(54 days)
No
The summary describes a standard automated clinical chemistry analyzer and associated reagents for measuring CRP. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The document explicitly states that the device is for "in vitro diagnostic use only" and is used to measure CRP levels, which is a diagnostic test, not a treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "For in vitro diagnostic use only" and measures C-reactive protein (CRP) to evaluate the risk of developing coronary heart disease (CHD), which is a diagnostic purpose.
No
The device description clearly outlines a physical chemistry analyzer system (VITROS 5.1 FS Chemistry System) and associated physical reagents and calibrators. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only." This is the most direct indicator.
- Measurement of Analytes in Human Specimens: The device description states it's a "fully automated clinical chemistry analyzer intended for use in the in vitro determination of various analytes in human specimens (serum, plasma, urine, and cerebrospinal fluid)." Measuring analytes in human specimens outside of the body is the core function of an IVD.
- Specific Analyte Measurement: The device is used to quantitatively measure C-reactive protein (CRP) in human serum and plasma. This is a specific diagnostic test performed on a biological sample.
- Diagnostic Purpose: The measurement of CRP is used to "evaluate the risk of developing coronary heart disease (CHD)." This clearly indicates a diagnostic purpose.
- Use of Reagents and Calibrators: The description mentions the use of "VITROS Chemistry Products hsCRP Reagent," "VITROS Chemistry Products Calibrator Kit 17," and "VITROS Chemistry Products hsCRP Performance Verifiers." These are all components typically used in in vitro diagnostic assays.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use only. VITROS Chemistry Products hsCRP Reagent is used to quantitatively measure C-reactive protein (CRP) in human serum and plasma. CRP is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with values of CRP that exceed 3 mg/L.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 17 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of C-reactive protein (CRP) using VITROS hsCRP Reagent.
For in vitro diagnostic use only. VITROS Chemistry Products hsCRP Performance Verifiers are assayed controls used to monitor performance of hsCRP Reagent on VITROS 5,1 FS Chemistry Systems.
Product codes (comma separated list FDA assigned to the subject device)
NQD, JIT, JJX
Device Description
The VITROS 5.1 FS Chemistry System is a fully automated clinical chemistry analyzer intended for use in the in vitro determination of various analytes in human specimens (serum, plasma, urine, and cerebrospinal fluid). The VITROS 5,1 FS Chemistry System is designed for use with VITROS Chemistry Products MicroTip and Thin Film assays.
The system is comprised of four main elements:
-
- The VITROS 5.1 FS Chemistry System instrumentation, which provides automated use of the chemistry reagents. The VITROS 5,1 FS Chemistry System was cleared for market by a separate 510(k) premarket notification (K031924).
-
- The VITROS Chemistry Products range of MicroTip assays, in this case the VITROS Chemistry Products hsCRP Reagent, VITROS Chemistry Products Calibrator Kit 17, VITROS Chemistry Products FS Calibrator 1, and the VITROS Chemistry Products hsCRP Performance Verifiers, which are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS hsCRP assay.
-
- The VITROS Chemistry Products Thin Film range of products, which are dry, multilayered, analytical elements, coated on polyester supports. The thin film products each have their own 510(k) clearance numbers and were cleared for market for use on the VITROS 5,1 FS Chemistry System through submission of information required by the ODE Guidance Document: "Data For Commercialization Of Original Equipment Manufacturer, Secondary and Generic Reagents For Automated Analyzers". The required information was provided in the VITROS 5,1 FS Chemistry System premarket notification (K031924).
-
- Common reagents used by multiple assays on the VITROS System (in this case, VITROS Chemistry Products FS Diluent Pack 2).
The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.
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)
Studies were performed to determine the precision, expected values, linearity, and specificity of the VITROS hsCRP assay. The relationship between the VITROS hsCRP assay and the predicate device was determined by least squares linear regression: VITROS hsCRP assay = 0.954 X + 0.063 mg/L with a correlation coefficient of 0.993, where X is the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
correlation coefficient of 0.993
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.
