IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP

K063057 · Diagnostic Products Corporation · NQD · Dec 22, 2006 · Immunology

Device Facts

• Record ID: K063057
• Device Name: IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP
• Applicant: Diagnostic Products Corporation
• Product Code: NQD · Immunology
• Decision Date: Dec 22, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Intended Use

The IMMULITE®/IMMULITE® 1000 High Sensitivity CRP assay is intended for use as follows: For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 Analyzer — for the quantitative measurement of C-Reactive protein (CRP) in serum or plasma as an aid in the detection and evaluation of infection, tissue injury and inflammatory disorders, and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndrome may be useful as an independent marker for recurrent events in patients with stable coronary disease or acute coronary syndrome. IMMULITE® 2000 High Sensitivity CRP assay is intended for use as follows: For in vitro diagnostic use with the IMMULITE 2000 Analyzer — for the quantitative measurement of C-Reactive protein (CRP) in serum or plasma as an aid in the detection and evaluation of infection, tissue injury and inflammatory disorders, and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndrome may be useful as an independent marker for recurrent events in patients with stable coronary disease or acute coronary syndrome.

Device Story

Solid-phase, chemiluminescent immunometric assay; utilizes 14-inch polystyrene bead coated with anti-ligand. Sample, murine monoclonal anti-CRP, and alkaline phosphatase-conjugated rabbit polyclonal anti-CRP co-incubated for 30 minutes on IMMULITE/IMMULITE 1000 or 2000 analyzers. Centrifugal wash removes unbound conjugate; substrate added; chemiluminescence measured by luminometer. Used in clinical laboratory settings by trained personnel. Output provides quantitative CRP concentration (mg/L). Results assist clinicians in evaluating inflammation, infection, and cardiovascular risk; used alongside traditional clinical assessments for acute coronary syndrome management. Benefits include standardized, sensitive detection of CRP levels for diagnostic and prognostic clinical decision-making.

Clinical Evidence

Bench testing only. Performance established via traceability studies to CRM 470 (N=156 for Immulite 1000; N=242 for Immulite 2000) showing high correlation (R=0.998). Functional sensitivity determined to be 0.28 mg/L (Immulite 1000) and 0.13 mg/L (Immulite 2000). Method comparison with predicate (N=189) showed slope 0.9445. No new clinical studies performed; relies on established clinical utility of hsCRP as a cardiovascular marker.

Technological Characteristics

Solid-phase chemiluminescent immunometric assay. Materials: 14-inch polystyrene bead, murine monoclonal anti-CRP, bovine calf intestine alkaline phosphatase-conjugated rabbit polyclonal anti-CRP. Energy source: luminometer. Connectivity: integrated with IMMULITE/IMMULITE 1000/2000 analyzer platforms. Standardization: WHO IS 85/506 and CRM 470. Analytical sensitivity: 0.1 mg/L.

Indications for Use

Indicated for quantitative measurement of C-Reactive protein (CRP) in serum or plasma to aid in detection/evaluation of infection, tissue injury, inflammatory disorders, and associated diseases; also as an aid in identifying individuals at risk for future cardiovascular disease and as an independent marker for recurrent events in patients with stable coronary disease or acute coronary syndrome.

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/K033908)

Submission Summary (Full Text)

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## SUMMARY OF SAFETY AND EFFECTIVENESS

# Assigned 510(k) Number

The assigned 510(k) number is

DEC 2 2 2006

#### Sponsor Name and Address

Diagnostic Products Corporation Corporate Offices 5210 Pacific Concourse Drive Los Angeles, CA 90045-6900 [phone]

### Contact

Deborah L. Morris Director, Clinical Affairs and Regulatory Submissions [phone] extension 7426 [e-mail]

### Device Name

| Trade Name: | IMMULITE®/IMMULITE® 1000,<br>IMMULITE® 2000 |
|----------------------|----------------------------------------------------------------|
| Common Name: | High Sensitivity C-Reactive Protein |
| Classification | 21 CFR 866.5270 |
| Product Code | NQD |
| DPC Catalog Numbers: | LKCRP (100 tests), L2KCRP2 (200 tests),<br>L2KCRP6 (600 tests) |

## Description of Device

The IMMULITE/IMMULITE 1000 and IMMULITE 2000 High Sensitivity CRP is a solid-phase, chemiluminescent immunometric assay. The assay utilizes a 14-inch polystyrene bead coated with anti-ligand. The bead is co-incubated with sample, murine monoclonal anti-CRP, and alkaline phosphatase (bovine calf intestine)-conjugated to rabbit polyclonal anti-CRP in buffer for 30 minutes on each IMMULITE/IMMULITE 1000 and IMMULITE 2000 platform. Unbound enzyme conjugate is removed by a centrifugal wash procedure. Substrate is added and the resulting chemiluminescence is read in the luminometer.

