QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL)

K973464 · Instrumentation Laboratory CO · DHR · Oct 22, 1997 · Immunology

Device Facts

• Record ID: K973464
• Device Name: QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL)
• Applicant: Instrumentation Laboratory CO
• Product Code: DHR · Immunology
• Decision Date: Oct 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5775
• Device Class: Class 2

Intended Use

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 Story

Quantex RF plus is an in vitro diagnostic reagent kit (latex, buffer, standard, control) used for the quantitative determination of human rheumatoid factors in serum. The device utilizes a turbidimetric immunoassay principle, designed for operation on automated clinical chemistry analyzers. By measuring turbidity changes in serum samples, the device quantifies rheumatoid factor levels. It is intended for use by laboratory professionals in clinical settings to aid in the diagnosis of rheumatoid arthritis. The output provides a quantitative concentration (IU/mL), which clinicians use to support diagnostic assessments. The device benefits patients by providing standardized, automated measurement of rheumatoid factors, facilitating timely clinical decision-making.

Clinical Evidence

Bench testing only. Method comparison studies were conducted on three automated platforms: Monarch (n=152, r=0.992), Hitachi (n=175, r=0.995), and Cobas Mira (n=261, r=0.990). Precision studies on the Monarch platform demonstrated within-run CVs < 3% and between-run CVs < 5%.

Technological Characteristics

In vitro diagnostic reagent kit consisting of latex, buffer, standard, and control. Operates via turbidimetric immunoassay on automated instrumentation. Analytical range: 0-200 IU/mL.

Indications for Use

Indicated for the quantitative determination of human rheumatoid factors in serum to aid in the diagnosis of rheumatoid arthritis using automated instrumentation.

Regulatory Classification

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.

Predicate Devices

• quantex RF plus (K896271)

Submission Summary (Full Text)

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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: [phone] [phone] 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: [phone]

Betty Lane Alternate: Phone: [phone]

### 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 < 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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] 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:

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.

(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)