(30 days)
VITROS Immunodiagnostic Products CEA Reagent Pack For in vitro diagnostic use only. The VITROS CEA Reagent Pack quantitatively measures carcinoembryonic antigen (CEA) concentration in human serum and plasma to aid in the prognosis and management of cancer patients in whom changing concentrations of CEA are observed. VITROS Immunodiagnostic Products CEA Calibrators For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of CEA in serum and plasma (EDTA or heparin). VITROS Immunodiagnostic Products CEA Range Verifiers For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of CEA.
The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in serum and plasma. Coated microwells are used as the solid phase separation system. The system is comprised of three main elements: The VITROS Immunodiagnostic Products range of immunoassay products (in this case VITROS Immunodiagnostic Products CEA Reagent Pack, VITROS Immunodiagnostic Products CEA Calibrators (both cleared under K990943), and VITROS Immunodiagnostic Products CEA Range Verifiers (K990984) which are combined by the VITROS Immunodiagnostic System to perform the VITROS CEA assay. The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919). Common reagents used by the VITROS System in each assay include the VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent which were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310). The VITROS System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.
The provided text describes a 510(k) summary for the VITROS Immunodiagnostic Products CEA Reagent Pack, Calibrators, and Range Verifiers. This is an in vitro diagnostic (IVD) device, and the information presented focuses on demonstrating substantial equivalence to a predicate device rather than novel performance metrics against acceptance criteria in a clinical study.
Therefore, many of the requested categories for a typical medical device performance study, such as sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable in the context of this 510(k) submission.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state numerical acceptance criteria in the traditional sense, as it aims to show substantial equivalence. Instead, the performance is demonstrated by comparing the characteristics of the new formulation device to the predicate device. The conclusion of the study is that the performance is "substantially equivalent."
| Characteristic | Predicate Device (Current) | New Device (Modified) |
|---|---|---|
| Number of Calibrators | 3 | 2 |
| Nominal Calibrator values | 0, 5 and 250 ng/mL | 3 & 250 ng/mL |
| Calibration range | 0 to 400 ng/mL | 0 to 400 ng/mL |
| Sample type | Serum and plasma (EDTA or heparin) | Serum and plasma (EDTA or heparin) |
| Antibody | Mouse monoclonal anti-CEA antibody in biotinylated antibody reagent | Mouse monoclonal anti-CEA antibody in biotinylated antibody reagent |
| Base Matrix: Calibrators and Range Verifiers | Liquid BSA | New Born Calf Serum |
| Preservative: Calibrators and Range Verifiers | Proclin | Kathon |
| Basic principle | Solid phase immunoassay | Solid phase immunoassay |
| Tracer | Enzyme labeled | Enzyme labeled |
| Instrumentation | VITROS Immunodiagnostic System | VITROS Immunodiagnostic System |
| Sample volume | 20μL | 20μL |
| Incubation time and temperature | 30 minutes at 37°C | 30 minutes at 37°C |
| Acceptance Criteria / Conclusion | N/A | Substantially Equivalent to predicate device |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Equivalent performance was demonstrated using manufactured reagents, positive and negative controls and testing human samples near the low end of the assay range."
- Sample Size: Not specified. The number of "human samples" used is not provided.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable: This is an IVD device measuring an analyte concentration. Ground truth would typically be established by reference methods or clinical outcomes, not expert interpretation of images or clinical findings.
4. Adjudication Method for the Test Set
- Not Applicable: Not relevant for an IVD assay measuring analyte concentration.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size
- Not Applicable: This is an IVD assay, not an imaging or diagnostic device requiring human reader interpretation in the context of MRMC studies.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- Done (implicitly): The device (VITROS CEA assay) is the standalone "algorithm" or system that quantitatively measures CEA. Its performance is compared to the predicate device. The performance data presented (e.g., precision, accuracy, linearity—though not detailed in this summary) are inherently "standalone" in the context of an IVD.
7. The Type of Ground Truth Used
- The summary indicates that "equivalent performance was demonstrated... testing human samples near the low end of the assay range." For an IVD, the "ground truth" would typically be established through:
- Reference methods: Comparing results to a recognized gold standard method for CEA measurement.
- Clinical correlation: Showing that the measured CEA levels correlate with clinical status or outcomes as expected, similar to the predicate device.
