(73 days)
For in vitro diagnostic use only. VITROS Chemistry Products RF Reagent is used to quantitatively measure rheumatoid factor (RF) concentration in human serum and plasma. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 16 is used in conjunction with VITROS FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of rheumatoid factor (RF).
For in vitro diagnostic use only. VITROS Chemistry Products RF Performance Verifiers I and II are assayed controls used to monitor the performance of RF Reagent on VITROS 5,1 FS Chemistry Systems.
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 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 Chemistry Products MicroTip range of liquid reagent products (in this case VITROS Chemistry Products RF Reagent, VITROS Chemistry Products Calibrator Kit 16 and VITROS Chemistry Products FS Calibrator 1, VITROS Chemistry Products RF Performance Verifiers I and II), which are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS RF assay.
- The VITROS Chemistry Products Thin Film range of dry products, which are dry, multilayered, analytical elements, coated on polyester supports.
- Common reagents used by multiple assays on the VITROS System (in this case, VITROS Chemistry Products FS Diluent Pack 2 and VITROS Chemistry Products FS Reconstitution Diluent).
The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.
Here's a breakdown of the acceptance criteria and study information for the VITROS Chemistry Products RF assay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than setting specific numerical acceptance criteria for a novel performance study beyond correlation. The key performance indicator is the correlation with the predicate device.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Correlation with Predicate | High correlation with predicate device (Cobas Integra Reagent Cassette for Rheumatoid Factors II (RF-II) assay) | Correlation coefficient of 0.986 |
| Regression Equation (VITROS RF vs. Predicate) | Close relationship demonstrating substantial equivalence | VITROS RF = 0.904 x X - 4.045 (IU/mL) |
| Precision | Acceptable precision for diagnostic use (details not provided in summary, but mentioned as studied) | Summaries of results available in VITROS RF Reagent Instructions for Use |
| Specificity | Acceptable specificity (details not provided in summary, but mentioned as studied) | Summaries of results available in VITROS RF Reagent Instructions for Use |
| Linearity | Acceptable linearity across reportable range (details not provided in summary, but mentioned as studied) | Summaries of results available in VITROS RF Reagent Instructions for Use |
| Antigen Excess | Acceptable performance regarding antigen excess (details not provided in summary, but mentioned as studied) | Summaries of results available in VITROS RF Reagent Instructions for Use |
| Lower Limit of Detection | Acceptable lower limit of detection (details not provided in summary, but mentioned as studied) | Summaries of results available in VITROS RF Reagent Instructions for Use |
| Expected Values | Acceptable expected values (details not provided in summary, but mentioned as studied) | Summaries of results available in VITROS RF Reagent Instructions for Use |
2. Sample Size Used for the Test Set and Data Provenance
The summary states that "Equivalence to predicate(s) was demonstrated using commercially available reagents along with patient samples."
- Sample Size for Test Set: Not explicitly stated in the provided summary.
- Data Provenance: "patient samples" (retrospective or prospective is not specified, nor is country of origin).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable for this type of in vitro diagnostic device (IVD) submission. Ground truth for an IVD measuring a quantitative analyte like rheumatoid factor is typically established by comparing its results against a "gold standard" or predicate method (another established IVD). Expert interpretation of images or clinical cases, which would require experts, is not the primary method for establishing ground truth in this context.
4. Adjudication Method for the Test Set
Not applicable. As described above, this is an IVD device measuring a quantitative analyte, not subject to expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically for image-based diagnostic devices where human readers interpret and classify images, and the AI assists in that interpretation. The VITROS RF assay is a quantitative laboratory test.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance study appears to be a standalone or algorithm-only evaluation. The VITROS RF assay is an automated in vitro diagnostic test performed on the VITROS 5,1 FS Chemistry System. Its performance is compared directly to another device (the predicate) and evaluated for analytical characteristics (precision, linearity, etc.) without human interpretation affecting the result of the assay itself.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation, in this context, is the results obtained from the legally marketed predicate device (Cobas Integra Reagent Cassette for Rheumatoid Factors II (RF-II) assay). The study aimed to demonstrate substantial equivalence by correlating the new device's measurements with those of the predicate device using patient samples.
8. The Sample Size for the Training Set
The provided summary does not mention a "training set" in the context of an AI/machine learning model. This device is an immunoassay (quantitative chemical test) and not an AI/ML software device in the modern sense that would require a distinct training set for algorithm development.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, this is an immunoassay, not an AI/ML algorithm requiring a training set with established ground truth. The development of such assays involves analytical method development and validation, not model training.
