(196 days)
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No
The description details a standard immunochemical reaction and nephelometry for quantitative determination, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is an in vitro diagnostic reagent used to measure C1-inactivator for diagnostic purposes, not for treating a disease or condition.
Yes
The device is an in vitro diagnostic reagent used to quantitatively determine C1-inactivator in human plasma and serum, which aids in the diagnosis of specific medical conditions like hereditary angioneurotic edema and angioedema associated with lymphoma.
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 with a Behring Nephelometer, which is a hardware instrument.
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 its purpose is for the "quantitative determination of C1-inactivator... in human plasma and serum." It also clearly states that the measurement "aids in the diagnosis of hereditary angioneurotic edema... and a rare form of angioedema associated with lymphoma." This directly aligns with the definition of an IVD, which is used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of disease.
- Device Description: The description further reinforces its IVD nature by detailing the immunochemical reaction used to measure the C1 Inhibitor in human plasma samples.
- Performance Studies: The inclusion of performance studies like correlation and precision, using human samples (serum), is typical for IVD devices to demonstrate their analytical performance.
The information provided strongly indicates that this device is intended for use in a laboratory setting to analyze human biological samples for diagnostic purposes, which is the core function of an IVD.
N/A
Intended Use / Indications for Use
In vitro diagnostic reagent for the quantitative determination of C1-inactivator, C1-esterase inhibitor) in human plasma and serum with the Behring Nephelometers. Measurement of C1 inhibitor aids in the diagnosis of hereditary angioneurotic edema (increased blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).
Product codes
866.5250
Device Description
In vitro diagnostic reagent for the quantitative determination of C1-inactivator, C1-esterase inhibitor) in human plasma and serum with the Behring Nephelometers. Measurement of C1 inhibitor aids in the diagnosis of hereditary angioneurotic edema (increased blood vessel permeability causing swelling of tissues) and a rare form of anqioedema associated with lymphoma (lymph node cancer).
In an immunochemical reaction, C1 Inhibitor in the human plasma sample form immune complexes with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.
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
Correlation: Results of comparative studies using the N Antiserum to C1 Inhibitor and the BIND A RID™ C1 for 50 serum samples gave a correlation coefficient of 0.973 and a y-intercept of 3.74 and a slope of 0.85.
Precision: Inter-assay precision studies were run over a 5 day period, twice per day, to total n=10 precision ranged from 0.89-7.73 %CV. Intra-assay precision was calculated from n=30 precision ranges from 1.31 - 2.89 %CV.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.5250 Complement C
1 inhibitor (inactivator) immunological test system.(a)
Identification. A complement C1 inhibitor (inactivator) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the complement C1 inhibitor (a plasma protein) in serum. Complement C1 inhibitor occurs normally in plasma and blocks the action of the C1 component of complement (a group of serum proteins which destroy infectious agents). Measurement of complement C1 inhibitor aids in the diagnosis of hereditary angioneurotic edema (increased blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).(b)
Classification. Class II (performance standards).
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AUG - 1 1996
attachment 1
510(k) Summary of Safety and Effectiveness for N Antiserum to C1 Inhibitor
- Manufacturer Name, Address, phone number, contact name and date of preparation:
- Behringwerke AG Manufacturer Postfach 1140 35001 Marburg Germany
- Distributor: Behring Diagnostics Inc., 151 University Avenue Westwood, MA 02090 617-320-3023 Contact name: Kathleen Dray-Lyons
date of preparation: June 27, 1996
2. Device Name/Classification:
Reagents for use in the determination of Complement C1 Inhibitor /Class II (866.5250)
Identification of the legally marketed device to which the submitter claims 3. equivalence.
The Binding Site Limited BIND A RID™ C1
Proposed Device Description: 4.
In vitro diagnostic reagent for the quantitative determination of C1-inactivator, C1-esterase inhibitor) in human plasma and serum with the Behring Nephelometers. Measurement of C1 inhibitor aids in the diagnosis of hereditary angioneurotic edema (increased blood vessel permeability causing swelling of tissues) and a rare form of anqioedema associated with lymphoma (lymph node cancer).
In an immunochemical reaction, C1 Inhibitor in the human plasma sample form immune complexes with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.
5. Proposed Device Intended Use:
In vitro diagnostic reagent for the quantitative determination of C1-inactivator, C1-esterase inhibitor) in human plasma and serum with the Behring Nephelometers. Measurement of C1 inhibitor aids in the diagnosis of hereditary angioneurotic edema
Image /page/0/Picture/17 description: The image shows a sequence of numbers, specifically "000010". The numbers are printed in a bold, sans-serif font, and they appear to be part of a larger document or label. The digits are evenly spaced and aligned horizontally.
1
(increased blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).
Medical device to which equivalence is claimed and comparison information: 6.
The C1 Inhibitor assay using the proposed product is substantially equivalent in intended use and results obtained to the BIND A RID™ C1 assay. The N Antiserum to C1 inhibitor like the proposed product, depends upon assaving standards of known C1 content to convert the measured value to concentration. Both tests utilize specific antibody to C1 inhibitor for capture of the C1 present in sample.
N Antiserum to C1 Inhibitor differs from the BIND A RID™ C1 test in that the BIND A RID™ C1 test measures the concentration of C1 Inhibitor in an unknown sample by measuring the ring diameter and manually reading off a calibration curve, while the N Antiserum to C1 Inhibitor measures C1 inhibitor concentration using a nephelometer. Also, the N Antiserum to C1 Inhibitor assay is based on a 5 point standard curve, whereas the BIND A RID™ C1 is based on a 3 point standard curve. Additionally, the BIND A RID™ C1 is intended for use with serum samples only, while the N Antiserum C1 is intended for use with both serum and plasma. These differences do not affect the safety and effectiveness as demonstrated by excellent to the BIND A RID™ C1 test across the assay range.
7. Proposed Device Performance characteristics:
Correlation:
Results of comparative studies using the N Antiserum to C1 Inhibitor and the BIND A RID™ C1 for 50 serum samples gave a correlation coefficient of 0.973 and a y-intercept of 3.74 and a slope of 0.85.
Precision:
Inter-assay precision studies were run over a 5 day period, twice per day, to total n=10 precision ranged from 0.89-7.73 %CV. Intra-assay precision was calculated from n=30 precision ranges from 1.31 - 2.89 %CV.