## Indications for Use

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The IMMULITE® IMMULITE® 1000 High Sensitivity CRP assay is intended for use as follows:

For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 Analyzer for the quantitative measurement of C-Reactive protein (CRP) in serum or plasma as an aid in the detection and evaluation of infection, tissue injury and inflammatory disorders, and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndrome may be useful as an independent marker for recurrent events in patients with stable coronary disease or acute coronary syndrome.

- IMMULITE® 2000 High Sensitivity CRP assay is intended for use as follows: For in vitro diagnostic use with the IMMULITE 2000 Analyzer - for the quantitative measurement of C-Reactive protein (CRP) in serum or plasma as an aid in the detection and evaluation of infection, tissue injury and inflammatory disorders, and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndrome may be useful as an independent marker for recurrent events in patients with stable coronary disease or acute coronary syndrome.
## Manufacturing Site

IMMULITE® IMMULITE® 1000 and IMMULITE 2000 High Sensitivity CRP assays are manufactured by Diagnostic Products Corporation at the following locations:

Diagnostic Products Corporation Reagent Manufacturing Division 5700 West 96th Street Los Angeles, CA 90045-5597 FDA Establishment #: 2017183

Diagnostic Products Corporation Corporate Offices 5210 Pacific Concourse Drive Los Angeles, CA 90045-6900 FDA Establishment #: 3005250747

### Comparison to the Predicate

The IMMULITE/IMMULITE 1000 and IMMULITE 2000 High Sensitivity CRP assay reagents, components and all assay performance characteristics remain as previously established in 510(k) K003372.

A summary of the features of the IMMULITE/IMMULITE 1000 and IMMULITE 2000 High Sensitivity CRP assay and the predicate device, Dade Behring N High Sensitivity CRP, (K991385/K033908) is presented below.

