name: Randox Laboratories Limited
Address: 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom.
Telephone: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 E-mail: marketing@randox.com
3. 510k NUMBER, DEVICE PROPRIETARY NAME, COMMON NAME, PURPOSE FOR SUBMISSION. REGULATORY CLASSIFCATION, PANEL, PRODUCT CODE AND 21 CFR NUMBER
510k No: K121603
Device Proprietary Name: Randox Immunoassay Speciality Control (II) Levels 1, 2 and 3
Common Name: Immunoassay Speciality Control (II) Levels 1, 2 and 3
Purpose for Submission: New Device
Multi-analyte Controls, All kinds (Assayed and Requiatory Classification: Unassayed)
Panel: Clinical Chemistry
Product Code: JJY
21 CFR Number: 21 CFR 862.1660
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4. PREDICATE DEVICE PROPRIETARY NAME AND 510 (k) NUMBER
Predicate Device Proprietary Name:
Biorad Lyphochek Immunoassay plus Control Levels 1, 2 and 3
510 (k) Numbers: K981532
5. INTENDED USE
The Randox Immunoassay Speciality Control (II), Level 1, Level 2, Level 3 are intended for in vitro diagnostic use as assayed quality control material for Calcitonin. Gastrin, and Procalcitonin to monitor the precision of the laboratory testing systems listed in the package insert. This device is for prescription use only.
6. DEVICE DESCRIPTION
Randox Immunoassay Speciality Control (II) is manufactured at three levels, Level 1, Level 2 and Level 3.
Each control is prepared from human serum with added constituents of human origin, chemicals, stabilizers and preservatives. They are supplied in lyophilised form in 5x1ml vials and require reconstitution with 1ml of distilled water.
The analyte concentrations in each of the three levels have been chosen to span a range that includes the chemically significant or medical decision level(s). The analyte concentrations have been reviewed by a panel of experts to ensure that the concentrations are clinically relevant for use in routine hospital laboratories.
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7. PREDICATE DEVICE COMPARISON TABLE
| CHARACTERISTICS | RANDOX SPECIALITY
IMMUNOASSAY CONTROL (II)
LEVELS 1, 2 AND 3 | BIO-RAD
LYPHOCHEKR
IMMUNOASSAY PLUS
CONTROL LEVELS 1, 2 & 3
K981532 |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INTENDED USE | The Randox Immunoassay Speciality
Control (II), Level 1, Level 2, Level 3 are
intended for in vitro diagnostic use as
assayed quality control material for
Calcitonin, Gastrin, and Procalcitonin to
monitor the precision of the laboratory
testing systems listed in the package
insert. This device is for prescription use
only. | For use as an assayed quality control
serum to monitor the precision of
laboratory testing procedures listed in the
package insert |
| SIZE | 1ml | 5ml |
| FORMAT | Lyophilised | Lyophilised |
| MATRIX | Human Serum | Human Serum |
| STORAGE
(Unopened) | 2 to 8 °C
Until expiration date | 2 to 8 °C
Until expiration date |
| OPEN VIAL CLAIM | Store refrigerated +2 to 8°C
In reconstituted serum Procalcitonin is
stable for 1day, Gastrin and Calcitonin are
stable for 8hours at +2 to 8°C if kept
capped in original container and free from
contamination. The control is stable if
frozen once for 28days at -20°C. | Once the control is reconstituted all
analytes will be stable for 7days when
stored tightly capped at +2 to 8°C with the
exceptions of Calcitonin and Gastrin,
which should be assayed immediately
after reconstitution. After reconstituting
and freezing the control, all analytes are
stable for 20days when stored tightly
capped at -10°C to -20°C with the
exception of Calcitonin as there is no
frozen stability claim supplied. |
| SHIPPING
TEMPERATURE | +2 to 8°C | +2 to 8°C |
| ANALYTES | Procalcitonin, Gastrin and Calcitonin. | There are a total of 92 analytes listed in
the package insert. However only
Gastrin and Calcitonin are applicable to
this comparison. |
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8. SUMMARY OF STABILITY STUDIES
Opened: Store refrigerated (+2°C to +8°C). In reconstituted serum, Procalcitonin is stable for 1 dav. Gastrin and Calcitonin are stable for 8 hours at +2℃ to +8℃ if kept capped in original container and free from contamination. The control is stable of frozen once for 28 days at -20°C. Only the required amount of the product should be removed. After use, any residual product should not be returned to the original vial.
Unopened: Store refrigerated (+20C to +80C). Stable to the expiration date printed on individual vials.
9. SUMMARY OF VALUE ASSIGNMENT
The value assignment for Calcitonin and Gastrin is performed at Randox Laboratories. The analysis is carried out on selected analysers. Two vials of sample are analyzed by running five replicates of each vial over the course of 2 days using the normal procedures for calibration on each day.
The mean value generated from the 20 replicates is used as the assigned value and ranges are set as +/- 25% of the assigned value.
The acceptance criteria for data is % coefficient of variation ≤ 15%.
| ANALYTE | SUPPLIER | PRODUCT
NUMBER | ORIGIN | SOURCE |
|---------------|----------|-------------------|----------------------------------------------|--------------------------------------------|
| Calcitonin | Sigma | T-3525 | Synthetic
Analytical
Grade
Chemical | Commercial source, added
volumetrically |
| Gastrin | Sigma | G-9020 | Human Gastrin | Commercial source, added
volumetrically |
| Procalcitonin | Randox | RCP9522 | Extracted and
purified from
E.coli | Commercial source, added
volumetrically |
10. TRACEABILITY
11. CONCLUSION
Testing results indicate that the proposed device is substantially equivalent to the predicate devices.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal lines above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
DEPARTMENT OF HEALTH & HUM AN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 20, 2012
Randox Laboratories Limited c/o Pauline Armstrong 55 Diamond Road, Crumlin County Antrim, BT29 4QY, United Kingdom.
Re: K121603
Trade/Device Name: Randox Immunoassay Speciality Control (II) Levels 1, 2 and 3 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material Regulatory Class: Class I, reserved . Product Code: JJY Dated: October 11, 2012 Received: October 15, 2012
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.
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 Part 801); 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.
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Page 2 - Pauline Armstrong
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Carol C. Benson
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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Indications for Use
510(k) Number (if known): K121603
Device Name: Randox Immunoassay Speciality Control (II) Levels 1, 2 and 3
Indication for Use:
The Randox Immunoassay Speciality Control (II) Levels 1, 2 and 3 are intended for in vitro diagnostic use as assayed quality control material for Calcitonin, Gastrin, and Procalcitonin to monitor the precision of the laboratory testing systems listed in the package insert.
This in vitro diagnostic device is intended for prescription use only.
Prescription Use > (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Yung Chan
Division/Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K121603