For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the quantitative measurement of folate in human serum, plasma (heparin) and whole blood.
For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the quantitative measurement of vitamin B12 in human serum and plasma [EDTA or heparin].

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:

The VITROS Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products Reagent Pack, VITROS Immunodiagnostic Products Calibrators, which are combined by the VITROS Immunodiagnostic System to perform a VITROS assay).
The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits.
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.

AI/ML Overview

The provided text describes a 510(k) summary for "VITROS Immunodiagnostic Products Folate Range Verifiers" and "VITROS Immunodiagnostic Products Vitamin B12 Range Verifiers." This document establishes substantial equivalence to a predicate device, rather than performing a de novo study to establish performance against acceptance criteria. Therefore, most of the requested information about device performance, study details, ground truth, and sample sizes is not applicable or not provided in this type of submission.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided. The submission focuses on demonstrating substantial equivalence to a predicate device, not on meeting predefined performance acceptance criteria for a novel device. The "performance" is inferred to be comparable to the predicate.

Acceptance Criteria	Reported Device Performance
Not Applicable (This submission demonstrates substantial equivalence to a predicate device, not de novo performance against acceptance criteria).	Not Applicable (The document asserts equivalence, rather than providing specific performance metrics against pre-defined criteria).

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

Not applicable/Not provided. The document does not describe a test set or data provenance in the context of validating a new device's performance against clinical data or a ground truth. The equivalence is demonstrated by comparing physical properties and intended uses.

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

Not applicable/Not provided. No expert panel was involved in establishing ground truth for a test set, as this was not a de novo study for performance validation.

4. Adjudication Method for the Test Set

Not applicable/Not provided. No test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a range verifier for an immunoassay system, not an AI-assisted diagnostic tool. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are irrelevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a diagnostic reagent, not an algorithm, so a standalone performance study as described is not relevant.

7. The Type of Ground Truth Used

Not applicable. The concept of "ground truth" as typically used in medical device validation (e.g., pathology, outcomes data) is not relevant here. The "truth" in this context is the established functionality and performance of the predicate device, against which the new device is compared for equivalence.

8. The Sample Size for the Training Set

Not applicable/Not provided. Since this is not a study involving algorithm training, no training set or sample size is mentioned.

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

Not applicable/Not provided. As there is no training set mentioned, the establishment of its ground truth is also not applicable.

Summary of Equivalence Statement:

The core of the submission lies in demonstrating substantial equivalence to the predicate device, VITROS Immunodiagnostic Products FSH Range Verifiers (K973517). This is achieved by comparing:

Intended Use: Both devices are used for verifying the calibration range of the VITROS Immunodiagnostic System. The difference is the specific analytes measured (Folate/Vitamin B12 for the new device vs. FSH for the predicate).
Matrix of Range Verifiers: Both utilize a base matrix of human plasma (liquid or freeze-dried) or buffered matrix spiked with the analyte.
Range Verifier Levels: Both have low and high levels.

The data presented demonstrate that the physical properties and intended uses of the VITROS Folate and Vitamin B12 Range Verifiers are comparable to the predicate device, leading to the conclusion of substantial equivalence. This implies that the new device is as safe and effective as the predicate.

Summary

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JAN 29 1999

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: 3990034 __

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 4, 1999

2. Device Name

Trade or Proprietary Name: VITROS Immunodiagnostic Products Folate Range Verifiers; VITROS Immunodiagnostic Products Vitamin B12 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 Folate and Vitamin B12.

3. Predicate Device

The VITROS Immunodiagnostic Products Folate and Vitamin B12 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 Reagent Pack, VITROS Immunodiagnostic Products Calibrators, which are combined by the VITROS Immunodiagnostic System to perform a VITROS 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 quantitative measurement of folate in human serum, plasma (heparin) and whole blood.

For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the quantitative measurement of vitamin B12 in human serum and plasma [EDTA or heparin].

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 Folate 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 FOLATERange Verifiers	PredicateDevice
Intended use	For use in verifying thecalibration range of theVITROSImmunodiagnostic Systemwhen used for themeasurement of aparticular analyte (see page11 for a list of analytes).	For use in verifying thecalibration range of theVITROSImmunodiagnosticSystem when used for themeasurement of FSH.
Matrix of Range Verifiers	A base matrix of liquid orfreeze-dried human plasmaor buffered matrix spikedwith analyte (see page 11for full details).	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 Folate and Vitamin B12 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 Folate and Vitamin B12 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three human profiles facing right. The profiles are stacked on top of each other, creating a sense of depth. Encircling the emblem is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

JAN 29 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Anne Zavertnik Regulatory Affairs Associate Ortho-Clinical Diagnostics Regulatory Affairs MC00882 100 Indigo Creek Drive Rochester, NY 14626-5101

Re: K990026
Trade Name: VITROS Immunodiagnostic Products Folate Range Verifiers VITROS Immunodiagnostic Products Vitamin B12 Range Verifiers Regulatory Class: I Product Code: JJX Dated: January 4, 1999 Received: January 5, 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Sutman

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):	K 990026
Device Name:	VITROS Immunodiagnostic Products Range Verifiers
Indications for Use:	For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the quantitative measurement of folate in human serum, plasma (heparin) and whole blood.
	For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the quantitative measurement of vitamin B12 in human serum and plasma [EDTA or heparin].

(Division Sign-Off)

Division of Clinical Laboratory Devices

510(k) Number: K990026

(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)
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Over-The-Counter Use(Optional Format 1-2-96)
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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.