QUANTEX ASO-CRP-RP CONTROL II

K984437 · Instrumentation Laboratory CO · JJT · Feb 2, 1999 · Clinical Chemistry

Device Facts

• Record ID: K984437
• Device Name: QUANTEX ASO-CRP-RP CONTROL II
• Applicant: Instrumentation Laboratory CO
• Product Code: JJT · Clinical Chemistry
• Decision Date: Feb 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The quantex ASO-CRP-RF control II is an in vitro diagnostic product intended for use in the quality control of automated instrumentation to monitor the results obtained with the quantex ASO plus, quantex CRP plus and quantex RF plus reagents using the turbidimetric method.

Device Story

The quantex ASO-CRP-RF control II is an in vitro diagnostic quality control material used in clinical laboratories. It contains known concentrations of antistreptolysin-O, C-reactive protein, and rheumatoid factor. When processed with quantex ASO plus, CRP plus, or RF plus latex reagents on automated instrumentation, the control induces agglutination. This agglutination is measured via turbidimetry to verify the performance and accuracy of the automated assay system. The device assists healthcare providers in ensuring the reliability of patient test results by monitoring the precision of the analytical process.

Clinical Evidence

Bench testing only. Comparative performance study conducted on a COBAS Mira analyzer. Precision evaluated via within-run %CV: 2.7% (ASO), 1.6% (CRP), and 1.1% (RF) for the subject device, compared to 4.8% (ASO), 3.5% (CRP), and 1.7% (RF) for the predicate control.

Technological Characteristics

In vitro diagnostic quality control material; liquid form; utilizes turbidimetric measurement principle; designed for use with automated clinical chemistry analyzers; no specific materials of construction or software algorithms described.

Indications for Use

Indicated for use as an in vitro diagnostic quality control material for monitoring automated instrumentation results obtained with quantex ASO plus, quantex CRP plus, and quantex RF plus reagents via turbidimetric methods.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• quantex ASO-CRP-RF control (K971777)

Submission Summary (Full Text)

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# 1984437

#### FEB 2 1999

## Section 3 quantex ASO-CRP-RF control II - 510(k) SUMMARY (Summary of Safety and Effectiveness)

#### Submitted by:

Carol Marble Regulatory Affairs Manager Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: [phone] Fax:

#### Contact Person:

Carol Marble Phone: [phone] / Fax: [phone]

### Summary Prepared:

December 11, 1998

#### Name of the device:

quantex ASO-CRP-RF control II

#### Classification name(s):

Quality Control Material (Assayed and Unassayed) Class I 862.1660

### Identification of predicate devices:

quantex ASO-CRP-RF control K971777

### Description of the device/intended use(s):

The quantex ASO-CRP-RF control II is an in vitro diagnostic product intended for use with automated instrumentation in monitoring the quality control of results obtained with the quantex ASO plus, quantex CRP plus and quantex RF plus reagents. When the combined control, which ADO prob, qualiten Ord problem of antistreptolysin-O, C-reactive protein and rheumatoid factor, commits a known asserver raias our suantex CRP plus, or quantex RF plus latex reagent, a clear agglutination occurs which can be measured by turbidimetry.

### Statement of how the Technological Characteristics of the Device compare to the Predicate device:

The new quantex ASO-CRP-RF control II is substantially equivalent in performance, intended use and safety and effectiveness to the predicate control: quantex ASO-CRP-RF control.

### Summary of Performance Data:

In a comparative performance study on a COBAS Mira, the new quantex ASO-CRP-RF control II exhibited excellent with-in run precision in comparison to the precise control. control 11 Exmoned excellent with in run %CV for the new control was 2.7% (ASO), 1.6% (CRP) and 1.1 (RF) as compared to with-in run %CV for the predicate control of 4.8% (ASO plus), 3.5% (CRP) and 1.7% (RF).

Section 3

quantex ASO-CRP-RF control II 510(k)

Page 1 of 1

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB | 2 1999

Carol Marble Regulatory Affairs Manager INSTRUMENTATION LABORATORY COMPANY 113 Hartwell Avenue Lexington, MA 02421

Re: K984437 Trade Name: quantex ASO-CRP-RF control II Requlatory Class: I Product Code: JJT December 11, 1998 Dated: December 14, 1998 Received:

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 legally marketed predicate 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 aqainst 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 regulation may result in In addition, FDA may publish further regulatory action. announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation 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 regulations.

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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 [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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):** K984437

Device Name: quantex ASO-CRP-RF control II

### Indications for Use:

The quantex ASO-CRP-RF control II is an in vitro diagnostic product intended for use in the quality control of automated instrumentation to monitor the results obtained with the quantex ASO plus, quantex CRP plus and quantex RF plus reagents using the turbidimetric method.

Peter E. Machin
(Division Sign-Off)
Division of Clinical Laboratory Devices

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.019)

OR Over-The-Counter Use _