(108 days)
K/DEN: Not Found
Not Found
No
The document describes liquid immunoassay controls, which are chemical reagents used for quality control in laboratory tests. There is no mention of AI or ML in the intended use, device description, or performance studies. The device's function is based on chemical properties, not algorithmic processing of data.
No
The device is described as an "in vitro diagnostic device" used for quality control of quantitative assays, not for treating any specific medical condition or disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "This in vitro diagnostic device is intended for prescription use only." This directly identifies the device as a diagnostic device.
No
The device is described as "liquid controls" and is intended for use in "in vitro diagnostic" assays, indicating it is a physical substance used for quality control, not a software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "This in vitro diagnostic device is intended for prescription use only."
- Purpose: The device is described as "liquid controls developed for use in the quality control of the quantitative assays stated on the package insert." This aligns with the definition of an IVD, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment. In this case, the controls are used to ensure the accuracy of assays that perform these functions.
- Device Description: The description of the controls and their intended use in "routine hospital laboratories" further supports its classification as an IVD used in a clinical setting.
N/A
Intended Use / Indications for Use
The Randox Liquid Immunoassay Premium Controls, Level 1, Level 2, Level 3 and Tri Level are liquid controls developed for use in the quality control of quantitative assays stated in the package insert.
The Randox Liquid Immunoassay Premium Controls Level 1, Level 2, Level 3 and Tri level are liquid controls developed for use in the quality control of the quantitative assays stated on the package insert. This in vitro diagnostic device is intended for prescription use only.
Product codes
JJY
Device Description
Randox Liquid Immunoassay Premium Controls are manufactured at three levels. Level 1. Level 2 and Level 3. as well as a Tri Level product. 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
Not Found
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
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Stability: Serum is stable for 7 days (when thawed) at +2 - +8°C. To assess the shelf life stability claims, real time stability studies of the device have been carried out. A shelf life stability claim of 12 months has been noted for the device, with 2 lots having achieved at least this claim, and tests ongoing to obtain real time data for 24 months.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Bio-Rad Liquichek Immunoassay Plus Controls Levels 1, 2 and 3
Reference Device(s)
Not Found
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 the word "RANDO" in a bold, sans-serif font. The letters are black and have a slightly textured appearance. The "O" in "RANDO" is represented by two concentric circles.
Image /page/0/Picture/2 description: The image shows a close-up of a dark, textured surface that fills most of the frame. The texture appears granular and uneven, with variations in shading that suggest depth and complexity. A curved, dark line defines the edge of the surface, creating a sense of containment within the frame. The overall impression is one of density and roughness, with a focus on the tactile qualities of the material.
510(k) Summary
Safety and Effectiveness as Required by 21 CFR 807.92
Manufacturer and Submitter
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
Device Name
Trade Name: Randox Liquid Immunoassay Premium Controls Levels 1, 2 and 3, and Tri Level
Common Name: Liquid Immunoassay Premium Controls Levels 1, 2 and 3, and Tri Level
Classification: Multianalyte Controls, All kinds (Assayed and Unassayed)
Product Code: JJY
Date of Summary Preparation 22nd November 2011
Predicate Devices
Bio-Rad Liquichek Immunoassay Plus Controls Levels 1, 2 and 3
Image /page/0/Picture/18 description: The image shows three different logos. The first logo has a crown on top of a cursive letter "e" with a bird-like figure in the middle, and the number "2007" below. The second logo is a circle with a checkmark inside, with the letters "SGS" below. The third logo is a square with a crown on top of a checkmark, with the letters "URAS" below.
Randox Laboratories Limited, 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom T +44 (0) 28 9442 2413 F +44 (0) 28 9445 2912 E marketing@randox.com | www.randox.com
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Image /page/1/Picture/0 description: The image shows the word "RANDOXX" in a bold, sans-serif font. The letters are filled with a textured pattern, giving them a slightly rough appearance. The two O's in the word are designed as concentric circles, adding a unique visual element to the text.
Image /page/1/Picture/1 description: The image shows a close-up of a dark, textured surface that fills most of the frame. The texture appears granular or speckled, with small, light-colored dots scattered across a darker background. The surface curves along the right and top edges, suggesting it might be part of a larger, rounded object. The lower-left corner of the image is a solid white, contrasting sharply with the textured area.
Device Description
Randox Liquid Immunoassay Premium Controls are manufactured at three levels. Level 1. Level 2 and Level 3. as well as a Tri Level product. 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.
Intended Use
The Randox Liquid Immunoassay Premium Controls, Level 1, Level 2, Level 3 and Tri Level are liquid controls developed for use in the quality control of quantitative assays stated in the package insert.
Similarity to Predicate Device
- Both are assayed quality control serums. �
- Both are intended to monitor the precision of laboratory testing procedures 0 for the analytes named in the product insert.
- Both are in vitro diagnostic medical devices. .
- Both devices are in liquid format and manufactured from human serum. .
Stability
Serum is stable for 7 days (when thawed) at +2 - +8°C. To assess the shelf life stability claims, real time stability studies of the device have been carried out. A shelf life stability claim of 12 months has been noted for the device, with 2 lots having achieved at least this claim, and tests ongoing to obtain real time data for 24 months.
Conclusion
Testing results indicate that the proposed device is substantially equivalent to the predicate device.
Randox Laboratories Limited, 55 Diamond Road, Crumlin, County Antrim, BT29 4QY: United Kingdom +44 (0) 28 9442 2413 F +44 (0) 28 9445 2912 E marketing@randox.com I www.randox.com
Image /page/1/Picture/16 description: The image contains three logos. The first logo has a crown on top of a cursive letter "e" and the number 2007 below it. The second logo is a circle with a checkmark inside and the letters "SGS" below it. The third logo has a crown on top of the letters "ULAL" and some lines below it.
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Image /page/2/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 image of an eagle or bird-like figure with outstretched wings.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Randox Laboratories Limited c/o Pauline Armstrong 55 Diamond Road Crumlin Antrim United Kingdom BT29 4QY
DEC - 1 2011
Re: K112337
Trade/Device Name: Randox Liquid Immunoassay Premium Controls, Level 1, level 3 and Tri Level Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material Regulatory Class: Class I, reserved Product Code: JJY Dated: October 4, 2011 Received: October 6, 2011
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 such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/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) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours.
signature
Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): Unknown
Device Name: Randox Liquid Immunoassay Premium Controls Level 1, Level 2, Level 3 and Tri-Level
Indication For Use:
The Randox Liquid Immunoassay Premium Controls Level 1, Level 2, Level 3 and Tri level are liquid controls developed for use in the quality control of the quantitative assays stated on 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 Diagnostic Devices (OIVD)
Rute Chale
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)_112337