BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM

K012337 · Bayer Corp. · DCN · Dec 6, 2001 · Immunology

Device Facts

• Record ID: K012337
• Device Name: BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM
• Applicant: Bayer Corp.
• Product Code: DCN · Immunology
• Decision Date: Dec 6, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Intended Use

This in vitro method is intended to quantitatively measure C-reactive protein (CRP) in serum on the Bayer ADVIA IMS systems. Measurements of CRP are used in the evaluation and treatment of injuries to body tissues and in monitoring the progress of traumatic injuries, rheumatic fever and rheumatoid arthritis.

Device Story

ADVIA IMS High Sensitivity CRP Assay; in vitro diagnostic reagent system. Input: human serum samples. Principle: quantitative measurement of CRP levels. Used in clinical laboratory settings; operated by laboratory technicians. Output: CRP concentration values (mg/L). Healthcare providers use results to assess tissue injury status and monitor disease progression (traumatic injuries, rheumatic fever, rheumatoid arthritis). Benefits: provides standardized, sensitive CRP quantification to aid clinical decision-making regarding patient treatment and monitoring.

Clinical Evidence

Bench testing only. Imprecision studies performed at normal (16.5-47.5 mg/L) and high sensitivity (0.25-1.21 mg/L) ranges, showing total CVs between 2.1% and 11.2%. Correlation study (N=165) against predicate system yielded regression Y=0.97X - 0.04 (R=0.998). Interference testing evaluated bilirubin, hemoglobin, and lipids, showing minimal effect on CRP measurement accuracy.

Technological Characteristics

In vitro diagnostic reagent kit for use on ADVIA IMS systems. Sensing principle: immunological test system. Form factor: liquid reagents and calibrators. Connectivity: integrated into ADVIA IMS platform. Sterilization: N/A (reagent).

Indications for Use

Indicated for the quantitative measurement of C-reactive protein (CRP) in human serum to evaluate and treat tissue injuries and monitor the progress of traumatic injuries, rheumatic fever, and rheumatoid arthritis.

Regulatory Classification

Identification

A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

Predicate Devices

• Dade/Behring N High Sensitivity CRP (K991385)

Submission Summary (Full Text)

{0}------------------------------------------------

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS High Sensitivity C-Reactive Protein (CRP) Method for ADVIA® IMS™

This summary of 510(k) safety and effectiveness information is being submitted in Fills Summary of 51 (1) Sales July 1998) and the Safe Medical Device Act of 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K012337

#### 1. Intended Use

This in vitro method is intended to quantitatively measure C-reactive protein (CRP) in serum on the Bayer ADVIA IMS systems. Measurements of CRP are used in the evaluation and treatment of injuries to body tissues and in monitoring the progress of traumatic injuries, rheumatic fever and rheumatoid arthritis.

### Predicate Device 2.

| Product Name | Reagent Part # | Calibrator Part # |
|----------------------------------------------------|----------------|-------------------|
| Dade/Behring N High<br>Sensitivity CRP,<br>K991385 | OQIY 21 | OQIK |

#### Device / Method 3.

| Product Name | Reagent BAN | Calibrator<br>BAN |
|---------------|--------------------------------------------|-------------------|
| ADVIA IMS CRP | 03987289 (100 test)<br>02136137 (250 test) | 02537697 |

### A. Imprecision (normal range)

| ADVIA IMS | |
|--------------|--------------|
| Level (mg/L) | Total CV (%) |
| 16.5 | 2.9 |
| 31.7 | 2.1 |
| 47.5 | 3.1 |

| Dade/Behring | |
|-----------------|----------------|
| BN100 | |
| Level<br>(mg/L) | Total<br>CV(%) |
| 10 | <5.7 |
| 25 | <5.7 |
| 60 | <5.7 |

{1}------------------------------------------------

### Imprecision (high sensitivity range)

| ADVIA IMS | | Dade/Behring<br>BN100 | |
|-----------------|-----------------|-----------------------|----------------|
| Level<br>(mg/L) | Total<br>CV (%) | Level<br>(mg/L) | Total<br>CV(%) |
| 0.25 | 11.2 | | |
| 0.52 | 5.3 | 0.5 | 2.5 |
| 1.21 | 2.5 | 1.3 | 3.8 |

