(110 days)
K920014/B
K920014/B
No
The summary describes a turbidimetric immunoassay for quantitative determination of Immunoglobulin A. 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 standard method comparison, not an evaluation of an AI/ML algorithm.
No.
The device is an in vitro diagnostic (IVD) product used for quantitative determination of IgA in serum and plasma, aiding in diagnosis, not for treating any condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "quantitative in vitro diagnostic determination of Immunoglobulin A". It further mentions that the measurement "aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents," directly linking its function to diagnosis.
No
The device description clearly lists physical components (reagents and buffer) which are essential for the device's intended use. This indicates it is a hardware-based in vitro diagnostic device, not a software-only medical device.
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 A in serum and plasma". The term "in vitro diagnostic" is clearly used.
- Purpose: The purpose of the test 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.
- Sample Type: The test is performed on serum and plasma, which are biological samples taken from the body.
- Method: The method used is turbidimetric immunoassay, which is a common technique for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
"This product permits the quantitative in vitro diagnostic determination of Immunoglobulin A in serum and plasma on the ILab Clinical Chemistry System by turbidimetric immunoassay method. Measurement of IgA 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
"quantitative in vitro diagnostic determination of Immunoglobulin A in serum and plasma on the ILab Clinical Chemistry System by turbidimetric immunoassay method."
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
"A comparative performance study was performed with IL Test™ IgA on a Monarch Clinical Chemistry System and Biokit's quantex IgA on an ILab Clinical Chemistry System. Method comparison studies evaluated IgA levels of forty-five serum samples on the respective instruments. The correlation (r) in these studies was 0.9905."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
"The correlation (r) in these studies was 0.9905."
Predicate Device(s)
K920014/B
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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 IgA - 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
Contact Person:
Betty Lane phone (617) 861-4182
Summary Prepared:
May 29, 1996
Name of the device:
| quantex IgA: | 8 x 6 mL anti-human IgA | P/N 3000-22133 |
|---|---|---|
| 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™ IgA
#K920014/B
Description of the device/intended use(s):
This product permits the quantitative in vitro diagnostic determination of Immunoglobulin A in serum and plasma on the ILab Clinical Chemistry System by turbidimetric immunoassay method. Measurement of IgA 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 IgA is substantially equivalent in performance, intended use, safety and effectiveness to the predicate, IL Test™ IgA -- 510(k) #K920014/B.
Summary of Performance Data:
A comparative performance study was performed with IL Test™ IgA on a Monarch Clinical Chemistry System and Biokit's quantex IgA on an ILab Clinical Chemistry System. Method comparison studies evaluated IgA levels of forty-five serum samples on the respective instruments. The correlation (r) in these studies was 0.9905.