VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS

K994145 · Ortho-Clinical Diagnostics, Inc. · JIS · Dec 22, 1999 · Clinical Chemistry

Device Facts

• Record ID: K994145
• Device Name: VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: JIS · Clinical Chemistry
• Decision Date: Dec 22, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

VITROS Free T3 Reagent Pack For in vitro diagnostic use only. The VITROS Free T3 Reagent Pack quantitatively measures free triodothyronine (FT3) concentration in serum and plasma (EDTA or heparin) to aid in the differential diagnosis of thyroid disease. VITROS Free T3 Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of Free T3 in serum and plasma (EDTA or heparin).

Device Story

The VITROS Free T3 assay is an in vitro diagnostic test performed on the VITROS Immunodiagnostic System. It utilizes a solid-phase immunoassay principle with enzyme-labeled tracers to measure Free T3 concentration in serum or plasma samples. The system uses coated microwells for solid-phase separation. The device requires 25µL of sample, which is incubated for 16 minutes at 37°C with shaking. The system uses luminescence as the signal for quantitative determination. The device is intended for use in clinical laboratory settings by trained personnel. The output provides a quantitative measurement of Free T3, which clinicians use to assist in the differential diagnosis of thyroid disease.

Clinical Evidence

Bench testing only. Equivalence was demonstrated using manufactured reagents and patient samples with Free T3 values spanning the assay range to confirm performance consistency between the new and original formulations.

Technological Characteristics

Solid-phase immunoassay using coated microwells. Employs enzyme-labeled tracer and luminescence signal detection. Instrumentation: VITROS Immunodiagnostic System. Sample volume: 25µL. Incubation: 16 minutes at 37°C. Reagents include sheep polyclonal anti-T3 antibody. Compatible with serum and plasma (EDTA or heparin).

Indications for Use

Indicated for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (EDTA or heparin) to aid in the differential diagnosis of thyroid disease.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• VITROS Immunodiagnostic Products Free T3 Reagent Pack (K970016)

Reference Devices

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

Submission Summary (Full Text)

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### DEC 22 1999

# 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: K994145

- Ortho-Clinical Diagnostics, Inc. 1. Submitter name, 100 Indigo Creek Drive address, Rochester. New York 14626-5101 contact [phone]
Marlene A. Shulman Contact Person:

- Date Special 510(k) prepared: December 7, 1999 2. Preparation date
- Trade or Proprietary Name: 3. Device name VITROS Immunodiagnostic Products Free T3 Reagent Pack VITROS Immunodiagnostic Products Free T3 Calibrators

: Free T3 assay Common Name Classification Name: Total triiodothyronine test system ( 21 CFR 862.1710).

- The VITROS Immunodiagnostic Products Free T3 Reagent Pack (new 4. Predicate device formulation) and VITROS Immunodiagnostic Products Free T3 Calibrators (new formulation) are substantially equivalent to the VITROS Immunodiagnostic Products Free T3 Reagent Pack (original formulation) and VITROS Immunodiagnostic Products Free T3 Calibrators (original formulation).
Continued on next page

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## 510(k) Summary, Continued

- The VITROS Immunodiagnostic System uses luminescence as the signal in 5. Device the quantitative and semi-quantitative determination of selected analytes in description human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements:

- 1. The VITROS Immunodiagnostic Products range of immunoassay products (in this case VITROS Immunodiagnostic Products Free T3 Reagent Pack, VITROS Immunodiagnostic Products Free T3 Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS Free T3 assay.
- 2. 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).
- 3. 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 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).

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

| 6. Device<br>intended<br>use | VITROS Free T3 Reagent Pack<br>For in vitro diagnostic use only.<br>The VITROS Free T3 Reagent Pack quantitatively measures Free<br>Triiodothyronine ( Free T3) concentration in serum and plasma (EDTA or<br>heparin).<br><br>VITROS Free T3 Calibrators - For <i>in vitro</i> use in the calibration of the |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

VITROS Immunodiagnostic System for the quantitative measurement of Free T3 in serum and plasma ( EDTA or heparin).

Continued on next page

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# 510(k) Summary, Continued

- The VITROS Immunodiagnostic Products Free T3 Reagent Pack (new 7. Comparison formulation) and VITROS Immunodiagnostic Products Free T3 Calibrators to predicate device (new formulation) are substantially equivalent to VITROS Immunodiagnostic Products Free T3 Reagent Pack for use with human serum which was cleared by the FDA (K970016) for in vitro diagnostic use.
Table 1 lists the characteristics of the assays performed using the VITROS Free T3 assay (new formulation) and the VITROS Free T3 assay (original formulation).

| Device<br>Characteristic | New Device<br>VITROS Free T3 assay<br>(New formulation) | Predicate Device<br>VITROS Free T3 assay<br>(Original formulation) |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Sample type | Serum and plasma (EDTA or<br>heparin). | Serum. |
| Antibody | One sheep polyclonal anti-T3<br>antibody in conjugate reagent.<br>Immunogen: T3-edestin (a<br>plant seed globulin.<br>Source: Purchased from a<br>supplier. | One sheep polyclonal anti-T3<br>antibody in conjugate reagent.<br>Immunogen: T3-bovine serum<br>albumin.<br>Source: In-house. |
| Calibration range | 0-35 pmol/L | 0-35 pmol/L |
| Basic principle | Solid phase immunoassay | Solid phase immunoassay |
| Tracer | Enzyme labeled | Enzyme labeled |
| Instrumentation | VITROS Immunodiagnostic<br>System | VITROS Immunodiagnostic<br>System |
| Sample volume | 25µL | 25µL |
| Incubation time and<br>temperature | 16 minutes at 37°C with<br>shaking | 16 minutes at 37°C with<br>shaking |

### Table 1 List of Assay Characteristics: Comparison to Predicate Device

Continued on next page

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## 510(k) Summary, Continued

8. Conclusions The information presented in the pre-market notification demonstrate that the performance of the VITROS Free T3 assay (new formulation) for use with human serum and plasma (EDTA or heparin) is substantially equivalent to the cleared predicate device.

> Equivalence was demonstrated using manufactured reagents along with patient samples with measured Free T3 values spanning the assay range.

The information presented in the premarket notification provide a reasonable assurance that the VITROS Free T3 assay (new formulation) for use with human serum and plasma (EDTA or heparin) is safe and effective for the stated intended use.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 22 1999

Ms. Marlene A. Shulman Regulatory Affairs Associate Ortho-Clinical Diagnostics 100 Indigo Creek Drive Rochester, New York 14626

K994145 Re:

: ・

Trade Name: VITROS Immunodiagnostic Products Free T3 Reagent Pack VITROS Immunodiagnostic Products Free T3 Calibrators Regulatory Class: II Product Code: JIS, CPD Dated: December 7, 1999 Received: December 8, 1999

Dear Ms. Shulman:

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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general infornation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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

S10(k) Number (if known):

Device Nume:

Indications for Use:

K994145

VITROS Immunodiagnostic Products Free T3 Reagent Pack VITROS Immunodiagnostic Products Free T3 Calibrators

VITROS Free T3 Reagent Pack For in vitro diagnostic use only. The VITROS Free T3 Reagent Pack quantitatively measures free triodothyronine (FT3) concentration in serum and plasma (EDTA or heparin) to aid in the differential diagnosis of thyroid disease.

VITROS Free T3 Calibrators - For in virro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of Free T3 in serum and plasma (EDTA or heparin)

Scan Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K974145

Di Div 510

(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)
OR
Over-The-Counter Use

Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Free T3 Reagent Pack

VITROS Immunodiagnostic Products Free T3 Calibrators

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