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| Item | IMMULITE/IMMULITE 1000 and<br>IMMULITE 2000 High Sensitivity CRP | Dade Behring N High Sensitivity<br>CRP using BN™ Systems |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Assay Type | Chemiluminescent immunometric | Particle enhanced immunoephelometry |
| Antibody | Anti-CRP Murine monoclonal and rabbit<br>polyclonal anti-CRP | Mouse monoclonal Anti-CRP |
| Expected Values | Expected high sensitivity CRP values for<br>healthy individuals has been established in the<br>literature as <3 mg/L.<br><br>A study performed on 100 apparently healthy<br>volunteers yielded a median of 1.4 mg/L and<br>an upper 97.5th percentile of 11 mg/L.<br><br>The AHA/CDC Scientific Statement<br>concerning inflammation and cardiovascular<br>markers reports that hsCRP values < 1 mg/L<br>are low risk for cardiovascular disease<br>prediction; values between 1-3 mg/L are<br>average risk for cardiovascular disease<br>prediction; and values > 3 mg/L are high risk<br>for cardiovascular disease prediction.<br><br>Increases in CRP are non-specific and should<br>not be interpreted without a complete clinical<br>history.<br>Consider these limits as guidelines only. Each<br>laboratory should establish its own reference<br>ranges. | Expected values for healthy individuals<br>as noted in the literature is <3 mg/L.<br><br>The normal range of CRP in the serum<br>of 2147 apparently healthy individuals<br>using the CardioPhase hsCRP Assay was<br>found to be<br>90% 1.69 mg/L<br>95% 2.87 mg/L<br><br>A subset of the Stanisless Cohort was<br>examined in this study. The cohort<br>subset used consisted of 1151 males and<br>996 females ranging in age from 5 to 71<br>years. All participants were of European<br>ancestry and free of previously<br>diagnosed serious or chronic disease<br>(such as cancer or cardiovascular<br>disease) and excluded individuals taking<br>anti-inflammatory drugs or antibiotics.<br><br>As CRP is a nonspecific indicator for a<br>wide range of disease processes, and as<br>the reference individuals are affected by<br>many factors that may differ for each<br>population studied, each laboratory<br>should determine its own reference<br>interval. |
| Reference<br>standards | WHO IS 85/506 and CRM 470 | CRM 470 |
| Indications for<br>Use | For <i>in vitro</i> diagnostic use with the<br>IMMULITE/IMMULITE 1000 and<br>IMMULITE 2000 Analyzers — for the<br>quantitative measurement of C-Reactive<br>protein (CRP) in serum or plasma as an aid in<br>the detection and evaluation of infection,<br>tissue injury and inflammatory disorders and<br>associated diseases. Measurements may also<br>be used as an aid in the identification of<br>individuals at risk for future cardiovascular<br>disease. High sensitivity CRP (hsCRP)<br>measurements when used in conjunction with<br>traditional clinical laboratory evaluation of<br>acute coronary syndrome may be useful as an<br>independent marker for recurrent events in<br>patients with stable coronary disease or acute<br>coronary syndrome. | N High Sensitivity CRP is an <i>in vitro</i><br>diagnostic reagent for the quantitative<br>determination of C-reactive protein<br>(CRP) in human serum, and heparin and<br>EDTA plasma by means of particle<br>enhanced immunoephelometry using the<br>BN Systems. In acute phase response,<br>increased levels of a number of plasma<br>proteins, including C-reactive protein is<br>observed. Measurement of CRP is<br>useful for the detection and evaluation of<br>infection, tissue injury, inflammatory<br>disorders and associated diseases.<br>Measurements may also be used as an<br>aid in the identification of individuals at<br>risk for future cardiovascular disease.<br>High sensitivity CRP (hsCRP)<br>measurements when used in conjunction |
| Item | IMMULITE/IMMULITE 1000 and<br>IMMULITE 2000 High Sensitivity CRP | Dade Behring N High Sensitivity<br>CRP using BNTTM Systems |
| | | with traditional clinical laboratory<br>evaluation of acute coronary syndromes<br>may be useful as an independent marker<br>for recurrent events in patients with<br>stable coronary disease or acute coronary<br>syndromes. |
| Working Range | IMMULITE/IMMULITE 1000: 0.3 to 100<br>mg/L<br>IMMULITE 2000: 0.2 to 100 mg/L | 0.175 to 1100 mg/L |
| Analytic<br>Sensitivity | IMMULITE/IMMULITE 1000: 0.1 mg/L<br>IMMULITE 2000: 0.1 mg/L | 0.175 mg/L |
| Functional<br>Sensitivity | IMMULITE/IMMULITE 1000: 0.3 mg/L<br>IMMULITE 2000: 0.2mg/L | Not reported in the package insert |
| Sample Type | Serum and Heparinized plasma | Serum, heparinized, and EDTA plasma |
| Interferences | No significant interference from conjugated<br>bilirubin (up to 200 mg/L), hemoglobin (up to<br>570 mg/dL for IMMULITE/IMMULITE<br>1000, and 512 mg/dL for IMMULITE 2000),<br>or triglycerides (up to 3000 mg/dL).<br><br>No cross-reactivity with human serum<br>albumin, human IgG, or transferrin | No significant interference from<br>bilirubin (up to 230 mg/L), hemoglobin<br>(up to 36 g/L) or triglycerides (up to 7.4<br>g/L). |
| Hook Effect | IMMULITE/IMMULITE 1000: No high dose<br>hook effect up to 3780 mg/L<br>IMMULITE 2000: No high dose hook effect<br>up to 3780 mg/L | Not reported in the package insert. |
| Calibration<br>Interval | Recommended 2 week adjustment interval | Reference curve valid for 4 weeks and<br>beyond as indicated by control results |

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### Standards/Guidance Documents Referenced

Guidance for Industry and FDA Staff: "Review Criteria for Assessment of C-Reactive Protein (CRP), High Sensitivity C-Reactive Protein (hsCRP) and Cardiac C-Reactive Protein CCRP Assays", issued September 22, 2005.

