(83 days)
Not Found
No
The summary describes a standard in vitro diagnostic assay based on turbidimetry and a calibration curve, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is an in vitro diagnostic assay used for the quantitative determination of C-Reactive Protein (CRP) in human serum and plasma, which is for diagnostic and risk assessment purposes, not for treating any condition.
Yes
The device is explicitly stated to be for "in vitro diagnostic use" and is described as performing quantitative determination of C-Reactive Protein (CRP) for the "detection and evaluation of infection, tissue injury, inflammatory disorders, and associated diseases," which are clear diagnostic purposes.
No
The device is an in vitro diagnostic assay and associated calibrators, which are physical reagents used with a chemistry analyzer system. It is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein assay is for in vitro diagnostic use..." and "The ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein Calibrators are for in vitro diagnostic use...".
- Nature of the Device: The device is designed to analyze human serum and plasma samples (biological specimens) outside of the body ("in vitro") to determine the concentration of C-Reactive Protein (CRP). This is a core characteristic of an IVD.
- Purpose: The assay is used for the "quantitative determination of the concentration of C-Reactive Protein (CRP)" for diagnostic purposes, such as detecting and evaluating infection, tissue injury, inflammatory disorders, and assessing cardiovascular risk. This aligns with the definition of an IVD.
- Calibrators: The calibrators are also explicitly stated to be for "in vitro diagnostic use" in calibrating the system for the assay.
Therefore, based on the provided text, this device is definitively an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein assay is for in vitro diagnostic use in the quantitative determination of the concentration of C-Reactive Protein (CRP) in human serum and plasma (lithium heparin or potassium EDTA) on the ADVIA Chemistry systems. In acute phase response, increased levels of a number of plasma proteins, including CRP, are observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders, and associated diseases. High sensitivity CRP (hsCRP) measurements may be used as an independent risk marker for the identification of individuals at risk for future cardiovascular disease. Measurement of hsCRP, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events in patients with stable coronary disease or acute coronary syndromes.
The ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein Calibrators are for in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the CardioPhase High Sensitivity C-Reactive Protein method.
Product codes (comma separated list FDA assigned to the subject device)
NQD, JIX
Device Description
The ADVIA Chemistry CardioPhase™ High Sensitivity C-Reactive Protein assay is for in vitro diagnostic use in the quantitative determination of the concentration of C-Reactive Protein (CRP) in human serum and plasma on the ADVIA Chemistry systems. The CardioPhaseTM hsCRP latex reagent is a suspension of uniform polystyrene latex particles coated with anti-CRP antibody. When serum or plasma containing CRP is mixed with the latex reagent, agglutination takes place resulting in an increase in turbidity. This turbidity is measured at 571 nm. The CRP concentration in serum or plasma is determined from a calibration curve that is generated with the calibrators.
The ADVIA® Chemistry CardioPhase™ High Sensitivity C-Reactive Protein Calibrators consist of six (6) levels of protein stabilized matrices containing varying concentrations of recombinant human CRP. The Calibrators have targeted values (lot specific) of 0, 0.53, 1.05, 1.58, 5.25, and 10.50 mg/L.
The calibrators (1 mL/vial) are liquid and ready to use. Storage is at 2 - 8℃.
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)
Substantial equivalence was demonstrated by testing several performance characteristics including imprecision, method comparison, interfering substances, serum/plasma equivalency, and analytical range. The following tables summarize the precision (within run), interfering substances, analytical range, and method comparison results.
All of the evaluation studies gave acceptable results compared to the predicate device (this predicate device was used in clinical studies supporting an indication for cardiovascular use). These studies support that the ADVIA Chemistry CardioPhase™ High Sensitivity C-Reactive Protein assay is substantially equivalent to the Siemens Healthcare CardioPhase™ High Sensitivity CRP on the BNII Systems that is currently marketed.
