(28 days)
Not Found
No
The description details a standard immunoassay method for measuring CRP concentration, relying on chemical reactions and optical density measurements. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
This device is for in vitro diagnostic use, measuring CRP levels in serum and plasma to detect and evaluate inflammatory disorders, tissue injury, and infections. It does not directly treat or prevent diseases.
Yes
The device quantitatively measures C-reactive protein (CRP) concentration in serum and plasma, and these measurements are stated to be "useful in the detection and evaluation of inflammatory disorders, tissue injury, and infections." This explicitly indicates its use in aiding in the diagnosis or evaluation of medical conditions.
No
The device description clearly outlines physical components (slides, calibrator kit) and a chemical reaction process performed on hardware systems (VITROS Chemistry and Integrated Systems). This is an in vitro diagnostic test with hardware and chemical components, 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 for both the VITROS Chemistry Products CRP Slides and the VITROS Chemistry Products Calibrator Kit 7 explicitly states "For in vitro diagnostic use only."
- Purpose: The device is intended to quantitatively measure C-reactive protein (CRP) in serum and plasma, which are biological samples taken from the human body.
- Clinical Relevance: The measurement of CRP is stated to be "useful in the detection and evaluation of inflammatory disorders, tissue injury, and infections," indicating its use in diagnosing or monitoring medical conditions.
- Methodology: The description details a laboratory-based assay using chemical reactions and measurement of reflection density, which is characteristic of in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
VITROS Chemistry Products CRP Slides: For in vitro diagnostic use only. VITROS Chemistry Products CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma using VITROS 250/350/5.1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. C-reactive protein is synthesized by the liver and is one of the acute phase response, increased concentrations of a number of plasma proteins, including CRP, are observed. CRP concentration measurements are useful in the detection and evaluation of inflammatory disorders, tissue injury, and infections.
VITROS Chemistry Products Calibrator Kit 7: For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 7 is used to calibrate VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of CRP.
Product codes (comma separated list FDA assigned to the subject device)
DCK, JIT
Device Description
The VITROS CRP Slide method is performed using the VITROS CRP Slides and the VITROS Chemistry Products Calibrator Kit 7 on VITROS Chemistry and Integrated Systems.
The VITROS CRP Slide is a multilayered, analytical element coated on a polyester support. The immuno-rate format for CRP is based on an enzymatic heterogeneous, sandwich immunoassay format. In this format a derivative of phosphorylcholine (PC) is covalently bound to polystyrene polymer beads and in the presence of calcium serves as a capture agent. Monoclonal anti-CRP antibody conjugated to horseradish peroxidase (HRP) serves as a signal generator. A drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. CRP in the sample binds to PC-linked capture beads and anti-CRP antibody labeled with horseradish peroxidase to form an insoluble sandwich complex in Incubation 1. The subsequent addition of 12 μL of VITROS Immuno-Wash Fluid to the slide removes unbound materials from the read area, while also providing the hydrogen peroxide required for the enzyme-mediated oxidation of leuco dye. The reflection density of the dye is measured after the addition of VITROS Immuno-Wash Fluid at the end of Incubation 2. This reflection density is directly proportional to the concentration of CRP in the sample. To determine if an adequate wash has occurred, the wash detection dye is read at 540 nm immediately after Incubation 2.
The VITROS Calibrator Kit 7 is prepared from processed human serum to which purified human C-reactive protein, inorganic salts, and preservatives have been added. The human blood products provided as components of VITROS Calibrator Kit 7 have been tested at the individual donor level and found nonreactive for hepatitis B surface antigen (HBsAg), antibody to HCV, and antibody to HIV using FDA approved methods.
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 method comparison, linearity and detection (analytical range).
Method Comparison: Method Comparison testing followed CLSI Protocol EP09-A3, Measurement Procedure Comparison and Bias Estimation Using Patient Samples. Human serum samples were tested with the VITROS Chemistry Products CRP assay traceable to ERM-DA474 and the obtained results were compared to the predicate method (VITROS Chemistry Products CRP assay traceable to ERM-DA472). 98 to 103 samples ranging from 5 to 90 mg/L were tested with both assays. The correlation between the assays on each VITROS System is summarized.
Limits of blank, detection, and quantitation: The Limit of Blank (LOB), Limit of Detection (LOD), and Limit of Quantitation (LOQ) of the VITROS CRP assay were determined according to CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures.
Linearity: Linearity was determined following CLSI EP6-A: Evaluation of the Linearity of Quantitative Measurement Procedures: a Statistical Approach: Approved Guideline. A high CRP serum pool was intermixed with a low serum pool to generate 14 concentration levels each tested in six replicate determinations. Linear results were compared to 2nd and 3rd order polynomial fits against a pre-specified allowable error. The linearity range was found to extend across the measuring range of 5 to 90 mg/L.