- Known concentrations: Using samples with accurately known CEA concentrations (e.g., controls, spiked samples).
The summary does not explicitly detail the type of ground truth, but implies comparison against the predicate device's established performance, and potentially reference methods for accuracy.
8. The Sample Size for the Training Set
- Not Applicable: This is a traditional immunoassay, not a machine learning or AI-based device requiring a separate "training set" in the computational sense. The "training" of the device is through its manufacturing and calibration processes.
9. How the Ground Truth for the Training Set was Established
- Not Applicable: See point 8.
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JUN 1 7 2004
Section 1: Summary Information 510(k) Summary
This summary of 510(k) safety and effectiveness information is being This Summary of 510(tr) Sales) a requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K041332
-
Ortho-Clinical Diagnostics, Inc. 1. Submitter Mail Stop 881 name, address, 100 Indigo Creek Drive contact Rochester, New York 14626-5101 (585) 453-4253
Sarah CV Parsons, RAC Contact Person: -
Date Special 510(k) prepared: May 17, 2004 Preparation 2. date
-
Trade or Proprietary Name: 3. Device
- VITROS Immunodiagnostic Products CEA Reagent Pack name VITROS Immunodiagnostic Products CEA Calibrator VITROS Immunodiagnostic Products CEA Range Verifiers
: VITROS CEA assay Common Name Classification Name: Tumor associated antigen immunological test system (21 CFR 866.6010).
- The VITROS Immunodiagnostic Products CEA Reagent Pack, VITROS 4. Predicate Immunodiagnostic Products CEA Calibrators (new formulation) and VITROS device Immunodiagnostic Products CEA Range Verifiers (new formulation) are substantially equivalent to the VITROS Immunodiagnostic Products CEA Reagent Pack and VITROS Immunodiagnostic Products CEA Calibrators (original formulation) and VITROS Immunodiagnostic Products CEA Range Verifiers (original formulation).
Continued on next page
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510(k) Summary, Continued
-
The VITROS Immunodiagnostic System uses luminescence as the signal in 5. Device The TITCOS intitutive and semi-quantitative determination of selected analytes in description the qualititude to and believe and plasma. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements: -
The VITROS Immunodiagnostic Products range of immunoassay . products (in this case VITROS Immunodiagnostic Products CEA Reagent Pack, VITROS Immunodiagnostic Products CEA Calibrators (both cleared under K990943), and VITROS Immunodiagnostic (bodi ctoal CEA Range Verifiers (K990984) which are combined by the VITROS Immunodiagnostic System to perform the VITROS CEA assay.
-
The VITROS Immunodiagnostic System instrumentation, which . provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).
-
Common reagents used by the VITROS System in each assay include . the VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent which were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).
The VITROS System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.
Continued on next page
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510(k) Summary, Continued
.
| 6. Deviceintendeduse | VITROS Immunodiagnostic Products CEA Reagent PackFor in vitro diagnostic use only.The VITROS CEA Reagent Pack quantitatively measures carcinoembryonicantigen (CEA) concentration in human serum and plasma to aid in theprognosis and management of cancer patients in whom changingconcentrations of CEA are observed. |
|---|---|
| VITROS Immunodiagnostic Products CEA CalibratorsFor in vitro use in the calibration of the VITROS Immunodiagnostic Systemfor the quantitative measurement of CEA in serum and plasma (EDTA orheparin). | |
| VITROS Immunodiagnostic Products CEA Range VerifiersFor in vitro use in verifying the calibration range of the VITROSImmunodiagnostic System when used for the measurement of CEA. | |
| 7. Comparisonto predicatedevice | The VITROS Immunodiagnostic Products CEA Reagent Pack, the VITROSImmunodiagnostic Products CEA Calibrators (new formulation) and theVITROS Immunodiagnostic Products CEA Range Verifiers (new formulation)are substantially equivalent to VITROS Immunodiagnostic Products CEAReagent Pack and VITROS Immunodiagnostic Products CEA Calibrators(K990943) and VITROS Immunodiagnostic Products CEA Range Verifiers(K990984) cleared by the FDA for in vitro diagnostic use. |
| Table 1 lists the characteristics of the VITROS CEA assay (new formulation)and the VITROS CEA Assay (original formulation). |
Continued on next page
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510(k) Summary, Continued
| DeviceCharacteristic | Predicate DeviceVITROS CEA assay(Current) | New DeviceVITROS CEA assay(Modified) |