Imprecision:
ADVIA Chemistry CardioPhase hsCRP on ADVIA 1650:
Level (mg/L): 0.21, Within run CV (%): 3.2%, Total CV (%): 4.2%
Level (mg/L): 1.04, Within run CV (%): 1.1%, Total CV (%): 1.2%
Level (mg/L): 3.12, Within run CV (%): 0.8%, Total CV (%): 1.3%
Level (mg/L): 10.27, Within run CV (%): 1.4%, Total CV (%): 1.6%
Siemens Healthcare (former Dade Behring) CardioPhase hsCRP on BNII:
Level (mg/L): 0.5, Within run CV (%): 2.5%
Level (mg/L): 1.3, Within run CV (%): 3.8%
Level (mg/L): 2.1, Within run CV (%): 2.1%
Level (mg/L): 14, Within run CV (%): 2.6%
Level (mg/L): 24, Within run CV (%): 3.9%
Correlation (y = ADVIA Chemistry CardioPhase hsCRP, x = comparison method/system):
Specimen type, System (y): Serum, ADVIA 1650
Comparison System (x): former Dade Behring CardioPhase hsCRP on BNII
N: 167
Regression Equation: Passing Bablok: Y = 1.00x + 0.01; Least Squares: Y = 1.01x - 0.01
Sy.x (mg/L): N/A (Passing Bablok), 0.13 (Least Squares)
r: N/A (Passing Bablok), 0.998 (Least Squares)
Sample Range (mg/L): 0.17 - 9.05
Interfering Substances (ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein on ADVIA 1650):
Hemoglobin: 500 mg/dL, CRP conc. (mg/L): 0.43, Effect (% change): -9%
Lipids (Intralipid): 1000 mg/dL, CRP conc. (mg/L): 0.52, Effect (% change): -7%
Bilirubin, free: 30 mg/dL, CRP conc. (mg/L): 0.53, Effect (% change): 4%
Bilirubin, conjugated: 30 mg/dL, CRP conc. (mg/L): 0.51, Effect (% change): 0%
Rheumatoid Factor: 1040 IU/mL, CRP conc. (mg/L): 3.15, Effect (% change): 8%
Analytical Range (Serum/Plasma) on ADVIA 1650: 0.16 to 10 mg/L
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
510(k) Summary
| Submitter information
Contact person: | Philip Liu
Manager, Regulatory Affairs & Compliance |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue
Tarrytown, NY 10591 |
| Phone: | 914-524-2443
914-524-2500 (fax) |
| Date summary prepared: | May 1, 2008 |
| Device Trade or Proprietary Names: | ADVIA® Chemistry CardioPhase High Sensitivity
C-Reactive Protein (hsCRP) Assay
ADVIA® Chemistry CardioPhase High Sensitivity
C-Reactive Protein (hsCRP) Calibrators |
| Device Common/Usual Name or
Classification Name: | Cardiac C-Reactive Protein, Antigen, Antiserum,
and Control
Calibrators |
| Classification Number/Class: | NQD / Class II
JIX / Class II |
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
| The assigned 510(k) number is: | K081294 |
|---|---|
| -------------------------------- | --------- |
Assay Predicate Devices:
| Predicate Device | |
|---|---|
| Device Name | CardioPhase™ High Sensitivity C-Reactive Protein |
| (hsCRP) on the BNII Systems | |
| Common name | High Sensitivity C-Reactive Protein (hsCRP) |
| 510(k) Number | K033908 |
| Manufacturer | Siemens Healthcare Diagnostics |
| (formerly Dade Behring, Inc.) |
Siemens Healthcare Diagnostics
ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein Premarket Notification 510(k) ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein Calibrators Premarket Notification 510(k) 510(k) Summary
Page 1 of 6
1
Calibrator Predicate Device:
| Predicate Device | ||
|---|---|---|
| Device Name | ADVIA Chemistry wrCRP | |
| Common name | C-Reactive Protein Calibrators | |
| 510(k) Number | K022682 (Randox Labs, Ltd) | |
| Manufacturer | Siemens Healthcare Diagnostics | |
| (formerly Siemens Medical Solutions Diagnostics) |
Device Description:
The ADVIA Chemistry CardioPhase™ High Sensitivity C-Reactive Protein assay is for in vitro diagnostic use in the quantitative determination of the concentration of C-Reactive Protein (CRP) in human serum and plasma on the ADVIA Chemistry systems. The CardioPhaseTM hsCRP latex reagent is a suspension of uniform polystyrene latex particles coated with anti-CRP antibody. When serum or plasma containing CRP is mixed with the latex reagent, agglutination takes place resulting in an increase in turbidity. This turbidity is measured at 571 nm. The CRP concentration in serum or plasma is determined from a calibration curve that is generated with the calibrators.
The ADVIA® Chemistry CardioPhase™ High Sensitivity C-Reactive Protein Calibrators consist of six (6) levels of protein stabilized matrices containing varying concentrations of recombinant human CRP. The Calibrators have targeted values (lot specific) of 0, 0.53, 1.05, 1.58, 5.25, and 10.50 mg/L.
The calibrators (1 mL/vial) are liquid and ready to use. Storage is at 2 - 8℃.
