(111 days)
Not Found
No
The summary describes a turbidimetric immunoassay for quantitative determination of IgG, a standard laboratory technique. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance study is a simple method comparison, not an evaluation of an AI/ML algorithm.
No.
This device is an in vitro diagnostic (IVD) product used for quantitative determination of Immunoglobulin G, which aids in diagnosis rather than therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "This product permits the quantitative in vitro diagnostic determination of Immunoglobulin G... Measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents," which directly indicates its use for diagnosis.
No
The device description explicitly lists physical components (reagents and buffer) which are not 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 product permits the "quantitative in vitro diagnostic determination of Immunoglobulin G in serum and plasma". The phrase "in vitro diagnostic determination" is a key indicator of an IVD.
- Purpose: The intended use also mentions that the measurement of IgG "aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents." This clearly indicates a diagnostic purpose.
- Sample Type: The device is designed to analyze "serum and plasma," which are biological samples commonly used in in vitro diagnostic testing.
- Method: The method used is a "turbidimetric immunoassay method," which is a common technique employed in IVD assays.
N/A
Intended Use / Indications for Use
This product permits the quantitative in vitro diagnostic determination of Immunoglobulin G in serum and plasma on the ILab Clinical Chemistry System by turbidimetric immunoassay method. Measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Product codes
Not Found
Device Description
quantex IgG: 8 x 6 mL anti-human IgG P/N 3000-22134
2 x 100 mL Buffer P/N 3000-22130
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
Not Found
Summary of Performance Studies
A comparative performance study was performed with IL Test™ IgG on a Monarch Clinical Chemistry System and Biokit's quantex IgG on an ILab Clinical Chemistry System. Method comparison studies evaluated IgG levels of forty-seven serum samples on the respective instruments. The correlation (r) in these studies was 0.9644.
Key Metrics
correlation (r) of 0.9644
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).
0
SECTION 3 quantex IgG - 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 2 6 1996
Contact Person:
Betty Lane phone (617) 861-4182
Summary Prepared:
May 29, 1996
Name of the device:
| quantex IgG: | 8 x 6 mL anti-human IgG | P/N 3000-22134 |
|---|---|---|
| 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™ IgG
#K920006/B
Description of the device/intended use(s):
This product permits the quantitative in vitro diagnostic determination of Immunoglobulin G in serum and plasma on the ILab Clinical Chemistry System by turbidimetric immunoassay method. Measurement of IgG 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 IgG is substantially equivalent in performance, intended use, safety and effectiveness to the predicate, IL Test™ IgG -- 510(k) #K920006/B.
Summary of Performance Data:
A comparative performance study was performed with IL Test™ IgG on a Monarch Clinical Chemistry System and Biokit's quantex IgG on an ILab Clinical Chemistry System. Method comparison studies evaluated IgG levels of forty-seven serum samples on the respective instruments. The correlation (r) in these studies was 0.9644.