(159 days)
Not Found
No
The summary describes a standard immunoturbidimetric assay for measuring beta-2-microglobulin levels. There is no mention of AI, ML, or any computational methods beyond standard data processing for calibration and result calculation.
No.
The device is an in vitro diagnostic assay used for the quantitative determination of beta-2-microglobulin concentration in human serum or plasma to aid in the diagnosis of certain conditions, not for direct therapy.
Yes
Explanation: The device is intended for the "Quantitative determination of beta-2-microglobulin concentration in human serum or plasma... as an aid in the diagnosis of active rheumatoid arthritis and kidney disease." This statement indicates its use in diagnosing medical conditions, thereby qualifying it as a diagnostic device.
No
The device description clearly states it is an "in vitro quantitative determination" using a "latex particle enhanced immunoturbidimetric assay" and mentions reagents, controls, and standards. It also refers to performance studies conducted on the "Abbott AEROSET® instrument," which is a piece of hardware. This indicates the device is a combination of reagents and likely hardware (the instrument), not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" and "Device Description" sections both explicitly state "For in vitro diagnostic use".
- Nature of the Assay: The device is a "latex particle enhanced immunoturbidimetric assay for the quantitative determination of beta-2-microglubulin concentration in human serum or plasma". This describes a test performed on biological samples outside of the body to provide information for diagnosis.
- Intended Use in Diagnosis: The assay is intended "as an aid in the diagnosis of active rheumatoid arthritis and kidney disease". This clearly indicates its role in the diagnostic process.
- Control and Standard Components: The inclusion of "Quantia PROTEINS Control" and "Quantia Beta-2 Microglobulin Standard" further supports its use as a diagnostic test system, as controls and standards are essential for ensuring the accuracy and reliability of IVD assays.
N/A
Intended Use / Indications for Use
The Quantia Beta-2 Microglobulin is intended as a latex particle enhanced immunoturbidimetric assay for The Quantitative determination of beta-2-microglubulin concentration in human serum or plasma the ?? Viro quarklative accension in the diagnosis of active rheumatoid arthritis and kidney disease.
Quantia PROTEINS Control is intended for use in monitoring the quality control of results obtained with the Quantia Beta-2 Microglobulin and Quantia A1-AT reagents by turbidimetry. (NOTE: This control has been also 510(k) FDA submitted for use with A1-AT) For in vitro diagnostic use
Quantia Beta-2 Microglobulin Standard is intended for use in establishing the calibration curve for the Quantia Beta-2 Microglobulin reagents by turbidimetry. For in vitro diagnostic use.
Product codes
JZG, JJS, JJX
Device Description
The Quantia Beta-2 Microglobulin is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of beta-2-microglubulin concentration in human serum or plasma (EDTA) on the AEROSET® instrument as an aid in the diagnosis of active rheumatoid arthritis and kidney disease.
Quantia PROTEINS Control is intended for use in monitoring the quality control of results obtained with the Quantia Beta-2 Microglobulin and Quantia A1-AT reagents by turbidimetry. (NOTE: This control has been also 510 (k) FDA submitted for use with Quantia A1-AT) For in vitro diagnostic use.
Quantia Beta-2 Microglobulin Standard is intended for use in establishing the calibration curve for the Quantia Beta-2 Microglobulin reagents by turbidimetry. For in vitro diagnostic use.
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
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Summary of Performance Studies
In a method comparison study 105 serum samples with Beta-2 Microglobulin levels ranging from 1.01 to 101.1 mg/L were evaluated on the Abbott AEROSET® instrument. The slope was 0.876 and the correlation coefficient (r) was 0.9986 for the Quantia Beta-2 Microglobulin versus the predicate device.
Within run precision was assessed using the Quantia PROTEINS Controls I and II (low and high) and a third control spiked with pure Beta-2 Microglobulin at 10-15 mg/L, run in duplicate twice a day over twenty days (following the NCCLS EP5-A guideline), on the Abbott AEROSET® instrument. Control I gave a CV of 1.1 % (at a mean of 1.00 mg/L), Control II gave a CV of 0.9 % (at a mean of 5.46 mg/L) and the third control gave a CV of 0.9 % (at a mean of 13.61 mg/L). Total run precision gave a CV of 1.9% for Control I, 1.3% for Control II and 1.1% for the third control.
Linearity was assessed according to NCCLS EP6-A guideline. The assay was found to be linear within the following ranges:
- 0.25 to 16 mg/L without the automatic rerun capability.
- 0.02 to 100 mg/l with the automatic rerun capability.
The Limit of Quantification was defined as the minimum quantity of analyte that can be measured with a within-run CV below 20% and an error below ± 20 %. Without the automatic rerun capability, the Limit of Quantification for the Beta-2 Microglobulin assay is 0.25 mg/L and, with the automatic rerun capability, 0.02 mg/L.
The Interference study was assessed using the NCCLS guideline EP7-A. Interference testing is summarized as follows:
No significant interference from lipemia up to sample absorbance of 2.1 AU/cm at 660 nm. No significant interference from triglycerides up to concentrations of 1300 mg/dL. No significant interference from bilirubin up to concentrations of 20 mg/dL. No significant interference from haemoglobin up to concentrations of 480 mg/dL. RF interference is below 10% up to 288 IU/mL.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5630
Beta -2-microglobulin immunological test system.(a)
Identification. Abeta -2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesbeta -2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement ofbeta -2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.(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 § 866.9.
