(94 days)
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No
The document describes a laboratory calibrator for protein assays and lists compatible analytical systems. There is no mention of AI or ML in the intended use, device description, or any other section.
No
Explanation: The device is described as a calibrator for in vitro diagnostic assays, not a device used for treating or diagnosing diseases in a patient.
No
Explanation: This calibrator is used for the calibration of assays and is identified as "For in vitro diagnostic use," meaning it is used in lab tests, not directly to diagnose a patient.
No
The device description is not found, but the intended use clearly describes a "Liquid Protein Calibrator" which is a physical substance used for calibrating laboratory instruments. This is a hardware component, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The text explicitly states: "For in vitro diagnostic use."
Furthermore, the intended use describes its function in calibrating assays for various proteins in human serum, which is a typical application for in vitro diagnostic devices used in laboratory settings to analyze biological samples.
N/A
Intended Use / Indications for Use
The Randox Laboratories Limited Liquid Protein Calibrator (for neat sample assays) is derived from normal human serum obtained from volunteer donors. It has been developed for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, IgA, IgG, IgM, Prealbumin, Transferrin and Haptoglobin assays (all neat sample assavs).
Assignment was performed at Randox Laboratories by immunoturbidimetry with reference to International Reference Material CRM 470. The constituent concentrations of these Calibrators are present at levels 1, 2, 3, 4 and 5.
This calibrator can be used on Abbott Spectrum, Abbott aeroset, Abbott Architect ഗ്രാമം Architect i2000sr, Ace Analyser, Bayer Advia 1650, Advia 2400, Advia 1200, Dade Dimension RXL, Dimension AR, Hitachi 704, Hitachi 717, Hitachi 911, Hitachi 917, Hitachi 912, Hitachi 747, Kone progress, Olympus AU800, AU600, AU400, AU2700, AU5400, Selectra vitalab, Synchron CX4 Synchron CX5 Synchron CX7, Synchron LX20, ILAB300, ILAB900, ILAB1800, ILAB600, RX Daytona, RX Imola, Cobas Mira, Cobas Mira S, Cobas Mira plus systems
The Randox Laboratories Limited Liquid Protein Calibrators, should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
For in vitro diagnostic use.
Product codes
JIX
Device Description
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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
suitably qualified laboratory personnel under appropriate laboratory conditions.
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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 U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or other bird in flight. The symbol is composed of three curved lines that suggest feathers or wings.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Randox Laboratories, Ltd. c/o Dr. Pauline Armstrong Regulatory Affairs 55 Diamond Rd. Crumlin, County Antrim United Kingdom, BT29 4QY
JUL 2 0 2006
Re: K061056
Trade/Device Name: Randox Liquid Protein Calibrators (For Neat Sample Assays) Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrators Regulatory Class: Class II Product Code: JIX Dated: April 11, 2006 Received: April 17, 2006
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 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); good manufacturing practice requirements as set forth in the quality systems (OS) 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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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Robert Becker
Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K061056
LIQUID PROTEIN CALIBRATORS (for neat sample assays ) Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Randox Laboratories Limited Liquid Protein Calibrator (for neat sample assays) is derived from normal human serum obtained from volunteer donors. It has been developed for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, IgA, IgG, IgM, Prealbumin, Transferrin and Haptoglobin assays (all neat sample assavs).
Assignment was performed at Randox Laboratories by immunoturbidimetry with reference to International Reference Material CRM 470. The constituent concentrations of these Calibrators are present at levels 1, 2, 3, 4 and 5.
This calibrator can be used on Abbott Spectrum, Abbott aeroset, Abbott Architect ഗ്രാമം Architect i2000sr, Ace Analyser, Bayer Advia 1650, Advia 2400, Advia 1200, Dade Dimension RXL, Dimension AR, Hitachi 704, Hitachi 717, Hitachi 911, Hitachi 917, Hitachi 912, Hitachi 747, Kone progress, Olympus AU800, AU600, AU400, AU2700, AU5400, Selectra vitalab, Synchron CX4 Synchron CX5 Synchron CX7, Synchron LX20, ILAB300, ILAB900, ILAB1800, ILAB600, RX Daytona, RX Imola, Cobas Mira, Cobas Mira S, Cobas Mira plus systems
The Randox Laboratories Limited Liquid Protein Calibrators, should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
For in vitro diagnostic use.
V Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 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)
ia M. Chen
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number KOG 1056
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