(110 days)
K920007/B
Not Found
No
The description focuses on a turbidimetric immunoassay method for quantitative determination of Complement 3, which is a standard laboratory technique and does not mention or imply the use of AI/ML.
No.
This device is an in vitro diagnostic (IVD) product used for quantitative determination of Complement 3 in serum and plasma to aid in the diagnosis of immunologic disorders, rather than directly treating or preventing a disease or condition.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the product permits "quantitative in vitro diagnostic determination" and that "Measurement of this protein aids in the diagnosis of immunologic disorders."
No
The device description explicitly lists physical components (reagents and buffer) which are essential for the intended use of the device (in vitro diagnostic determination). This indicates it is a hardware-based diagnostic kit, not a software-only 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 Complement 3 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 device is intended for use with "serum and plasma," which are biological samples typically analyzed in a laboratory setting for diagnostic purposes.
- Purpose: The measurement of Complement 3 is stated to "aid in the diagnosis of immunologic disorders," which is a diagnostic purpose.
N/A
Intended Use / Indications for Use
This product permits the quantitative in vitro diagnostic determination of Complement 3 in serum and plasma on the ILab Clinical Chemistry System by turbidimetric immunoassay method. C3 is one of a group of serum proteins which destroy infectious agents. Measurement of this protein aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of C3.
Product codes
866.5240
Device Description
quantex C3: 8 x 6 mL anti-human C3 P/N 3000-22136; 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™ C3 on a Monarch Clinical Chemistry System and Biokit's quantex C3 on an ILab Clinical Chemistry System. Method comparison studies evaluated C3 levels of fifty serum samples on the respective instruments. The correlation (r) in these studies was 0.9842.
Key Metrics
correlation (r) in these studies was 0.9842
Predicate Device(s)
K920007/B
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5240 Complement components immunological test system.
(a)
Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.(b)
Classification. Class II (performance standards).
0
SECTION 3 quantex C3 - 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 C3: | 8 x 6 mL anti-human C3 | P/N 3000-22136 |
|---|---|---|
| 2 x 100 mL Buffer | P/N 3000-22130 |
Classification name(s):
866.5240 Complement components immunological test systems Class II
Identification of predicate device(s):
IL Test™ C3
#K920007/B
Description of the device/intended use(s):
This product permits the quantitative in vitro diagnostic determination of Complement 3 in serum and plasma on the ILab Clinical Chemistry System by turbidimetric immunoassay method. C3 is one of a group of serum proteins which destroy infectious agents. Measurement of this protein aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of C3.
Statement of how the Technological Characteristics of the Device compare to the Predicate device:
Biokit's quantex C3 is substantially equivalent in performance, intended use, safety and effectiveness to the predicate, IL Test™ C3 -- 510(k) #K920007/B.
Summary of Performance Data:
A comparative performance study was performed with IL Test™ C3 on a Monarch Clinical Chemistry System and Biokit's quantex C3 on an ILab Clinical Chemistry System. Method comparison studies evaluated C3 levels of fifty serum samples on the respective instruments. The correlation (r) in these studies was 0.9842.