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.

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 and is intended as an aid in the diagnosis of Rheumatoid Arthritis.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the quantex RF plus device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Explicit or Implied)	Reported Device Performance
Method Comparison/Correlation	Substantial equivalence in performance to the predicate device, implying strong correlation between the new device and the predicate device across different automated instrumentation with extended analysis range (0-200 IU/mL). (Implied: High correlation coefficient (r))	Monarch: r = 0.992 (with n=152 samples) Hitachi: r = 0.995 (with n=175 samples) Cobas Mira: r = 0.990 (with n=261 samples)
Precision (Within Run CV)	Within run coefficient of variation (CVs) < 3% for various rheumatoid factor levels (as per package insert claims, which the study supports).	Within run CVs of < 3% for three serum samples with different levels of rheumatoid factors over multiple runs on a Monarch. (The text states the study "support[s] package insert claims," implying the criteria were met.)
Precision (Between Run CV)	Between run coefficient of variation (CVs) < 5% for various rheumatoid factor levels (as per package insert claims, which the study supports).	Between run CVs of < 5% for three serum samples with different levels of rheumatoid factors over multiple runs on a Monarch. (The text states the study "support[s] package insert claims," implying the criteria were met.)
Analysis Range	Capability to operate within an extended analysis range of 0-200 IU/mL (compared to the predicate's 0-100 IU/mL). (This is a design modification, the performance data implicitly supports the accuracy within this new range by demonstrating strong correlation with the predicate which previously only covered up to 100 IU/mL, and an overall statement of "substantially equivalent in performance".)	The new quantex RF plus has an analysis range extended from 0-100 IU/mL to 0-200 IU/mL. The method comparison studies (listed above) were conducted with this new range in mind, showing strong correlation.
Intended Use	Maintaining the same intended use as the predicate device: in vitro diagnostic for quantitative determination of human rheumatoid factors in serum by turbidimetric immunoassay, as an aid in diagnosis of Rheumatoid Arthritis.	"Substantially equivalent in performance, intended use, safety and effectiveness to the predicate device." The stated intended use is identical to the predicate: "quantitative determination of human rheumatoid factors in serum by turbidimetric immunoassay and is intended as an aid in the diagnosis of Rheumatoid Arthritis."
Safety and Effectiveness	Substantial equivalence in safety and effectiveness to the predicate device.	"Substantially equivalent in performance, intended use, safety and effectiveness to the predicate device as supported by the performance data and labeling."

2. Sample Sizes Used for the Test Set and Data Provenance

Method Comparison Studies (Test Set):
- Monarch: N = 152 samples
- Hitachi: N = 175 samples
- Cobas Mira: N = 261 samples
Precision Study (Test Set):
- Three serum samples with different levels of rheumatoid factors. (Specific N not provided beyond "three serum samples").
Data Provenance: The document does not explicitly state the country of origin. It is a submission to the US FDA. The studies were likely internal validation studies conducted by Instrumentation Laboratory Company. The data provenance is retrospective, as it describes the results of already completed method comparison and precision studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the summary. For an in vitro diagnostic device measuring an analyte (rheumatoid factor), the "ground truth" is typically established by comparing the device's results against a well-characterized reference method or against the predicate device itself, rather than expert interpretation of images or clinical findings. The "experts" in this context would likely be skilled laboratory technicians or specialists performing the reference assays, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not applicable/not provided in the context of this type of IVD performance study. Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective interpretation of medical images or clinical cases by multiple readers. For an assay comparing quantitative measurements, the comparison is statistical against a reference or predicate.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools that assist human readers in interpreting complex data (e.g., radiology images). The quantex RF plus is an in vitro diagnostic test that quantitatively measures an analyte directly.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the performance data presented (method comparison correlations, precision CVs) represents the standalone performance of the quantex RF plus device itself, operating as an automated in vitro diagnostic test. There is no human-in-the-loop performance component described; the device yields a quantitative result.

7. The Type of Ground Truth Used

The ground truth used for the method comparison studies was the measurements obtained from the predicate device (quantex RF plus with the original 0-100 IU/mL range), run on different automated instruments (Monarch, Hitachi, Cobas Mira). The new device's extended range performance is validated by its correlation with the established predicate. For the precision study, the "ground truth" for each sample's RF level was its own repeated measurement, used to calculate the variation.

8. The Sample Size for the Training Set

This information is not provided and is generally not applicable for a turbidimetric immunoassay like quantex RF plus. This device is not an AI/machine learning algorithm that requires a "training set" in the computational sense. Its performance is based on chemical and optical principles, factory calibration, and performance characteristics established through validation studies.

9. How the Ground Truth for the Training Set Was Established

As stated above, the concept of a "training set" and associated "ground truth" establishment in the AI/ML context is not applicable to this device. For traditional IVDs, the "calibration" or optimization would be based on reference materials and established assay principles, rather than a data-driven training process.

Summary

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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):

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 < 3% and between run CVs of < 5%.

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Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPT. OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping wave-like shapes, possibly representing human figures or abstract forms.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Carol Marble Requlatory Affairs Engineer Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02173

OCT 2 2 1997

K973464 Re: Trade Name: quantex RF plus (layex, buffer, standard, control) Regulatory Class: II Product Code: DHR September 11, 1997 Dated: Received: September 12, 1997

Dear Ms. Marble: ""

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. this response to your premarket notification Please note: submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: quantex RF plus (latex, buffer, standard, control)

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter E. Mahari

Prescription Use
(Per 21 CFR 801.019)
✓

OR Over-The-Counter Use

ter Use

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Section 2

quantex RF plus 510(k)

Regulation Number and Section

§ 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).