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Chapter 1 – Summary Information
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: K041863
| 1. Submitter name, address, contact | Ortho-Clinical Diagnostics, Inc.100 Indigo Creek DriveRochester, New York 14626-5101(585) 453-4041Contact Person: Marlene A. Hanna |
|---|---|
| 2. Preparation date | Date 510(k) prepared: July 8, 2004 |
| 3. Device name | Trade or Proprietary Name:VITROS Chemistry Products RF ReagentVITROS Chemistry Products Calibrator Kit 16VITROS Chemistry Products FS Calibrator 1VITROS Chemistry Products RF Performance Verifiers I and IICommon Name: RF assayClassification Name: Rheumatoid factor immunological test system (866.5775):Class: II (performance standards)Classification Name: Quality Control material (assayed and unassayed) (862.1660):Class I (general controls). Since this device is an assayed control, it meets the reserved criteria under Section 510(l) of the Food, Drug, and Cosmetic Act. |
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.
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510(k) Summary, Continued
-
a. The VITROS Chemistry Products RF assay is substantially equivalent to the 4. Predicate Cobas Integra Reagent Cassette for Rheumatoid Factors II (RF-II) assay. Device
b. The VITROS Chemistry Products RF Performance Verifiers I and II are substantially equivalent to the VITROS Chemistry Products Performance Verifiers I and II. -
The VITROS 5,1 FS Chemistry System is a fully automated clinical chemistry 5. Device analyzer intended for use in the in vitro determination of various analytes in human description specimens (serum, plasma, urine, and cerebrospinal fluid). The VITROS 5,1 FS 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 MicroTip range of liquid reagent products (in this case VITROS Chemistry Products RF Reagent, VITROS Chemistry Products Calibrator Kit 16 and VITROS Chemistry Products FS Calibrator 1, VITROS Chemistry Products RF Performance Verifiers I and II), which are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS RF assay.
-
- The VITROS Chemistry Products Thin Film range of dry 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 and VITROS Chemistry Products FS Reconstitution Diluent).
The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.
Continued on next page
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6. Device a. VITROS Chemistry Products RF Reagent: For in vitro diagnostic use only. intended VITROS Chemistry Products RF Reagent is used to quantitatively measure rheumatoid factor (RF) concentration in human serum and plasma. use
b. VITROS Chemistry Products Calibrator Kit 16 and VITROS Chemistry Products FS Calibrator 1: For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 16 is used in conjunction with VITROS FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of rheumatoid factor (RF).
c. VITROS Chemistry Products RF Performance Verifiers I and II: For in vitro diagnostic use only. VITROS Chemistry Products RF Performance Verifiers I and II are assayed controls used to monitor the performance of RF Reagent on VITROS 5,1 FS Chemistry Systems.
7. Comparison to predicate device(s):
Reagent Pack and Calibrators
ース アート スリー レディー ストー ストー ストー ベット ショップ アイデリア アイデリア アイデリア ア
The VITROS Chemistry Products RF Reagent and VITROS Chemistry Products Calibrator Kit 16 and FS Calibrator 1 are substantially equivalent to the Cobas Integra Reagent Cassette for Rheumatoid Factors II (RF-II) assay (predicate device) which was cleared by the FDA (K000534) for IVD use.
The relationship between the VITROS RF and the predicate device, determined by least squares linear regression, is:
VITROS RF = 0.904 x X - 4.045 (IU/mL),
with a correlation coefficient of 0.986, where X is the Cobas Integra Reagent Cassette for Rheumatoid Factors II (RF-II) assay.
In addition to the above mentioned correlation studies were performed to determine the precision, specificity, linearity, antigen excess, lower limit of detection, and expected values of the VITROS RF assay, (refer to the VITROS RF Reagent Instructions for Use for summaries of the results of these studies).
Continued on next page
Ortho-Clinical Diagnostics, Inc.
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510(k) Summary, Continued
Table 1 lists the characteristics of the assays performed using the VITROS RF assay and the Cobas Integra Reagent Cassette for Rheumatoid Factors II (RF-II) assay.
Table 1
Table 1 lists the characteristics of the VITROS RF (new device) and the RF (predicate device)
| DeviceCharacteristic | VITROS RF(New device) | RF(Predicate device) |
|---|---|---|
| Intended Use | For in vitro diagnostic useonly. VITROS ChemistryProducts RF Reagent isused to quantitativelymeasure rheumatoid factor(RF) concentration inhuman serum and plasma. | The cassette COBASINTEGRA RheumatoidFactors II (RF-II) containsan in vitro diagnosticreagent system intended foruse on COBAS INTEGRAsystems for the quantitativeimmunologicaldetermination of humanrheumatoid factors inserum and plasma. |
| Method | Immunoturbidimetric | Immunoturbidimetric |
| Reportable Range | 6-120 IU/mL | 0-120 IU/mL |
| Sample Type | Serum and Plasma (heparinand EDTA) | Serum and Plasma(heparin, EDTA, Citrate) |
| Reactive Ingredient | Latex particles coated withhuman IgG | Latex particles coated withhuman IgG |
| Instrumentation | VITROS 5,1 FS ChemistrySystem | COBAS INTEGRASystems |
| Wavelength | 575 nm | 583 nm |
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510(k) Summary, Continued
Performance Verifiers
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The VITROS Chemistry Products RF Performance Verifiers I and II are substantially equivalent to the VITROS Chemistry Products Performance Verifiers (predicate device) which were cleared by the FDA (K904768) for IVD use.
