(110 days)
K920008/B
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No
The summary describes a standard turbidimetric immunoassay for measuring IgM levels and does not mention any AI or ML components.
No
The device is an in vitro diagnostic product used for quantitative determination of Immunoglobulin M, which aids in diagnosis, not treatment.
Yes
The "Intended Use / Indications for Use" states that the product permits "quantitative in vitro diagnostic determination of Immunoglobulin M in serum and plasma" and that "Measurement of IgM aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents."
No
The device description explicitly lists physical components (reagents and buffer) and the intended use describes an in vitro diagnostic test performed on a clinical chemistry system, indicating a hardware component is essential.
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 product permits the "quantitative in vitro diagnostic determination of Immunoglobulin M in serum and plasma". The term "in vitro diagnostic" is clearly used.
- Method: The method described is a "turbidimetric immunoassay method," which is a common technique used in in vitro diagnostics to measure substances in biological samples.
- Sample Type: The product is intended for use with "serum and plasma," which are biological samples analyzed in vitro.
- Purpose: The purpose of the measurement is to "aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents," 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
This product permits the quantitative in vitro diagnostic determination of Immunoglobulin M in serum and plasma on the ILab Clinical Chemistry System by turbidimetric immunoassay method. Measurement of IgM aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Product codes
866.5510
Device Description
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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
A comparative performance study was performed with IL Test™ IgM on a Monarch Clinical Chemistry System and Biokit's quantex IgM on an ILab Clinical Chemistry System. Method comparison studies evaluated IgM levels of forty-eight serum samples on the respective instruments. The correlation (r) in these studies was 0.9912.
Key Metrics
correlation (r) in these studies was 0.9912.
Predicate Device(s)
K920008/B
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.5550 Immunoglobulin (light chain specific) immunological test system.
(a)
Identification. An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques both kappa and lambda types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues. In some disease states, an excess of light chains are produced by the antibody-forming cells. These free light chains, unassociated with gamma globulin molecules, can be found in a patient's body fluids and tissues. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.(b)
Classification. Class II (performance standards).
0
SECTION 3 quantex IgM - 510(k) SUMMARY (Summary of Safety and Effectiveness)
Submitted by:
Betty Lane Director, Regulatory Affairs Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02173 phone (617) 861-4182 fax (617) 861-4464
SEP 28 1996
Contact Person:
Betty Lane phone (617) 861-4182
Summary Prepared:
May 29, 1996
Name of the device:
| quantex IgM: 8 x 6 mL anti-human IgM | P/N 3000-22135 |
|---|---|
| 2 x 100 mL Buffer | P/N 3000-22130 |
Classification name(s):
866.5510 Immunoglobulins A, G, M, D and E immunological test systems Class II
Identification of predicate device(s):
IL Test™ IgM
#K920008/B
Description of the device/intended use(s):
This product permits the quantitative in vitro diagnostic determination of Immunoglobulin M in serum and plasma on the ILab Clinical Chemistry System by turbidimetric immunoassay method. Measurement of IgM aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Statement of how the Technological Characteristics of the Device compare to the Predicate device:
Biokit's quantex IgM is substantially equivalent in performance, intended use, safety and effectiveness to the predicate, IL Test™ IgM -- 510(k) #K920008/B.
Summary of Performance Data:
A comparative performance study was performed with IL Test™ IgM on a Monarch Clinical Chemistry System and Biokit's quantex IgM on an ILab Clinical Chemistry System. Method comparison studies evaluated IgM levels of forty-eight serum samples on the respective instruments. The correlation (r) in these studies was 0.9912.