# B. Correlation (Y=ADVIA IMS, X=Comparison system) for Normal and High Sensitivity Ranges

| Specimen type | Comparison<br>System (X) | N | Regression<br>Equation | Syx<br>(mg/L) | R | Sample<br>Range<br>(mg/L) |
|---------------|--------------------------|-----|------------------------|---------------|-------|---------------------------|
| Serum | BN100 | 165 | Y=0.97X - 0.04 | 2.41 | 0.998 | 1.0 - 179.0 |
| Serum | BN100 | 25 | Y=0.90X - 0.08 | 0.11 | 0.997 | 0.2-5.1 |

# C. Interfering Substances (normal range)

| Interfering<br>Substance | Interfering Sub.<br>Conc. (mg/dL) | CRP Conc.<br>(mg/L) | Effect<br>(% change) |
|-----------------------------|-----------------------------------|---------------------|----------------------|
| Bilirubin<br>(unconjugated) | 20 | 5.0 | +6 |
| Bilirubin<br>(conjugated) | 20 | 5.3 | +6 |
| Hemoglobin | 500 | 5.4 | +4 |
| Lipids<br>(Triglycerides) | 1000 | 5.2 | +2 |

# Interfering Substances (high sensitivity range)

| Interfering<br>Substance | Interfering Sub.<br>Conc. (mg/dL) | CRP Conc.<br>(mg/L) | Effect<br>(% change) |
|-----------------------------|-----------------------------------|---------------------|----------------------|
| Bilirubin<br>(unconjugated) | 25 | 1.79 | -7 |
| Bilirubin<br>(conjugated) | 25 | 1.95 | +1 |
| Hemoglobin | 500 | 1.94 | 0 |
| Lipids<br>(Triglycerides) | 500 | 1.82 | -6 |

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug `Administration 2098 Gaither Road Rockville MD 20850

DEC 0 6 2001

Kenneth T. Edds, Ph. D. Regulatory Affairs Bayer Corporation Diagnostics Division 511 Benedict Avenue Tarrytown, NY 10591-5097

k012337 Re:

K012537
Trade/Device Name: ADVIA IMS High Sensitivity C-Reactive Protein Assay Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCN Dated: October 12, 2001 Received: October 16, 2001

Dear Dr. Edds:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally b r (c) fee device is substantially equivalent (for the indications felerenced above and nave acterimes ally marketed predicate devices marketed in interstate for use stated in the choosars) to regard) the enactment date of the Medical Device Americans, or to Commerce pror to May 20, 1978, the canomance with the provisions of the Federal Food, Drug, devices mat have been recuire approval of a premarket approval application (PMA). and Cosment Act (Act) that ao not required to the general controls provisions of the Act. The T ou may, merciolo, market the act include requirements for annual registration, listing of general controls provisions of vactice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (soc above) and existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation Fift thay be subject to suen additional seculations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oouv cements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rease oc advised that I Dri 3 issualites or our device complies with other requirements of the Act mall I DA has made a determinations administered by other Federal agencies. You must of any I coural statutes and registments, including, but not limited to: registration and listing (21 comply with an the 110 CFR Part 801); good manufacturing practice requirements as set CI K Fart 6077, adoling (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 -

This letter will allow you to begin marketing your device as described in your 510(k) premarket I his lotter will and in your your substantial equivalence of your device to a legally marketed nouthoution. "The 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 1 If you desire specific as in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, [phone]. Tradiation f Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small information on 90 in 100pal and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/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

{4}------------------------------------------------

Page 1 of 1

510(k) Number: K012337

Device Name: ADVIA IMS High Sensitivity C-Reactive Protein Assay

Indications for Use:

The Bayer Advia IMS C-Reactive Protein (CRP) assay is an in vitro diagnostic device into ded to measure C-Reactive Protein in human serum. Measurements of CRP are used in the evaluation and treatment on injuries to body tissues and in monitoring the progress of traumatic injuries, rheumatic fever and rheumatoid arthritis.

(Division Sign-Off)

Division of Clinical Laboratory Devices
510(k) Number K012337

(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 801.109)

OR

Over-The-CounterUse

(Optional Format 1-2-96)