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
1.0 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: Ko41799
1.1 Submitter name, address, contact
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 Phone: (585) 453-3482 Fax: (585) 453-3368
Contact Person: Carey A. Mayo, M.S., RAC
1.2 Date of Preparation: July 1, 2004
1.3 Device Proprietary Name(s)
Trade Name(s) VITROS Chemistry Products hsCRP Reagent VITROS Chemistry Products Calibrator Kit 17 VITROS Chemistry Products FS Calibrator 1 VITROS Chemistry Products hsCRP Performance Verifier I, II, and III
Common Name C-Reactive Protein assay and controls
1.4 Classification Name(s)
C-Reactive Protein Immunological Test System: Class II (21 CFR 866.5270) Assayed Controls: Class I, reserved (21 CFR 862.1660)
1.5 Predicate device
The VITROS Chemistry Products hsCRP assay is substantially equivalent to the N High Sensitivity CRP assay (Dade Behring, Inc.).
The VITROS Chemistry Products hsCRP Performance Verifiers are substantially equivalent to the VITROS Chemistry Products CRP Performance Verifiers.
1
1.6 Device description
The VITROS 5.1 FS Chemistry System is a fully automated clinical chemistry analyzer intended for use in the in vitro determination of various analytes in human specimens (serum, plasma, urine, and cerebrospinal fluid). The VITROS 5,1 FS Chemistry System is designed for use with VITROS Chemistry Products MicroTip and Thin Film assays.
The system is comprised of four main elements:
-
- The VITROS 5.1 FS Chemistry System instrumentation, which provides automated use of the chemistry reagents. The VITROS 5,1 FS Chemistry System was cleared for market by a separate 510(k) premarket notification (K031924).
-
- The VITROS Chemistry Products range of MicroTip assays, in this case the VITROS Chemistry Products hsCRP Reagent, VITROS Chemistry Products Calibrator Kit 17, VITROS Chemistry Products FS Calibrator 1, and the VITROS Chemistry Products hsCRP Performance Verifiers, which are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS hsCRP assay.
-
- The VITROS Chemistry Products Thin Film range of products, which are dry, multilayered, analytical elements, coated on polyester supports. The thin film products each have their own 510(k) clearance numbers and were cleared for market for use on the VITROS 5,1 FS Chemistry System through submission of information required by the ODE Guidance Document: "Data For Commercialization Of Original Equipment Manufacturer, Secondary and Generic Reagents For Automated Analyzers". The required information was provided in the VITROS 5,1 FS Chemistry System premarket notification (K031924).
-
- Common reagents used by multiple assays on the VITROS System (in this case, VITROS Chemistry Products FS Diluent Pack 2).
The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.
2
1.7 Device intended use
VITROS Chemistry Products hsCRP Reagent: For in vitro diagnostic use only. VITROS Chemistry Products hsCRP Reagent is used to quantitatively measure Creactive protein (CRP) in human serum and plasma. CRP is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with values of CRP that exceed 3 mg/L.
VITROS Chemistry Products Calibrator Kit 17: For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 17 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of C-reactive protein (CRP) using VITROS hsCRP Reagent.
VITROS Chemistry Products hsCRP Performance Verifier I, II and III: For in vitro diagnostic use only. VITROS Chemistry Products hsCRP Performance Verifiers are assayed controls used to monitor performance of hsCRP Reagent on VITROS 5,1 FS Chemistry Systems.
Comparison to predicate device: Reagent Kit and Calibrators 1.8
The VITROS Chemistry Products hsCRP Reagent, VITROS Chemistry Products Calibrator Kit 17 and VITROS Chemistry Products FS Calibrator 1 are substantially equivalent to the N High Sensitivity CRP Assay (Dade Behring, Inc.), which was cleared by FDA (K033908) for IVD use.
The relationship between the VITROS hsCRP assay and the predicate device, determined by least squares linear regression, is:
VITROS hsCRP assay = 0.954 X + 0.063 mg/L with a correlation coefficient of 0.993, where X is the predicate device.
In addition to the above mentioned correlation study, studies were performed to determine the precision, expected values, linearity, and specificity of the VITROS hsCRP assay, (refer to the VITROS Chemistry Products hsCRP Reagent Instructions for Use for summaries of the results of these studies).
