For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of carcinoembryonic antigen (CEA).

Device Description

The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum, plasma and urine. Coated microwells are used as the solid phase separation system. The system is comprised of three main elements: 1. The VITROS ECi Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products RangeVerifiers, which are used along with VITROS Immunodiagnostic Products Reagent Pack and VITROS Immunodiagnostic Products Calibrators by the VITROS ECi Immunodiagnostic System to perform a VITROS assay). 2. The VITROS ECi Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. 3. Common reagents used by the VITROS ECi System in each assay. The VITROS ECi System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products.

AI/ML Overview

The provided document is a 510(k) summary for the VITROS Immunodiagnostic Products CEA Range Verifiers. This device is a range verifier used to check the calibration of an immunoassay system (VITROS Immunodiagnostic System) for measuring carcinoembryonic antigen (CEA).

Based on the document, here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly define specific numerical acceptance criteria or present performance data for the VITROS Immunodiagnostic Products CEA Range Verifiers. Instead, it relies on a demonstration of "substantial equivalence" to a predicate device, the VITROS Immunodiagnostic Products FSH Range Verifiers.

The "performance" is implicitly demonstrated through the similarities in characteristics and intended use, and the conclusion that these similarities are sufficient to ensure safety and effectiveness.

Acceptance Criteria Category	Specific Acceptance Criteria (Not explicitly stated in document)	Reported Device Performance (Implied from substantial equivalence)
Intended Use	Verifies calibration range for CEA measurement	Similar to predicate device, but for CEA instead of FSH.
Matrix	Buffered bovine serum albumin spiked with human origin analyte	Similar to predicate device, which uses freeze-dried human plasma spiked with human pituitary FSH. The difference in matrix and analyte type is acknowledged but deemed acceptable for equivalence.
Range Verifier Levels	Low and high	Matches predicate device.
Safety & Effectiveness	Device is safe and effective for its intended use	Data presented provide "reasonable assurance" of safety and effectiveness, based on comparison to predicate.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not report any specific sample sizes for a "test set" or provide details on the data provenance (e.g., country of origin, retrospective/prospective). The submission primarily relies on comparing the characteristics of the new device to a predicate device rather than presenting new performance data from testing a specific sample set of the CEA Range Verifiers.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not applicable or not provided in the document. Since no specific "test set" of patient samples is described, there's no mention of experts establishing ground truth for such a set. The ground truth for the device itself (its intended function) is implicitly based on the established clinical utility of range verifiers in general and comparison to the predicate device.

4. Adjudication Method for the Test Set:

This information is not applicable or not provided in the document, as no specific test set or adjudication process is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This information is not applicable or not provided. An MRMC study is typically performed for diagnostic devices that involve human interpretation (e.g., radiologists reading images using AI assistance). This device is a laboratory control/range verifier, not a diagnostic imaging AI, so such a study would not be relevant.

6. Standalone (Algorithm Only) Performance Study:

This information is not applicable or not provided. This device is a physical reagent used in conjunction with an instrument (VITROS ECi Immunodiagnostic System). It does not involve a standalone algorithm in the sense of AI or image analysis. Its "performance" is in its ability to reliably verify the calibration range within the complete assay system.

7. Type of Ground Truth Used:

The "ground truth" for demonstrating the substantial equivalence of the CEA Range Verifiers is primarily comparison to the established characteristics and performance of the predicate device (VITROS FSH Range Verifiers). This is not ground truth in the sense of pathology, patient outcomes, or expert consensus on clinical cases, but rather a regulatory "ground truth" derived from an already approved, similar product.

8. Sample Size for the Training Set:

This information is not applicable or not provided. This device is a chemical reagent, not a machine learning model, so there is no "training set."

9. How Ground Truth for the Training Set Was Established:

This information is not applicable or not provided, as there is no training set for this type of device.

