Assayed controls for in vitro use in monitoring the performance of the VITROS Immunodiagnostic System when used for the measurement of the analytes listed in this package insert (ferritin, folate, and vitamin B12).

Device Description

The VITROS Immunodiagnostic System uses in human body fluids, commonly serum. semi-quantitative determination of selected analytics and statem semi-quantitative determination of hersen in the solid phase separation system.

The system is comprised of three main elements:

1. The VITROS Immunodiagnostic Products range of products in this case VITROS The VTROS Immunodiagnostic Products fallge of -propriments Products Calibrators Immunodiagnostic Products Reagent Pack, VITROS Immunodiagnostic Products assay Immunodiagnostic Products Reagent Fack, PFFNAS stices stic System to perform a VITROS assay. which are combined by the VITROS Immunodiagnostic System to perform a VITROS ass
1. The VITROS Immunodiagnostic System instrumentation, which provides automatical use of The VITROS Immunodiagnostic System - matimemation, Microp the immunoassay kits. The VITROS Immodiagnostic System was cleared for market by a reas and the VITROS Imments on 11 the immunoussay komarket notification (K962919).
1. Common reagents used by the VTROS System in each assay. The VTROS Immundiagnostic Same of the VTROS System in and in and in Products Universal Wash Rauent Common reagent and VITROS Immunodiagnostic Products Universal Wash Reagent Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Products Signal Products Signal Reagent and VITROS Immunodiagnostic Products Total T3 510(k) pre-market were cleared as part of the VITROS Immunodiagnostic Products Total T3 510(k) pre-marke notification (K964310).

The VITROS System and common reagents are dedicated specifically only for use with the The VITROS System and commond of immunoassay products.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in the way one might expect for a quantitative device performance study (e.g., "sensitivity must be >X%, specificity >Y%"). Instead, the core acceptance criterion for this 510(k) submission is Substantial Equivalence to a predicate device.

The reported device performance, in this context, is the demonstration of this substantial equivalence.

Acceptance Criterion	Reported Device Performance (as demonstrated by comparison)
Substantial Equivalence to Predicate Device (Bio-Rad Lyphochek® Immunoassay Plus Control levels 1, 2, and 3, K981532) in terms of:
- Intended Use	Similar: Both are intended for use in monitoring the performance of an immunoassay system for the measurement of selected analytes. The new device is specific to the VITROS System, while the predicate is a general assayed quality control serum.
- Matrix of controls	Different but Acceptable: New device: composed of buffer and horse serum, spiked with analytes. Predicate device: human serum with added constituents of human origin and pure chemicals. The FDA's clearance implies this difference in matrix did not impede substantial equivalence for safety and effectiveness.
- Control levels	Identical: Both offer Low, Medium, and High control levels.
- Expected values	Similar Approach: New device: mean value derived from a minimum of 10 assays and a standard deviation anticipated for singleton determinations across different labs and reagent batches; values are lot-specific. Predicate device: mean values and acceptable ranges printed in the insert, derived from replicate analyses, specific for that lot, performed by the reagent manufacturer and/or independent labs using manufacturer-supported reagents and a representative sampling of the lot. The methodologies for establishing expected values are similar in principle (replicate testing to establish lot-specific values).
Safety and Effectiveness	Reasonable assurance provided: "The data presented in the premarket notification provide a reasonable assurance that the VITROS Anemia Controls are safe and effective for the stated intended use." (This is the ultimate conclusion of meeting acceptance criteria for market clearance).

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

Sample Size: The document states that for the new device's expected values, a "minimum of 10 assays" were used to derive the mean value for each specific analyte. It also mentions "a number of different laboratories using different reagent batches." This indicates a test set, but not a single, combined sample size across all aspects. For the predicate device, it mentions "replicate analyses" and "a representative sampling of this control lot."
Data Provenance: The document does not explicitly state the country of origin or whether the studies were retrospective or prospective. Given the nature of a control material submission, the studies would typically be prospective during the product development and validation phase, taking place at the manufacturer's facility and potentially collaborating laboratories.

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

This type of information is generally not applicable to a quality control material. The "ground truth" for a control material is its assigned value and acceptable range, which is derived through rigorous analytical testing and statistical analysis of the material itself, not through expert interpretation of a clinical case.

4. Adjudication Method for the Test Set

Not applicable for a quality control material. Adjudication methods (like 2+1, 3+1) are used to reconcile discrepancies among human readers or expert reviewers in studies involving subjective interpretation (e.g., imaging, pathology). For a diagnostic control, the "truth" is established by analytical methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a quality control material, not an AI-powered diagnostic tool, and involves no human-in-the-loop interaction for interpretation in a clinical context.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This describes a quality control product, not an algorithm or AI.

