CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)

K040579 · Cholestech Corp. · DCK · Jun 18, 2004 · Immunology

Device Facts

• Record ID: K040579
• Device Name: CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)
• Applicant: Cholestech Corp.
• Product Code: DCK · Immunology
• Decision Date: Jun 18, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Intended Use

Cholestech LDX high sensitivity C-Reactive Protein (hs-CRP) is an in vitro diagnostic test for the quantitative determination of CRP in whole blood or serum. Measurement of CRP is useful as an aid in the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.

Device Story

System uses lateral flow immunoassay with colloidal gold-coated monoclonal antibodies to measure CRP levels. Input: whole blood (fingerstick/venous) or serum applied to disposable cassette. Cassette contains internal mechanism to separate plasma from blood cells. Analyzer uses reflectance photometry to measure reaction color. Calibration data stored on magnetic stripe on each cassette, read by analyzer upon insertion. Used in point-of-care settings by professionals. Output: CRP concentration in mg/L displayed to clinician. Results assist in clinical evaluation of inflammatory states and tissue injury.

Clinical Evidence

Bench testing only. Precision evaluated per NCCLS EP5-A; total CVs ranged from 11.4% to 14.3% for controls and 6.6% to 17.4% for whole blood. Linearity established for 0.3–10 mg/L (whole blood) and 0.3–8 mg/L (serum). Method comparison with nephelometric reference (n=72) showed slope 1.02, intercept 0.21, r=0.976. Matrix comparison (n=78) between serum and whole blood showed high correlation (r=0.977–0.982). Analytical specificity tested against 14 common substances with <10% interference.

Technological Characteristics

Lateral flow immunoassay; colloidal gold particles coated with monoclonal antibodies; reflectance spectrophotometry detection. Dimensions: desk-top analyzer. Connectivity: magnetic stripe reader for calibration. Sample: whole blood or serum. Software: embedded firmware for reflectance-to-concentration conversion.

Indications for Use

Indicated for the quantitative determination of C-reactive protein (CRP) in whole blood or serum to aid in the detection and evaluation of infection, tissue injury, inflammatory disorders, and associated diseases in patients.

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 assay on the BN100 (K991385)

Submission Summary (Full Text)

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#### 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: KLYCS 79

## Submitter Information (21 CFR 807.92(a)(1))

Cholestech Corporation Submitter: 3347 Investment Boulevard Hayward, CA 94545 phone: [phone] [phone] fax:

- Thomas E. Worthy, PhD. Contact: Vice President, Research and Regulatory Affairs Cholestech Corporation.
March 1, 2004 Summary Date:

### Name of Device and Classification (21 CFR 807.92(a)(2))

| Name (trade): | Cholestech LDX high sensitivity C-Reactive Protein (hs-CRP) |
|-----------------|---------------------------------------------------------------|
| Name (usual): | Immunoassay for the determination of C-Reactive Protein (CRP) |
| Classification: | 21 CFR 866.5270, Class II, Product code DCK |

## Identification of Legally Marketed Predicate Device(s) (21 CFR 807.92 (a)(3))

LDX hs-CRP is substantially equivalent to the Dade Behring N High Sensitivity CRP assay on the BN100 (Dade Behring, Newark, DE). The LDX hs-CRP method is identical or similar to its predicate in terms of: intended use, measurement principle (immunoassay), undiluted sample measurement (assay) range, specimen type, and the requirement for an analyzer.

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## Description of Device (21 CFR 807.92 (a)(4))

The Cholestech LDX System combines immunoassay and solid-phase technology to measure CRP. Samples used for testing can be whole blood from a fingerstick (collected in a lithium heparin coated capillary tube), venous whole blood or serum. The sample is applied to a Cholestech LDX hs-CRP cassette. The cassette is then placed into the Cholestech LDX Analyzer where a unique system on the cassette separates the plasma from the blood cells. The resultant color in the reaction is measured by reflectance photometry.

A brown magnetic stripe on each cassette contains the calibration information required for the Cholestech LDX Analyzer to convert the reflectance reading to the CRP concentration in mg/L.

#### Intended Use (21 CFR 807.92 (a)(5))

Cholestech LDX high sensitivity C-Reactive Protein (hs-CRP) is an in vitro diagnostic test for the quantitative determination of CRP in whole blood or serum.

Measurement of CRP is useful as an aid in the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.

### Similarities to the Predicate(s) (21 CFR 807.92 (a)(6))

A summary table of the similarities and differences between the LDX hs-CRP and the predicate device follows.

| Device Name | LDX hs-CRP<br>(new device) | Dade Behring N High Sensitivity CRP<br>Assay<br>(K991385) |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for use | Cholestech LDX high sensitivity C-<br>Reactive Protein (hs-CRP) test is an<br><i>in vitro</i> diagnostic test for the<br>quantitative determination of C-<br>reactive protein (CRP) in whole<br>blood or serum.<br>Measurement of CRP is useful as<br>an aid in the detection and<br>evaluation of infection, tissue | <i>N High Sensitivity CRP is an in vitro</i><br>diagnostic assay intended for the quantitative<br>determination of C-reactive protein (CRP) in<br>human serum and heparin- and EDTA- plasma<br>by means of particle enhanced<br>immunonephelometry using BN™ Systems. In<br>acute phase response, increased levels of a<br>number of plasma proteins, including C-<br>reactive protein, are observed. Measurement |

