QUANTEX ASO-CRP-RF CONTROL

K971777 · Instrumentation Laboratory CO · JJT · May 27, 1997 · Clinical Chemistry

Device Facts

• Record ID: K971777
• Device Name: QUANTEX ASO-CRP-RF CONTROL
• Applicant: Instrumentation Laboratory CO
• Product Code: JJT · Clinical Chemistry
• Decision Date: May 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Biokit's ASO-CRP-RF control 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

In vitro diagnostic control material; contains known assayed values of antistreptolysin-O, C-reactive protein, and rheumatoid factor. Used in clinical laboratory settings to monitor quality control of automated instrumentation. When mixed with quantex ASO plus, CRP plus, or RF plus latex reagents, produces agglutination measured by turbidimetry. Healthcare providers use output to verify instrument performance and result accuracy. Benefits patient by ensuring reliability of diagnostic test results.

Clinical Evidence

Bench testing only. Comparative performance study on COBAS Mira analyzer evaluated within-run precision. Subject device CV% was 2.8% (ASO), 3.3% (CRP), and 1.8% (RF), compared to predicate CV% values of 1.9% (ASO), 2.6% (CRP), and 1.7% (RF).

Technological Characteristics

In vitro diagnostic quality control material; liquid form; contains antistreptolysin-O, C-reactive protein, and rheumatoid factor. Principle of operation: turbidimetric measurement of agglutination reaction with latex reagents. Designed for use with automated clinical chemistry analyzers.

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 plus control (K894486)
• quantex CRP plus control (K896272)
• quantex RF plus control (K896271)

Submission Summary (Full Text)

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K971777

# MAY 27 1997

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

# Submitted by:

国家 发布时

Betty Lane Director, Regulatory Affairs Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02173 phone [phone] fax [phone]

### Contact Person:

Betty Lane phone [phone]

## Summary Prepared:

May 2, 1997

### Name of the device:

quantex ASO-CRP-RF control

#### Classification name(s):

Quality Control Material (Assayed and Unassayed) Class I 862.1660

## Identification of predicate devices:

| quantex ASO plus control | K894486 |
|--------------------------|---------|
| quantex CRP plus control | K896272 |
| quantex RF plus control | K896271 |

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

Biokit's ASO-CRP-RF control 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 contains a known assayed value of antistreptolysin-O, C-reactive protein and rheumatoid factor, is mixed with the quantex ASO plus, quantex 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:

Biokit's quantex ASO-CRP-RF control substantially equivalent in performance, intended use, safety and effectiveness to the predicate devices: Biokit's quantex ASO plus control (K894486), quantex CRP plus control (K896272), and quantex RF plus control (K896271).

### Summary of Performance Data:

In a comparative performance study on a COBAS Mira, the quantex ASO-CRP-RF control exhibited statistically similar with-in run variance to the predicate controls: quantex ASO plus, quantex CRP plus, and quantex RF plus controls. With-in run %CV for the new combined control was 2.8% (ASO), 3.3% (CRP) and 1.8 (RF) as compared to 1.9% (quantex ASO plus), 2.6% (quantex CRP plus) and 1.7% (quantex RF plus).

Section 3

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 27 1997

Betty Lane Director, Requlatory Affairs Instrumentation Laboratory Company 101 Hartwell Avenue Lexington, Massachusetts 02173-3190

K971777 Re : Biokit's Quantex ASO-CRP-RF Control Regulatory Class: I Product Code: JJT Dated: May 13, 1997 Received: May 14, 1997

Dear Ms. Lane:

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 Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further 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 To determine if it does, you should contact categorization. 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 requlation (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 qeneral 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/dsmamain.html".

Sincerely yours,
Steven Gutman

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 ASO-CRP-RF control

# Indications for Use:

Biokit's ASO-CRP-RF control 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division | |
|------------------------------|---------|
| Division of Clinical Devices | |
| 510(k) Number | K971777 |

Prescription Use __________ OR __________ Over-The-Counter Use

(Per 21 CFR 801.019)

Section 2 quantex ASO-CRP-RF control 510(k) Page 1 of 1