Clinical Laboratory Standard Institute (CLSI). Protocols for the Determination of Limits of Detection and Limits of Quantitation; Approved Guideline. CLSI document EP17-A Vol 24 No 34. CLSI 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004.

Clinical Laboratory Standard Institute (CLSI). Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second Edition. CLSI document EP5-A2. CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004.

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# Working Range

The IMMULITE/IMMULITE 1000 High Sensitivity CRP reportable range is 0.3 to 100 mg/L and the IMMULITE 2000 High Sensitivity CRP reportable range is 0.2 to 100 mg/L.

# Standardization

The IMMULITE 1000 and IMMULITE 2000 High Sensitivity CRP assays are standardized to both the WHO IS 85/506 and CRM 470 reference standards.

# Analytical Sensitivity

The IMMULITE/IMMULITE 1000 and IMMULITE 2000 High Sensitivity CRP assays' analytical sensitivity is 0.1 mg/L as previously reported and cleared in Pre-market Notification 510(k) K003372 for IMMULITE/IMMULITE 1000 and IMMULITE 2000 hsCRP.

# Functional Sensitivity

The IMMULITE / MMULITE 1000 High Sensitivity CRP assay's functional sensitivity (lowest concentration that can be measured with a total CV% of 10%) is 0.3 mg/L.

The IMMULITE 2000 High Sensitivity CRP assay's functional sensitivity (lowest concentration that can be measured with a total CV% of 10%) is 0.2 mg/L.

# Precision

As previously reported and cleared in Pre-market Notification 510(k) K003372 IMMULITE/IMMULITE 1000 High Sensitivity CRP intra- and inter-assay CV% were not greater than 7.5% at 0.8 mg/L, 6% at 1.5 mg/L, 4.8% at 3.1 mg/L, and 4.9% at 15.0 mg/L. Intra-assay CV% did not exceed 6.0% for all samples tested over the range 0.3 mg/L to 78 mg/L. Inter-assay CV% did not exceed 10% for all samples tested over the range 0.3 mg/L to 78 mg/L.

As previously reported and cleared in Pre-market Notification 510(k) K003372 IMMULITE 2000 High Sensitivity CRP intra- and inter-assay CV% were not greater than 7.1% at 0.85 mg/L, 3.1% at 3.2 mg/L, and 3.3% at 12.3 mg/L. Intra-assay CV% did not exceed 8.7% for all samples tested over the range 0.23 mg/L to 93.7 mg/L. Interassay CV% did not exceed 8.7% for all samples tested over the range 0.23 mg/L to 93.7 mg/L.

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# Linearity

The IMMULITE/IMMULITE 1000 and IMMULITE 2000 High Sensitivity CRP assays demonstrate linearity of dilution within the precision of the assay as previously reported and cleared in Pre-market Notification 510(k) K003372 for IMMULITE/IMMULITE 1000 and IMMULITE 2000 hsCRP .

# Spiked Recovery

The IMMULITE/IMMULITE 1000 and IMMULITE 2000 High Sensitivity CRP assays demonstrate accuracy of spiked recovery within the precision of the assay as previously reported and cleared in Pre-market Notification 510(k) K003372 for IMMULITE/IMMULITE 1000 and IMMULITE 2000 hsCRP.

# Interfering substances

The IMMULITE/IMMULITE 1000 and IMMULITE 2000 High Sensitivity CRP assays demonstrate that presence of conjugated bilirubin in concentrations up to 200 mg/L has no effect on results within the precision of the assay as previously reported and cleared in Pre-market Notification 510(k) K003372 for IMMULITE/IMMULITE 1000 and IMMULITE 2000 hsCRP.

The IMMULITE/IMMULITE 1000 and IMMULITE 2000 High Sensitivity CRP assays demonstrate that presence of hemoglobin in concentrations up to 570 mg/L on IMMULITE/IMMULITE 1000 and 512 mg/L on IMMULITE 2000 has no effect on results within the precision of the assay as previously reported and cleared in Pre-market Notification 510(k) K003372 for the IMMULITE/IMMULITE 1000 and IMMULITE 2000 hsCRP.

The IMMULITE 1000 and IMMULITE 2000 High Sensitivity CRP assays demonstrate that presence of triglycerides in concentrations up to 3,000 mg/L has no effect on results within the precision of the assay as previously reported and cleared in Pre-market Notification 510(k) K003372 for the IMMULITE/IMMULITE 1000 and IMMULITE 2000 hsCRP.

