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 Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products AFP Reagent Pack, VITROS Immunodiagnostic Products AFP Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS AFP assay). 2. The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. 3. Common reagents used by the VITROS System in each assay. The VITROS System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products. The VITROS Immunodiagnostic Products AFP Range Verifiers are for use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of alpha-fetoprotein (AFP). The matrix of the Range Verifiers is a base matrix of freeze-dried human serum (low) or cord serum AFP in human serum (high). There are low and high Range Verifier levels.

AI/ML Overview

This document describes the VITROS Immunodiagnostic Products AFP Range Verifiers, a device intended for in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of alpha-fetoprotein (AFP).

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document is a 510(k) summary for a range verifier, which is a quality control device. For such devices, acceptance criteria are typically related to their ability to reliably verify the operational range of a primary assay, rather than diagnostic performance metrics like sensitivity or specificity. The summary focuses on demonstrating substantial equivalence to a predicate device based on intended use and physical characteristics. Therefore, explicit "acceptance criteria" and "device performance" in terms of clinical accuracy or statistical measures are not directly presented in the provided text for the range verifier itself.

Instead, the document asserts:

Characteristic	Acceptance Criteria (Implied by equivalence)	Reported Device Performance (as stated in the submission)
Intended Use	To be substantially equivalent to the predicate device in its intended use, which is verifying the calibration range of the VITROS Immunodiagnostic System.	"For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of alpha-fetoprotein (AFP)." This matches the predicate device's intended use with the analyte changed from FSH to AFP.
Matrix Type	To have a matrix suitable for its intended use, comparable in principle to the predicate device's matrix.	"A base matrix of freeze-dried human serum (low) or cord serum AFP in human serum (high)." This is described and compared to the predicate's matrix (freeze-dried human plasma spiked with human pituitary FSH). While different, the context implies suitability for the purpose.
Range Verifier Levels	To provide at least two distinct levels for verifying the calibration range.	"Low and high." This is identical to the predicate device.
Safety & Effectiveness	To provide reasonable assurance of safety and effectiveness for the stated intended use.	"The data presented in the premarket notification provide a reasonable assurance that the VITROS AFP Range Verifiers are safe and effective for the stated intended use."
Substantial Equivalence	To demonstrate substantial equivalence to a legally marketed predicate device.	"The VITROS Immunodiagnostic Products AFP Range Verifiers are substantially equivalent to VITROS FSH Range Verifiers (predicate device)." The conclusion states, "Equivalence was demonstrated by comparing the physical properties and intended uses of these devices..."

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

The provided 510(k) summary does not contain information about a test set sample size, data provenance, or specific study data for the AFP Range Verifiers. The submission focuses on substantial equivalence based on a comparison of device characteristics and intended use to a predicate device. There is no mention of a separate performance study with a test set for this specific device.

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

This information is not applicable as the document does not describe a performance study involving a test set that requires expert-established ground truth for the VITROS AFP Range Verifiers.

4. Adjudication Method for the Test Set:

This information is not applicable as the document does not describe a performance study involving a test set.

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

An MRMC comparative effectiveness study was not performed or, at least, is not mentioned in this 510(k) summary. This type of study is typically associated with diagnostic devices where human readers interpret results, and the AI's impact on their performance is evaluated. The VITROS AFP Range Verifiers are quality control materials, not diagnostic AI algorithms.

6. Standalone Performance Study:

A standalone performance study (i.e., algorithm only without human-in-the-loop performance) was not explicitly described for the VITROS AFP Range Verifiers. The summary's focus is on demonstrating equivalence to an existing predicate device rather than presenting new performance data for this type of quality control product.

7. Type of Ground Truth Used:

The concept of "ground truth" as typically used in diagnostic algorithm evaluation (e.g., pathology, outcomes data) is not applicable or discussed for this device. The VITROS AFP Range Verifiers are quality control materials. Their "truth" relates to their assigned concentration values and their stability, which would be established through a manufacturing and quality control process, not by comparing to clinical outcomes or pathology.

8. Sample Size for the Training Set:

This information is not applicable. The VITROS AFP Range Verifiers are reagents, not an AI algorithm that requires a training set.

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

This information is not applicable as the device is not an AI algorithm and therefore does not have a training set or associated ground truth established in that context.

Summary

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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: K 99 00(o

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: January, 1999.

2. Device Name

Trade or Proprietary Name: VITROS Immunodiagnostic Products AFP 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 alpha-fetoprotein (AFP).

3. Predicate Device

The VITROS Immunodiagnostic Products AFP 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 Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products AFP Reagent Pack, VITROS Immunodiagnostic Products AFP Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS AFP assay).
  Continued on next page

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510(k) Summary, Continued.

1. 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).
1. Common reagents used by the VITROS 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 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 alpha-fetoprotein (AFP).

6. Comparison to Predicate Device

The VITROS Immunodiagnostic Products AFP 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 AFP Range Verifiers with the predicate device, VITROS FSH Range Verifiers.

Continued on next page

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510(k) Summary, Continued

		Table 1 List of the assay characteristics
--	--	-------------------------------------------	--	--

DeviceCharacteristic	VITROS AFP RangeVerifiers	PredicateDevice
Intended use	For use in verifying thecalibration range of theVITROSImmunodiagnostic Systemwhen used for themeasurement of alpha-fetoprotein (AFP).	For use in verifying thecalibration range of theVITROSImmunodiagnosticSystem when used for themeasurement of FSH.
Matrix of Range Verifiers	A base matrix of freeze-dried human serum (low)or cord serum AFP inhuman serum (high)	A base matrix of freeze-dried human plasmaspiked with humanpituitary FSH.
Range Verifier levels	Low and high	Low and high

7. Conclusions

The data presented in the pre-market notification demonstrate that the VITROS AFP 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 AFP Range Verifiers are safe and effective for the stated intended use.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its body and wings, and three curved lines below representing its talons.

JAN 25 1999

Food and Drug Administration 2098 Gaither Road 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

K990061 Re:

Trade Name: VITROS Immunodiagnostic Products AFP Range Verifiers Regulatory Class: I Product Code: JJX Dated: January 7, 1999 Received: January 8, 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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Page 2

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

Page 1 of 1 K990061 510(k) Number (if known): VITROS Immunodiagnostic Products AFP Range Verifiers Device Name: For in vitro use in verifying the calibration range of the VITROS Indications for Use: Immunodiagnostic System when used for the measurement of alpha-fetoprotein (AFP).

Lesn Cooper
(Division Sign-Off)

Division of Clinical Labo tory Devices 510(k) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(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.