(40 days)
Not Found
No
The summary describes a turbidimetric immunoassay for rheumatoid factors, 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 studies focus on correlation and precision, which are standard metrics for immunoassay validation.
No
This device is an in vitro diagnostic test intended for the diagnosis of rheumatoid arthritis, not for treating any condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the product "is an in vitro diagnostic test" and "is intended as an aid in the diagnosis of rheumatoid arthritis." The "Device Description" also refers to it as "an in vitro diagnostic product" and reiterates its intended use as "an aid in the diagnosis of Rheumatoid Arthritis."
No
The device description explicitly states it is an "in vitro diagnostic product" and includes components like "latex, buffer, standard, control," which are physical reagents, not software. It is used with "automated instrumentation," implying hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "quantex RF plus (latex, buffer, standard, control) is an in vitro diagnostic test for use with automated instrumentation in the quantitative determination of human rheumatoid factors in serum by turbidimetric immunoassay and is intended as an aid in the diagnosis of theumatoid arthritis."
The "Device Description" section also confirms this: "Biokit's quantex RF plus (latex, buffer, standard, control) is an in vitro diagnostic product for use with automated instrumentation in the quantitative determination of human theumatoid factors in serum by turbidimetric immunoassay and is intended as an aid in the diagnosis of Rheumatoid Arthritis."
N/A
Intended Use / Indications for Use
quantex RF plus (latex, buffer, standard, control) is an in vitro diagnostic product for use with automated instrumentation in the quantitative determination of human theumatoid factors in serum by turbidimetric immunoassay and is intended as an aid in the diagnosis of Rheumatoid Arthritis.
quantex RF plus (latex, buffer, standard, control) is an in vitro diagnostic test for use with automated instrumentation in the quantitative determination of human rheumatoid factors in serum by turbidimetric immunoassay and is intended as an aid in the diagnosis of theumatoid arthritis.
Product codes (comma separated list FDA assigned to the subject device)
DHR
Device Description
Biokit's quantex RF plus (latex, buffer, standard, control) is an in vitro diagnostic product for use with automated instrumentation in the quantitative determination of human theumatoid factors in serum by turbidimetric immunoassay.
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)
In three different method comparison studies comparing the new quantex RF plus to the predicate, the correlation (r) on the Monarch (n=152) was 0.992, on the Hitachi (n=175) was 0.995 and on the Cobas Mira (n=261) was 0.990. Results from a precision study on a Monarch that accessed three serum samples with different levels of rheumatoid factors over multiple runs support package insert claims of within run CVs of
§ 866.5775 Rheumatoid factor immunological test system.
(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).
0
K973464
Oct. 02, 1997
SECTION 3
quantex RF plus - 510(k) SUMMARY (Summary of Safety and Effectiveness)
Submitted by:
Carol Marble Regulatory Affairs Engineer Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02173 Phone: (617) 861-4467 (617) 861-4464 Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax:
Contact Persons:
Carol Marble Phone: (617) 861-4467
Betty Lane Alternate: Phone: (617) 861-4182
Summary Prepared:
September 11, 1997
Name of the device:
quantex RF plus (latex, buffer, standard, control)
Classification name(s):
| 866.5775 Rheumatoid factor immunological test systems | Class II | |
|---|---|---|
| 82DHR | System, test, rheumatoid factor |
Identification of predicate device(s):
K896271 quantex RF plus (latex, buffer, standard, control)
Description of the device/intended use(s):
Biokit's quantex RF plus (latex, buffer, standard, control) is an in vitro diagnostic product for use with automated instrumentation in the quantitative determination of human theumatoid factors in serum by turbidimetric immunoassay and is intended as an aid in the diagnosis of Rheumatoid Arthritis.
Statement of how the Technological Characteristics of the Device compare to the Predicate device:
The new quantex RF plus (latex, buffer, standard, control) is a modified version of the predicate quantex RF plus (latex, buffer, standard, control) with an analysis range extended from 0-100 IU/mL to 0-200 IU/mL. It is substantially equivalent in performance, intended use, safety and effectiveness to the predicate device as supported by the performance data and labeling.
Summary of Performance Data:
In three different method comparison studies comparing the new quantex RF plus to the predicate, the correlation (r) on the Monarch (n=152) was 0.992, on the Hitachi (n=175) was 0.995 and on the Cobas Mira (n=261) was 0.990. Results from a precision study on a Monarch that accessed three serum samples with different levels of rheumatoid factors over multiple runs support package insert claims of within run CVs of