(111 days)
K920010/B
Not Found
No
The description focuses on a turbidimetric immunoassay method for quantitative determination of Complement 4, which is a standard laboratory technique and does not mention or imply the use of AI/ML.
No
Explanation: This device is an in vitro diagnostic product designed to quantify Complement 4 for diagnostic purposes, not to treat or cure a medical condition.
Yes
This device is intended for the quantitative in vitro diagnostic determination of Complement 4 to aid in the diagnosis of immunologic disorders, which clearly indicates a diagnostic purpose.
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 Complement 4 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 analyzed in vitro.
- Purpose: The purpose is to "aid in the diagnosis of immunologic disorders", which is a diagnostic application.
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 Complement 4 in serum and plasma on the ILab Clinical Chemistry System by turbidimetric immunoassay method. C4 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 C4.
Product codes (comma separated list FDA assigned to the subject device)
866.5240
Device Description
quantex C4: 8 x 6 mL anti-human C4 P/N 3000-22137; 2 x 100 mL Buffer P/N 3000-22130
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A comparative performance study was performed with IL Test™ C4 on a Monarch Clinical Chemistry System and Biokit's quantex C4 on an ILab Clinical Chemistry System. Method comparison studies evaluated C4 levels of thirty-eight serum samples on the respective instruments. The correlation (r) in these studies was 0.9791.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The correlation (r) in these studies was 0.9791.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K920010/B
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 866.5240 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 C4 - 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 26 1988
Contact Person:
Betty Lane phone (617) 861-4182
Summary Prepared:
May 29, 1996
Name of the device:
| quantex C4: | 8 x 6 mL anti-human C4 | P/N 3000-22137 | |
|---|---|---|---|
| 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™ C4
#K920010/B
Description of the device/intended use(s):
This product permits the quantitative in vitro diagnostic determination of Complement 4 in serum and plasma on the ILab Clinical Chemistry System by turbidimetric immunoassay method. C4 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 C4.
Statement of how the Technological Characteristics of the Device compare to the Predicate device:
Biokit's quantex C4 is substantially equivalent in performance, intended use, safety and effectiveness to the predicate, IL Test™ C4 -- 510(k) #K920010/B.
Summary of Performance Data:
A comparative performance study was performed with IL Test™ C4 on a Monarch Clinical Chemistry System and Biokit's quantex C4 on an ILab Clinical Chemistry System. Method comparison studies evaluated C4 levels of thirty-eight serum samples on the respective instruments. The correlation (r) in these studies was 0.9791.