K Number
K031608
Device Name
RANDOX LIQUID PROTEIN CALIBRATOR
Date Cleared
2003-08-08

(78 days)

Product Code
Regulation Number
862.1150
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Randox Laboratories Limited Liquid Protein Calibrators (for neat sample assays) are liguid calibrators derived from normal human serum obtained from volunteer donors. They have been developed for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, IgA, IgG, IgM, Prealbumin and Transferrin assays (all neat sample assays). Assignment was performed at Randox Laboratories by immunoturbidimetry with reference to material standardised against appropriate International Reference Preparations. The constituent concentrations of these Calibrators are present at levels 0, 1, 2, 3, 4 and 5. These calibrators also contain α-1-Antitrypsin (AAT) and Rheumatoid Factor (RF) for use in the calibration of AAT and RF assays on the Bayer Advia 1650 analyser only. The Randox Laboratories Liquid Protein Calibrators (for diluted sample assays) are liquid calibrators derived from normal human serum obtained from volunteer donors. They have been developed for the calibration of α-1-acid glycoprotein, IgA, IgG, IgM and Transferrin assays which require sample pre-dilution. Assignment was performed at Randox Laboratories by immunoturbidimetry with reference to material standardised against appropriate International Reference Preparations. The constituent concentrations of these calibrators are present at levels 1, 2, 3, 4 and 5.
Device Description
Liquid calibrators derived from normal human serum obtained from volunteer donors.
More Information

Not Found

Not Found

No
The document describes liquid calibrators for laboratory assays and does not mention any AI or ML components.

No.
Explanation: This device is described as a liquid calibrator for diagnostic assays, which is used for calibration and measurement rather than direct treatment or therapy.

No.
This device is a calibrator used to test the accuracy of diagnostic assays. It is not a diagnostic device itself because it does not directly diagnose a condition or disease in a patient.

No

The device description explicitly states it is "Liquid calibrators derived from normal human serum," indicating a physical, biological product, not software.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that these calibrators are for the "calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, IgA, IgG, IgM, Prealbumin and Transferrin assays" and other protein assays. These assays are performed in vitro (outside the body) on biological samples (serum).
  • Device Description: The device is described as "Liquid calibrators derived from normal human serum obtained from volunteer donors." These are reagents used in laboratory testing.
  • Function: Calibrators are essential components of many in vitro diagnostic tests. They are used to establish the relationship between the signal measured by the instrument and the concentration of the analyte in the sample, ensuring accurate and reliable test results.

Therefore, based on the provided information, the Randox Laboratories Limited Liquid Protein Calibrators fit the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The Randox Laboratories Limited Liquid Protein Calibrators (for neat sample assays) are liguid calibrators derived from normal human serum obtained from volunteer donors. They have been developed for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, IgA, IgG, IgM, Prealbumin and Transferrin assays (all neat sample assays). Assignment was performed at Randox Laboratories by immunoturbidimetry with reference to material standardised against appropriate International Reference Preparations. The constituent concentrations of these Calibrators are present at levels 0, 1, 2, 3, 4 and 5. These calibrators also contain α-1-Antitrypsin (AAT) and Rheumatoid Factor (RF) for use in the calibration of AAT and RF assays on the Bayer Advia 1650 analyser only.

The Randox Laboratories Liquid Protein Calibrators (for diluted sample assays) are liquid calibrators derived from normal human serum obtained from volunteer donors. They have been developed for the calibration of α-1-acid glycoprotein, IgA, IgG, IgM and Transferrin assays which require sample pre-dilution. Assignment was performed at Randox Laboratories by immunoturbidimetry with reference to material standardised against appropriate International Reference Preparations. The constituent concentrations of these calibrators are present at levels 1, 2, 3, 4 and 5.

Product codes

JIX

Device Description

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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

The Randox Laboratories Limited Liquid Protein Calibrators, should only be used by 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)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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Predicate Device(s)

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Reference Device(s)

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Predetermined Change Control Plan (PCCP) - All Relevant Information

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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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around it. The logo is black and white.

AUG - 8 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dr. Lynne Hamilton Regulatory Affairs Randox Laboratories Ltd. Biochemical Manufacturers Ardmore, Diamond Road Crumlin, Co. Antrim United Kingdom, BT29 4QY

Re: K031608

Trade/Device Name: Liquid Protein Calibrators (for neat sample assays) & Liquid Protein Calibrators (for diluted sample assays) Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: May 19, 2003 Received: June 27, 2003

Dear Dr. Hamilton:

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).

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Page 2 -

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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

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510(k) Number (if known)

LIQUID PROTEIN CALIBRATORS (for neat sample assays) & Device Name

LIQUID PROTEIN CALIBRATORS (for diluted sample assays)

Indications For Use :

The Randox Laboratories Limited Liquid Protein Calibrators (for neat sample assays) are liguid calibrators derived from normal human serum obtained from volunteer donors. They have been developed for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, IgA, IgG, IgM, Prealbumin and Transferrin assays (all neat sample assays). Assignment was performed at Randox Laboratories by immunoturbidimetry with reference to material standardised against appropriate International Reference Preparations. The constituent concentrations of these Calibrators are present at levels 0, 1, 2, 3, 4 and 5. These calibrators also contain α-1-Antitrypsin (AAT) and Rheumatoid Factor (RF) for use in the calibration of AAT and RF assays on the Bayer Advia 1650 analyser only.

The Randox Laboratories Liquid Protein Calibrators (for diluted sample assays) are liquid calibrators derived from normal human serum obtained from volunteer donors. They have been developed for the calibration of α-1-acid glycoprotein, IgA, IgG, IgM and Transferrin assays which require sample pre-dilution. Assignment was performed at Randox Laboratories by immunoturbidimetry with reference to material standardised against appropriate International Reference Preparations. The constituent concentrations of these calibrators are present at levels 1, 2, 3, 4 and 5.

The Randox Laboratories Limited Liquid Protein Calibrators, should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Concurrence of CDRH, Office of Device Evaluation (ODE)
J. Pleeves for J, Bautista
(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) NumberK031608
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| Prescription Use
(Per 21 CFR 801.109) | OR | Over-The-Counter Use
(Optional format 1-2-96) |

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