Analytical Range (Serum/Plasma): Results from linearity and detection studies support the analytical measuring range of the VITROS Chemistry Products Slides on the VITROS Systems.
Key results:
Method Comparison Results:
VITROS 350 Chemistry System: Slope (95% CI) 1.009 (1.008 to 1.010), y-intercept (95% CI) -4.819 (4.886 to -4.751)
VITROS 5,1 FS Chemistry System: Slope (95% CI) 1.009 (1.007 to 1.011), y-intercept (95% CI) -4.938 (-5.070 to -4.805)
VITROS 4600 Chemistry System: Slope (95% CI) 1.009 (1.006 to 1.012), y-intercept (95% CI) -4.952 (-5.114 to -4.790)
VITROS 5600 Chemistry System: Slope (95% CI) 1.009 (1.006 to 1.011), y-intercept (95% CI) -4.905 (-5.052 to -4.759)
Limits of blank, detection, and quantitation:
LOB: 2.03 mg/L
LOD: 2.72 mg/L
LOQ: 4.80 mg/L
Analytical Range (Serum/Plasma):
VITROS 250/350, 5,1 FS, and 4600 Chemistry System, VITROS 5600 Integrated System: 5 to 90 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
Image /page/0/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center of the circle is the department's symbol, which is a stylized image of three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ORTHO-CLINICAL DIAGNOSTICS, INC. MS. JESSICA MILLER SENIOR REGULATORY AFFAIRS ASSOCIATE 100 INDIGO CREEK DRIVE ROCHESTER, NEW YORK 14626
Re: K152433
Trade/Device Name: VITROS Chemistry Products CRP Slides VITROS Chemistry Products Calibrator Kit 7 Regulation Number: 21 CFR 866.5270 Regulation Name: C-Reactive Protein immunological test system Regulatory Class: II Product Code: DCK, JIT Dated: August 26, 2015 Received: August 27, 2015
Dear Ms. Miller:
September 24, 2015
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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
1
807): labeling (21 CFR Parts 801 and 809); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm.
Sincerely yours,
Kelly Oliner -S
FOR
Leonthena Carrington, MS, MBA, MT (ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152433
Device Name
VITROS Chemistry Products CRP Slides and VITROS Chemistry Products Calibrator Kit 7
Indications for Use (Describe)
VITROS Chemistry Products CRP Slides:
For in vitro diagnostic use only.
VITROS Chemistry Products CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma using VITROS 250/350/5.1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
C-reactive protein is synthesized by the liver and is one of the acute phase response, increased concentrations of a number of plasma proteins, including CRP, are observed. CRP concentration measurements are useful in the detection and evaluation of inflammatory disorders, tissue injury, and infections.
VITROS Chemistry Products Calibrator Kit 7:
For in vitro diagnostic use only.
VITROS Chemistry Products Calibrator Kit 7 is used to calibrate VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of CRP.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary VITROS Chemistry Products CRP Slides, Calibrator Kit 7
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
| Submitter Information | |
|---|---|
| Name | Ortho-Clinical Diagnostics, Inc. |
| Address | 100 Indigo Creek Drive |
| Rochester, New York 14626 | |
| Phone number | 908-218-8173 |
| Fax number | 908-218-8168 |
| Establishment Registration Number | 1319681 |
| Name of contact person | Jessica Miller |
| Date prepared | August 26, 2015 |
| Name of devices | |
| Trade or proprietary name | VITROS Chemistry Products CRP Slides |
| VITROS Chemistry Products Calibrator Kit 7 | |
| Common or usual name | C-reactive protein immunological test system |
| Classification name | C-reactive protein, antigen, antiserum, and control |
| Classification panel | Immunology |
| Regulation | 21 CFR 866.5270: C-Reactive Protein immunological test |
| system | |
| 21 CFR 862.1150: Calibrator | |
| Classification: Class II | |
| Product Code(s) | DCK, JIT |
| Legally marketed | |
| device(s) to which | |
| equivalence is | |
| claimed | The VITROS Chemistry Products CRP Slides and VITROS |
| Chemistry Products Calibrator Kit 7 (modified) is substantially | |
| equivalent to the VITROS Chemistry Products CRP Slides and | |
| VITROS Chemistry Products Calibrator Kit 7 (current), | |
| cleared March, 2003 (K030626). | |
| Device description | The VITROS CRP Slide method is performed using the |
| VITROS CRP Slides and the VITROS Chemistry Products | |
| Calibrator Kit 7 on VITROS Chemistry and Integrated | |
| Systems. | |
| The VITROS CRP Slide is a multilayered, analytical element | |
| coated on a polyester support. The immuno-rate format for | |
| CRP is based on an enzymatic heterogeneous, sandwich | |