Statement of Intended Use:
The ADVIA Chemistry CardioPhase™ High Sensitivity C-Reactive Protein assay is for in vitro diagnostic use in the quantitative determination of the concentration of C-Reactive Protein (CRP) in human serum and plasma (lithium heparin and potassium EDTA) on the ADVIA Chemistry systems. In acute phase response, increased levels of a number of plasma proteins, including CRP, are observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injurv, inflammatory disorders, and associated diseases. High sensitivity CRP (hsCRP) measurements may be used as an independent risk marker for the identification of individuals at risk for future cardiovascular disease. Measurement of hsCRP, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events in patients with stable coronary disease or acute coronary syndromes.
The ADVIA Chemistry CardioPhase™ High Sensitivity C-Reactive Protein Calibrators are for in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the CardioPhase High Sensitivity C-Reactive Protein method.
2
Comparisons to the Predicate Device:
Assay Similarities
| | ADVIA Chemistry CardioPhase™
High Sensitivity C-Reactive Protein
(hsCRP)
( new device ) | Siemens Healthcare CardioPhase™
High Sensitivity CRP on the BNII
Systems
(formerly Dade Behring)
( predicate device ) |
|-----------------|---------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use in the
quantitative determination of C-
Reactive Protein | For in vitro diagnostic use in the
quantitative determination of C-
Reactive Protein |
| Specimen Type | Human serum or plasma (lithium
heparin, potassium EDTA) | Human serum or plasma (lithium
heparin, potassium EDTA) |
| Calibration | Multi-point (6) | Reference curves generated by multi-
point calibration |
| Standardization | IRMM Reference Material CRM 470 | IRMM Reference Material CRM 470 |
| Expected Values | Healthy individuals ≤ 3 mg/L | Healthy individuals ≤ 3 mg/L |
| | Risk for cardiovascular disease
prediction*:
Low 3 mg/L | Relative risk/average hsCRP:
Low 3.0 mg/L |
*AHA/CDC Scientific Statement
Assay Differences
| | ADVIA Chemistry CardioPhase™
High Sensitivity C-Reactive Protein
(hsCRP)
( new device ) | Siemens Healthcare CardioPhase™
High Sensitivity CRP on the BNII
Systems
(formerly Dade Behring)
( predicate device ) |
|----------------------------|---------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Assay Principle | Latex-enhanced immuno-turbidimetric
assay | Particle enhanced immuno-
nephelometry on the BN system |
| Calibrator | ADVIA Chemistry CardioPhase™
High Sensitivity C-Reactive Protein
Calibrators | N Rheumatology Standard SL
N Diluent |
| Reagents | Two liquid reagents, ready to use | Ready to use reagent |
| Analytical Range
(mg/L) | 0.16 – 10.0 mg/L | 0.10 – 20 mg/L |
.
3
Calibrator Similarities
| | ADVIA Chemistry
CardioPhase High Sensitivity
C-Reactive Protein Calibrators
( new device ) | ADVIA Chemistry
Wide Range C-Reactive Protein
Calibrators
( predicate device ) |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use in the
calibration of ADVIA Chemistry
systems for the Cardiophase hsCRP
method | For in vitro diagnostic use in the
calibration of ADVIA Chemistry
systems for the wrCRP method |
| Matrix | Liquid, ready to use | Liquid, ready to use |
| Calibrator Levels | 6 | 6 |
| Calibrator
Ingredients | Recombinant human CRP in a
stabilized protein matrix; contains
sodium azide | Recombinant human CRP in a
stabilized protein matrix; contains
sodium azide |
| Shelf Life | 18 months | 18 months |
| Standardization | CRM-470 | CRM-470 |
Calibrator Differences
| | ADVIA Chemistry
CardioPhase High Sensitivity
C-Reactive Protein Calibrators
(new device) | ADVIA Chemistry
Wide Range C-Reactive Protein
Calibrators
(predicate device) |
|---------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Expected Values | Lot specific:
0, 0.53, 1.05, 1.58, 5.25, and 10.50
mg/L | Lot specific:
0, 2.5, 10, 20, 80, and 160 mg/L |
| Open Vial
(capped) Stability | 60 days stored @2-8°C | 28 days stored @2-8°C |
Performance:
Substantial equivalence was demonstrated by testing several performance characteristics including imprecision, method comparison, interfering substances, serum/plasma equivalency, and analytical range. The following tables summarize the precision (within run), interfering substances, analytical range, and method comparison results.
All of the evaluation studies gave acceptable results compared to the predicate device (this predicate device was used in clinical studies supporting an indication for cardiovascular use). These studies support that the ADVIA Chemistry CardioPhase™ High Sensitivity C-Reactive Protein assay is substantially equivalent to the Siemens Healthcare CardioPhase™ High Sensitivity CRP on the BNII Systems that is currently marketed.
