HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS

K023269 · Instrumentation Laboratory CO · DCK · Dec 23, 2002 · Immunology

Device Facts

• Record ID: K023269
• Device Name: HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS
• Applicant: Instrumentation Laboratory CO
• Product Code: DCK · Immunology
• Decision Date: Dec 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Intended Use

HemosIL High Sensitivity - C Reactive Protein is an in vitro diagnostic high sensitivity automated latex enhanced immunoassay for the quantitative determination of C Reactive Protein in human citrated plasma on IL Coagulation Systems. C Reactive Protein (CRP) aids in detecting and evaluating infection, tissue disorder, inflammatory disorders and associated diseases. HemosIL High Sensitivity - C Reactive Protein Controls are assayed human serum controls intended to monitor the accuracy and precision of quantitative C Reactive Protein (CRP) assays.

Device Story

In vitro diagnostic latex-enhanced immunoturbidimetric assay; quantifies C-Reactive Protein (CRP) in human citrated plasma. Input: plasma sample mixed with latex reagent and reaction buffer. Principle: CRP-induced agglutination of coated latex particles; degree of agglutination proportional to CRP concentration; measured via decrease in transmitted light. Used on IL Coagulation Systems (ACL 9000, ACL Futura) in clinical laboratory settings; operated by laboratory technicians. Output: quantitative CRP concentration. Healthcare providers use results to detect/evaluate infection, tissue disorders, and inflammatory conditions. Controls (assayed human serum) monitor assay accuracy and precision.

Clinical Evidence

Bench testing only. Method comparison study (n=153 samples, range 0.18-258 mg/L) on ACL 9000 and ACL Futura systems showed high correlation with predicate (r=0.9950 and 0.9945 respectively). Precision assessed via within-run and total CV% across two control levels; ACL 9000 total CV% ranged 1.50-2.57%; ACL Futura total CV% ranged 3.42-3.63%.

Technological Characteristics

Latex particle enhanced immunoturbidimetric assay. Analyzes light transmission decrease due to agglutination. Automated system (IL Coagulation Systems).

Indications for Use

Indicated for quantitative determination of C-Reactive Protein (CRP) in human citrated plasma to aid in detection and evaluation of infection, tissue disorder, inflammatory disorders, and associated diseases. Controls are indicated for monitoring accuracy and precision of CRP assays.

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

• N High Sensitivity CRP (K991385)

Submission Summary (Full Text)

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10232469

DEC 2 3 2002

# Section 3 HemosIL High Sensitivity - C Reactive Protein 510(k) Summary (Summary of Safety and Effectiveness)

## Submitted by:

Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: [phone] Fax: [phone]

#### Contact Person:

Carol Marble. Regulatory Affairs Manager Phone: [phone] / Fax: [phone]

## Summary Prepared:

September 30, 2002

## Name of the Device:

HemosIL High Sensitivity - C Reactive Protein, AND HemosIL High Sensitivity - C Reactive Protein Controls

## Classification Name(s):

| 866.5270 | C-Reactive Protein Immunological Test System | Class II |
|----------|-----------------------------------------------------|----------|
| 81DCK | C-Reactive Protein, Antigen, Antiserum, and Control | |

## Identification of predicate device(s):

N High Sensitivity CRP K991385

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

Hemos IL High Sensitivity - C Reactive Protein is an in vitro diagnostic high sensitivity automated latex enhanced immunoassay for the quantitative determination of C Reactive Protein in human citrated plasma on IL Coagulation Systems. C Reactive Protein (CRP) aids in detecting and evaluating infection, tissue disorder, inflammatory disorders and associated diseases.

HemosIL High Sensitivity - C Reactive Protein Controls are assayed human serum controls intended to monitor the accuracy and precision of quantitative C Reactive Protein (CRP) assays.

The HS-CRP is a latex particle enhanced immunoturbidimetric assay to quantify CRP in When a plasma containing CRP is mixed with the Latex Reagent and the Reaction plasma. Buffer included in the kit, the coated latex particles agglutinate. The degree of agglutination is directly proportional to the concentration of CRP in the sample and is determined by measuring the decrease of transmitted light caused by the aggregates. The test range is well suited to cover apparent normality as well as the requirements as a marker of infectious and inflammatory diseases.

## Statement of Technological Characteristics of the Device Compared to Predicate Device:

HemosIL High Sensitivity - C Reactive Protein is substantially equivalent to the commercially available predicate device (N High Sensitivity CRP) in performance and intended use.

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# Section 3 HemosIL High Sensitivity - C Reactive Protein 510(k) Summary (Summary of Safety and Effectiveness)

## Summary of Performance Data:

## Method Comparison

In method comparison studies evaluating 153 samples with CRP levels ranging from 0.18 to 258 mg/L on an ACL 9000 and an ACL Futura, the slopes and correlation coefficients (r) for HemosIL High Sensitivity -- C Reactive Protein versus the predicate device are shown below:

| IL System | Slope | Intercept | r |
|------------|-------|-----------|--------|
| ACL 9000 | 0.972 | -0.070 | 0.9950 |
| ACL Futura | 0.942 | -0.027 | 0.9945 |

## Precision

Within run and total precision assessed over multiple runs using two levels of control gave the following results:

| ACL 9000 | Mean<br>mg/L CRP | Within run<br>CV% | Total<br>CV% |
|---------------------|-------------------|-------------------|--------------|
| Low HS-CRP Control | 2.594 | 1.75 | 2.57 |
| High HS-CRP Control | 6.186 | 1.01 | 1.50 |
| ACL Futura | Mean<br>mg/dL CRP | Within run<br>CV% | Total<br>CV% |
| Low HS-CRP Control | 0.255 | 3.04 | 3.42 |
| High HS-CRP Control | 0.607 | 3.42 | 3.63 |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three wavy lines that converge at the bottom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration
2098 Gaither Road
Rockville MD 20850

Ms. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Company 101 Hartwell Avenue Lexington, MA 02421-3125

Re: k023269

> Trade/Device Name: HemosIL High Sensitivity - C Reactive Protein AND HemosIL High Sensitivity - C Reactive Protein Controls Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCK Dated: December 16, 2002 Received: December 17, 2002

Dear Ms. Marble:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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. Drue, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

# 510(k) Number (if known):

Device Name: HemosIL High Sensitivity - C Reactive Protein AND HemosIL High Sensitivity - C Reactive Protein Controls

# Indications for Use:

HemosIL High Sensitivity - C Reactive Protein is an in vitro diagnostic high sensitivity automated latex enhanced immunoassay for the quantitative determination of C Reactive Protein in human citrated plasma on IL Coagulation Systems. C Reactive Protein (CRP) aids in detecting and evaluating infection, tissue disorder, inflammatory disorders and associated diseases,

HemosIL High Sensitivity - C Reactive Protein Controls are assayed human serum controls intended to monitor the accuracy and precision of quantitative C Reactive Protein (CRP) assays.

Jean Coogh

(Division Sign-Off)
Division or Clinical Laboratory Devices
510(k) Number 6023269

(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 | |
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|----------------------|--|

High Sensitivity - C Reactive Protein 510(k)