| immunoassay format. In this format a derivative of | |
| phosphorylcholine (PC) is covalently bound to polystyrene | |
| polymer beads and in the presence of calcium serves as a | |
| capture agent. Monoclonal anti-CRP antibody conjugated to | |
| horseradish peroxidase (HRP) serves as a signal generator. | |
| A drop of patient sample is deposited on the slide and is evenly | |
| distributed by the spreading layer to the underlying layers. | |
| CRP in the sample binds to PC-linked capture beads and anti- | |
| CRP antibody labeled with horseradish peroxidase to form an | |
| insoluble sandwich complex in Incubation 1. The subsequent | |
| addition of 12 $ \mu $ L of VITROS Immuno-Wash Fluid to the slide | |
| removes unbound materials from the read area, while also | |
| providing the hydrogen peroxide required for the enzyme- | |
| mediated oxidation of leuco dye. | |
| The reflection density of the dye is measured after the addition | |
| of VITROS Immuno-Wash Fluid at the end of Incubation 2. | |
| This reflection density is directly proportional to the | |
| concentration of CRP in the sample. To determine if an | |
| adequate wash has occurred, the wash detection dye is read at | |
| 540 nm immediately after Incubation 2. |
The VITROS Calibrator Kit 7 is prepared from processed
human serum to which purified human C-reactive protein,
inorganic salts, and preservatives have been added.
The human blood products provided as components of
VITROS Calibrator Kit 7 have been tested at the individual
donor level and found nonreactive for hepatitis B surface
antigen (HBsAg), antibody to HCV, and antibody to HIV
using FDA approved methods. |
| Intended
Use/Indications for Use | CRP Slide:
For in vitro diagnostic use only.
VITROS Chemistry Products CRP Slides quantitatively
measure C-reactive protein (CRP) concentration in serum and
plasma using VITROS 250/350/5,1 FS and 4600 Chemistry
Systems and the VITROS 5600 Integrated System |
| C-reactive protein is synthesized by the liver and is one of the
acute phase proteins. In the acute phase response, increased | |
| concentrations of a number of plasma proteins, including CRP, | |
| are observed. CRP concentration measurements are useful in | |
| the detection and evaluation of inflammatory disorders, tissue | |
| injury, and infections. | |
| Calibrator Kit 7: | |
| For in vitro diagnostic use only. | |
| VITROS Chemistry Products Calibrator Kit 7 is used to | |
| calibrate VITROS 250/350/5,1 FS and 4600 Chemistry | |
| Systems and the VITROS 5600 Integrated System for the | |
| quantitative measurement of CRP. | |
4
5
Comparison with Predicate Devices:
Table 1: VITROS Chemistry Products CRP Slides
| Characteristic | Predicate [VITROS CRP Slides
(Current), K030626] | New Device [VITROS CRP
Slides (Modified)] |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use only.
VITROS Chemistry Products CRP
Slides quantitatively measure C-
reactive protein (CRP) concentration
in serum and plasma using VITROS
250/350/950/5,1 FS and 4600
Chemistry Systems and the VITROS
5600 Integrated System. | For in vitro diagnostic use only.
VITROS Chemistry Products CRP
Slides quantitatively measure C-
reactive protein (CRP)
concentration in serum and plasma
using VITROS 250/350/5,1 FS and
4600 Chemistry Systems and the
VITROS 5600 Integrated System. |
| Basic Principle | Fixed-point immuno-rate | No Change |
6
| Characteristic | Predicate [VITROS CRP Slides (Current), K030626] | New Device [VITROS CRP Slides (Modified)] |
|---|---|---|
| Reagent | ||
| Composition | Reactive Ingredients: | |
| Immobilized phosphorylcholine; | ||
| mouse anti-CRP | ||
| antibody labeled with horseradish | ||
| peroxidase; calcium | ||
| chloride; and 2-(3,5-dimethoxy-4- | ||
| hydroxyphenyl)-4,5- | ||
| bis(4-dimethylaminophenyl) | ||
| imidazole (leuco dye) |
Other Ingredients:
Binders, buffer, surfactants, cross-
linking agent, polymer beads,
proteins, stabilizers and wash
detection dye. | No Change |
| Sample volume | 11 μL | No Change |
| Sample type | Serum, plasma | No Change |
| Assay Range
Serum, Plasma | 5 - 90 mg/L | No Change |
| Incubation time
and temperature | 7.5 minutes at 37°C | No Change |
| Calibration
Traceability of
Values (VITROS
Chemistry
Products
Calibrator Kit 7) | IRMM Reference Material ERM-
DA472 | IRMM Reference Material ERM-
DA474/IFCC |
Table 1: VITROS Chemistry Products CRP Slides
7
| Characteristic | Predicate [VITROS Calibrator Kit 7
(Current), K030626] | New Device
[VITROS Calibrator Kit 7
(Modified)] |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use only.