In summary:

This 510(k) submission for the VITROS Immunodiagnostic Products CEA Range Verifiers primarily demonstrates substantial equivalence to a predicate device (VITROS FSH Range Verifiers) by comparing their intended uses and device characteristics. It does not present new performance data from clinical or laboratory studies using a specific test set, nor does it involve AI algorithms, human readers, or the concept of training for a machine learning model. The acceptance criteria are implicitly met by showing enough similarity to an already approved device to conclude equivalent safety and effectiveness.

Summary

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4/8/99

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: Y H0984

1. Submitter name, address, contact

Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 (716) 453-3790

Contact Person: Anne Zavertnik

Date 510(k) prepared: March 22, 1999

2. Device Name

Trade or Proprietary Name: VITROS Immunodiagnostic Products CEA Range Verifiers Common Name: Range Verifiers

Classification Name: VITROS Range verifiers for use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of immunoassays which include CEA.

3. Predicate Device

The VITROS Immunodiagnostic Products CEA Range Verifiers are substantially equivalent to VITROS Immunodiagnostic Products FSH Range Verifiers (K973517).

4. Device Description

The system is comprised of three main elements:

1. The VITROS ECi Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products RangeVerifiers, which are used along with VITROS Immunodiagnostic Products Reagent Pack and VITROS Immunodiagnostic Products Calibrators by the VITROS ECi Immunodiagnostic System to perform a VITROS assay).

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510(k) Summary, Continued.

1. The VITROS ECi Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS ECi System was cleared for market by a separate 510(k) pre-market notification (K962919).
1. Common reagents used by the VITROS ECi System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 510(k) pre-market notification (K964310).

The VITROS ECi System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products.

5. Device Intended Use

For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of carcinoembryonic antigen (CEA).

6. Comparison to Predicate Device

The VITROS Immunodiagnostic Products Range Verifiers are substantially equivalent to VITROS FSH Range Verifiers (predicate device), which was approved by FDA (K973517) for IVD use.

Table 1 lists the similarities and differences of the device characteristics between the VITROS CEA Range Verifiers with the predicate device, VITROS FSH Range Verifiers.

Continued on next page

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510(k) Summary, Continued

Characteristics	New Device	Predicate Device
Intended use	For use in verifying thecalibration range of theVITROSImmunodiagnostic Systemwhen used for themeasurement ofcarcinoembryonic antigen(CEA)	For use in verifying thecalibration range of theVITROSImmunodiagnostic Systemwhen used for themeasurement of FSH.
Matrix of Range Verifiers	A base matrix of bufferedbovine serum albuminspiked with analyte ofhuman origin	A base matrix of freeze-dried human plasmaspiked with humanpituitary FSH.
Range Verifier levels	Low and high	Low and high

10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 -

Table 1 List of the assay characteristics

7. Conclusions

The data presented in the pre-market notification demonstrate that the VITROS CEA Range Verifiers are substantially equivalent to the predicate device, for which there is FDA clearance.

Equivalence was demonstrated by comparing the physical properties and intended uses of these devices with commercially available reagents.

The data presented in the premarket notification provide a reasonable assurance that the VITROS CEA Range Verifiers are safe and effective for the stated intended use.

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Public Health Service

APR 8 1999 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Anne Zavertnik Regulatory Affairs Associate Ortho-Clinical Diagnostics A Johnson & Johnson Company 100 Indigo Creek Drive Rochester, New York 14626-5101

K990984 Re:

Trade Name: VITROS Immunodiagnostic Products CEA Range Verifiers Regulatory Class: I Product Code: JJX Dated: March 22, 1999 Received: March 24, 1999

Dear Ms. Zavertnik:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Steven Butman

Steven I. Gutman, M.D. M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Intended Use

510(k) Number (if known):

K990984/

Page 1 of 1

Device Name:

(

VITROS Immunodiagnostic Products CEA Range Verifiers

Indications for Use:

For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of CEA.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device-Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	K990984

Prescription Use (Per 21 CFR 801.109)		OR	Over-The-Counter Use
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(Optional Format 1-2-96)

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.