7. The Type of Ground Truth Used

For a quality control material, the "ground truth" is the analytically derived mean values and acceptable ranges for each analyte within the control. This is established through:

Replicate analyses of the control material using accepted reference methods or the target diagnostic system.
Statistical analysis of these results to determine the mean and standard deviation.
Consideration of variability across different reagent batches and laboratory conditions.

8. The Sample Size for the Training Set

Not applicable. Training sets are relevant for machine learning algorithms. This device is a biochemical control material.

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

Not applicable. There is no concept of a "training set" or "ground truth for a training set" in the context of this device.

Summary

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Chapter 1 - Summary Information

510(k) Summary

This summary of 510(k) safety and effectiveness information is heing submitted in accordance with
t accordance of the 1948 - 1 21 CVD 807 92 This summary of 910(K) safety safety safety of CFR 807.92

The assigned 510(k) number is: 49900 12-

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: December 31, 1998

Device Name 2.

Trade or Proprietary Name: VITROS Immunodiagnostic Products Anemia Controls Common Name: Anemia controls Common Name: Anemia controls
Classification Name: 21CFR 862.1660 Quality Control Material (Assayed and Unassayed)..

3. Predicate Device

Predicate Device
The VITROS Immunodiagnostic Products Anemia controls are substantially equivalent to Bio-Rad The VTTROS Immunodiagnestic Production 1, 2 and 3 (K981532).

4. Device Description

Device Description The VIIROS Immunodiagnosue System ases in human body fluids, commonly serum.
semi-quantitative determination of selected analytics and statem semi-quantitative determination of hersen in the solid phase separation system.

The system is comprised of three main elements:

1. The VITROS Immunodiagnostic Products range of products in this case VITROS The VTROS Immunodiagnostic Products fallge of -propriments Products Calibrators
  Immunodiagnostic Products Reagent Pack, VITROS Immunodiagnostic Products assay Immunodiagnostic Products Reagent Fack, PFFNAS stices stic System to perform a VITROS assay.
  which are combined by the VITROS Immunodiagnostic System to perform a VITROS ass

{1}------------------------------------------------

510(k) Summary, continued.

1. The VITROS Immunodiagnostic System instrumentation, which provides automatical use of The VITROS Immunodiagnostic System - matimemation, Microp
  the immunoassay kits. The VITROS Immodiagnostic System was cleared for market by a
  reas and the VITROS Imments on 11 the immunoussay komarket notification (K962919).
1. Common reagents used by the VTROS System in each assay. The VTROS Immundiagnostic
  Same of the VTROS System in and in and in Products Universal Wash Rauent Common reagent and VITROS Immunodiagnostic Products Universal Wash Reagent
  Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Products Signal Products Signal Reagent and VITROS Immunodiagnostic Products Total T3 510(k) pre-market
  were cleared as part of the VITROS Immunodiagnostic Products Total T3 510(k) pre-marke notification (K964310).

The VITROS System and common reagents are dedicated specifically only for use with the The VITROS System and commond of immunoassay products.

5. Device Intended Use

Device Intended Use
The VITROS Anemia Controls are intended for in vitro use in montoring the performance of the The VITROS Anemia Controls are michded for the measurement of selected analytes.
VITROS Immunodiagnostic System when used for the measurement of selected analytes.

6. Comparison to Predicate Device

Comparison to Predicate Device
The VITROS Immunodiagnostic Products Anemia Controls is substantially equivalent to Bio-Rad The VTROS Immunodiagnosuc Froducts Anema Comicolor of chared by FDA (K981532)
Lyphochck® Immunoassay Plus Control 1.cvels 1. 2 and 3 which was cleared by FDA (K981532) for IVD use.

Table 1 lists the similarities and differences of the device characteristics between the VITROS Anemia Controls and the predicate device.

Table 1 List of the controls characteristics

Characteristics	New Device	Predicate Device
Intended use	For use in monitoringthe performance of theVITROS System whenused for themeasurement ofselected analytes	For use as an assayedquality control serum tomonitor the precision oflaboratory testingprocedures
Matrix of controls	Composed of bufferand horse serum, spikedwith different analytesto achieve the requiredlevels	Human serum withadded constituents ofhuman origin and purechemicals
Control levels	Low, medium and high	Low, medium and high

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510(k) Summary, continued.

