VITROS IMMUNODIAGNOSTIC PRODUCTS ANEMIA CONTROLS

K990016 · Ortho-Clinical Diagnostics, Inc. · JJY · May 19, 1999 · Clinical Chemistry

Device Facts

• Record ID: K990016
• Device Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANEMIA CONTROLS
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: May 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended 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).

Device Story

VITROS Immunodiagnostic Products Anemia Controls are quality control materials used to monitor the performance of the VITROS Immunodiagnostic System. The system performs semi-quantitative determination of analytes (ferritin, folate, vitamin B12) in human body fluids, typically serum. The controls consist of buffer and horse serum spiked with analytes at low, medium, and high levels. The VITROS System uses these controls to verify the precision of laboratory testing procedures. Healthcare providers, such as laboratory technicians, use the controls to ensure the system is operating within expected parameters before reporting patient results. The controls provide a mean value and standard deviation for each analyte, derived from multiple assays across different laboratories, allowing for lot-specific performance verification.

Clinical Evidence

Bench testing only. Performance was established by comparing the VITROS Anemia Controls to the predicate device. Expected values for each analyte were derived from a minimum of 10 assays and standard deviations were calculated for singleton determinations across different laboratories using various reagent batches.

Technological Characteristics

Quality control material composed of buffer and horse serum spiked with ferritin, folate, and vitamin B12. Provided in low, medium, and high levels. Designed for use with the VITROS Immunodiagnostic System, which utilizes a solid-phase separation immunoassay platform. The system is automated and uses specific reagents (Universal Wash Reagent, Signal Reagent).

Indications for Use

Indicated for in vitro use as assayed quality control material to monitor the performance of the VITROS Immunodiagnostic System for the measurement of ferritin, folate, and vitamin B12.

Regulatory Classification

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.

Predicate Devices

• Bio-Rad Lyphochek® Immunoassay Plus Control Levels 1, 2 and 3 (K981532)

Reference Devices

• VITROS Immunodiagnostic System (K962919)
• VITROS Immunodiagnostic Products Total T3 (K964310)

Submission Summary (Full Text)

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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 [phone]

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

3. 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

4. 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

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## 510(k) Summary, continued.

- 2. 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).
- 3. 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

5. 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

6. 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 monitoring<br>the performance of the<br>VITROS System when<br>used for the<br>measurement of<br>selected analytes | For use as an assayed<br>quality control serum to<br>monitor the precision of<br>laboratory testing<br>procedures |
| Matrix of controls | Composed of buffer<br>and horse serum, spiked<br>with different analytes<br>to achieve the required<br>levels | Human serum with<br>added constituents of<br>human origin and pure<br>chemicals |
| 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 quoted<br>for each specific analyte<br>a mean value derived<br>from a minimum of 10<br>assays and a standard<br>deviation anticipated<br>for singleton<br>determinations of each<br>control in a number of<br>different laboratories<br>using different reagent<br>batches. Values are lot<br>specific. | The mean values and<br>acceptable ranges<br>printed in the insert<br>were derived from<br>replicate analyses and<br>are specific for this lot<br>of Bio-Rad<br>Lyphochek®<br>Immunoassay Plus<br>Control Levels 1, 2 and<br>3. The tests listed were<br>performed by the<br>reagent manufacturer<br>and/or independent<br>laboratories using<br>manufacturer supported<br>reagents and a<br>representative sampling<br>of 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.

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#### 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 [phone].

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, [phone]. 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 [phone] or [phone], or at its
Manufacturers Assistance at its toll-free number [phone], 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 <i>in vitro</i> 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<br>(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 .

.

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