# Cross-Reactivity

The IMMULITE 1000 and IMMULITE 2000 High Sensitivity CRP assays demonstrate no cross-reactivity to human serum albumin (HSA) at levels up to 1,000 mg/dL added HSA, human IgG at 1,000 mg/dL added IgG or transferrin at 1,000 mg/dL added tranferrin as previously reported and cleared in Pre-market Notification 510(k) K003372 for the IMMULITE/IMMULITE 1000 and IMMULITE 2000 hsCRP.

# High Dose Hook Effect

The IMMULITE/IMMULITE 1000 and IMMULITE 2000 High Sensitivity CRP assays demonstrate no high dose hook effect up to 3780 mg/L.

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# Expected Values

Expected high sensitivity CRP values for healthy individuals has been established in the literature as <3 mg/L.

A study performed on 100 apparently healthy volunteers yielded a median of 1.4 mg/L and an upper 97.5th percentile of 11 mg/L.

The AHA/CDC Scientific Statement concerning inflammation and cardiovascular markers reports that hsCRP values < 1 mg/L are low risk for cardiovascular disease prediction; values between 1-3 mg/L are average risk for cardiovascular disease prediction; and values > 3 mg/L are high risk for cardiovascular disease prediction.

Increases in CRP are non-specific and should not be interpreted without a complete clinical history..

Consider these limits as guidelines only. Each laboratory should establish its own reference ranges.

### Comparison of IMMULITE/IMMULITE 1000 and IMMULITE 2000 hsCRP Results to the Predicate Dade Behring N High Sensitivity CRP

#### IMMULITE/IMMULITE 1000 hsCRP versus Dade Behring N HSCRP

The IMMULITE/IMMULITE 1000 High Sensitivity CRP assay was compared to the Dade Behring N High Sensitivity CRP assay.

By linear regression {N=175, range 0.3 to 22.9 mg/L by Dade Behring, slope = 0.952 95%CI 0.939 to 0.965, intercept = 0.022 95%CI -0.0372 to 0.0817) Mean Dade Behring: 2.7 mg/L Mean IMMULITE: 2.6 mg/L

IMMULITE/IMMULITE 1000=0.952 Dade Behring + 0.022 mg/L; r = 0.996

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Image /page/7/Figure/0 description: This image is a scatter plot that compares IMMULITE mg/L to Dade Behring BNII mg/L. The x-axis represents Dade Behring BNII mg/L, ranging from 0 to 25, while the y-axis represents IMMULITE mg/L, ranging from -5 to 25. The data points are clustered around a regression line, which is described by the equation y = 0.9516x + 0.0222.

Using the same data set in the range no greater than 10 mg/L, by linear regression (N=165, range 0.3 to 9.4 mg/L by Dade Behring, slope = 0.943 95%CI 0.9195 to 0.9665, intercept = 0.0303 95%CI-0.0327 to 0.0933)

Mean Dade Behring: 1.9 mg/L Mean IMMULITE: 1.8 mg/L

#### IMMULITE/IMMULITE 1000= 0.943 Dade Behring + 0.030 mg/L; r = 0.987

Image /page/7/Figure/4 description: This image is a scatter plot that compares IMMULITE mg/L to Dade Behring BNII mg/L. The x-axis represents Dade Behring BNII mg/L, ranging from 0 to 10, while the y-axis represents IMMULITE mg/L, ranging from -1 to 9. The plot shows a strong positive correlation between the two variables, with data points clustered around a regression line represented by the equation y = 0.943x + 0.0303. There are also lines above and below the regression line.

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#### IMMULITE 2000 HSCRP VERSUS Dade Behring N HSCRP

The IMMULITE 2000 High Sensitivity CRP assay was compared to the Dade Behring N High Sensitivity CRP assay.

By linear regression (N=185, range 0.2 to 22.9 mg/L by Dade Behring, slope = 1.010 95%CI 0.9954 to 1.0246, intercept = - 0.0888 95% CI -- 0.1542 to -- 0.0235) Mean Dade Behring: 2.6 mg/L Mean IMMULITE 2000: 2.5 mg/L

IMMULITE 2000 = 1.01 Dade Behring - 0 .0888 mg/L; r = 0.995

Image /page/8/Figure/4 description: This image is a scatter plot comparing two different methods of measuring a substance, IMMULITE 2000 and Dade Behring BNII, both measured in mg/L. The x-axis represents Dade Behring BNII, and the y-axis represents IMMULITE 2000. The plot shows a strong positive correlation between the two methods, with data points clustered tightly around a regression line. The regression equation is given as y = 1.01x - 0.0888.

