(31 days)
The Randox Laboratories Limited Apolipoprotein Calibrator is based on lyophilised human serum and has been developed for use in the calibration of Apolipoprotein A-1 and Apolipoprotein B assays. The constituent concentrations of the Randox Laboratories Limited Apolipoprotein Calibrator are present at 1 level. The Randox Labotatories Limited Apolipoprotein Calibrator should only be used by suitably qualified personnel, under appropriate laboratory conditions.
Based on lyophilised human serum and has been developed for use in the calibration of Apolipoprotein A-1 and Apolipoprotein B assays. The constituent concentrations are present at 1 level.
The provided document is a 510(k) premarket notification letter from the FDA for a device called "APOLIPOPROTEIN CALIBRATOR." This type of document does not contain the detailed study results, acceptance criteria, or performance data typically found in a clinical study report or a more comprehensive premarket submission.
Therefore, I cannot provide the requested information, such as:
- A table of acceptance criteria and the reported device performance: This document only states that the device is "substantially equivalent" to a legally marketed predicate device, but does not provide specific performance metrics or acceptance criteria for this particular calibrator.
- Sample size used for the test set and the data provenance: Not available in this document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
- Adjudication method for the test set: Not available in this document.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: MRMC studies are typically for imaging devices or those requiring human interpretation, which is not the case for a calibrator. This information is not available.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a calibrator.
- The type of ground truth used: Not available for a calibrator in this context.
- The sample size for the training set: Not applicable or available for a calibrator.
- How the ground truth for the training set was established: Not applicable or available for a calibrator.
What the document does tell us:
- Device Name: APOLIPOPROTEIN CALIBRATOR
- Manufacturer: Randox Laboratories, Ltd.
- Indications For Use: "The Randox Laboratories Limited Apolipoprotein Calibrator is based on lyophilised human serum and has been developed for use in the calibration of Apolipoprotein A-1 and Apolipoprotein B assays. The constituent concentrations of the Randox Laboratories Limited Apolipoprotein Calibrator are present at 1 level."
- Regulatory Class: Class II (Special Controls)
- Product Code: JIX
- Nature of the Device: It is a calibrator, meaning it's used to establish the reference points for an assay that measures Apolipoprotein A-1 and Apolipoprotein B in human serum. Its primary function is to ensure the accuracy and reliability of these assays. The review by the FDA determined it was "substantially equivalent" to a predicate device already on the market.
To obtain the detailed performance data and acceptance criteria, one would typically need to review the full 510(k) submission, which is generally not publicly available in its entirety, or the device's labeling and instructions for use, which might contain more specific performance claims if required.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 098 Gaither Road Rockville MD 20850
Dr. Pauline Armstrong Randox Laboratories, Ltd. Biochemical Manufacturers Ardmore, Diamond Road Crumlin, CO. Antrim United Kingdom BT29 4QY
OCT 2 4 2002
Re: K023158
Trade/Device Name: APOLIPROTEIN CALIBRATOR Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: September 16, 2002 Received: September 23, 2002
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 (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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This letter will allow you to begin marketing your device as described in your 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 and " additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrlvdsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known)
Ko23158 NOT KNOWN
Device Name:
APOLIPOPROTEIN CALIBRATOR
Indications For Use :
The Randox Laboratories Limited Apolipoprotein Calibrator is based on lyophilised human serum and has been developed for use in the calibration of Apolipoprotein A-1 and Apolipoprotein B assays. The constituent concentrations of the Randox Laboratories Limited Apolipoprotein Calibrator are present at 1 level.
The Randox Labotatories Limited Apolipoprotein Calibrator should only be used by suitably qualified personnel, under appropriate laboratory conditions.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional format 1-2-96)
Juan Cooper
(Division Sign-Off) Division of Clinical Labgratory 510(k) Number -
§ 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.