0
AUG 1 6 2005
Ko50 6/3
Section 3 Quantia Beta-2 Microglobulin 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:
August 10th, 2005
Name of the device:
Quantia Beta-2 Microglobulin
Classification name(s):
| 866.5630 | Beta-2-microglobulin immunological test system | Class I |
|---|---|---|
| JZG | System, Test, Beta-2-Microglobulin Immunological |
ldentification of predicate device(s):
IL Test Beta-2-Microglobulin (Instrumentation Laboratory Co.) K943686
Description of the device/intended use(s):
The Quantia Beta-2 Microglobulin is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of beta-2-microglubulin concentration in human serum or plasma (EDTA) on the AEROSET® instrument as an aid in the diagnosis of active rheumatoid arthritis and kidney disease.
Quantia PROTEINS Control is intended for use in monitoring the quality control of results obtained with the Quantia Beta-2 Microglobulin and Quantia A1-AT reagents by turbidimetry. (NOTE: This control has been also 510 (k) FDA submitted for use with Quantia A1-AT) For in vitro diagnostic use.
Quantia Beta-2 Microglobulin Standard is intended for use in establishing the calibration curve for the Quantia Beta-2 Microglobulin reagents by turbidimetry. For in vitro diagnostic use.
Statement of Technological Characteristics of the Device Compared to Predicate Device:
Quantia Beta-2 Microglobulin is substantially equivalent to the commercially available predicate device, IL Test Beta-2-Microglobulin, in performance and intended use.
1
Summary of Performance Data:
In a method comparison study 105 serum samples with Beta-2 Microglobulin levels ranging from 1.01 to 101.1 mg/L were evaluated on the Abbott AEROSET® instrument. The slope was 0.876 and the correlation coefficient (r) was 0.9986 for the Quantia Beta-2 Microglobulin versus the predicate device.
Within run precision was assessed using the Quantia PROTEINS Controls I and II (low and high) and a third control spiked with pure Beta-2 Microglobulin at 10-15 mg/L, run in duplicate twice a day over twenty days (following the NCCLS EP5-A guideline), on the Abbott AEROSET® instrument. Control I gave a CV of 1.1 % (at a mean of 1.00 mg/L), Control II gave a CV of 0.9 % (at a mean of 5.46 mg/L) and the third control gave a CV of 0.9 % (at a mean of 13.61 mg/L). Total run precision gave a CV of 1.9% for Control I, 1.3% for Control II and 1.1% for the third control.
Linearity was assessed according to NCCLS EP6-A guideline. The assay was found to be linear within the following ranges:
- 0.25 to 16 mg/L without the automatic rerun capability.
- 0.02 to 100 mg/l with the automatic rerun capability.
The Limit of Quantification was defined as the minimum quantity of analyte that can be measured with a within-run CV below 20% and an error below ± 20 %. Without the automatic rerun capability, the Limit of Quantification for the Beta-2 Microglobulin assay is 0.25 mg/L and, with the automatic rerun capability, 0.02 mg/L.
The Interference study was assessed using the NCCLS guideline EP7-A. Interference testing is summarized as follows:
No significant interference from lipemia up to sample absorbance of 2.1 AU/cm at 660 nm. No significant interference from triglycerides up to concentrations of 1300 mg/dL. No significant interference from bilirubin up to concentrations of 20 mg/dL. No significant interference from haemoglobin up to concentrations of 480 mg/dL. RF interference is below 10% up to 288 IU/mL.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the text "Biokit S.A. c/o Ms Joan Guixer Quality Assurance & Regulatory Affairs Director Can Malé". The text appears to be an address or contact information for a company or individual. The text is black and is on a white background.
Barcelona 08186, Spain
Lliçà d'Amunt
AUG 1 6 2005
Food and Drive Administration 2098 Gaither Road Rockville MD 20850
Re: K050613 Trade/Device Name: Ouantia Beta-2 Microglobulin Quantia Proteins Control Quantia Beta-2 Microglobulin Standard Regulation Number: 21 CFR 866.5630 Regulation Name: Beta-2-microglobulin Immunological Test System Regulatory Class: Class II Product Code: JZG, JJS, JJX Dated: March 3, 2005 Received: March 10, 2005
Dear Ms. Guixer:
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.
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 legally
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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), please 11 you attitle Office of Compliance at (240) 276-0131. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other Whoormation 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,
Robert L. Becker h
Robert L. Becker, Jr., M.D., PhD Director Division of Immunology and Hematology Devices 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): K050613
Device Name: Quantia Beta-2 Microglobulin
Indications for Use:
The Quantia Beta-2 Microglobulin is intended as a latex particle enhanced immunoturbidimetric assay for The Quantitative determination of beta-2-microglubulin concentration in human serum or plasma the ?? Viro quarklative accension in the diagnosis of active rheumatoid arthritis and kidney disease.
Quantia PROTEINS Control is intended for use in monitoring the quality control of results obtained with the Quantia Beta-2 Microglobulin and Quantia A1-AT reagents by turbidimetry. (NOTE: This control has been also 510(k) FDA submitted for use with A1-AT) For in vitro diagnostic use
Quantia Beta-2 Microglobulin Standard is intended for use in establishing the calibration curve for the Quantia Beta-2 Microglobulin reagents by turbidimetry. For in vitro diagnostic use.
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)
Mana Chan
Division Sign Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K050613