(78 days)
Not Found
No
The device description details a standard immunometric assay and the performance studies focus on analytical and functional sensitivity and precision, with no mention of AI or ML.
No.
This device is an in vitro diagnostic (IVD) assay used to measure C-Reactive protein (CRP) in serum or plasma as an aid in diagnosis and risk assessment, not for direct therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "For in vitro diagnostic use" and is intended "as an aid in the detection and evaluation of infection, tissue injury and inflammatory disorders, and associated diseases" and "as an aid in the identification of individuals at risk for future cardiovascular disease," which are all diagnostic purposes.
No
The device description explicitly details a solid-phase, chemiluminescent immunometric assay utilizing physical components like a polystyrene bead, reagents, and requiring a luminometer for reading results. This indicates a hardware-based in vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 Analyzer..."
- "For in vitro diagnostic use with the IMMULITE 2000 Analyzer..."
This clearly indicates that the device is intended to be used outside of the body to examine specimens (serum or plasma) for diagnostic purposes.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
NQD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
IMMULITE/IMMULITE 1000 hsCRP versus Dade Behring N HSCRP
- Study type: Comparison study (linear regression)
- Sample size: N=175 (range 0.3 to 22.9 mg/L by Dade Behring)
- Key results:
- Linear regression equation: IMMULITE/IMMULITE 1000 = 0.952 Dade Behring + 0.022 mg/L; r = 0.996
- Mean Dade Behring: 2.7 mg/L
- Mean IMMULITE: 2.6 mg/L
- Study type: Comparison study (linear regression)
- Sample size: N=165 (range 0.3 to 9.4 mg/L by Dade Behring)
- Key results:
- Linear regression equation: IMMULITE/IMMULITE 1000 = 0.943 Dade Behring + 0.030 mg/L; r = 0.987
- Mean Dade Behring: 1.9 mg/L
- Mean IMMULITE: 1.8 mg/L
IMMULITE 2000 HSCRP VERSUS Dade Behring N HSCRP
- Study type: Comparison study (linear regression)
- Sample size: N=185 (range 0.2 to 22.9 mg/L by Dade Behring)
- Key results:
- Linear regression equation: IMMULITE 2000 = 1.01 Dade Behring - 0.0888 mg/L; r = 0.995
- Mean Dade Behring: 2.6 mg/L
- Mean IMMULITE 2000: 2.5 mg/L
- Study type: Comparison study (linear regression)
- Sample size: N=175 (range 0.2 to 9.4 mg/L by Dade Behring)
- Key results:
- Linear regression equation: IMMULITE 2000 = 1.0006 Dade Behring - 0.0818 mg/L; r = 0.993
- Mean Dade Behring: 1.8 mg/L
- Mean IMMULITE: 1.7 mg/L
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Analytical Sensitivity:
- IMMULITE/IMMULITE 1000 and IMMULITE 2000 High Sensitivity CRP assays' analytical sensitivity is 0.1 mg/L.
Functional Sensitivity:
- 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.
- 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 (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.
Precision (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.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.5270 C-reactive protein immunological test system.
(a)
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.(b)
Classification. Class II (performance standards).
0
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 (310) 645-8200
Contact
Deborah L. Morris Director, Clinical Affairs and Regulatory Submissions (310) 645-8200 extension 7426 dmorris@dpconline.com
Device Name
| Trade Name: | IMMULITE®/IMMULITE® 1000,
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),
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
IMMULITE 2000 High Sensitivity CRP | Dade Behring N High Sensitivity
CRP using BN™ Systems |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Assay Type | Chemiluminescent immunometric | Particle enhanced immunoephelometry |
| Antibody | Anti-CRP Murine monoclonal and rabbit
polyclonal anti-CRP | Mouse monoclonal Anti-CRP |
| Expected Values | Expected high sensitivity CRP values for
healthy individuals has been established in the
literature as 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. | Expected values for healthy individuals
as noted in the literature is in vitro diagnostic use with the
IMMULITE/IMMULITE 1000 and
IMMULITE 2000 Analyzers — 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. | N High Sensitivity CRP is an in vitro
diagnostic reagent for the quantitative
determination of C-reactive protein
(CRP) in human serum, and heparin and
EDTA plasma by means of particle
enhanced immunoephelometry using the
BN Systems. In acute phase response,
increased levels of a number of plasma
proteins, including C-reactive protein is
observed. Measurement of CRP is
useful for the detection and evaluation of
infection, tissue injury, 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 |
| Item | IMMULITE/IMMULITE 1000 and
IMMULITE 2000 High Sensitivity CRP | Dade Behring N High Sensitivity
CRP using BNTTM Systems |
| | | with traditional clinical laboratory
evaluation of acute coronary syndromes
may be useful as an independent marker
for recurrent events in patients with
stable coronary disease or acute coronary
syndromes. |
| Working Range | IMMULITE/IMMULITE 1000: 0.3 to 100
mg/L
IMMULITE 2000: 0.2 to 100 mg/L | 0.175 to 1100 mg/L |
| Analytic
Sensitivity | IMMULITE/IMMULITE 1000: 0.1 mg/L
IMMULITE 2000: 0.1 mg/L | 0.175 mg/L |
| Functional
Sensitivity | IMMULITE/IMMULITE 1000: 0.3 mg/L
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
bilirubin (up to 200 mg/L), hemoglobin (up to
570 mg/dL for IMMULITE/IMMULITE
1000, and 512 mg/dL for IMMULITE 2000),
or triglycerides (up to 3000 mg/dL).
No cross-reactivity with human serum
albumin, human IgG, or transferrin | No significant interference from
bilirubin (up to 230 mg/L), hemoglobin
(up to 36 g/L) or triglycerides (up to 7.4
g/L). |
| Hook Effect | IMMULITE/IMMULITE 1000: No high dose
hook effect up to 3780 mg/L
IMMULITE 2000: No high dose hook effect
up to 3780 mg/L | Not reported in the package insert. |
| Calibration
Interval | Recommended 2 week adjustment interval | Reference curve valid for 4 weeks and
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 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
10
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 (240) 276-0490. 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 (800) 638-2041 or (240) 276-3150 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
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frice of In Vitro Diagnostic Device Valuation and Safety
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