## Comparison Table: Cholestech LDX bs-CRP vs Dade Behring BN100 high sensitivity CRP

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| Device Name | LDX hs-CRP<br>(new device) | Dade Behring N High Sensitivity CRP<br>Assay<br>(K991385) |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | injury, inflammatory disorders and<br>associated diseases. | of CRP is useful for the detection and<br>evaluation of infection, tissue injury,<br>inflammatory disorders and associated<br>diseases |
| Instrument<br>Required | Cholestech LDX Analyzer | Dade Behring BN-100 Nephelometer |
| Technology | Lateral flow immunoassay utilizing<br>colloidal gold particles coated with<br>monoclonal antibodies detected by<br>reflectance spectrophotometry. | Agglutination of polystyrene particle coated<br>with monoclonal antibodies detected by<br>nephelometry |
| Assay Range | 0.2 to 10 mg/L | 0.175 to 11 mg/L<br>up to 1100 mg/dL with sample dilution |
| Sample Type | Whole blood (capillary and venous)<br>and serum | Serum or plasma |
| Calibration<br>Requirements | No calibration performed by the<br>user; test information is encoded on<br>the magnetic stripe of the cassette,<br>and the stripe is read by the LDX<br>Analyzer each time a cassette is<br>run. | Calibration required via the use of the N CRP<br>Standard SY; under typical operating<br>conditions, the HS-CRP reagents must be<br>calibrated every 4 weeks, and also with certain<br>parts replacement or maintenance procedures. |
| Testing<br>Environment | Professional-Use, point-of-care | Professional-Use, conventional laboratory |

Brief Discussion of Nonclinical and Clinical Performance Data (21 CFR 807.92(b)(1,2,3)}

- Assay range: 0.2- 10 mg/L .
- Hematocrit tolerance: 30-55% .
- Interference testing: less than 10% interference when challenged by evaluated levels of . endogenous substances
- Precision: 2 levels of Controls (Low- ~1.2 mg/L CRP, and High- ~2.9 mg/L CRP) were . tested in duplicate, twice a day, over a 20 day period for a total of 80 replicates per level. The percent coefficient of variation (%CV) from the testing of the Low Control was 14.3%, and 11.5% from the testing of the High Control. When the same testing protocol was performed with a serum sample at 6.5 mg/L, the %CV was 11.4%.

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- Accuracy: The LDX hs-CRP test was compared to the Dade Behring N high sensitivity CRP . test with 70 matched serum samples. Additionally, results obtained from testing 76 whole blood samples (both venous and fingerstick) on the LDX were compared to the serum results obtained on the Dade Behring N high sensitivity CRP. (Dade Behring N high sensitivity CRP on x-axis).

| | n | slope | y-intercept | "r" | Range of Values |
|--------------|----|-------|-------------|-------|------------------|
| Serum | 70 | 1.01 | 0.22 | 0.975 | 0.20 - 7.18 mg/L |
| Whole Blood | 76 | 1.06 | 0.07 | 0.976 | 0.20 - 7.18 mg/L |
| Fingersticks | 76 | 1.08 | -0.02 | 0.981 | 0.20 - 8.65 mg/L |

LDX hs-CRP vs Dade Behring N high sensitivity CRP

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

JUN 1 8 2004

Food and Drug Administratio 2098 Gaither Road Rockville MD 20850

Thomas E. Worthy, Ph.D. Vice President, Development and Regulatory Affairs Cholestech Corp. 3347 Investment Blvd. Hayward, CA 94545

k040579 Re:

K040377
Trade/Device Name: Cholestech LDX High-Sensitivity C-Reactive Protein (HS-CRP) Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCK Dated: May 19, 2004 Received: May 20, 2004

Dear Dr. Worthy:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) to the enactment date of the Medical Device Amendments, or to conninered pror to rial) 2011-11-11, accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). and Cosmetic For (110) that the device, subject to the general controls provisions of the Act. The I ou may, merelore, mainer of the Act include requirements for annual registration, listing of general controls profisioning 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 your device is elassine additional controls. Existing major regulations affecting your device It may be subject to bach added 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 r lease be action and i bermination that your device complies with other requirements of the Act that I Dri has intatutes and regulations administered by other Federal agencies. You must or any it cacial statutes and regaranents, including, but not limited to: registration and listing (21 Comply with an the Tits 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) I ms letter will anow you to ough manceing of substantial equivalence of your device to a legally premarket notification: "The PDF intentigation 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, If you desire specific mionitiation assessions of your device, please contact the Office of of questions on the promises and Safety at [phone]. Also, please note the In Vir o Diagliostic Do rios Branding by reference to premarket notification" (21CFR Part 807.97). Tegulation other general information on your responsibilities under the Act from the Tou may oounn outer gefarers, 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,

Jean M. Cooper, MS, Div.

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K040579

Device Name: Cholestech LDX High-Sensitivity C-Reactive Protein (HS-CRP)

Indications For Use:

Cholestech LDX high sensitivity C-Reactive Protein (hs-CRP) is an in vitro diagnostic test for the Cholestech LDX high sensitive i tolen (no only in end in servin. Measurement of CRP is
quantitative determination C-reactive protein in whole blood or serving inflammatory quantitative determination citeactive protein in whole blood be of the counting to the matory
useful as an aid in the detection and evaluation of infection, tissue injury, in disorders, and associated diseases.

Prescription Use _ x x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carl C. Benson
Division Stop-Off

Office of In Vito Diognos Device Evaluation and Sc

K040579

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