Using the same data set in the range no greater than 10 mg/L by linear regression (N=175, range 0.2 to 9.4 mg/L by Dade Behring, slope = 1.0006 95%CI 0.9833 to 1.0179, intercept = - 0.0818 95%CI -0.1270 to -0.0367)

Mean Dade Behring: 1.8 mg/L Mean IMMULITE: 1.7 mg/L

IMMULITE 2000 = 1.0006 Dade Behring - 0.0818 mg/L; r = 0.993

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Image /page/9/Figure/0 description: This image is a scatter plot comparing IMMULITE 2000 mg/L and Dade Behring BNII mg/L. The x-axis represents Dade Behring BNII mg/L, ranging from 0 to 10, while the y-axis represents IMMULITE 2000 mg/L, ranging from -2 to 10. The plot shows a strong positive correlation between the two variables, with data points clustered around a regression line represented by the equation y = 1.0006x - 0.0818.

#### Conclusions

The IMMULITE/IMMULITE 1000 and IMMULITE 2000 hsCRP assays demonstrate substantial equivalence to the Dade Behring N High Sensitivity CRP assay.

The IMMULITE/IMMULITE 1000 and IMMULITE 2000 hsCRP assays are thereby safe and effective for the following intended use:

The IMMULITE®/IMMULITE® 1000 High Sensitivity CRP assay is intended for in vitro diagnostic use with the IMMULITE/IMMULITE 1000 Analyzer -- for the quantitative measurement of C-Reactive protein (CRP) in serum or plasma as an aid in the detection and evaluation of infection, tissue injury and inflammatory disorders, and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndrome may be useful as an independent marker for recurrent events in patients with stable coronary disease or acute coronary syndrome.

IMMULITE® 2000 High Sensitivity CRP assay is intended for in vitro diagnostic use with the IMMULITE 2000 Analyzer — for the quantitative measurement of C-Reactive protein (CRP) in serum or plasma as an aid in the detection and evaluation of infection, tissue injury and inflammatory disorders, and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndrome may be useful as an

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independent marker for recurrent events in patients with stable coronary disease or acute coronary syndrome.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/11/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its body and wing. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Deborah L. Morris Director, Clinical Affairs and Regulatory Submissions Diagnostic Products Corporation Corporate Offices 5210 Pacific Concourse Drive Los Angeles CA 90045-6900

DEC 2 2 2006

k063057 Re:

> Trade/Device Name: Immulite®/ Immulite® 1000 High Sensitivity CRP Immulite® 2000 High Sensitivity CRP Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: NQD Dated: September 15, 2006 Received: October 5, 2006

Dear Ms. Deborah L. Morris:

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, Drug, 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). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jean m. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., 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): K063057

Device Name: IMMULITE® IMMULITE® 1000 High Sensitivity CRP IMMULITE® 2000 High Sensitivity CRP

Indications For Use:

- The IMMULITE® 1000 High Sensitivity CRP assay is intended for use as follows: For in vitro diagnostic use with the IMMULITE/MMULTE 1000 Analyzer - for the quantitative measurement of C-Reactive protein (CRP) in serum or plasma as an aid in the detection and evaluation of infection, tissue injury and inflammatory disorders, and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndrome may be useful as an independent marker for recurrent events in patients with stable coronary disease or acute coronary syndrome.
- MMULITE® 2000 High Sensitivity CRP assay is intended for use as follows:

For in vitro diagnostic use with the IMMULITE 2000 Analyzer - for the quantitative measurement of C-Reactive protein (CRP) in serum or plasma as an aid in the detection and evaluation of infection, tissue injurv and inflammatory disorders, and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndrome may be useful as an independent marker for recurrent events in patients with stable coronary disease or acute coronary syndrome.

AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 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)

Carol Benam
Sign-Off

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frice of In Vitro Diagnostic Device Valuation and Safety

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