3
The table below lists the characteristics of the VITROS hsCRP Assay and the N High Sensitivity CRP Assay (Dade Behring, Inc.).
| Device
Characteristic | VITROS hsCRP Assay
(New device #1) | N High Sensitivity CRP Assay
(Predicate device #1) |
|--------------------------|---------------------------------------------------------|-------------------------------------------------------|
| Intended Use | Quantitative measurement
of C-reactive protein (CRP) | Same |
| Basic principle | Latex particle enhanced
Immunoturbidimetry | Particle enhanced
immunonephelometry |
| Traceability | CRM 470 | CRM 470 |
| Reagents | Liquid ready to use | Liquid ready to use |
| Instrumentation | VITROS 5,1 FS Chemistry
System | Dade Behring BN ProSpec
System |
| Sample type | Serum and plasma (Heparin) | Serum and plasma (heparin and
EDTA) |
Comparison to predicate device: Performance Verifiers 1.9
VITROS Chemistry Products hsCRP Performance Verifiers are substantially equivalent to VITROS Chemistry Products CRP Performance Verifiers (predicate device) which were cleared by the FDA (K953197) for IVD use.
The table below lists the characteristics of the VITROS Chemistry Products hsCRP Performance Verifiers and the VITROS Chemistry Products CRP Performance Verifiers.
| Device
Characteristic | VITROS hsCRP
Performance Verifiers
(New device #2) | VITROS CRP Performance
Verifiers
(Predicate device #2) |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | VITROS hsCRP
Performance Verifiers are
assayed controls used to
monitor performance of
hsCRP Reagent on VITROS
5,1 FS Chemistry Systems. | VITROS CRP Performance
Verifier is an assayed control
used to monitor performance
on VITROS Chemistry
Systems. |
| Matrix | A base matrix of human
plasma and plasma proteins
to which stabilizers and
preservative have been
added. | A base matrix of human
serum to which purified
human C-reactive protein,
inorganic salts and
preservatives have been
added. |
| Levels | Low, Medium, and High | Low and High |
4
1.10 Conclusions
The data presented in the premarket notification provide a reasonable assurance that the VITROS Chemistry Products hsCRP assay and the VITROS hsCRP Performance Verifiers are safe and effective for the stated intended uses and are substantially equivalent to the cleared predicate devices. Equivalence to the predicates was demonstrated using a commercially available assay along with patient samples.
5
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird-like figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Carey A. Mayo, M.S., RAC Regulatory Affairs Associate Ortho-Clinical Diagnostics 100 Indigo Creek Drive Rochester, NY 14626-5101
AUG 2 5 2004
K041799 Re:
Trade/Device Name: VITROS Chemistry Products hsCRP Reagent VITROS Chemistry Products Calibrator Kit 17 VITROS Chemistry Products FS Calibrato VITROS Chemistry Products hsCRP Performance Verifiers I. II and III Regulation Number: 21 CFR 866.5270 Regulation Name: C-Reactive protein immunological test system Regulatory Class: Class II Product Code: NQD, JIT, JJX Dated: July 1, 2004 Received: July 2, 2004
Dear Ms. Mayo:
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).
6
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 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 (301) 594-3084. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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2.0 Indications for Use Statement
Page 1 of 1
| 510(k) Number (if known): | K041799 |
|---|---|
| Device Name: | VITROS Chemistry Products hsCRP ReagentVITROS Chemistry Products Calibrator Kit 17VITROS Chemistry Products FS Calibrator 1VITROS Chemistry Products hsCRP Performance Verifiers I, II, and III |
| Indications for Use: | For in vitro diagnostic use only. VITROS Chemistry Products hsCRP Reagent is used to quantitatively measure C-reactive protein (CRP) in human serum and plasma. CRP is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with values of CRP that exceed 3 mg/L.& 3. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 17 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of C-reactive protein (CRP) using VITROS hsCRP Reagent.For in vitro diagnostic use only. VITROS Chemistry Products hsCRP Performance Verifiers are assayed controls used to monitor performance of hsCRP Reagent on VITROS 5,1 FS Chemistry Systems. |
| Prescription Use
(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use
(21 CFR 807 Subpart C) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|------------------------------------------------|
| | | ____________________ |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carol Benem
Division Sign Off
Division Sign-Off
Office of In Vitro Dlagnostic Device Evaluation and Safety
510(k) K041799