(142 days)
No
The summary describes a standard immunoturbidimetric assay for measuring a specific protein concentration, with no mention of AI or ML in the device description, intended use, or performance studies.
No
This device is an in vitro diagnostic (IVD) assay intended for quantitative determination of a biomarker to aid in diagnosis, not to treat or directly restore health.
Yes.
The device is intended "as an aid in the diagnosis of active rheumatoid arthritis and kidney disease."
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 device is intended for "in vitro quantitative determination of beta-2-microglobulin concentration in human serum, plasma (EDTA) or urine". The term "in vitro" is a key indicator of an IVD, meaning it is used to test samples taken from the human body outside of the body.
- Device Description: The "Device Description" section reiterates the "in vitro quantitative determination" of beta-2-microglobulin.
- Sample Types: The device is designed to analyze human serum, plasma, and urine, which are biological samples commonly used in in vitro diagnostic testing.
- Purpose: The assay is used "as an aid in the diagnosis of active rheumatoid arthritis and kidney disease," which is a diagnostic purpose.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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, plasma (EDTA) or urine on the AEROSET ® Instrument as an aid in the diagnosis of active rheumatoid arthritis and kidney disease.
Product codes
JZG
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, plasma (EDTA) or urine on the AEROSET ® Instrument as an aid in the diagnosis of active rheumatoid arthritis and kidney disease.
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
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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
In a method comparison study 110 urine samples with Beta-2 Microglobulin levels ranging from 0.01 to 18.85 mg/L were evaluated on the Abbott AEROSET® instrument. The slope was 1.088, and the correlation coefficient (r) was 0.9894 for the Quantia Beta-2 Microglobulin versus the predicate device.
Within run precision assessed over multiple runs (with the Dilution Protocol 2) using urine samples on an AEROSET®, gave a CV of 4.2 % (at a mean of 0.066 mg/L), 1.7 % (at a mean of 0.094 mg/L), 1.5 % (at a mean of 0.204 mg/L) and 1.6 % (at a mean of 0.302 mg/L),
The linear range using urine samples is 0.025 to 1.6 mg/L with the automatic rerun capability (Dilution Protocol 2), 0.250 to 16 mg/L with Standard Dilution Protocol, and 16 to 96 mg/L with the automatic rerun capability Dilution Protocol 1.
There are no significant interferences in urine with this assay for conjugated bilirubin up to 20.9 mg/dL, high protein immunoglobulin (IgG) up to 100 mg/L and no positive or negative influence of the pH has been found. Ascorbic acid interference is below 10% up to 20 mg/dL. Do not use hemolyzed urine (hemoglobin interference is below 10% up to 23.6 mg/dL).
Key Metrics
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Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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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
DEC 1 9 2007
Contact Person:
Contact: Joan Guixer, Quality Assurance and Regulatory Affairs Director Phone: 34 - 93 860 90 00
Summary Prepared:
July 16, 2007
Name of the device:
Quantia Beta-2 Mcroglobulin
Classification name(s):
| 866.5630 | Beta-2-microglobulin immunological test system |
|---|---|
| JZG | System, Test, Beta-2-Microglobulin Immunological |
ldentification of predicate device(s):
K943686 IL Test Beta-2-Microglobulin (Instrumentation Laboratory Co.)
Quantia Beta-2-Microglobulin reagent was already 510(k) cleared as Quantia Beta-2-Microglobulin for its use with serum and EDTA plasma (K050613). A new submission for the Quantia Beta-2-Microglobulin reagent has been prepared as it is intended to also claim urine as a sample. The kit Quantia Beta-2-Microglobulin already cleared, contained Buffer and Latex Reagent. The Calibrators were already cleared in the submission K050613. There have also been added two different levels of controls in a separate kit. The controls are supplied by Bio-Rad (K851202/A1) and the values are assigned at Biokit S.A. This test with Biokit labeling was cleared K050596.
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, plasma (EDTA) or urine on the AEROSET ® Instrument as an aid in the diagnosis of active rheumatoid arthritis and kidney disease.
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.
Quantia Beta-2-Microglobulin 510(K)
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Class II
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Summary of Performance Data:
In a method comparison study 110 urine samples with Beta-2 Microglobulin levels ranging from 0.01 to 18.85 mg/L were evaluated on the Abbott AEROSET® instrument. The slope was 1.088, and the correlation coefficient (r) was 0.9894 for the Quantia Beta-2 Microglobulin versus the predicate device.
Within run precision assessed over multiple runs (with the Dilution Protocol 2) using urine samples on an AEROSET®, gave a CV of 4.2 % (at a mean of 0.066 mg/L), 1.7 % (at a mean of 0.094 mg/L), 1.5 % (at a mean of 0.204 mg/L) and 1.6 % (at a mean of 0.302 mg/L),
The linear range using urine samples is 0.025 to 1.6 mg/L with the automatic rerun capability (Dilution Protocol 2), 0.250 to 16 mg/L with Standard Dilution Protocol, and 16 to 96 mg/L with the automatic rerun capability Dilution Protocol 1.
There are no significant interferences in urine with this assay for conjugated bilirubin up to 20.9 mg/dL, high protein immunoglobulin (IgG) up to 100 mg/L and no positive or negative influence of the pH has been found. Ascorbic acid interference is below 10% up to 20 mg/dL. Do not use hemolyzed urine (hemoglobin interference is below 10% up to 23.6 mg/dL).
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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 stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" are arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 9 2007
Biokit S.A. c/o Ms. Joan Guixer QA & RA Director Can Malé s/n 08186 Lliçà d'Amunt Barcelona, Spain
Re: K072078
Trade/Device Name: Quantia Beta-2 Microglobulin Regulation Number: 21 CFR 866.5630 Regulation Name: Beta-2-microglobulin immunological test system Regulatory Class: Class II Product Code: JZG Dated: November 12, 2007 Received: November 14, 2007
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
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forth in the quality systems (QS) regulation (21 CFR Part 820). 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) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For a restions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Robert Alsted
Robert L. Becker, Jr., M.D., PH.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K072078
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 in vitro quantitative determination of beta-2microglobulin concentration in human serum, plasma (EDTA) or urine on the AEROSET® Instrument as an aid in the diagnosis of active rheumatoid arthritis and kidney disease.
The Quantia Beta-2 Microglobulin is intended to be used with the already cleared Quantia PROTEINS Control (K050596) and the Beta-2 Microglobulin Standard (K050613).
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
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)
Maria M Char
Division Sign-Off
OF CH. IV. Pt.
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K072078
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