(60 days)
Not Found
No
The description details a standard immunoturbidimetric assay for quantitative determination of Lp(a), which is a chemical/biological measurement technique and does not involve AI or ML. There are no mentions of AI, ML, image processing, or any related concepts in the provided text.
No
The device is an in vitro diagnostic assay used for quantitative determination of lipoprotein(a) for evaluating lipid metabolism disorders and atherosclerotic cardiovascular diseases. It does not provide any treatment or therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular diseases in specific populations, when used in conjunction with clinical evaluation." This indicates that the device provides information for the diagnosis or assessment of medical conditions.
No
The device is described as a latex particle enhanced immunoturbidimetric assay, which is a laboratory test method involving reagents and physical components, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the Quantia Lp(a) is intended for the "in vitro quantitative determination of lipoprotein(a) [Lp(a)] concentration in human serum or plasma". The term "in vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Sample Type: The device analyzes human serum or plasma, which are biological specimens taken from the body.
- Purpose: The measurement of Lp(a) is used to evaluate lipid metabolism disorders and assess atherosclerotic cardiovascular diseases, which are medical conditions. This indicates the device is used for diagnostic purposes.
- Device Description: The "Device Description" reiterates the intended use and the analysis of human serum or plasma.
- Control and Standard: The inclusion of a control and standard is typical for IVD assays to ensure accuracy and reliability of the results.
- Performance Studies: The performance studies describe method comparison and precision, which are standard evaluations for IVD devices.
- Predicate Device: The mention of a predicate device (N-latex Lp(a)) with a K number (K013128) indicates that this device is being compared to a previously cleared IVD.
All of these factors strongly indicate that the Quantia Lp(a) is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Quantia Lp(a) is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of lipoprotein(a) [Lp(a)] concentration in human serum or plasma (EDTA, Heparin, Citrate) on the Clinical Chemistry Systems. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular diseases in specific populations, when used in conjunction with clinical evaluation.
Quantia Lp(a) Control is intended for use in monitoring the quality control of results obtained with the Quantia Lp(a) reagents by turbidimetry.
Quantia Lp(a) Standard is intended for use in establishing the calibration curve for the Quantia Lp(a) reagents by turbidimetry.
Product codes (comma separated list FDA assigned to the subject device)
DFC, JIS, JJX
Device Description
The Quantia Lp(a) is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of lipoprotein(a) [Lp(a)] concentration in human serum or plasma (EDTA, Heparin, Citrate) on the Clinical Chemistry Systems.
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
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In a method comparison study evaluating 104 samples with Lp(a) levels ranging from 2.4 to 188 mg/dL on the Abbott AEROSET® instrument, the slope was 1.121 and the correlation coefficient (r) was 0.9754 for Quantia Lp(a) versus the predicate device.
Within run precision was assessed over multiple runs using three different levels of control: (Quantia Lp(a) controls I and II and a mixture of control I and control II) on an Abbott Aeroset. The precision assessed gave a CV of 2.3% (at a mean of 16.1 mg/dL) and 0.9% (at a mean of 57.9 mg/dL). The third control (control II) gave a CV of 1.5 % (at a mean of 38.1 mg/dL).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Slope: 1.121
Correlation coefficient (r): 0.9754
Within run precision CV: 2.3% (at a mean of 16.1 mg/dL), 0.9% (at a mean of 57.9 mg/dL), 1.5% (at a mean of 38.1 mg/dL)
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.
K013128 N-latex Lp(a) (Dade Behring)
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.
Not Found
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).
Not Found
§ 866.5600 Low-density lipoprotein immunological test system.
(a)
Identification. A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.(b)
Classification. Class II (performance standards).
0
Kosoy487
APR 2 6 2005
page 1 of 2
Section 3 Quantia Lp(a) 510(k) Summary (Summary of Safety and Effectiveness)
Submitted by:
Biokit S.A. Can Male, Llissa d'Amunt Barcelona
08186 Spain
Contact Person:
Contact: Joan Guixer, Quality Assurance and Regulatory Affairs Director
Phone: 34 - 93 860 90 00
Summary Prepared:
February 15, 2005
Name of the device:
Quantia Lp(a)
Classification name(s):
Class II Low-density lipoprotein immunological test system 866.5600 DFC lipoprotein, low-density, antigen, antiserum, control
ldentification of predicate device(s):
K013128 N-latex Lp(a) (Dade Behring)
Description of the device/intended use(s):
The Quantia Lp(a) is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of lipoprotein(a) [Lp(a)] concentration in human serum or plasma (EDTA, Heparin, Citrate) on the Clinical Chemistry Systems. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular diseases in specific populations, when used in conjunction with clinical evaluation.
Quantia Lp(a) Control is intended for use in monitoring the quality control of results obtained with the Quantia Lp(a) reagents by turbidimetry.
Quantia Lp(a) Standard is intended for use in establishing the calibration curve for the Quantia Lp(a) reagents by turbidimetry.
Statement of Technological Characteristics of the Device Compared to Predicate Device:
Quantia Lp(a) is substantially equivalent to the commercially available predicate device, N-latex Lp(a) (Dade Behring), in performance and intended use.
1
L'050487
page 2 of 2
Summary of Performance Data:
In a method comparison study evaluating 104 samples with Lp(a) levels ranging from 2.4 to 188 mg/dL on the Abbott AEROSET® instrument, the slope was 1.121 and the correlation coefficient (r) was 0.9754 for Quantia Lp(a) versus the predicate device.
Within run precision was assessed over multiple runs using three different levels of control: (Quantia Lp(a) controls I and II and a mixture of control I and control II) on an Abbott (Gaamille The precision assessed gave a CV of 2.3% (at a mean of 16.1 mg/dL) and 0.9% (at a mean of 57.9 mg/dL). The third control (control II) gave a CV of 1.5 % (at a mean of 38.1 mg/dL).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
APR 2 6 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Joan Guixer Ouality Assurance &Regulatory Affairs Director Biokit S.A. Can Male Llissa D'Amunt Barcelona, Spain 08186
K050487 Trade/Device Name: Quantia Lp(a) Regulation Number: 21 CFR 866.5600 Regulation Name: Low-density lipoprotein immunological test system Regulatory Class: Class II Product Code: DFC, JIS, JJX Dated: February 22, 2005 Received: February 25, 2005
Dear Ms. Guixer:
Re:
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).
3
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 (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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Sean M. Cooper MS, DUM
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K050481
Device Name: Quantia Lp(a)
Indications for Use:
The Quantia Lp(a) is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of lipoprotein(a) [Lp(a]] concentration in human serum or plasma (EDTA, heparin, citrate) on Clinical Chemistry Systems. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular diseases in specific populations, when used in conjunction with clinical evaluation.
Quantia Lp(a) Control is intended for use in monitoring the quality control of results obtained with the Quantia Lp(a) reagents by turbidimetry.
Quantia Lp(a) standard is intended for use in establishing the calibration curve for the Quantia Lp(a) reagents by turbidimetry.
Prescription Use
(Part 21 CFR 801 Subpart D)
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)
ctay
(Division Sign-Off)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K050487