(130 days)
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No
The description details a standard immunoturbidimetric assay based on chemical reactions and absorbance measurements, with no mention of AI or ML technologies.
No.
This device is an in vitro diagnostic reagent used to determine Lipoprotein (a) levels, which helps evaluate disorders and assess risk, but it does not treat or alleviate a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro diagnostic reagent for the quantitative determination of Lipoprotein (a) in serum and plasma," and further elaborates on its use "to evaluate disorders of lipid metabolism and to assess coronary heart disease." This clearly identifies it as a diagnostic device.
No
The device is an in vitro diagnostic reagent kit, which is a physical product containing chemical components for laboratory testing, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states it is an "in vitro diagnostic reagent" and is intended for the "quantitative determination of Lipoprotein (a) in serum and plasma." It also describes its use in evaluating lipid metabolism disorders and assessing coronary heart disease, which are diagnostic purposes.
- Device Description: The description reiterates that it is an "in vitro diagnostic reagent."
- Method: The method described (immunoturbidimetric assay using antigen-antibody reaction in serum/plasma) is a common technique used in in vitro diagnostics to analyze biological samples.
- Intended User/Care Setting: The intended user is "suitably qualified laboratory personnel under appropriate laboratory conditions," which is typical for IVD devices used in clinical laboratories.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Randox Laboratories Ltd. Lipoprotein (a) test kit is an in vitro diagnostic reagent for the quantitative determination of Lipoprotein (a) in serum and plasma.
The method is an immunoturbidimetric assay in which agglutination occurs due to an antigenantibody reaction between Lp(a) in a sample and anti-Lp(a) antibody adsorbed to latex particles. The agglutination is detected as an absorbance change at 700nm proportional to the concentration of Lp(a) in the sample.
Lp(a) determination is intended for use in conjunction with clinical evaluation, patient risk assessment and other lipid tests to evaluate disorders of lipid metabolism and lto assess coronary heart disease in specific populations.
Product codes
JIS, DFC, JJS
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
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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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human profile, composed of three curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 2 8 2001
Dr. Heather Anderson Regulatory Affairs Randox Laboratories, Ltd. Ardmore, Diamond Rd., Crumlin Co. Antrim, United Kingdom, BT29 4QY
K011568 Re:
Trade/Device Name: Lipoprotein (a) Regulation Number: 21 CFR 862.1150; 21 CFR 866.5600; 21 CFR 862.1660 Regulation Name: Calibrator; Low density lipoprotein immunological test system; Quality control material (assayed and unassayed) Regulatory Class: Class II; Class II; Class I, reserved Product Code: JIS; DFC; JJS Dated: August 2, 2001 Received: August 3, 2001
Dear Dr. Anderson:
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 i 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/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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): NOT KNOWN K011568
Device Name:
Lipoprotein (a)
Indications For Use :
The Randox Laboratories Ltd. Lipoprotein (a) test kit is an in vitro diagnostic reagent for the quantitative determination of Lipoprotein (a) in serum and plasma.
The method is an immunoturbidimetric assay in which agglutination occurs due to an antigenantibody reaction between Lp(a) in a sample and anti-Lp(a) antibody adsorbed to latex particles. The agglutination is detected as an absorbance change at 700nm proportional to the concentration of Lp(a) in the sample.
Lp(a) determination is intended for use in conjunction with clinical evaluation, patient risk assessment and other lipid tests to evaluate disorders of lipid metabolism and lto assess coronary heart disease in specific populations.
\This Application Sheet has been developed for the Hitachi 717 analyser and must be used by suitably qualified laboratory 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
Kesia Alexander for Sean Cooper
(Division Sign-Off)
(Division Sign-Off) Division of Clinical 510(k) Number .
Over-The-Counter Use (Optional format 1-2-96)