(78 days)
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.
Liquid calibrators derived from normal human serum obtained from volunteer donors.
This is a 510(k) premarket notification for "Liquid Protein Calibrators" and the provided text is a letter from the FDA determining substantial equivalence to a predicate device. This type of document, particularly for calibrators, does not typically contain the detailed acceptance criteria and study design information that would be found for a diagnostic device or imaging AI.
Therefore, many of the requested categories simply cannot be extracted from this document.
Here's a breakdown of what can be inferred or directly stated, and where information is missing:
1. A table of acceptance criteria and the reported device performance
- Cannot be extracted. This document is a regulatory clearance letter, not a performance study report. It states that the device is "substantially equivalent" to a legally marketed predicate, implying that its performance is acceptable based on comparison to that predicate, but specific acceptance criteria or performance metrics are not detailed here.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be extracted. No information about a "test set" in the context of device performance evaluation is provided. The calibrators themselves are derived from "normal human serum obtained from volunteer donors," but this refers to the source material for the calibrators, not a test set for performance validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Cannot be extracted. This relates to performance evaluation, which is not detailed in this clearance letter. The document mentions "Assignment was performed at Randox Laboratories by immunoturbidimetry with reference to material standardised against appropriate International Reference Preparations." This describes how the values of the calibrators were established ("ground truth" for the calibrator values themselves), but not a ground truth for a diagnostic test set. It does not mention expert consensus for establishing ground truth as one would for an AI device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Cannot be extracted. No test set or human interpretation requiring adjudication is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a calibrator, not an AI or diagnostic tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a calibrator, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the calibrator values: The "ground truth" for the constituent concentrations of the calibrators was established by "immunoturbidimetry with reference to material standardised against appropriate International Reference Preparations." This indicates a reference to established scientific standards and methods.
8. The sample size for the training set
- Not applicable / Cannot be extracted. This device is a calibrator and does not involve a "training set" in the context of machine learning. The calibrators are "derived from normal human serum obtained from volunteer donors," but the number of donors is not specified, nor is this a "training set" in the AI sense.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
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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) Number | K031608 |
|---|---|
| --------------- | --------- |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter Use(Optional format 1-2-96) |
|---|---|---|
| ------------------------------------------ | ---- | -------------------------------------------------- |
§ 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.