|---|---|---|
| Number of Calibrators | 3 | 2 |
| Nominal Calibrator values | 0, 5 and 250 ng/mL | 3 & 250 ng/mL |
| Calibration range | 0 to 400 ng/mL | 0 to 400 ng/mL |
| Sample type | Serum and plasma (EDTA orheparin). | Serum and plasma (EDTA orheparin). |
| Antibody | Mouse monoclonal anti-CEAantibody in biotinylatedantibody reagent | Mouse monoclonal anti-CEAantibody in biotinylatedantibody reagent |
| Base Matrix: Calibrators andRange Verifiers | Liquid BSA | New Born Calf Serum |
| Preservative: Calibrators andRange Verifiers | Proclin | Kathon |
| Basic principle | Solid phase immunoassay | Solid phase immunoassay |
| Tracer | Enzyme labeled | Enzyme labeled |
| Instrumentation | VITROS ImmunodiagnosticSystem | VITROS ImmunodiagnosticSystem |
| Sample volume | 20μL | 20μL |
| Incubation time andtemperature | 30 minutes at 37°C | 30 minutes at 37°C |
Table 1 List of Assay Characteristics: Comparison to Predicate Device
- The information presented in the pre-market notification demonstrates that the 8. Conclusions performance of the VITROS Immunodiagnostic Products CEA assay (new formulation) is substantially equivalent to the cleared predicate device.
Equivalent performance was demonstrated using manufactured reagents, positive and negative controls and testing human samples near the low end of the assay range.
The information presented in the premarket notification provide a reasonable assurance that the VITROS CEA Assay is safe and effective for the stated intended use.
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Image /page/4/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 parallel lines forming its body and wings. The eagle is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. The text is in uppercase letters and is evenly spaced around the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Sarah Parsons, RAC Regulatory Affairs Associate Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101
JUN 1 7 2004
K041322 Re:
Trade/Device Name: VITROS Immunodiagnostic Products CEA Reagent Pack VITROS Immunodiagnostic Products CEA Calibrators VITROS Immunodiagnostic Products CEA Range Verifiers Regulation Number: 21 CFR § 866.6010 Regulation Name: Carcinoembryonic Antigen (CEA) Immunological Test System Regulatory Class: II Product Code: DHX, JJX Dated: May 17, 2004 Received: May 18, 2004
Dear Ms. Parsons:
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). 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.
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Page 2
If you desire specific information about the application of labeling requirements to your device, IT you desire specific mornitures as advertising of your device, please contact the Office of In of questions on the promotion and Safety at (301) 594-3084. Also, please note the vitro Diagnounding by reference to premarket notification" (21CFR Part 807.97). Tegulation other general information on your responsibilities under the Act from the Tou may oount other geleral missational 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
{6}------------------------------------------------
Statement of Intended Use
Page 1 of 1
| 510(k) Number (if known): | K041322 |
|---|---|
| Device Name: | VITROS Immunodiagnostic Products CEA Reagent PackVITROS Immunodiagnostic Products CEA CalibratorsVITROS Immunodiagnostic Products CEA Range Verifiers |
| Indications for Use: | VITROS Immunodiagnostic Products CEA Reagent PackFor in vitro diagnostic use only.The VITROS CEA Reagent Pack quantitatively measurescarcinoembryonic antigen (CEA) concentration in human serumand plasma to aid in the prognosis and management of cancerpatients in whom changing concentrations of CEA are observed.VITROS Immunodiagnostic Products CEA CalibratorsFor in vitro use in the calibration of the VITROSImmunodiagnostic System for the quantitative measurement ofCEA in serum and plasma (EDTA or heparin).VITROS Immunodiagnostic Products CEA Range VerifiersFor in vitro use in verifying the calibration range of the VITROSImmunodiagnostic System when used for the measurement ofCEA. |
Prescription Use _____________________________________________________________________________________________________________________________________________________________ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21CFR807 Subpart C) (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
CONTINUE - CONTINUE WEEDED NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
| 510(k) | K041322 |
|---|---|
| -------- | --------- |
Ortho-Clinical DiagnosticsPage 7 of 56
Or
Ortho-Clinical Dragnostic Products CEA Reagent Pack, Calibrator, Range Verifier
§ 866.6010 Tumor-associated antigen immunological test system.
(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.