(300 days)
Abbott IMx B2 Microglobulin
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No
The device description and performance studies focus on standard nephelometry techniques and do not mention any AI or ML components.
No
The device is an in vitro diagnostic reagent used to measure B2-microglobulin to aid in the diagnosis of specific conditions, not for treatment.
Yes
The "Intended Use / Indications for Use" section states that the reagent "aids in the diagnosis of active rheumatoid arthritis and kidney disease."
No
The device is an in vitro diagnostic reagent, which is a chemical substance used in laboratory tests, not a software-only medical device. It is used in conjunction with a physical instrument (nephelometer) to perform the test.
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 N Latex B2-Microglobulin Reagent is an "in vitro diagnostic reagent". It is intended for the quantitative determination of a substance (human B2-microglobulin) in a sample taken from the human body (serum).
- Device Description: The description details how the reagent interacts with the sample in vitro (outside the body) to produce a measurable result using a nephelometer.
- Purpose: The measurement of B2-microglobulin is stated to "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
N Latex B2-Microglobulin Reagent is an in vitro diagnostic reagent for the quantiative determination of human B2-microglobulin in serum by means of particle-enhanced nephelometry. Measurement of B2 -microblobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.
Product codes
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Device Description
The N Latex Microglobulin Reagent intended to be used together with the Behring Nephelometer Systems in the quantitative determination of B2-microglobulin in serum. Polystyrene latex particles coated with specific antibodies to human B2-microglobulin are agglutinated when mixed with samples containing B2-microglobulin. The intensity of the resulting scattered light measured by the nephelometer is dependent upon the B2microglobulin content of the sample which is determined by reference to standards of known concentrations.
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
Assay range and sensitivity: The N Latex Bo-Microglobulin Reagent is designed to measure Bo-microglobulin concentrations within an assay range of approx. 0.62 to 20 mg/l for a sample dilution of 1:100. If a sample dilution of 1:400 is used the assay range is extended to approx. 8 0 mg/l. The sensitivity is given by the lower limit of the reference curve and thus depends on the Bo-microglobulin concentration of the standard.
Precision and reproducibility: Intra-assay precision was determined by assaying three B2-microglobulin concentrations (approx. 1.2, 1.5 and 6.0 mg/l) in replicates of twenty (20), the coefficient of variation ranged from 2.5 to 3.3 %. Inter-assay precision was determined by assaying three Bo-microglobulin concentrations (approx. 1.0, 1.4, and 5.8 mg/l) for a total of eight (8) replicates, the coefficient of variation ranged from 2.1 to 3.0%.
Method comparison (accuracy): Results of comparative studies using the N Latex (S2-Microglobulin Reagent and a commercially available enzyme immunoassay for 84 serum samples gave a correlation coefficient of 0.987, a y-intercept of 0.215, and a slope of 0.967.
Key Metrics
Coefficient of variation for Intra-assay precision: 2.5% to 3.3%
Coefficient of variation for Inter-assay precision: 2.1% to 3.0%
Correlation coefficient (method comparison): 0.987
Y-intercept (method comparison): 0.215
Slope (method comparison): 0.967
Predicate Device(s)
Abbott IMx B2 Microglobulin
Reference Device(s)
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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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Behring Diagnostic Inc N Latex B2- Microglobulin Reagent 510(k) Notification
OCT - 3 199
Attachment 1
Summary of Safety and Effectiveness for 510(k) N Latex B2-Microglobulin Reagent
Manufactures Name, Address, Telephone, and contact person, date of 1 . preparation:
Manufacturer
Behringwerke AG Postfach 1140 35001 Marburg Germany
Distributor
Behring Diagnostics Inc. 151 University Avenue Westwood, MA 02090 617-320-3000 Attn: Kathleen Dray-Lyons
Preparation date: July 16, 1996
2 . Name/ Classification: Device
N Latex B2-Microblobulin Reagent for the quantitative determination of B2-Microglobulin Classification Number: class 11 (866.5630)
3 . Identification of the legally marketed device:
Abbott IMx B2 Microglobulin
4 . Proposed Device Description:
The N Latex Microglobulin Reagent intended to be used together with the Behring Nephelometer Systems in the quantitative determination of B2-microglobulin in serum. Polystyrene latex particles coated with specific antibodies to human B2-microglobulin are agglutinated when mixed with samples containing B2-microglobulin. The intensity of the resulting scattered light measured by the nephelometer is dependent upon the B2microglobulin content of the sample which is determined by reference to standards of known concentrations.
5 . Proposed Device Intended Use:
N Latex B2-Microglobulin Reagent is an in vitro diagnostic reagent for the quantiative determination of human B2-microglobulin in serum by means of particle-enhanced nephelometry. Measurement of B2 -microblobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.
1
Behring Diagnostic Inc N Latex B2- Microglobulin Reagent 510(k) Notification
Partistics and Carling
Medical device to which equivalence is claimed and comparison 6 . information:
The B2-Microglobulin assay using the proposed product is substantially equivalent in intended use and results obtained to the Abbott IMx B2 Microglobulin. The Abbott IMx B2 Microglobulin like the proposed product, depends upon assaying standards of known B2microglobulin content to convert the measured signal to concentrations. Both tests utilize specific antibody to B2-microglobulin for capture of the B2-microglobulin present in sample.
The N Latex B2-Microglobulin Reagent differs from the Abbott IMx B2 Microglobulin in that the Abbott IMx B2 Microglobulin assay is a sequential binding assay which consists of an antibody-antigen complex that is transfered to a glass fiber and measured using a fluorometer; while the N Latex B2-Microglobulin Reagent contains antibody that is affixed to a polystyrene particle which binds the B2-microglobulin in the patient sample. The polystyrene particles agglutinate, increasing the amount of light a given concentration of B2-microglobulin can scatter, effectively amplifying the signal when measure by a nepholometer.
7 . Proposed Device Performance Characteristics:
Assay range and sensitivity
The N Latex Bo-Microglobulin Reagent is designed to measure Bo-microglobulin concentrations within an assay range of approx. 0.62 to 20 mg/l for a sample dilution of 1:100. If a sample dilution of 1:400 is used the assay range is extended to approx. 8 0 mg/l.
The sensitivity is given by the lower limit of the reference curve and thus depends on the Bo-microglobulin concentration of the standard.
Precision and reproducibility
B2-microglobulin Intra-assay by assaying three precision was determined concentrations (approx. 1.2, 1.5 and 6.0 mg/l) in replicates of twenty (20), the coefficient of variation ranged from 2.5 to 3.3 %.
Inter-assay precision was determined by assaying three Bo-microglobulin concentrations (approx. 1.0, 1.4, and 5.8 mg/l) for a total of eight (8) replicates, the coefficient of variation ranged from 2.1 to 3.0%.
Method comparison (accuracy)
Results of comparative studies using the N Latex (S2-Microglobulin Reagent and a commercially available enzyme immunoassay for 84 serum samples gave a correlation coefficient of 0.987, a y-intercept of 0.215, and a slope of 0.967.