Table 2 lists the similarities and differences of the device characteristics between the VITROS RF Performance Verifiers I and II with the predicate device the VITROS Performance Verifiers I and II.
| DeviceCharacteristic | VITROS RF (New Device) | RF (Predicate Device) |
|---|---|---|
| Intended Use | For in vitro diagnostic useonly. VITROS ChemistryProducts RF PerformanceVerifiers I and II are assayedcontrols used to monitor theperformance of RF Reagenton VITROS 5,1 FSChemistry Systems. | For in vitro diagnostic use only.VITROS Chemistry ProductsPerformance Verifiers I and II areassayed controls used to monitorthe performance of VITROSChemistry Systems. |
| Matrix | A base matrix of freeze-driedhuman serum to whichpurified human proteins,bovine serum albumin andpreservative have beenadded. | A base matrix of freeze-driedhuman serum to which enzymes,electrolytes, stabilizers,preservatives and other organicanalytes have been added. |
| PerformanceVerifier Levels | Low and High | Low and High |
Table 2
Conclusions
:
The data presented in the premarket notification provide a reasonable assurance that the VITROS RF assay and the VITROS Chemistry Products RF Performance Verifiers are safe and effective for the stated intended uses and are substantially equivalent to the cleared predicate devices.
- Equivalence to predicate(s) was demonstrated using commercially available reagents along with patient samples.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing left. 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
Ms. Marlene A. Hanna, RAC Regulatory Affairs Associate Ortho-Clinical Diagnostics, Inc. Regualtory Affairs MC00881 100 Indigo Creek Drive Rochester, New York 14626-5101
SEP 2 0 2004
K041863 Re:
Trade/Device Name: VITROS Chemistry Products RF Reagent, VITROS Chemistry Products Calibrator Kit 16, VITROS Chemistry Products FS Calibrator 1, VITROS Chemistry Products RF Performance Verifiers I and II, Regulation Number: 21 CFR § 866.5775 Regulation Name: Rheumatoid Factor Immunological Test System Regulatory Class: II Product Code: DHR, JIT, JJX Dated: July 8, 2004 Received: July 9, 2004
Dear Ms. Hanna:
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 for use suated in the energes, 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, de necs mat have been resuire approval of a premarket approval application (PMA). and Cosmetre Frev (10) - 100 (100) - 100 (2008) - 10 the general controls provisions of the Act. The r ou may , atest provisions of the Act include requirements for annual registration, listing of general volurols profice, 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 If your device is clubsition (600 as controls. Existing major regulations affecting your device can may oc subject of sach adamons and Regulations (CFR), Parts 800 to 895. In addition, FDA be found in Title 21, Coooooements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advisou that I Dr o local that your device complies with other requirements of the Act that I Dri has Intacted and regulations administered by other Federal agencies. You must of any I each statutes and regaranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice CI IC Part 6077, adoming (21 OF Creaty systems (QS) regulation (21 CFR Part 820). This letter requirenches as bet form in the ug your device as described in your Section 510(k) premarket will anow you to begin marketing your intral equivalence of your device to a legally marketed
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Page 2
If you desire specific information about the application of labeling requirements to your device, r you desire op the promotion and advertising of your device, please contact the Office of In or queetions on and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation other general information on your responsibilities under the Act from the Tou may ooutin other generational 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,
Robert L. Becker Jr.
Robert L. Becker, Jr., M.D., Ph. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
KO4 1863
510(k) Number (if known):
Device Name(s):
Indications for Use:
VITROS Chemistry Products RF Reagent VITROS Chemistry Products Calibrator Kit 16 VITROS Chemistry Products FS Calibrator 1 VITROS Chemistry Products RF Performance Verifiers I and II
For in vitro diagnostic use only. VITROS Chemistry Products RF Reagent is used to quantitatively measure rheumatoid factor (RF) concentration in human serum and plasma. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 16 is used in conjunction with VITROS FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of rheumatoid factor (RF).
For in vitro diagnostic use only. VITROS Chemistry Products RF Performance Verifiers I and II are assayed controls used to monitor the performance of RF Reagent on VITROS 5,1 FS Chemistry Systems.
V Prescription Use _ (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use ___ (Per 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)
Page 1 of 1
Mana Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K041863
§ 866.5775 Rheumatoid factor immunological test system.
(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).