4
Imprecision
| ADVIA Chemistry
CardioPhase hsCRP | | | Siemens Healthcare
(former Dade Behring)
CardioPhase hsCRP | |
|--------------------------------------|----------------------|-----------------|------------------------------------------------------------------|----------------------|
| ADVIA 1650 | | | BNII | |
| Level (mg/L) | Within run
CV (%) | Total
CV (%) | Level (mg/L) | Within run
CV (%) |
| 0.21 | 3.2% | 4.2% | 0.5 | 2.5% |
| 1.04 | 1.1% | 1.2% | 1.3 | 3.8% |
| 3.12 | 0.8% | 1.3% | 2.1 | 2.1% |
| 10.27 | 1.4% | 1.6% | 14 | 2.6% |
| | | | 24 | 3.9% |
Correlation
(y = ADVIA Chemistry CardioPhase hsCRP, x = comparison method/system)
| Specimen type,
System (y) | Comparison System (x) | N | Regression
Equation | Sy.x
(mg/L) | r | Sample
Range
(mg/L) |
|------------------------------|-----------------------------------------------------|-----|---------------------------------------|----------------|-------|---------------------------|
| Serum,
ADVIA 1650 | former Dade Behring
CardioPhase hsCRP on
BNII | 167 | Passing Bablok:
$Y = 1.00x + 0.01$ | N/A | N/A | 0.17 - 9.05 |
| Serum,
ADVIA 1650 | former Dade Behring
CardioPhase hsCRP on
BNII | 167 | Least Squares:
$Y = 1.01x - 0.01$ | 0.13 | 0.998 | 0.17 - 9.05 |
Interfering Substances
(ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein on ADVIA 1650)
| Interfering Substance | Interferent
Conc. (mg/dL) | CRP conc.
(mg/L) | Effect
(% change) |
|-----------------------|------------------------------|---------------------|----------------------|
| Hemoglobin | 500 mg/dL | 0.43 | - 9% |
| Lipids (Intralipid) | 1000 mg/dL | 0.52 | - 7% |
| Bilirubin, free | 30 mg/dL | 0.53 | 4% |
| Bilirubin, conjugated | 30 mg/dL | 0.51 | 0 |
| Rheumatoid Factor | 1040 IU/mL | 3.15 | 8% |
Analytical Range (Serum/Plasma)
| Platform | ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein |
|---|---|
| ADVIA 1650 | 0.16 to 10 mg/L |
Siemens Healthcare Diagnostics ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein Premarket Notification 510(k) ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein Calibrators Premarket Notification 510(k) 510(k) Summary
5
Conclusions:
The ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein assay is substantially equivalent to other products in commercial distribution intended for similar Most notably, it is substantially equivalent to the currently marketed Siemens use. Healthcare Diagnostics (formerly Dade Behring) CardioPhase High Sensitivity CRP on the BNII Systems (this predicate device was used in clinical studies supporting an indication for cardiovascular use).
The ADVIA® Chemistry CardioPhase High Sensitivity C-Reactive Protein Calibrators are substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed ADVIA Chemistry Wide Range C-Reactive Protein Calibrators (K022682).
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Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its wings and body. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 2 9 2008
Siemens Healthcare Diagnostics Inc. c/o Philip Liu Manager, Regulatory Affairs & Compliance 511 Benedict Avenue Tarrytown, NY 10591
Re: K081294
Trade/Device Name: ADVIA® Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Assay, ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein Calibrators Regulation Number: 21CFR Sec .- 866.5270 Regulation Name: C-Reactive Protein Immunological Test System. Regulatory Class: Class II Product Code: NQD, JIX Dated: May 5, 2008 Received: May 7, 2008
Dear Dr. Liu:
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
7
Page 2 -
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 logally marketed predicate device results in a classification for your device of July , 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 othe 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 the (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
8
Indications for Use
510(k) Number (if known):
Device Name(s):
ADVIA CHEMISTRY CardioPhase™ High Sensitivity C-Reactive Protein Assay ADVIA CHEMISTRY CardioPhase™ High Sensitivity C-Reactive Protein Calibrators
Indications For Use:
The ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein assay is for in vitro diagnostic use in the quantitative determination of the concentration of C-Reactive Protein (CRP) in human serum and plasma (lithium heparin or potassium EDTA) on the ADVIA Chemistry systems. In acute phase response, increased levels of a number of plasma proteins, including CRP, are observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders, and associated diseases. High sensitivity CRP (hsCRP) measurements may be used as an independent risk marker for the identification of individuals at risk for future cardiovascular disease. Measurement of hsCRP, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events in patients with stable coronary disease or acute coronary syndromes.
The ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein Calibrators are for in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the CardioPhase High Sensitivity C-Reactive Protein method.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
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 Djagnostic Devices (OIVD) and
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Office of In Vitro Diagnostic Device Evaluation and Safety