VITROS Chemistry Products Calibrator
Kit 7 is used to calibrate VITROS
250/350/950/5,1 FS and 4600 Chemistry
Systems and the VITROS 5600 Integrated
System for the quantitative measurement
of CRP. | For in vitro diagnostic use
only.
VITROS Chemistry Products
Calibrator Kit 7 is used to
calibrate VITROS
250/350/5,1 FS and 4600
Chemistry Systems and the
VITROS 5600 Integrated
System for the quantitative
measurement of CRP. |
| Matrix/
Ingredients | Liquid; processed human serum to which
purified human C-reactive protein,
inorganic salts, and preservatives have
been added. | No Change |
| Traceability of
Values | IRMM Reference Material ERM-DA472 | IRMM Reference Material
ERM-DA474/IFCC |
| Nominal Values
for CRP | Vial 1: 7 mg/L
Vial 2: 25 mg/L
Vial 3: 100 mg/L | No Change |
Table 2: VITROS Chemistry Products Calibrator Kit 7
8
Performance Summary:
Substantial Equivalence was demonstrated by testing several performance characteristics including method comparison, linearity and detection (analytical range).
Method Comparison:
Method Comparison testing followed CLSI Protocol EP09-A3, Measurement Procedure Comparison and Bias Estimation Using Patient Samples. Human serum samples were tested with the VITROS Chemistry Products CRP assay traceable to ERM-DA474 and the obtained results were compared to the predicate method (VITROS Chemistry Products CRP assay traceable to ERM-DA472). 98 to103 samples ranging from 5 to 90 mg/L were tested with both assays. The correlation between the assays on each VITROS System is summarized below.
| Analyzer | Parameter | Result |
|---|---|---|
| VITROS 350 Chemistry | ||
| System | Slope (95% CI) | 1.009 (1.008 to1.010) |
| y-intercept (95% CI) | -4.819 (4.886 to -4.751) | |
| VITROS 5,1 FS Chemistry | ||
| System | Slope (95% CI) | 1.009 (1.007 to 1.011) |
| y-intercept (95% CI) | -4.938 (-5.070 to -4.805) | |
| VITROS 4600 Chemistry | ||
| System | Slope (95% CI) | 1.009 (1.006 to 1.012) |
| y-intercept (95% CI) | -4.952 (-5.114 to -4.790) | |
| VITROS 5600 Chemistry | ||
| System | Slope (95% CI) | 1.009 (1.006 to 1.011) |
| y-intercept (95% CI) | -4.905 (-5.052 to -4.759) |
Limits of blank, detection, and quantitation:
The Limit of Blank (LOB), Limit of Detection (LOD), and Limit of Quantitation (LOQ) of the VITROS CRP assay were determined according to CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures. The following limits were determined:
LOB: 2.03 mg/L LOD: 2.72 mg/L LOO: 4.80 mg/L
9
Linearity:
Linearity was determined following CLSI EP6-A: Evaluation of the Linearity of Quantitative Measurement Procedures: a Statistical Approach: Approved Guideline. A high CRP serum pool was intermixed with a low serum pool to generate 14 concentration levels each tested in six replicate determinations. Linear results were compared to 2nd and 3rd order polynomial fits against a pre-specified allowable error. The linearity range was found to extend across the measuring range of 5 to 90 mg/L.
Analytical Range (Serum/Plasma):
Results from linearity and detection studies support the analytical measuring range of the VITROS Chemistry Products Slides on the VITROS Systems as seen below.
| Analyzers | VITROS Chemistry Products CRP Assay |
|---|---|
| VITROS 250/350, 5,1 FS, and 4600 | |
| Chemistry System, VITROS 5600 | |
| Integrated System | 5 to 90 mg/L |
Conclusion:
The conclusions drawn from the nonclinical tests (discussed above) demonstrate the modified VITROS Chemistry Products CRP Slides and VITROS Chemistry Products Calibrator Kit 7 are as safe and effective as the predicate devices. The information submitted in the premarket notification is complete and supports a substantial equivalence decision.