Table 1, (continued)

Characteristics	New Device	Predicate Device
Expected values	Each control has quotedfor each specific analytea mean value derivedfrom a minimum of 10assays and a standarddeviation anticipatedfor singletondeterminations of eachcontrol in a number ofdifferent laboratoriesusing different reagentbatches. Values are lotspecific.	The mean values andacceptable rangesprinted in the insertwere derived fromreplicate analyses andare specific for this lotof Bio-RadLyphochek®Immunoassay PlusControl Levels 1, 2 and3. The tests listed wereperformed by thereagent manufacturerand/or independentlaboratories usingmanufacturer supportedreagents and arepresentative samplingof this control lot.

7. Conclusions

The data presented in the pre-market notification demonstrate that the VITROS Anemia The data presented in the pre-marine the predicate device Bio-Rad Lynhochek®
Controls are substantially equivalent to the prodicate device Bio-Rad by EDA (K981532) Controls are substantinly equivatent to the predicate accessed by FDA (K981532) for IVD use.

The data presented in the premarket notification provide a reasonable assurance that the I he uata prescined in the promises
VITROS Anemia Controls are safe and effective for the stated intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features the department's name in a circular arrangement around an emblem. The emblem consists of a stylized representation of what appears to be a human figure or symbol, with three lines extending upwards and to the right.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 21 1999

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

K990016 Re: K990016
Trade Name: VITROS Immunodiagnostic Products Anemia Controls Regulatory Class: I Product Code: JJY Dated: March 26, 1999 Received: March 31, 1999

Dear Ms. Zavertnik:

This corrects the letter dated May 19, 1999 where the incorrect K#, K99016, was referenced I his corrects the referen dated way of intent to market the device referenced We have reviewed your Scellon >10(x) notifically equivalent (for the indications for use above and we nave delemined the devices sedicate devices marketed in interstate commerce stated in the enclosure) to legally marked processor is a local mendments, or to devices that prior to May 26, 1970, the chaement atte of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of controls provisions of Act (Act). You may, therefore, market the device, subject to the general controls provisions of Act (Act). You may, therefore, market the device, casifiements for annual registration, the Act. The general contrins provisions of the free models of the models and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classined (see above) into entil additional controls. Existing major regulations. (Premarket Approval), it may be sunject to such additional Regulations, Times 800 to 895.
affecting your device can be found in the Code of Federal Regulations, Times 800 to A substantially equivalent determination assumes compliance with the Current Good A substantially equivalent determination assames in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS
Medical Devices: General regulation (21 CFR Part 820) and that, the martiens of inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to inspections, the Food and Drug Administration (1717) was vion, In addition, FDA may publish
comply with the GMP regulation may result in regulation in crian Plasse note: comply with the GMF Tegulation in regulation in regards offect one obligation you mi turther announcements concerning your uchosen and affect any obligation you might have
response to your premarket notification submission of a filestrania Product Ragiation response to your prematics nomication submission access the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{4}------------------------------------------------

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLA-88), this device may
15 the Under the Clinical Laboratory Improvenient Aniences of to does, you should contact the
require a CLIA complexity categorization. To determine if it does, you should contact require a CLIA complexity Categorized (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will allow you to begilt marketing your device of your device to a legally marketed
notification. The FDA finding of substantial equivales and the permits your d notification. The FITA finding of substantial equivaled of 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 If you desire specific advice for your devices), please contact the Office of Compliance at
additionally 809.10 for in vitro diagnostic devices), please contact the office of additionally 809.10 for in viro diagnosions on the promotion and advertising of your device, (301) 594-4588. Additionally, for questions of the pressence the regulation please contact the Office of Compliation of (30) - 7721 CFR 807.97). Other general
entitled, "Misbranding by reference to premarks antinentification fight of Small entitled, "Misbranding by reterence openialser may be obtaind (in Bironthe Division of Small
information on your responsibilities under the Act may be obtains of Small information on your responsibilities under (800) 638-2041 or (301) 443-6597, or at its
Manufacturers Assistance at its toll-free number (800) 638-6597, or at its
entify of Mainufacturers 7155f5tan100 av 1da.gov/cdrh/dsma/dsmamain.html".
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

510(k) Number (if known):
Device Name:	VITROS Immunodiagnostic Products Anemia Controls
Indications for Use:	Assayed controls for in vitro use in monitoring the performance of the VITROS Immunodiagnostic System when used for the measurement of the analytes listed in this package insert (ferritin, folate, and vitamin B12).

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

NEFFECT NEFF - NEEDED) NEEDED)

	Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use(Per 21 CFR 801.109)
	OR
	Over-The-Counter Use
	(Optional Format 1-2-96)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	K990016

510(k) Number .

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.